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  Subjects -> PHARMACY AND PHARMACOLOGY (Total: 575 journals)
Showing 1 - 200 of 253 Journals sorted by number of followers
Nature Reviews Drug Discovery     Full-text available via subscription   (Followers: 352)
Journal of Clinical Oncology     Hybrid Journal   (Followers: 260)
International Journal of Drug Policy     Hybrid Journal   (Followers: 241)
Journal of Medicinal Chemistry     Hybrid Journal   (Followers: 167)
Drugs     Full-text available via subscription   (Followers: 146)
Journal of Pharmaceutical Sciences     Hybrid Journal   (Followers: 140)
Advanced Drug Delivery Reviews     Hybrid Journal   (Followers: 95)
European Journal of Pharmaceutical Sciences     Hybrid Journal   (Followers: 84)
Drug Safety     Full-text available via subscription   (Followers: 81)
Pharmaceutical Research     Hybrid Journal   (Followers: 69)
Drug Discovery Today     Full-text available via subscription   (Followers: 63)
Biomaterials     Hybrid Journal   (Followers: 54)
Annals of Pharmacotherapy     Hybrid Journal   (Followers: 52)
Clinical Pharmacology & Therapeutics     Hybrid Journal   (Followers: 31)
Pharmacoepidemiology and Drug Safety     Hybrid Journal   (Followers: 29)
AAPS Journal     Hybrid Journal   (Followers: 29)
Annual Review of Pharmacology and Toxicology     Full-text available via subscription   (Followers: 27)
Journal of Pain & Palliative Care Pharmacotherapy     Hybrid Journal   (Followers: 26)
Regulatory Toxicology and Pharmacology     Hybrid Journal   (Followers: 26)
British Journal of Clinical Pharmacology     Hybrid Journal   (Followers: 25)
Journal of Controlled Release     Hybrid Journal   (Followers: 25)
Drug Development and Industrial Pharmacy     Hybrid Journal   (Followers: 25)
International Journal of Pharmacy Practice     Full-text available via subscription   (Followers: 24)
European Journal of Pharmaceutics and Biopharmaceutics     Hybrid Journal   (Followers: 23)
International Journal of Pharmaceutics     Hybrid Journal   (Followers: 23)
Journal of Clinical Psychopharmacology     Hybrid Journal   (Followers: 23)
Journal of Pharmacy and Pharmacology     Full-text available via subscription   (Followers: 23)
Critical Reviews in Toxicology     Hybrid Journal   (Followers: 22)
PharmacoEconomics     Full-text available via subscription   (Followers: 21)
American Journal of Cardiovascular Drugs     Hybrid Journal   (Followers: 20)
Chemical Research in Toxicology     Hybrid Journal   (Followers: 20)
Trends in Pharmacological Sciences     Full-text available via subscription   (Followers: 17)
Clinical Toxicology     Hybrid Journal   (Followers: 17)
Clinical Pharmacokinetics     Full-text available via subscription   (Followers: 16)
Critical Reviews in Clinical Laboratory Sciences     Hybrid Journal   (Followers: 16)
Journal of Natural Products     Hybrid Journal   (Followers: 16)
Journal of Pharmacokinetics and Pharmacodynamics     Hybrid Journal   (Followers: 16)
Toxicology and Applied Pharmacology     Hybrid Journal   (Followers: 16)
Pharmaceutical Development and Technology     Hybrid Journal   (Followers: 16)
Journal of Applied Toxicology     Hybrid Journal   (Followers: 15)
Psychopharmacology     Hybrid Journal   (Followers: 15)
Journal of Clinical Pharmacy and Therapeutics     Hybrid Journal   (Followers: 14)
Journal of Oncology Pharmacy Practice     Hybrid Journal   (Followers: 14)
Journal of the American Pharmacists Association     Full-text available via subscription   (Followers: 14)
Toxicology     Hybrid Journal   (Followers: 14)
International Journal of Toxicology     Hybrid Journal   (Followers: 13)
Journal of Pharmaceutical and Biomedical Analysis     Hybrid Journal   (Followers: 13)
Journal of Pharmacy Practice     Hybrid Journal   (Followers: 13)
Biopharmaceutics and Drug Disposition     Hybrid Journal   (Followers: 12)
Cardiovascular Drugs and Therapy     Hybrid Journal   (Followers: 12)
Clinical Trials     Hybrid Journal   (Followers: 12)
Toxicology Letters     Hybrid Journal   (Followers: 12)
Drug and Chemical Toxicology     Hybrid Journal   (Followers: 12)
American Journal of Therapeutics     Hybrid Journal   (Followers: 11)
Basic & Clinical Pharmacology & Toxicology     Hybrid Journal   (Followers: 11)
European Journal of Clinical Pharmacology     Hybrid Journal   (Followers: 11)
Journal of Psychopharmacology     Hybrid Journal   (Followers: 11)
Pharmacy Education     Full-text available via subscription   (Followers: 11)
Clinical Therapeutics     Hybrid Journal   (Followers: 10)
CNS Drugs     Full-text available via subscription   (Followers: 10)
Pharmaceutical Statistics     Hybrid Journal   (Followers: 10)
Seminars in Oncology Nursing     Full-text available via subscription   (Followers: 10)
Journal of Clinical Pharmacology     Hybrid Journal   (Followers: 10)
Toxicological Sciences     Hybrid Journal   (Followers: 10)
Advances in Pharmacological and Pharmaceutical Sciences     Open Access   (Followers: 10)
Biochemical Pharmacology     Hybrid Journal   (Followers: 9)
ChemMedChem     Hybrid Journal   (Followers: 9)
Drug Metabolism and Disposition     Hybrid Journal   (Followers: 9)
Drugs & Aging     Full-text available via subscription   (Followers: 9)
Drugs & Therapy Perspectives     Full-text available via subscription   (Followers: 9)
Medicinal Chemistry     Hybrid Journal   (Followers: 9)
Seminars in Hematology     Hybrid Journal   (Followers: 9)
Current Opinion in Pharmacology     Hybrid Journal   (Followers: 8)
Current Pharmaceutical Biotechnology     Hybrid Journal   (Followers: 8)
Drug Development Research     Hybrid Journal   (Followers: 8)
Epilepsy Research     Hybrid Journal   (Followers: 8)
European Neuropsychopharmacology     Hybrid Journal   (Followers: 8)
Food Additives & Contaminants Part A     Hybrid Journal   (Followers: 8)
Progress in Neuro-Psychopharmacology and Biological Psychiatry     Hybrid Journal   (Followers: 8)
Toxicology in Vitro     Hybrid Journal   (Followers: 8)
Inhalation Toxicology     Hybrid Journal   (Followers: 8)
Antiviral Research     Hybrid Journal   (Followers: 7)
Current Medicinal Chemistry     Hybrid Journal   (Followers: 7)
Drug Delivery     Open Access   (Followers: 7)
Environmental Toxicology and Pharmacology     Hybrid Journal   (Followers: 7)
Experimental and Clinical Psychopharmacology     Full-text available via subscription   (Followers: 7)
Frontiers in Drug Design & Discovery     Hybrid Journal   (Followers: 7)
Journal of Veterinary Pharmacology and Therapeutics     Hybrid Journal   (Followers: 7)
Prescriber     Hybrid Journal   (Followers: 7)
Toxicology Mechanisms and Methods     Hybrid Journal   (Followers: 7)
Journal of Pharmaceutical Innovation     Hybrid Journal   (Followers: 7)
AAPS PharmSciTech     Hybrid Journal   (Followers: 6)
Biometrical Journal     Hybrid Journal   (Followers: 6)
Clinical Drug Investigation     Full-text available via subscription   (Followers: 6)
Current Drug Delivery     Hybrid Journal   (Followers: 6)
Anti-Inflammatory & Anti-Allergy Agents in Medicinal Chemistry     Hybrid Journal   (Followers: 6)
Expert Review of Pharmacoeconomics & Outcomes Research     Full-text available via subscription   (Followers: 6)
Human & Experimental Toxicology     Hybrid Journal   (Followers: 6)
Toxicology and Industrial Health     Hybrid Journal   (Followers: 6)
Current Cancer Therapy Reviews     Hybrid Journal   (Followers: 5)
Current Drug Discovery Technologies     Hybrid Journal   (Followers: 5)
Anti-Infective Agents     Hybrid Journal   (Followers: 5)
Current Therapeutic Research     Open Access   (Followers: 5)
Reviews of Physiology, Biochemistry and Pharmacology     Hybrid Journal   (Followers: 5)
Expert Review of Anti-infective Therapy     Full-text available via subscription   (Followers: 5)
Expert Review of Molecular Diagnostics     Full-text available via subscription   (Followers: 5)
Fitoterapia     Hybrid Journal   (Followers: 5)
Journal of Pain Management & Medicine     Open Access   (Followers: 5)
Journal of Cardiovascular Pharmacology and Therapeutics     Hybrid Journal   (Followers: 5)
Journal of Separation Science     Hybrid Journal   (Followers: 5)
Scandinavian Journal of Clinical and Laboratory Investigation     Hybrid Journal   (Followers: 5)
Clinical Research and Regulatory Affairs     Hybrid Journal   (Followers: 5)
Pharmacogenomics Journal     Hybrid Journal   (Followers: 5)
ASSAY and Drug Development Technologies     Hybrid Journal   (Followers: 4)
BioDrugs     Full-text available via subscription   (Followers: 4)
Cancer Chemotherapy and Pharmacology     Hybrid Journal   (Followers: 4)
Current Pharmaceutical Design     Hybrid Journal   (Followers: 4)
Expert Review of Cardiovascular Therapy     Full-text available via subscription   (Followers: 4)
International Journal of Pharmaceutical and Healthcare Marketing     Hybrid Journal   (Followers: 4)
Pharmaceutical Medicine     Full-text available via subscription   (Followers: 4)
Journal of Child and Adolescent Psychopharmacology     Hybrid Journal   (Followers: 4)
Journal of Infection and Chemotherapy     Hybrid Journal   (Followers: 4)
Journal of Labelled Compounds and Radiopharmaceuticals     Hybrid Journal   (Followers: 4)
Journal of Pharmacology and Experimental Therapeutics     Hybrid Journal   (Followers: 4)
Neuropharmacology     Hybrid Journal   (Followers: 4)
Planta Medica     Hybrid Journal   (Followers: 4)
Immunopharmacology and Immunotoxicology     Hybrid Journal   (Followers: 4)
Physiology International     Full-text available via subscription   (Followers: 3)
Archiv der Pharmazie     Hybrid Journal   (Followers: 3)
BMC Pharmacology     Open Access   (Followers: 3)
Cardiovascular Therapeutics     Open Access   (Followers: 3)
Clinical and Experimental Pharmacology and Physiology     Hybrid Journal   (Followers: 3)
CNS Drug Reviews     Open Access   (Followers: 3)
Current Drug Metabolism     Hybrid Journal   (Followers: 3)
Current Pharmacogenomics and Personalized Medicine     Hybrid Journal   (Followers: 3)
Drug Resistance Updates     Hybrid Journal   (Followers: 3)
European Journal of Pharmacology     Hybrid Journal   (Followers: 3)
Frontiers in Medicinal Chemistry     Hybrid Journal   (Followers: 3)
Human Psychopharmacology Clinical and Experimental     Hybrid Journal   (Followers: 3)
Inflammation Research     Hybrid Journal   (Followers: 3)
Investigational New Drugs     Hybrid Journal   (Followers: 3)
Journal of Aerosol Medicine and Pulmonary Drug Delivery     Hybrid Journal   (Followers: 3)
Journal of Cardiovascular Pharmacology     Hybrid Journal   (Followers: 3)
Journal of Ethnopharmacology     Hybrid Journal   (Followers: 3)
Journal of Medical Marketing     Hybrid Journal   (Followers: 3)
Journal of Pharmacological and Toxicological Methods     Hybrid Journal   (Followers: 3)
Microbial Drug Resistance     Hybrid Journal   (Followers: 3)
International Journal of Neuropsychopharmacology     Open Access   (Followers: 3)
Therapeutic Drug Monitoring     Hybrid Journal   (Followers: 3)
Drug Metabolism Reviews     Hybrid Journal   (Followers: 3)
Acta Pharmacologica Sinica     Hybrid Journal   (Followers: 2)
Behavioural Pharmacology     Hybrid Journal   (Followers: 2)
Biomedicine & Pharmacotherapy     Full-text available via subscription   (Followers: 2)
Clinical Neuropharmacology     Hybrid Journal   (Followers: 2)
Current Drug Therapy     Hybrid Journal   (Followers: 2)
Current Enzyme Inhibition     Hybrid Journal   (Followers: 2)
Drugs in R & D     Full-text available via subscription   (Followers: 2)
Inflammopharmacology     Hybrid Journal   (Followers: 2)
Inpharma Weekly     Full-text available via subscription   (Followers: 2)
International Clinical Psychopharmacology     Hybrid Journal   (Followers: 2)
International Immunopharmacology     Hybrid Journal   (Followers: 2)
Letters in Drug Design & Discovery     Hybrid Journal   (Followers: 2)
Medicinal Research Reviews     Hybrid Journal   (Followers: 2)
Pharmacology & Therapeutics     Hybrid Journal   (Followers: 2)
Pharmacology Biochemistry and Behavior     Hybrid Journal   (Followers: 2)
Pharmacopsychiatry     Hybrid Journal   (Followers: 2)
Pulmonary Pharmacology & Therapeutics     Hybrid Journal   (Followers: 2)
Research in Social and Administrative Pharmacy     Hybrid Journal   (Followers: 2)
The Brown University Psychopharmacology Update     Hybrid Journal   (Followers: 2)
Toxicological & Environmental Chemistry     Hybrid Journal   (Followers: 2)
Toxicon     Hybrid Journal   (Followers: 2)
Journal of Microencapsulation: Microcapsules, Liposomes, Nanoparticles, Microcells, Microspheres     Hybrid Journal   (Followers: 2)
Canadian Journal of Physiology and Pharmacology     Hybrid Journal   (Followers: 1)
Current Neuropharmacology     Hybrid Journal   (Followers: 1)
Current Pharmaceutical Analysis     Hybrid Journal   (Followers: 1)
Current Vascular Pharmacology     Hybrid Journal   (Followers: 1)
Fundamental & Clinical Pharmacology     Hybrid Journal   (Followers: 1)
Journal of Drug Targeting     Hybrid Journal   (Followers: 1)
Journal of Inflammation     Open Access   (Followers: 1)
Journal of Neuroimmune Pharmacology     Hybrid Journal   (Followers: 1)
Journal of Texture Studies     Hybrid Journal   (Followers: 1)
Pharmacogenetics and Genomics     Hybrid Journal   (Followers: 1)
Particulate Science and Technology: An International Journal     Hybrid Journal   (Followers: 1)
Pharmaceutical Biology     Open Access  
Journal of Liposome Research     Hybrid Journal  
Vascular Pharmacology     Hybrid Journal  
Toxin Reviews     Hybrid Journal  
Kaohsiung Journal of Medical Sciences     Open Access  
Redox Report     Open Access  
Pharmacological Research     Hybrid Journal  
PharmacoEconomics & Outcomes News     Full-text available via subscription  
Pharmaceutical Chemistry Journal     Hybrid Journal  
NeuroMolecular Medicine     Hybrid Journal  
Journal of Ocular Pharmacology and Therapeutics     Hybrid Journal  
Harm Reduction Journal     Open Access  
Current Nanoscience     Hybrid Journal  
Infectious Disorders - Drug Targets     Hybrid Journal  
Current Bioactive Compounds     Hybrid Journal  
Cancer Biotherapy & Radiopharmaceuticals     Hybrid Journal  
Autonomic & Autacoid Pharmacology     Hybrid Journal  

