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  Subjects -> PHARMACY AND PHARMACOLOGY (Total: 575 journals)
Showing 1 - 200 of 253 Journals sorted alphabetically
AAPS Journal     Hybrid Journal   (Followers: 24)
AAPS Open     Open Access   (Followers: 4)
AAPS PharmSciTech     Hybrid Journal   (Followers: 6)
AboutOpen     Open Access  
ACS Pharmacology & Translational Science     Hybrid Journal   (Followers: 3)
Acta Pharmaceutica     Open Access   (Followers: 4)
Acta Pharmaceutica Indonesia     Open Access  
Acta Pharmaceutica Sinica B     Open Access   (Followers: 1)
Acta Pharmacologica Sinica     Hybrid Journal   (Followers: 3)
Acta Physiologica Hungarica     Full-text available via subscription  
Actualites Pharmaceutiques     Full-text available via subscription   (Followers: 4)
Advanced Drug Delivery Reviews     Hybrid Journal   (Followers: 96)
Advanced Herbal Medicine     Open Access   (Followers: 8)
Advanced Therapeutics     Hybrid Journal   (Followers: 1)
Advances in Pharmacoepidemiology & Drug Safety     Open Access   (Followers: 2)
Advances in Pharmacological and Pharmaceutical Sciences     Open Access   (Followers: 9)
Advances in Pharmacology     Full-text available via subscription   (Followers: 18)
Advances in Pharmacology and Pharmacy     Open Access   (Followers: 5)
Advances in Traditional Medicine     Hybrid Journal   (Followers: 3)
Adverse Drug Reaction Bulletin     Full-text available via subscription   (Followers: 5)
AJP : The Australian Journal of Pharmacy     Full-text available via subscription   (Followers: 8)
Alternatives to Laboratory Animals     Full-text available via subscription   (Followers: 9)
American Journal of Cardiovascular Drugs     Hybrid Journal   (Followers: 19)
American Journal of Drug Discovery and Development     Open Access   (Followers: 3)
American Journal of Health-System Pharmacy     Full-text available via subscription   (Followers: 55)
American Journal of Pharmacological Sciences     Open Access   (Followers: 1)
American Journal of Pharmacology and Toxicology     Open Access   (Followers: 23)
American Journal of Therapeutics     Hybrid Journal   (Followers: 13)
Analytical Methods     Hybrid Journal   (Followers: 8)
Annales Pharmaceutiques Francaises     Full-text available via subscription  
Annals of Pharmacotherapy     Hybrid Journal   (Followers: 56)
Annual Review of Pharmacology and Toxicology     Full-text available via subscription   (Followers: 37)
Anti-Infective Agents     Hybrid Journal   (Followers: 5)
Anti-Inflammatory & Anti-Allergy Agents in Medicinal Chemistry     Hybrid Journal   (Followers: 5)
Antibiotics     Open Access   (Followers: 10)
Antibody Therapeutics     Open Access  
Antiviral Chemistry and Chemotherapy     Open Access   (Followers: 1)
Antiviral Research     Hybrid Journal   (Followers: 8)
Applied Clinical Trials     Full-text available via subscription   (Followers: 7)
Archiv der Pharmazie     Hybrid Journal   (Followers: 3)
Archives of Drug Information     Hybrid Journal   (Followers: 4)
Archives of Pharmacal Research     Full-text available via subscription   (Followers: 2)
Archives of Pharmacy and Pharmaceutical Sciences     Open Access   (Followers: 1)
Archives of Razi Institute     Open Access  
Archivos Venezolanos de Farmacología y Terapéutica     Open Access  
Ars Pharmaceutica     Open Access  
Asian Journal of Medical and Pharmaceutical Researches     Open Access  
Asian Journal of Pharmaceutical Research and Health Care     Open Access   (Followers: 2)
Asian Journal of Pharmaceutical Sciences     Open Access   (Followers: 1)
Asian Journal of Pharmaceutics     Open Access   (Followers: 1)
Asian Journal of Research in Medical and Pharmaceutical Sciences     Open Access  
ASSAY and Drug Development Technologies     Hybrid Journal   (Followers: 3)
Australian Journal of Herbal Medicine     Full-text available via subscription   (Followers: 4)
Australian Pharmacist     Full-text available via subscription   (Followers: 7)
Autonomic & Autacoid Pharmacology     Hybrid Journal  
Avicenna Journal of Phytomedicine     Open Access   (Followers: 1)
Bangladesh Journal of Pharmacology     Open Access  
Bangladesh Journal of Physiology and Pharmacology     Open Access  
Bangladesh Pharmaceutical Journal     Full-text available via subscription  
Basic & Clinical Pharmacology & Toxicology     Hybrid Journal   (Followers: 14)
Behavioural Pharmacology     Hybrid Journal   (Followers: 2)
Bioanalysis     Full-text available via subscription   (Followers: 11)
Biochemical Pharmacology     Hybrid Journal   (Followers: 11)
BioDrugs     Full-text available via subscription   (Followers: 8)