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Clinical Drug Investigation
Journal Prestige (SJR): 0.719
Citation Impact (citeScore): 2
Number of Followers: 6  
 
  Full-text available via subscription Subscription journal
ISSN (Print) 1173-2563 - ISSN (Online) 1179-1918
Published by Adis Homepage  [21 journals]
  • Effectiveness and Safety of Upadacitinib for Adolescents with Atopic
           Dermatitis in a Real-World Setting

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      Abstract: Background and Objective The estimated prevalence of atopic dermatitis (AD) among adolescents (12–17 years of age) is about 14.8%. AD compromises sleep quality and may be associated with poor scholastic performance, mood disruptions, low self-esteem, and difficulty in building social relationships. Upadacitinib was recently approved by the European Medicines Agency for the treatment of moderate-to-severe AD in patients aged ≥ 12 years who are candidates for systemic treatment. The aim of this real-world study was to determine the effectiveness in disease control and safety of upadacitinib in adolescents aged 12–17 years with moderate-to-severe AD. Methods This is a retrospective study in adolescents with moderate-to-severe AD treated with upadacitinib 15 mg between July 2022 and February 2024 at six Italian dermatological referral centres. The primary endpoint was to analyse the evolution of the response in terms of absolute Eczema Area and Severity Index (EASI) value, as well as the percentage of patients achieving 75% and 90% improvement in EASI (EASI75 and EASI90) from baseline to weeks (W) 4, 16, 24, and 52. Secondary endpoints included the assessment of treatment efficacy in terms of Numerical Rating Scale (NRS) for pruritus (P-NRS) and sleep (S-NRS), Children’s Dermatology Life Quality Index (c-DLQI), and safety. Results Thirty-six patients [males: 18 (50%)] were evaluated. A statistically significant improvement of EASI was observed at each timepoint, as stated by a mean percentage reduction from baseline of 72.2% at W4, 82.7% at W16, of 86.4% at W24 (n = 34) and of 92.7% at W52 (n = 18) (p < 0.0001). At W4, 21/36 (58.3%) achieved EASI75 and 12/36 (33.3%) EASI90. At W16, 29/36 (80.5%) achieved EASI75 and 19/36 (52.8%) EASI90. At W24, 32/34 (94.1%) reached EASI75 and 24/34 (70.6%) EASI90. Finally, at W52 all the assessed patients (n = 18) maintained EASI75 and 14/18 (77.7%) reached EASI90. Likewise, a statistically significant reduction of c-DLQI, P-NRS and S-NRS was observed at each timepoint. Conclusion Our real-world experience seems to confirm the efficacy and safety of upadacitinib for the long-term treatment of moderate-to-severe AD in adolescents.
      PubDate: 2024-07-16
       
  • AVT04: An Ustekinumab Biosimilar

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      Abstract: Abstract AVT04 (Uzpruvo®) is a biosimilar of the reference anti-interleukin (IL)-12 and IL-23 monoclonal antibody ustekinumab. It is approved in the EU for plaque psoriasis, paediatric plaque psoriasis, psoriatic arthritis and Crohn’s disease as per the reference product. AVT04 has similar physicochemical characteristics to those of reference ustekinumab, and the pharmacokinetic similarity of the agents has been shown in healthy volunteers and patients with moderate to severe chronic plaque psoriasis. AVT04 demonstrated clinical efficacy similar to that of reference ustekinumab in patients with moderate to severe chronic plaque psoriasis, and was generally well tolerated in this population. The tolerability, safety and immunogenicity profiles of AVT04 were similar to those of reference ustekinumab, and switching from reference ustekinumab to AVT04 had no impact on efficacy, safety or immunogenicity. The role of reference ustekinumab in the management of inflammatory diseases is well established and AVT04 provides an effective biosimilar alternative for patients requiring ustekinumab therapy.
      PubDate: 2024-07-04
       
  • Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in
           Parkinson’s Disease: A Systematic Review and Meta-Analysis

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      Abstract: Background Although selective serotonin reuptake inhibitors (SSRIs) are usually considered safe to use in patients with Parkinson’s disease (PD), there are mixed data about their effectiveness, and only a few investigations have led to a total improvement of depressive symptoms in patients with PD. Objectives We aimed to conduct a comprehensive systematic review and meta-analysis of all studies that investigated the effectiveness of SSRIs in treating depression in the context of PD. Methods From its commencement to June 2024, the databases of MEDLINE via PubMed, Scopus, Embase, and Google Scholar were electronically searched for the relevant papers. All full-text journal articles assessing the effectiveness of SSRIs in treating depression in patients with PD were included. The tool developed by the Cochrane Collaboration was utilized to evaluate the bias risk. Data were analyzed utilizing a pair-wise comparison meta-analysis using the standardized mean difference. Results A total of 19 articles and 22 separate interventions were included. We found that SSRI treatment attenuated depression in patients with PD (1.242 standardized mean difference, 95% confidence interval 0.956, 1.529, p < 0.001). The general heterogeneity of the studies was medium (ϰ2 = 72.818, T2 = 0.317, df = 21, I2 = 71.15%, p < 0.001). The funnel plot was reasonably symmetrical. However, three studies were trimmed to the left of the mean. Begg’s test (p = 0.080), Egger’s test (p = 0.121), and funnel plot showed no significant risk of publication bias. The meta-regression showed that the treatment effect increased as a function of paroxetine treatment duration (slope p = 0.001) but decreased as a function of sertraline treatment duration (slope p = 0.019). Conclusions There are few controlled antidepressant trials on the PD population, even though patients with PD frequently experience depression and use antidepressants. Clinical studies that are larger and better structured are needed in the future to determine if antidepressants are useful for treating patients with PD with depression.
      PubDate: 2024-07-03
       
  • Real-World Safety and Effectiveness of Letermovir in Patients Undergoing
           Allogenic Hematopoietic Stem Cell Transplantation: Final Results of
           Post-Marketing Surveillance in Japan

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      Abstract: Background and Objective Cytomegalovirus (CMV) is a common opportunistic infection after allogenic hematopoietic stem cell transplantation (allo-HSCT). Letermovir, an inhibitor of CMV DNA terminase, is approved for CMV prophylaxis in allo-HSCT patients. We report the final results of post-marketing surveillance of letermovir in Japan. Methods The case report forms were drafted in part by the Japanese Data Center for Hematopoietic Cell Transplantation using data elements in the Transplant Registry Unified Management Program and sent to individual HSCT centers to decrease the burden of reporting. Hematopoietic stem cell transplantation patients who received letermovir between May 2018 and May 2022 were registered. Data collected included physician-assessed adverse events/adverse drug reactions and clinical effectiveness (development of CMV disease, CMV antigen status, and use of preemptive therapy). Results A total of 821 HSCT patients were included in the safety analyses. Adverse drug reactions occurred in 11.33% of patients, with serious adverse drug reactions in 3.05%. The five most common adverse drug reactions were nausea (1.58%), renal impairment (1.46%), and acute graft versus host disease, CMV test positive, and hepatic function abnormal (0.61% each). A total of 670 patients were eligible for effectiveness analyses. Among these patients, 16.57% and 28.66% required preemptive therapy through week 14 and week 48, respectively. In addition, relatively few patients developed CMV disease throughout the follow-up period (1.34% at week 14 and 3.85% at week 48). Conclusions This final analysis of post-marketing surveillance with up to 48 weeks follow-up period in Japan provides further evidence supporting the safety profile and effectiveness of letermovir for CMV prophylaxis in patients undergoing allo-HSCT in real-world settings.
      PubDate: 2024-06-27
       
  • Efficacy and Safety of BP02 (Trastuzumab Biosimilar) in HER2-Positive
           Metastatic Breast Cancer: A Multicenter Phase III Study

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      Abstract: Background and Objective Trastuzumab targets human epidermal growth factor receptor 2 (HER2) receptors and is indicated for treating HER2-positive metastatic breast cancer. BP02, a recombinant IgG1 kappa humanized monoclonal antibody, is being developed as a trastuzumab biosimilar. The objective of this study was to evaluate the equivalence of BP02 with reference trastuzumab (RT: Herceptin®-EU) in patients with HER2-positive metastatic breast cancer. Methods This double-blinded, 1:1 randomized, parallel-group, active-controlled, phase III equivalence trial recruited women aged 18–75 years with histologically/cytologically confirmed HER2- positive, locally recurrent or metastatic breast cancer with systemic metastasis, from 59 sites in India. Patients were randomly allocated 1:1 stratified by estrogen receptor/progesterone receptor status to receive BP02/RT (8-mg/kg loading dose on day 1-cycle 1, 6 mg/kg on day 1-cycles 2–8, of each 3-week cycle) combined with docetaxel (75 mg/m2 on day 1-cycles 1–8) [induction phase]. Participants with complete or partial response, or stable disease at the end of the induction phase continued the study drug until disease progression/treatment discontinuation [maintenance phase]. The primary efficacy endpoint was the objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Results Between 23 September, 2020 and 16 September, 2022, 690 patients were recruited (n = 345 each to BP02/RT). At the end of the induction phase (intent-to-treat population), a similar proportion of patients achieved an objective response rate with BP02 (n = 231 [67.0%], 95% confidence interval [CI] 62.0, 71.9) and RT (n = 238 [69.0%], 95% CI 64.1, 73.9). The 95% CI of risk difference (−2.03, 95% CI −9.15, 5.09) and 90% CI of risk ratio (0.97, 90% CI 0.89, 1.06) were within equivalence margins of ± 13% and (0.80, 1.25), respectively. Treatment-emergent adverse events leading to treatment withdrawal were reported in 2.9% and 3.2% patients with BP02 and RT, respectively. Conclusions BP02 showed an equivalent efficacy and similar safety profile to RT at the end of 24 weeks. Clinical Trial Registration CTRI Number: CTRI/2020/04/024456.
      PubDate: 2024-06-27
       
  • Sodium Phenylbutyrate and Tauroursodeoxycholic Acid: A Story of Hope
           Turned to Disappointment in Amyotrophic Lateral Sclerosis Treatment