Biological & Pharmaceutical Bulletin     Full-text available via subscription   (Followers: 3)
Biomarkers in Drug Development     Partially Free   (Followers: 2)
Biomaterials     Hybrid Journal   (Followers: 55)
Biomedical and Environmental Sciences     Full-text available via subscription   (Followers: 1)
Biomedicine & Pharmacotherapy     Full-text available via subscription   (Followers: 2)
Biometrical Journal     Hybrid Journal   (Followers: 9)
Biopharm International     Full-text available via subscription   (Followers: 20)
Biopharmaceutics and Drug Disposition     Hybrid Journal   (Followers: 11)
BMC Pharmacology     Open Access   (Followers: 2)
BMC Pharmacology & Toxicology     Open Access   (Followers: 8)
Brazilian Journal of Pharmaceutical Sciences     Open Access   (Followers: 1)
British Journal of Clinical Pharmacology     Hybrid Journal   (Followers: 30)
British Journal of Pharmacology     Hybrid Journal   (Followers: 17)
British Journal of Pharmacy (BJPharm)     Open Access   (Followers: 2)
Bulletin of Faculty of Pharmacy, Cairo University     Open Access   (Followers: 2)
CADTH Technology Overviews     Free  
Canadian Journal of Pain     Open Access   (Followers: 3)
Canadian Journal of Physiology and Pharmacology     Hybrid Journal   (Followers: 2)
Canadian Pharmacists Journal / Revue des Pharmaciens du Canada     Hybrid Journal   (Followers: 3)
Cancer Biotherapy & Radiopharmaceuticals     Hybrid Journal  
Cancer Chemotherapy and Pharmacology     Hybrid Journal   (Followers: 6)
Cardiovascular Drugs and Therapy     Hybrid Journal   (Followers: 14)
Cardiovascular Therapeutics     Open Access   (Followers: 3)
Cephalalgia Reports     Open Access  
Chemical and Pharmaceutical Bulletin     Full-text available via subscription   (Followers: 1)
Chemical Research in Toxicology     Hybrid Journal   (Followers: 22)
ChemMedChem     Hybrid Journal   (Followers: 11)
Chemotherapy     Full-text available via subscription   (Followers: 3)
Chinese Herbal Medicines     Full-text available via subscription   (Followers: 1)
Chinese Journal of Pharmaceutical Analysis     Full-text available via subscription  
Ciencia e Investigación     Open Access  
Ciência Equatorial     Open Access  
Clinical and Experimental Pharmacology and Physiology     Hybrid Journal   (Followers: 7)
Clinical and Translational Science     Open Access   (Followers: 4)
Clinical Complementary Medicine and Pharmacology     Open Access  
Clinical Drug Investigation     Full-text available via subscription   (Followers: 8)
Clinical Medicine Insights : Therapeutics     Open Access  
Clinical Neuropharmacology     Hybrid Journal   (Followers: 2)
Clinical Pharmacist     Partially Free   (Followers: 12)
Clinical Pharmacokinetics     Full-text available via subscription   (Followers: 28)
Clinical Pharmacology & Therapeutics     Hybrid Journal   (Followers: 45)
Clinical Pharmacology in Drug Development     Hybrid Journal   (Followers: 4)
Clinical Pharmacology: Advances and Applications     Open Access   (Followers: 6)
Clinical Research and Regulatory Affairs     Hybrid Journal   (Followers: 12)
Clinical Therapeutics     Hybrid Journal   (Followers: 34)
Clinical Toxicology     Hybrid Journal   (Followers: 18)
Clinical Trials     Hybrid Journal   (Followers: 19)
CNS Drug Reviews     Open Access   (Followers: 4)
CNS Drugs     Full-text available via subscription   (Followers: 10)
Combination Products in Therapy     Open Access  
Consultant Pharmacist     Full-text available via subscription   (Followers: 2)
Consumer Drugs     Full-text available via subscription  
Contract Pharma     Full-text available via subscription  
Cosmetics     Open Access   (Followers: 4)
CPT : Pharmacometrics & Systems Pharmacology     Open Access   (Followers: 10)
Critical Reviews in Clinical Laboratory Sciences     Hybrid Journal   (Followers: 19)
Critical Reviews in Therapeutic Drug Carrier Systems     Full-text available via subscription   (Followers: 5)
Critical Reviews in Toxicology     Hybrid Journal   (Followers: 26)
Current Bioactive Compounds     Hybrid Journal  
Current Cancer Therapy Reviews     Hybrid Journal   (Followers: 5)
Current Clinical Pharmacology     Hybrid Journal   (Followers: 4)
Current Drug Delivery     Hybrid Journal   (Followers: 6)
Current Drug Discovery Technologies     Hybrid Journal   (Followers: 6)
Current Drug Metabolism     Hybrid Journal   (Followers: 5)
Current Drug Safety     Hybrid Journal   (Followers: 8)
Current Drug Targets     Hybrid Journal   (Followers: 5)
Current Drug Therapy     Hybrid Journal   (Followers: 3)
Current Enzyme Inhibition     Hybrid Journal   (Followers: 1)
Current Issues in Pharmacy and Medical Sciences     Open Access   (Followers: 2)