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      Abstract: Abstract The absence of a definitive cure for amyotrophic lateral sclerosis (ALS) emphasizes the crucial need to explore new and improved treatment approaches for this fatal, progressive, and disabling neurodegenerative disorder. As at the end of 2023, five treatments – riluzole, edaravone, dextromethorphan hydrobromide + quinidine sulfate (DHQ), tofersen, and sodium phenylbutyrate-tauroursodeoxycholic acid (PB-TUDCA) – were FDA approved for the treatment of patients with ALS. Among them PB-TUDCA has been shown to impact DNA processing impairments, mitochondria dysfunction, endoplasmic reticulum stress, oxidative stress, and pathologic folded protein agglomeration defects, which have been associated with ALS pathophysiology. The Phase 2 CENTAUR trial demonstrated significant impact of PB-TUDCA on the ALS Functional Rating Scale-Revised (ALSFRS-R) risk of death, hospitalization, and the need for tracheostomy or permanent assisted ventilation in patients with ALS based on post hoc analyses. More recently, contrasting with the CENTAUR trial results, results from the Phase 3 PHOENIX trial (NCT05021536) showed no change in ALSFRS-R total score at 48 weeks. Consequently, the sponsor company initiated the process with the US FDA and Health Canada to voluntarily withdraw the marketing authorizations for PB-TUDCA. In the present article, we review ALS pathophysiology, with a focus on PB-TUDCA’s proposed mechanisms of action and recent clinical trial results and discuss the implications of conflicting trial data for ALS and other neurological disorders.
      PubDate: 2024-06-23
       
  • Current Findings and Potential Mechanisms of KarXT (Xanomeline–Trospium)
           in Schizophrenia Treatment

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      Abstract: Standard schizophrenia treatment involves antipsychotic medications that target D2 dopamine receptors. However, these drugs have limitations in addressing all symptoms and can lead to adverse effects such as motor impairments, metabolic effects, sedation, sexual dysfunction, cognitive impairment, and tardive dyskinesia. Recently, KarXT has emerged as a novel drug for schizophrenia. KarXT combines xanomeline, a muscarinic receptor M1 and M4 agonist, with trospium, a nonselective antimuscarinic agent. Of note, xanomeline can readily cross blood–brain barrier (BBB) and, thus, enter into the brain, thereby stimulating muscarinic receptors (M1 and M4). By doing so, xanomeline has been shown to target negative symptoms and potentially improve positive symptoms. Trospium, on the other hand, is not able to cross BBB, thereby not affecting M1 and M4 receptors; instead, it acts as an antimuscarinic agent and, hence, diminishes peripheral activity of muscarinic receptors to minimize side effects probably stemming from xanomeline in other organs. Accordingly, ongoing clinical trials investigating KarXT’s efficacy in schizophrenia have demonstrated positive outcomes, including significant improvements in the Positive and Negative Syndrome Scale (PANSS) total score and cognitive function compared with placebo. These findings emphasize the potential of KarXT as a promising treatment for schizophrenia, providing symptom relief while minimizing side effects associated with xanomeline monotherapy. Despite such promising evidence, further research is needed to confirm the efficacy, safety, and tolerability of KarXT in managing schizophrenia. This review article explores the current findings and potential mechanisms of KarXT in the treatment of schizophrenia. Graphical KarXT, a promising medication for schizophrenia, combines xanomeline, an agonist for muscarinic receptors M1 and M4, with trospium, an antimuscarinic agent. Xanomeline can effectively penetrate the blood–brain barrier (BBB), allowing it to target and stimulate muscarinic receptors in the brain, leading to decline or eliminate of positive and negative symptoms as well as cognitive improvement. On the other hand, trospium lacks the ability to cross the BBB and primarily acts as an antimuscarinic agent in peripheral organs, reducing the potential side effects associated with xanomeline. These findings underscore the potential of KarXT as a viable treatment option for schizophrenia, offering symptom relief while minimizing the adverse effects typically associated with xanomeline as a monotherapy.
      PubDate: 2024-06-21
       
  • Radiomic Parameters for the Evaluation of Response to Treatment in
           Metastatic Colorectal Cancer Patients with Liver Metastasis: Findings from
           the CAVE-GOIM mCRC Phase 2 Trial

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      Abstract: Background CAVE is a single arm, Phase 2 trial, that demonstrated anti-tumor activity of cetuximab rechallenge plus avelumab in patients with RAS wild type (wt) metastatic colorectal cancer (mCRC). Objective We conducted a post hoc analysis to identify potential radiomic biomarkers for patients with CRC liver metastasis (LM). Patients and Methods Patients with LM that could be measured by enhanced contrast phase computed tomography (CT) imaging at baseline and at first response evaluation were included. Multiple texture parameters were extracted with the LifeX Software. Delta-texture (D-TA) variations were calculated by comparing data at baseline and after treatment. Results Overall, 55/77 patients (71%) had LM; 39 met the inclusion criteria for the current analysis. The D-TA parameters that significantly correlated at univariate analysis with median progression-free survival (mPFS) were EntropyHistogram (p = 0.021), HomogeneityGLCM (p < 0.001) and Dissimilarity GLCM (p = 0.002). At multivariate analysis, only HomogeneityGLCM resulted significant for PFS (p = 0.001). Patients (19/39, 48.7%) with reduction of HomogeneityGLCM experienced better mPFS (4.6 vs 2.9 months; HR 0.45; 95% CI 0.23–0.88; p = 0.021) and median overall survival (mOS) (17.3 vs 6.8 months; HR 0.40, 95% CI 0.21–0.80; p = 0.010). A trend to better mPFS, was also observed in patients with RAS/BRAF wt circulating tumor DNA and reduction of HomogeneityGLCM. Overall survival was significantly better in this subgroup of patients with low HomogeneityGLCM: mOS was 17.8 (95% CI 15.5–20.2) versus 6.8 months (95% CI 3.6–10.0) (HR 0.34, 95% CI 0.14–0.81; p = 0.016). Conclusion Reduction in the D-TA parameter HomogeneityGLCM by radiomic analysis correlates with improved outcomes in patients with LM receiving cetuximab rechallenge plus avelumab therapy. Larger prospective studies are needed to validate and confirm these findings.
      PubDate: 2024-06-17
       
  • Drug–Drug Interactions and Their Association with Adverse Health
           Outcomes in the Older Community-Dwelling Population: A Prospective Cohort
           Study

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      Abstract: Background Evidence on associations between drug–drug interactions (DDIs) and health outcomes in the older community-dwelling population is limited. Objective We estimate potentially clinically important DDI prevalence and examine the association between DDIs and (1) adverse drug events (ADEs), (2) emergency hospital attendance and (3) health-related quality of life (HRQoL) in an older community-dwelling population in Ireland. Methods This is a prospective cohort study of community-dwelling older adults (N = 904) aged ≥ 70 years from 15 general practices in Ireland recruited in 2010 (wave-1) and followed-up over 2 years (wave-2; 2012–2013), with linked national pharmacy claims data. Individuals dispensed two or more drugs (wave-1: N = 842; wave-2: N = 763) were included. DDI prevalence at baseline, follow-up and 6 months prior to each health outcome was estimated. Multi-level regression was used to model the association between DDI-exposure and health outcomes at follow-up. DDI prevalence, adjusted incidence-rate ratios (aIRR), adjusted odds ratios (aOR), β coefficients and robust standard error (RSE) from multi-level regression analyses, and 95% confidence intervals (CIs) are reported. Results At wave-1, n = 196 (23.3% [95% CI 20.5–26.3]), individuals were potentially exposed to ≥ 1 DDI, increasing to n = 345 (45.2% [41.7–48.9]) at wave-2. At 2-year follow-up, the median number of ADEs was 3 (interquartile range [IQR 2–5]); 229 (30.1%) had ≥ 1 emergency hospital attendance, and the mean EQ-5D was 0.74 (± 0.23). Evidence for the association between DDI-exposure and emergency hospital attendance at follow-up was lacking (aOR = 1.38 [0.42–4.53]). DDI-exposure was associated with an increasing number of ADEs (aIRR = 1.26 [1.03–1.55]), and decreasing EQ-5D utility (β = − 0.07, [−0.11 to −0.04], RSE = 0.02). Aspirin–warfarin, clarithromycin–prednisolone, amiodarone–furosemide, clarithromycin–salbutamol, rosuvastatin–warfarin, amiodarone–bisoprolol, and aspirin–nicorandil were common DDIs 6 months preceding these health outcomes. Conclusions We found a two-fold increase in DDI prevalence between wave 1 and 2. DDI exposure was associated with increasing ADEs and declining HRQoL at 2-year follow-up. Common DDIs involved anticoagulants, cardiovascular and antimicrobial drugs, which should be targeted for medicine optimisation.
      PubDate: 2024-06-15
       
  • Prediction Models for Intravenous Immunoglobulin Non-Responders of
           Kawasaki Disease Using Machine Learning

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      Abstract: Background and Objective Intravenous immunoglobulin (IVIG) is a prominent therapeutic agent for Kawasaki disease (KD) that significantly reduces the incidence of coronary artery anomalies. Various methodologies, including machine learning, have been employed to develop IVIG non-responder prediction models; however, their validation and reproducibility remain unverified. This study aimed to develop a predictive scoring system for identifying IVIG nonresponders and rigorously test the accuracy and reliability of this system. Methods The study included an exposure group of 228 IVIG non-responders and a control group of 997 IVIG responders. Subsequently, a predictive machine learning model was constructed. The Shizuoka score, including variables such as the “initial treatment date” (cutoff: < 4 days), sodium level (cutoff: < 133 mEq/L), total bilirubin level (cutoff: ≥ 0.5 mg/dL), and neutrophil-to-lymphocyte ratio (cutoff: ≥ 2.6), was established. Patients meeting two or more of these criteria were grouped as high-risk IVIG non-responders. Using the Shizuoka score to stratify IVIG responders, propensity score matching was used to analyze 85 patients each for IVIG and IVIG-added prednisolone treatment in the high-risk group. In the IVIG plus prednisolone group, the IVIG non-responder count significantly decreased (p < 0.001), with an odds ratio of 0.192 (95% confidence interval 0.078–0.441). Conclusions Intravenous immunoglobulin non-responders were predicted using machine learning models and validated using propensity score matching. The initiation of initial IVIG-added prednisolone treatment in the high-risk group identified by the Shizuoka score, crafted using machine learning models, appears useful for predicting IVIG non-responders.
      PubDate: 2024-06-13
       
  • A Randomized Control Trial of Dexketoprofen/Vitamin B (Thiamine,
           Pyridoxine and Cyanocobalamin) Fixed-Dose Combination in Post-Traumatic
           Grade I–II Cervical Sprains

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      Abstract: Background Musculoskeletal disorders are an important cause of work absence. Clinical practice guidelines recommend nonsteroidal anti-inflammatory drugs (NSAIDs) for grade I–II cervical sprains. The combination of thiamine + pyridoxine + cyanocobalamin vitamins has been used, alone and in combination with NSAIDs, for pain and inflammation in musculoskeletal disorders. Objective The objective of this study was to demonstrate the analgesic synergy of dexketoprofen, and the combination of vitamins thiamine + pyridoxine + cyanocobalamin in a fixed-dose combination (FDC) for the treatment of acute pain caused by grade I–II cervical sprains. Methods We conducted a multicentre, prospective, randomized, double-blind, phase IIIb clinical study comparing two treatment groups: (1) dexketoprofen 25 mg/vitamin B (thiamine 100 mg, pyridoxine 50 mg and cyanocobalamin 0.50 mg) in an FDC (two or more active ingredients combined in a single dosage form) versus (2) dexketoprofen 25 mg monotherapy (single drug to treat a particular disease), one capsule or tablet orally, every 8 h for 7 days. Final mean, average change, and percentage change in pain perception (measured using a visual analogue scale [VAS]) were compared with baseline between groups. A p value < 0.05 was considered statistically significant. Analyses were conducted using SPSS software, v.29.0. Results A statistically significant reduction in pain intensity was observed from the third day of treatment with the FDC compared with monotherapy (− 3.1 ± − 1.5 and − 2.6 ± − 1.1 cm, respectively) measured using the VAS (p = 0.011). Regarding the degree of disability, using the Northwick Park Neck Pain Questionnaire (NPQ), statistical difference was observed for the final measurement (7.5%, interquartile range [IQR] 2.5, 10.5; vs. 7.9%, IQR 5.0, 13.8; p = 0.028). A lower proportion of adverse events was reported when using the FDC. Conclusions The FDC of dexketoprofen/thiamine + pyridoxine + cyanocobalamin vitamins demonstrated superior efficacy and a better safety profile compared with dexketoprofen monotherapy for pain treatment in patients with grade I–II cervical sprains. Clinical Trials Registration NCT05001555, registered 29 July 2021 (https://clinicaltrials.gov/study/NCT05001555).
      PubDate: 2024-06-06
       
  • Overall Survival Benefit with Sacituzumab Govitecan in Metastatic Breast
           Cancer: A Post Hoc Interaction Analyses of a Randomized Controlled Trail

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      PubDate: 2024-06-05
       
  • An Early Cost-Utility Model of mRNA-Based Therapies for the Treatment of
           Methylmalonic and Propionic Acidemia in the United Kingdom

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      Abstract: Background and Objective Novel messenger RNA (mRNA)-based therapies, currently in development, are emerging as a promising potential treatment modality for a broad range of life-threatening and life-limiting inherited liver diseases, including methylmalonic acidemia (MMA) and propionic acidemia (PA). However, owing in part to their complexity, they are likely to come at considerable financial cost to healthcare systems. The objective of this research was to synthesize available evidence on the costs and clinical consequences associated with MMA and PA for the purpose of exploratory economic evaluation of novel mRNA-based therapies using an early cost-utility model from the United Kingdom payer perspective. Methods A Markov model was constructed to simulate the costs and outcomes associated with novel mRNA therapies, compared with a combination of dietary management and organ transplantation (standard of care) among hypothetical cohorts of new-born patients with MMA and PA. Key model drivers were identified, and a price threshold analysis was performed to estimate value-based price ranges for future mRNA therapies given willingness-to-pay thresholds for orphan diseases. Results mRNA therapy was associated with an additional 5.7 and 1.3 quality-adjusted life-years (QALYs) gained per patient lifetime among patients with MMA and PA, respectively. Key drivers of cost-effectiveness were relative improvement in utility among patients who receive mRNA-based therapy and transplantation, and the cost of mRNA therapy. Assuming a willingness to pay range of £100,000–£300,000 per QALY gained, the model demonstrated mRNA therapy to be cost-effective in MMA and PA at an annual treatment cost of £70,452–£94,575 and £31,313–£36,695, respectively. Conclusions Despite the lack of a strong evidence base in MMA and PA, this model provides a useful tool to estimate the cost-effectiveness, and inform value-based pricing, of new mRNA-based therapies. Our analyses also identified areas for research that will have the greatest value in reducing uncertainty in future health economic evaluations of such treatments.
      PubDate: 2024-05-25
       
  • Systematic Review with Meta-analysis: Efficacy and Safety of Upadacitinib
           in Managing Moderate-to-Severe Crohn’s Disease and Ulcerative Colitis

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      Abstract: Background In the panorama of therapeutic strategies for inflammatory bowel diseases, oral upadacitinib stands out for its potential to improve short-term and long-term patient outcomes. Objective This meta-analysis aspires to collate and assess the available evidence regarding the efficacy and safety of upadacitinib in managing moderate-to-severe Crohn’s disease and ulcerative colitis. Methods A meta-analysis was conducted using studies sourced from MEDLINE/PubMed, Cochrane Library, Scopus, and Embase, published from January 2010 to March 2024. Peer-reviewed articles that reported data on the effects of upadacitinib in adult patients with Crohn’s disease and ulcerative colitis were included based on established inclusion and exclusion criteria. Results Eight studies, encompassing a total of 2818 patients treated with upadacitinib, were included. In primary outcomes, for patients with Crohn’s disease who were using upadacitinib, the weighted pooled clinical remission rate was found to be 45.8% (95% confidence interval [CI] 0.39–0.52), while for patients with ulcerative colitis who were using upadacitinib, the rate was 25.4% (95% CI 0.17–0.36). The pooled clinical response rate for Crohn’s disease was 53.6% (95% CI 0.50–0.57), and for ulcerative colitis it was 72.6% (95% CI 0.69–0.76). The pooled serious adverse event rate was 6.0% (95% CI 0.07–0.09). Conclusions Upadacitinib demonstrates significant efficacy in achieving clinical remission and response in patients with moderate-to-severe Crohn’s disease and ulcerative colitis, as shown by clinical remission rates of 44.9% and 36.0%, respectively. The treatment also maintains a favorable safety profile with a serious adverse event rate of 7.8%, making it an effective option for those resistant or intolerant to traditional immunosuppressants or tumor necrosis factor antagonists.
      PubDate: 2024-05-23
       
  • Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Oral
           AL01211 in Healthy Chinese Volunteers

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      Abstract: Background and Objective Aberrant accumulation of glycosphingolipids (GSLs) in the lysosome leads to GSL storage diseases. Glucosylceramide synthase inhibitors (GCSi) have the potential to treat several GSL storage diseases by reducing the synthesis of the disease-causing GSLs. AL01211 is a potent oral GCSi under investigation for Type 1 Gaucher disease and Fabry disease. Here, we evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of AL01211 in healthy Chinese volunteers. Methods AL01211 was tested in a Phase 1, single-center, randomized, double-blind, placebo-controlled study with single-dose (15 and 60 mg) and multiple-dose (30 mg) arms. Results Results of AL01211 demonstrated dose-dependent pharmacokinetics, rapid absorption (median time to maximum plasma concentration [tmax] 2.5–4 hours), relatively slow clearance rate (mean apparent total clearance from plasma [CL/F] 88.3–200 L/h) and the mean terminal half-life above 30 hours. Repeated once-daily oral administration of AL01211 for 14 days had an approximately 2-fold accumulation, reaching steady-state levels between 7 and 10 days, and led to a 73% reduction in plasma glucosylceramide (GL1) on Day 14. AL01211 was safe and well tolerated, with no identified serious adverse events. Conclusion AL01211 showed a favorable pharmacokinetic, pharmacodynamics, safety, and tolerability profile in healthy Chinese volunteers. These data support the further clinical development of AL01211 as a therapy for GSL storage diseases. Clinical Trial Registry Clinical Trial Registry no. CTR20221202 (http://www.chinadrugtrials.org.cn) registered on 6 June 2022 and ChiCTR2200061431 (http://www.chictr.org.cn) registered on 24 June 2022.
      PubDate: 2024-05-02
       