Current Medical Science     Hybrid Journal  
Current Medicinal Chemistry     Hybrid Journal   (Followers: 13)
Current Molecular Pharmacology     Hybrid Journal  
Current Nanoscience     Hybrid Journal  
Current Neuropharmacology     Hybrid Journal   (Followers: 1)
Current Opinion in Pharmacology     Hybrid Journal   (Followers: 9)
Current Pharmaceutical Analysis     Hybrid Journal   (Followers: 1)
Current Pharmaceutical Biotechnology     Hybrid Journal   (Followers: 10)
Current Pharmaceutical Design     Hybrid Journal   (Followers: 11)
Current Pharmacogenomics and Personalized Medicine     Hybrid Journal   (Followers: 3)
Current Pharmacology Reports     Hybrid Journal  
Current Protocols in Pharmacology     Hybrid Journal  
Current Radiopharmaceuticals     Hybrid Journal   (Followers: 1)
Current Research in Drug Discovery     Open Access   (Followers: 1)
Current Research in Pharmacology and Drug Discovery     Open Access   (Followers: 1)
Current Therapeutic Research     Open Access   (Followers: 6)
Current trends in Biotechnology and Pharmacy     Open Access   (Followers: 8)
Current Vascular Pharmacology     Hybrid Journal   (Followers: 4)
Dhaka University Journal of Pharmaceutical Sciences     Open Access  
Die Pharmazie - An International Journal of Pharmaceutical Sciences     Full-text available via subscription   (Followers: 6)
Dose-Response     Open Access  
Drug and Chemical Toxicology     Hybrid Journal   (Followers: 14)
Drug and Therapeutics Bulletin     Hybrid Journal   (Followers: 9)
Drug Delivery     Open Access   (Followers: 9)
Drug Delivery and Translational Research     Hybrid Journal   (Followers: 2)
Drug Design, Development and Therapy     Open Access   (Followers: 3)
Drug Development and Industrial Pharmacy     Hybrid Journal   (Followers: 30)
Drug Development Research     Hybrid Journal   (Followers: 13)
Drug Discovery Today: Technologies     Full-text available via subscription   (Followers: 13)
Drug Metabolism and Disposition     Hybrid Journal   (Followers: 13)
Drug Metabolism and Pharmacokinetics     Hybrid Journal   (Followers: 6)
Drug Metabolism Letters     Hybrid Journal   (Followers: 3)
Drug Metabolism Reviews     Hybrid Journal   (Followers: 8)
Drug Research     Hybrid Journal   (Followers: 3)
Drug Resistance Updates     Hybrid Journal   (Followers: 3)
Drug Safety     Full-text available via subscription   (Followers: 82)
Drug Safety - Case Reports     Open Access   (Followers: 2)
Drug Target Insights     Open Access  
Drug, Healthcare and Patient Safety     Open Access   (Followers: 10)
Drugs     Full-text available via subscription   (Followers: 114)
Drugs & Aging     Full-text available via subscription   (Followers: 9)
Drugs & Therapy Perspectives     Full-text available via subscription   (Followers: 8)
Drugs : Real World Outcomes     Hybrid Journal   (Followers: 1)
Drugs and Therapy Studies     Open Access  
Drugs in R & D     Full-text available via subscription   (Followers: 2)
Drugs of the Future     Full-text available via subscription   (Followers: 8)
East and Central African Journal of Pharmaceutical Sciences     Open Access   (Followers: 1)
Egyptian Pharmaceutical Journal     Open Access  
EJNMMI Radiopharmacy and Chemistry     Open Access  
EMC - Cosmetologia Medica e Medicina degli Inestetismi Cutanei     Full-text available via subscription  
Emerging Trends in Drugs, Addictions, and Health     Open Access  
Environmental Toxicology and Pharmacology     Hybrid Journal   (Followers: 9)
Epilepsy Research     Hybrid Journal   (Followers: 7)
Ethiopian Pharmaceutical Journal     Full-text available via subscription   (Followers: 1)
EUREKA : Health Sciences     Open Access  
European Journal of Clinical Pharmacology     Hybrid Journal   (Followers: 13)
European Journal of Drug Metabolism and Pharmacokinetics     Hybrid Journal   (Followers: 8)
European Journal of Hospital Pharmacy : Science and Practice (EJHP)     Hybrid Journal   (Followers: 5)
European Journal of Medicinal Plants     Open Access   (Followers: 2)
European Journal of Pharmaceutical Sciences     Hybrid Journal   (Followers: 85)
European Journal of Pharmaceutics and Biopharmaceutics     Hybrid Journal   (Followers: 35)
European Journal of Pharmacology     Hybrid Journal   (Followers: 9)
European Neuropsychopharmacology     Hybrid Journal   (Followers: 8)
European Review for Medical and Pharmacological Sciences     Full-text available via subscription   (Followers: 1)
Experimental and Clinical Psychopharmacology     Full-text available via subscription   (Followers: 7)
Expert Opinion on Drug Delivery     Hybrid Journal   (Followers: 18)
Expert Opinion on Drug Discovery     Hybrid Journal   (Followers: 18)

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Drugs : Real World Outcomes
Number of Followers: 1  
 
  Hybrid Journal Hybrid journal (It can contain Open Access articles)
ISSN (Print) 2199-1154 - ISSN (Online) 2198-9788
Published by Springer-Verlag Homepage  [2469 journals]
  • Serious Cardiovascular Adverse Events Associated with
           Hydroxychloroquine/Chloroquine Alone or with Azithromycin in Patients with
           COVID-19: A Pharmacovigilance Analysis of the FDA Adverse Event Reporting
           System (FAERS)

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      Abstract: Background The use of hydroxychloroquine or chloroquine (HCQ/CQ) as monotherapy or combined with azithromycin for the treatment of coronavirus disease 2019 (COVID-19) may increase the risk of serious cardiovascular adverse events (SCAEs). Objective Our objective was to describe and evaluate the risk of SCAEs with HCQ/CQ as monotherapy or combined with azithromycin compared with that for therapeutic alternatives. Methods We performed a disproportionality analysis and descriptive case series using the US FDA Adverse Event Reporting System. Results Compared with remdesivir, HCQ/CQ was associated with increased reporting of SCAEs (reporting odds ratio [ROR] 2.1; 95% confidence interval [CI] 1.8–2.5), torsade de pointes (TdP)/QTc prolongation (ROR 35.4; 95% CI 19.4–64.5), and ventricular arrhythmia (ROR 2.5; 95% CI 1.6–3.9); similar results were found in comparison with other therapeutic alternatives. Compared with lopinavir/ritonavir, HCQ/CQ was associated with increased reporting of ventricular arrhythmia (ROR 10.5; 95% CI 3.3–33.4); RORs were larger when HCQ/CQ was used in combination with azithromycin. In 2020, 312 of the 575 reports of SCAEs listed concomitant use of HCQ/CQ and azithromycin, including QTc prolongation (61.4%), ventricular arrhythmia (12.0%), atrial fibrillation (8.2%), TdP (4.9%), and cardiac arrest (4.4%); 88 (15.3%) cases resulted in hospitalization and 79 (13.7%) resulted in death. In total, 122 fatal QTc prolongation-related cardiovascular reports were associated with 1.4 times higher odds of reported death than those induced by SCAEs; 87 patients received more than one QTc-prolonging agent. Conclusions Patients treated with HCQ/CQ monotherapy or HCQ/CQ + azithromycin may be at increased risk of SCAEs, TdP/QTc prolongation, and ventricular arrhythmia. Cardiovascular risks need to be considered when evaluating the benefit/harm balance of treatment with HCQ/CQ, especially with the concurrent use of QTc-prolonging agents and cytochrome P450 3A4 inhibitors when treating COVID-19.
      PubDate: 2022-04-06
       