  • PB006: A Natalizumab Biosimilar

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      Abstract: Abstract PB006 (Tyruko®) is the first biosimilar of the reference monoclonal anti-α4-integrin antibody natalizumab. It is approved for use in the same indications for which reference natalizumab is approved, as a single disease-modifying therapy in adults with highly active relapsing-remitting multiple sclerosis (RRMS). PB006 has similar physicochemical and pharmacodynamic properties to those of reference natalizumab, and the pharmacokinetic similarity of the agents has been demonstrated in a study in healthy subjects. PB006 demonstrated clinical efficacy similar to that of reference natalizumab in patients with RRMS, and was generally well tolerated in this population. The tolerability, safety and immunogenicity profiles of PB006 were similar to those of reference natalizumab, and switching from reference natalizumab to PB006 appeared to have no impact on tolerability or immunogenicity. The role of reference natalizumab in the management of RRMS is well established and PB006 provides an effective biosimilar alternative for patients requiring natalizumab therapy.
      PubDate: 2024-04-29
       
  • Differential Utility Losses in Herpes Zoster Cases Between Vaccinated and
           Unvaccinated Subjects: A Meta-analysis of Three Clinical Trials

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      Abstract: Background and Objective Recombinant zoster vaccine (RZV) is approved in adults for the prevention of herpes zoster. The effect of RZV in moderating the severity of breakthrough cases of herpes zoster has been noted but not explicitly quantified before. In this study, a meta-analysis was undertaken to estimate differential utility losses between unvaccinated (Placebo) and vaccinated (RZV) subjects in breakthrough cases of herpes zoster from three RZV clinical trials. Methods Differential utility losses between the two groups were estimated in units of quality-adjusted life-years (QALYs), leveraging aggregate patient data from the ZOE-50 (NCT01165177), ZOE-70 (NCT01165229), and ZOE-HSCT (NCT01610414) clinical trials. Differential utility losses and the ratio of mean utility losses were analyzed using random-effects and fixed-effects meta-regression models. Results The mean QALY loss differences between the unvaccinated (Placebo) and vaccinated (RZV) groups were 0.008, 0.004, and 0.011 in the ZOE-50, ZOE-70, and ZOE-HSCT studies, respectively, yielding an overall estimated difference of 0.007 (95% confidence interval 0.002–0.012) QALYs. Quality-adjusted life-year loss in the vaccinated group was estimated to be 35.5% of the value in the placebo group. A sensitivity analysis estimated an overall difference of 0.005 (95% confidence interval 0.001–0.009) QALYs, corresponding to 48.6% of the QALY loss value in the placebo group. Conclusions Recombinant zoster vaccine is effective in alleviating disease severity in breakthrough cases of herpes zoster. The results may be useful in distinguishing QALY losses between vaccinated and unvaccinated cohorts in health economics studies, particularly cost-effectiveness analyses.
      PubDate: 2024-04-25
       
  • Safety, Tolerability, and Pharmacokinetics of Oral BI 1358894 in Healthy
           Japanese Male Volunteers

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      Abstract: Background and Objectives BI 1358894, a novel small-molecule inhibitor of transient receptor potential canonical ion channels, is under development for treatment of major depressive disorder. Phase I trials assessing the safety and pharmacokinetics of BI 1358894 in Caucasian male healthy volunteers (HVs) have been performed. This Phase I, double-blind, placebo-controlled, parallel-group trial assessed the safety, tolerability and pharmacokinetics of BI 1358894 in Japanese male HVs. Methods Male HVs were randomized to receive oral BI 1358894 (n = 18) or placebo (n = 6) after a high-fat, high-calorie meal within three dose groups (50 mg, 100 mg, 200 mg), administered sequentially in dose-ascending order. The primary endpoint was number of HVs with drug-related adverse events (DRAEs). Secondary endpoints were the pharmacokinetic parameters of BI 1358894. Results Overall, 24 male HVs entered the trial [mean (standard deviation) age: 30.0 (7.6) years]. DRAEs occurred in 3/18 HVs (BI 1358894 100 mg group: one HV experienced dizziness and headache; BI 1358894 200 mg group: one HV experienced headache, another reported sleep disorder). BI 1358894 exposure increased dose dependently and proportionally, peaking 4–6 h after administration before declining in a multiphasic manner with a terminal elimination half-life of ~70 h in the 50 mg and 100 mg dose groups, and 203 h in the 200 mg dose group. Conclusion BI 1358894 was well tolerated with a favorable pharmacokinetic profile in Japanese male HVs, similar to findings from a previous study in Caucasian male HVs. Trial Registration ClinicalTrials.gov (NCT03875001; 08-Mar-2019).
      PubDate: 2024-04-24
       
  • Risk of Cardiovascular Events in Schizophrenic Patients Treated with
           Paliperidone Palmitate Once-Monthly Injection (PP1M): A Population-Based
           Retrospective Cohort Study in Taiwan

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      Abstract: Background Schizophrenia is one of the leading causes of disability. Paliperidone palmitate once-monthly injection (PP1M) was developed to provide consistent drug delivery and improve medication adherence for maintenance treatment. It is well known that patients with schizophrenia have higher cardiovascular risks, however little is known about the cardiovascular risks of patients with schizophrenia treated with PP1M in Asia. Objective This study aimed to estimate the incidence of cardiovascular events after initiating PP1M treatment and evaluate the cardiovascular risk associations compared with oral second-generation antipsychotics (SGAs). Methods Data from Taiwan’s National Health Insurance Research Database were used to identify a cohort of adult patients with schizophrenia who received any SGAs from 1 March 2012 to 31 December 2018. Patients who initiated PP1M treatment were enrolled for descriptive analysis of incidence rates. PP1M patients were propensity matched 1:1 to patients initiating a new oral SGA, for comparative analysis based on demographics, clinical characteristics and treatment history at baseline, in three-step matching procedures, following the prevalent new-user design to enhance comparability. Follow-up ended at the end of the treatment episode of index drug, death, last record available, or end of the study (31 December 2019). Study endpoints included serious cardiovascular events (including severe ventricular arrhythmia and sudden death), expanded serious cardiovascular events (which further included acute myocardial infarction and ischemic stroke), and cardiovascular hospitalizations. Risks of study endpoints between matched cohorts were compared using Cox regression. Results Overall, 11,023 patients initiating PP1M treatment were identified (49.5% were females; mean age of 43.2 [12.2] years). Overall incidences for serious cardiovascular events, expanded serious cardiovascular events, and cardiovascular hospitalizations were 3.92, 7.88 and 51.96 per 1000 person-years, respectively. In matched cohort analysis (N = 10,115), the hazard ratios (HRs) between initiating PP1M and a new oral SGA for serious cardiovascular events, expanded serious cardiovascular events, and cardiovascular hospitalizations were 0.86 (95% confidence interval [CI] 0.55–1.36), 0.88 (95% CI 0.63–1.21), and 0.78 (95% CI 0.69–0.89), respectively. Conclusion This study reported the population-based incidence of cardiovascular events in schizophrenic patients initiating PP1M treatment. PP1M was not associated with increased risks of serious cardiovascular events but was potentially associated with lower risks of cardiovascular hospitalizations compared with oral SGAs.
      PubDate: 2024-04-15
       
  • Impact of Viloxazine Extended-Release Capsules (Qelbree®) on Select
           Cytochrome P450 Enzyme Activity and Evaluation of CYP2D6 Genetic
           Polymorphisms on Viloxazine Pharmacokinetics

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      Abstract: Background and Objective Viloxazine extended-release (ER) [Qelbree®] is a nonstimulant attention-deficit/hyperactivity disorder (ADHD) treatment. In vitro studies suggested potential for viloxazine to inhibit cytochrome 450 (CYP) enzymes 1A2, 2B6, 2D6 and 3A4. This clinical study therefore evaluated viloxazine ER effects on index substrates for CYP1A2, 2D6, and 3A4, and secondarily evaluated the impact of CYP2D6 polymorphisms on viloxazine pharmacokinetics. Methods Thirty-seven healthy subjects received a modified Cooperstown cocktail (MCC; caffeine 200 mg, dextromethorphan 30 mg, midazolam 0.025 mg/kg) on Day 1, viloxazine ER 900 mg/day on Days 3–5, and a combination of viloxazine ER 900 mg and MCC on Day 6. Viloxazine ER effects on MCC substrates were evaluated using analysis of variance. The impact of CYP2D6 genetic polymorphisms on steady-state viloxazine plasma concentrations was evaluated using Student’s t test assessing pharmacokinetic parameter differences between poor versus extensive metabolizers. Results The least squares geometric mean ratio [GMR%] (90% CI) of MCC substrate + viloxazine ER/MCC substrate alone for caffeine maximum concentration (Cmax), area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUCt), and area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC∞) was 99.11 (95.84–102.49), 436.15 (398.87–476.92), and 583.35 (262.41–1296.80), respectively; 150.76 (126.03–180.35), 185.76 (155.01–222.61), and 189.71 (160.37–224.42) for dextromethorphan Cmax, AUCt, and AUC∞, respectively; and 112.81 (104.71–121.54), 167.56 (153.05–183.45), and 168.91 (154.38–184.80) for midazolam Cmax, AUCt, and AUC∞, respectively. At steady state, viloxazine least squares GMR (90% CI) for poor/extensive CYP2D6 metabolizers were Cmax 120.70 (102.33–142.37) and area under the plasme concentration-time curve from time 0 to 24 hours (AUC0–24 125.66 (105.36–149.87)). Conclusion Viloxazine ER is a strong CYP1A2 inhibitor and a weak CYP2D6 and CYP3A4 inhibitor. CYP2D6 polymorphisms did not meaningfully alter the viloxazine ER pharmacokinetic profile.
      PubDate: 2024-04-10
       
 
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  Subjects -> PHARMACY AND PHARMACOLOGY (Total: 575 journals)
Showing 1 - 200 of 253 Journals sorted by number of followers
Nature Reviews Drug Discovery     Full-text available via subscription   (Followers: 352)
Journal of Clinical Oncology     Hybrid Journal   (Followers: 260)
International Journal of Drug Policy     Hybrid Journal   (Followers: 241)
Journal of Medicinal Chemistry     Hybrid Journal   (Followers: 167)
Drugs     Full-text available via subscription   (Followers: 146)
Journal of Pharmaceutical Sciences     Hybrid Journal   (Followers: 140)
Advanced Drug Delivery Reviews     Hybrid Journal   (Followers: 95)
European Journal of Pharmaceutical Sciences     Hybrid Journal   (Followers: 84)
Drug Safety     Full-text available via subscription   (Followers: 81)
Pharmaceutical Research     Hybrid Journal   (Followers: 69)
Drug Discovery Today     Full-text available via subscription   (Followers: 63)
Biomaterials     Hybrid Journal   (Followers: 54)
Annals of Pharmacotherapy     Hybrid Journal   (Followers: 52)
Clinical Pharmacology & Therapeutics     Hybrid Journal   (Followers: 31)
Pharmacoepidemiology and Drug Safety     Hybrid Journal   (Followers: 29)
AAPS Journal     Hybrid Journal   (Followers: 29)
Annual Review of Pharmacology and Toxicology     Full-text available via subscription   (Followers: 27)
Journal of Pain & Palliative Care Pharmacotherapy     Hybrid Journal   (Followers: 26)
Regulatory Toxicology and Pharmacology     Hybrid Journal   (Followers: 26)
British Journal of Clinical Pharmacology     Hybrid Journal   (Followers: 25)
Journal of Controlled Release     Hybrid Journal   (Followers: 25)
Drug Development and Industrial Pharmacy     Hybrid Journal   (Followers: 25)
International Journal of Pharmacy Practice     Full-text available via subscription   (Followers: 24)
European Journal of Pharmaceutics and Biopharmaceutics     Hybrid Journal   (Followers: 23)
International Journal of Pharmaceutics     Hybrid Journal   (Followers: 23)
Journal of Clinical Psychopharmacology     Hybrid Journal   (Followers: 23)
Journal of Pharmacy and Pharmacology     Full-text available via subscription   (Followers: 23)
Critical Reviews in Toxicology     Hybrid Journal   (Followers: 22)
PharmacoEconomics     Full-text available via subscription   (Followers: 21)
American Journal of Cardiovascular Drugs     Hybrid Journal   (Followers: 20)
Chemical Research in Toxicology     Hybrid Journal   (Followers: 20)
Trends in Pharmacological Sciences     Full-text available via subscription   (Followers: 17)
Clinical Toxicology     Hybrid Journal   (Followers: 17)
Clinical Pharmacokinetics     Full-text available via subscription   (Followers: 16)
Critical Reviews in Clinical Laboratory Sciences     Hybrid Journal   (Followers: 16)
Journal of Natural Products     Hybrid Journal   (Followers: 16)
Journal of Pharmacokinetics and Pharmacodynamics     Hybrid Journal   (Followers: 16)
Toxicology and Applied Pharmacology     Hybrid Journal   (Followers: 16)
Pharmaceutical Development and Technology     Hybrid Journal   (Followers: 16)
Journal of Applied Toxicology     Hybrid Journal   (Followers: 15)
Psychopharmacology     Hybrid Journal   (Followers: 15)
Journal of Clinical Pharmacy and Therapeutics     Hybrid Journal   (Followers: 14)
Journal of Oncology Pharmacy Practice     Hybrid Journal   (Followers: 14)
Journal of the American Pharmacists Association     Full-text available via subscription   (Followers: 14)
Toxicology     Hybrid Journal   (Followers: 14)
International Journal of Toxicology     Hybrid Journal   (Followers: 13)
Journal of Pharmaceutical and Biomedical Analysis     Hybrid Journal   (Followers: 13)
Journal of Pharmacy Practice     Hybrid Journal   (Followers: 13)
Biopharmaceutics and Drug Disposition     Hybrid Journal   (Followers: 12)
Cardiovascular Drugs and Therapy     Hybrid Journal   (Followers: 12)
Clinical Trials     Hybrid Journal   (Followers: 12)
Toxicology Letters     Hybrid Journal   (Followers: 12)
Drug and Chemical Toxicology     Hybrid Journal   (Followers: 12)
American Journal of Therapeutics     Hybrid Journal   (Followers: 11)
Basic & Clinical Pharmacology & Toxicology     Hybrid Journal   (Followers: 11)
European Journal of Clinical Pharmacology     Hybrid Journal   (Followers: 11)
Journal of Psychopharmacology     Hybrid Journal   (Followers: 11)
Pharmacy Education     Full-text available via subscription   (Followers: 11)
Clinical Therapeutics     Hybrid Journal   (Followers: 10)
CNS Drugs     Full-text available via subscription   (Followers: 10)
Pharmaceutical Statistics     Hybrid Journal   (Followers: 10)
Seminars in Oncology Nursing     Full-text available via subscription   (Followers: 10)
Journal of Clinical Pharmacology     Hybrid Journal   (Followers: 10)
Toxicological Sciences     Hybrid Journal   (Followers: 10)
Advances in Pharmacological and Pharmaceutical Sciences     Open Access   (Followers: 10)
Biochemical Pharmacology     Hybrid Journal   (Followers: 9)
ChemMedChem     Hybrid Journal   (Followers: 9)
Drug Metabolism and Disposition     Hybrid Journal   (Followers: 9)
Drugs & Aging     Full-text available via subscription   (Followers: 9)
Drugs & Therapy Perspectives     Full-text available via subscription   (Followers: 9)
Medicinal Chemistry     Hybrid Journal   (Followers: 9)
Seminars in Hematology     Hybrid Journal   (Followers: 9)
Current Opinion in Pharmacology     Hybrid Journal   (Followers: 8)
Current Pharmaceutical Biotechnology     Hybrid Journal   (Followers: 8)
Drug Development Research     Hybrid Journal   (Followers: 8)
Epilepsy Research     Hybrid Journal   (Followers: 8)
European Neuropsychopharmacology     Hybrid Journal   (Followers: 8)
Food Additives & Contaminants Part A     Hybrid Journal   (Followers: 8)
Progress in Neuro-Psychopharmacology and Biological Psychiatry     Hybrid Journal   (Followers: 8)
Toxicology in Vitro     Hybrid Journal   (Followers: 8)
Inhalation Toxicology     Hybrid Journal   (Followers: 8)
Antiviral Research     Hybrid Journal   (Followers: 7)
Current Medicinal Chemistry     Hybrid Journal   (Followers: 7)
Drug Delivery     Open Access   (Followers: 7)
Environmental Toxicology and Pharmacology     Hybrid Journal   (Followers: 7)
Experimental and Clinical Psychopharmacology     Full-text available via subscription   (Followers: 7)
Frontiers in Drug Design & Discovery     Hybrid Journal   (Followers: 7)
Journal of Veterinary Pharmacology and Therapeutics     Hybrid Journal   (Followers: 7)
Prescriber     Hybrid Journal   (Followers: 7)
Toxicology Mechanisms and Methods     Hybrid Journal   (Followers: 7)
Journal of Pharmaceutical Innovation     Hybrid Journal   (Followers: 7)
AAPS PharmSciTech     Hybrid Journal   (Followers: 6)
Biometrical Journal     Hybrid Journal   (Followers: 6)
Clinical Drug Investigation     Full-text available via subscription   (Followers: 6)
Current Drug Delivery     Hybrid Journal   (Followers: 6)
Anti-Inflammatory & Anti-Allergy Agents in Medicinal Chemistry     Hybrid Journal   (Followers: 6)
Expert Review of Pharmacoeconomics & Outcomes Research     Full-text available via subscription   (Followers: 6)
Human & Experimental Toxicology     Hybrid Journal   (Followers: 6)
Toxicology and Industrial Health     Hybrid Journal   (Followers: 6)
Current Cancer Therapy Reviews     Hybrid Journal   (Followers: 5)
Current Drug Discovery Technologies     Hybrid Journal   (Followers: 5)
Anti-Infective Agents     Hybrid Journal   (Followers: 5)
Current Therapeutic Research     Open Access   (Followers: 5)
Reviews of Physiology, Biochemistry and Pharmacology     Hybrid Journal   (Followers: 5)
Expert Review of Anti-infective Therapy     Full-text available via subscription   (Followers: 5)
Expert Review of Molecular Diagnostics     Full-text available via subscription   (Followers: 5)
Fitoterapia     Hybrid Journal   (Followers: 5)
Journal of Pain Management & Medicine     Open Access   (Followers: 5)
Journal of Cardiovascular Pharmacology and Therapeutics     Hybrid Journal   (Followers: 5)
Journal of Separation Science     Hybrid Journal   (Followers: 5)
Scandinavian Journal of Clinical and Laboratory Investigation     Hybrid Journal   (Followers: 5)
Clinical Research and Regulatory Affairs     Hybrid Journal   (Followers: 5)
Pharmacogenomics Journal     Hybrid Journal   (Followers: 5)
ASSAY and Drug Development Technologies     Hybrid Journal   (Followers: 4)
BioDrugs     Full-text available via subscription   (Followers: 4)
Cancer Chemotherapy and Pharmacology     Hybrid Journal   (Followers: 4)
Current Pharmaceutical Design     Hybrid Journal   (Followers: 4)
Expert Review of Cardiovascular Therapy     Full-text available via subscription   (Followers: 4)
International Journal of Pharmaceutical and Healthcare Marketing     Hybrid Journal   (Followers: 4)
Pharmaceutical Medicine     Full-text available via subscription   (Followers: 4)
Journal of Child and Adolescent Psychopharmacology     Hybrid Journal   (Followers: 4)
Journal of Infection and Chemotherapy     Hybrid Journal   (Followers: 4)
Journal of Labelled Compounds and Radiopharmaceuticals     Hybrid Journal   (Followers: 4)
Journal of Pharmacology and Experimental Therapeutics     Hybrid Journal   (Followers: 4)
Neuropharmacology     Hybrid Journal   (Followers: 4)
Planta Medica     Hybrid Journal   (Followers: 4)
Immunopharmacology and Immunotoxicology     Hybrid Journal   (Followers: 4)
Physiology International     Full-text available via subscription   (Followers: 3)
Archiv der Pharmazie     Hybrid Journal   (Followers: 3)
BMC Pharmacology     Open Access   (Followers: 3)
Cardiovascular Therapeutics     Open Access   (Followers: 3)
Clinical and Experimental Pharmacology and Physiology     Hybrid Journal   (Followers: 3)
CNS Drug Reviews     Open Access   (Followers: 3)
Current Drug Metabolism     Hybrid Journal   (Followers: 3)
Current Pharmacogenomics and Personalized Medicine     Hybrid Journal   (Followers: 3)
Drug Resistance Updates     Hybrid Journal   (Followers: 3)
European Journal of Pharmacology     Hybrid Journal   (Followers: 3)
Frontiers in Medicinal Chemistry     Hybrid Journal   (Followers: 3)
Human Psychopharmacology Clinical and Experimental     Hybrid Journal   (Followers: 3)
Inflammation Research     Hybrid Journal   (Followers: 3)
Investigational New Drugs     Hybrid Journal   (Followers: 3)
Journal of Aerosol Medicine and Pulmonary Drug Delivery     Hybrid Journal   (Followers: 3)
Journal of Cardiovascular Pharmacology     Hybrid Journal   (Followers: 3)
Journal of Ethnopharmacology     Hybrid Journal   (Followers: 3)
Journal of Medical Marketing     Hybrid Journal   (Followers: 3)
Journal of Pharmacological and Toxicological Methods     Hybrid Journal   (Followers: 3)
Microbial Drug Resistance     Hybrid Journal   (Followers: 3)
International Journal of Neuropsychopharmacology     Open Access   (Followers: 3)
Therapeutic Drug Monitoring     Hybrid Journal   (Followers: 3)
Drug Metabolism Reviews     Hybrid Journal   (Followers: 3)
Acta Pharmacologica Sinica     Hybrid Journal   (Followers: 2)
Behavioural Pharmacology     Hybrid Journal   (Followers: 2)
Biomedicine & Pharmacotherapy     Full-text available via subscription   (Followers: 2)
Clinical Neuropharmacology     Hybrid Journal   (Followers: 2)
Current Drug Therapy     Hybrid Journal   (Followers: 2)
Current Enzyme Inhibition     Hybrid Journal   (Followers: 2)
Drugs in R & D     Full-text available via subscription   (Followers: 2)
Inflammopharmacology     Hybrid Journal   (Followers: 2)
Inpharma Weekly     Full-text available via subscription   (Followers: 2)
International Clinical Psychopharmacology     Hybrid Journal   (Followers: 2)
International Immunopharmacology     Hybrid Journal   (Followers: 2)
Letters in Drug Design & Discovery     Hybrid Journal   (Followers: 2)
Medicinal Research Reviews     Hybrid Journal   (Followers: 2)
Pharmacology & Therapeutics     Hybrid Journal   (Followers: 2)
Pharmacology Biochemistry and Behavior     Hybrid Journal   (Followers: 2)
Pharmacopsychiatry     Hybrid Journal   (Followers: 2)
Pulmonary Pharmacology & Therapeutics     Hybrid Journal   (Followers: 2)
Research in Social and Administrative Pharmacy     Hybrid Journal   (Followers: 2)
The Brown University Psychopharmacology Update     Hybrid Journal   (Followers: 2)
Toxicological & Environmental Chemistry     Hybrid Journal   (Followers: 2)
Toxicon     Hybrid Journal   (Followers: 2)
Journal of Microencapsulation: Microcapsules, Liposomes, Nanoparticles, Microcells, Microspheres     Hybrid Journal   (Followers: 2)
Canadian Journal of Physiology and Pharmacology     Hybrid Journal   (Followers: 1)
Current Neuropharmacology     Hybrid Journal   (Followers: 1)
Current Pharmaceutical Analysis     Hybrid Journal   (Followers: 1)
Current Vascular Pharmacology     Hybrid Journal   (Followers: 1)
Fundamental & Clinical Pharmacology     Hybrid Journal   (Followers: 1)
Journal of Drug Targeting     Hybrid Journal   (Followers: 1)
Journal of Inflammation     Open Access   (Followers: 1)
Journal of Neuroimmune Pharmacology     Hybrid Journal   (Followers: 1)
Journal of Texture Studies     Hybrid Journal   (Followers: 1)
Pharmacogenetics and Genomics     Hybrid Journal   (Followers: 1)
Particulate Science and Technology: An International Journal     Hybrid Journal   (Followers: 1)
Pharmaceutical Biology     Open Access  
Journal of Liposome Research     Hybrid Journal  
Vascular Pharmacology     Hybrid Journal  
Toxin Reviews     Hybrid Journal  
Kaohsiung Journal of Medical Sciences     Open Access  
Redox Report     Open Access  
Pharmacological Research     Hybrid Journal  
PharmacoEconomics & Outcomes News     Full-text available via subscription  
Pharmaceutical Chemistry Journal     Hybrid Journal  
NeuroMolecular Medicine     Hybrid Journal  
Journal of Ocular Pharmacology and Therapeutics     Hybrid Journal  
Harm Reduction Journal     Open Access  
Current Nanoscience     Hybrid Journal  
Infectious Disorders - Drug Targets     Hybrid Journal  
Current Bioactive Compounds     Hybrid Journal  
Cancer Biotherapy & Radiopharmaceuticals     Hybrid Journal  
Autonomic & Autacoid Pharmacology     Hybrid Journal  

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