  • Estimating the National Population of Hospitalized Chronic Baclofen Users:
           A Cross-Sectional Analysis of a Commercial Claims Database

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      Abstract: Background Baclofen is an effective treatment for spasticity. Abrupt cessation of intrathecal (IT) or oral baclofen risks the development of withdrawal symptoms; however, the magnitude of the problem is unknown. Objectives The aims for this study were as follows: (1) using an administrative claims database, estimate the number of patients in the United States on baclofen, and (2) estimate the annual percent hospitalized pediatric and adult populations consequently at risk for interruption of chronic baclofen therapy. Methods Using 2011–2014 data representing commercially insured individuals, patients were selected based on insurance coverage; evidence of a baclofen claim; and hospitalization. All patients hospitalized while receiving chronic baclofen were assumed to be at risk for baclofen discontinuation. Yearly counts were determined and then extrapolated to national estimates using census data. Results Extrapolating from the claims database, oral or IT baclofen was prescribed annually to 33,061 or 1486 patients ≤ 18 years, and 654,294 or 7084 patients 19–64 years, respectively. The estimated national mean number of at-risk hospitalizations per year for patients aged 19–64 years on chronic oral or IT baclofen was 31,116 and 3774, respectively; patients ≤ 18 years numbered 4691 and 959, respectively. The mean percent of patients hospitalized per year was 42% in those ≤ 18 years receiving IT baclofen compared with 30% in adults, and 3–10% in the populations receiving oral baclofen. Conclusions Extrapolation from an administrative claims database was used to estimate the national number and demographics of hospitalized chronic baclofen users. Patients ≤ 18 years receiving IT baclofen were at highest risk of withdrawal due to a high occurrence of hospitalization.
      PubDate: 2022-03-31
       
  • Being Transparent About Brilliant Failures: An Attempt to Use Real-World
           Data in a Disease Model for Patients with Castration-Resistant Prostate
           Cancer

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      Abstract: Background Real-world disease models spanning multiple treatment lines can provide insight into the (cost) effectiveness of treatment sequences in clinical practice. Objective Our objective was to explore whether a disease model based solely on real-world data (RWD) could be used to estimate the effectiveness of treatments for patients with castration-resistant prostate cancer (CRPC) that could then be suitably used in a cost-effectiveness analysis. Methods We developed a patient-level simulation model using patient-level data from the Dutch CAPRI registry as input parameters. Time to event (TTE) and overall survival (OS) were estimated with multivariate regression models, and type of event (i.e., next treatment or death) was estimated with multivariate logistic regression models. To test internal validity, TTE and OS from the simulation model were compared with the observed outcomes in the registry. Results Although patient characteristics and survival outcomes of the simulated data were comparable to those in the observed data (median OS 20.6 vs. 19.8 months, respectively), the disease model was less accurate in estimating differences between treatments (median OS simulated vs. observed population: 18.6 vs. 17.9 [abiraterone acetate plus prednisone], 24.0 vs. 25.0 [enzalutamide], 20.2 vs. 18.7 [docetaxel], and 20.0 vs. 23.8 months [radium-223]). Conclusions Overall, the disease model accurately approximated the observed data in the total CRPC population. However, the disease model was unable to predict differences in survival between treatments due to unobserved differences. Therefore, the model is not suitable for cost-effectiveness analysis of CRPC treatment. Using a combination of RWD and data from randomised controlled trials to estimate treatment effectiveness may improve the model.
      PubDate: 2022-03-21
       
  • Context and Considerations for Use of Two Japanese Real-World Databases in
           Japan: Medical Data Vision and Japanese Medical Data Center

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      Abstract: Abstract In Japan, an increasing interest in real-world evidence for hypothesis generation and decision-making has emerged in order to overcome limitations and restrictions of clinical trials. We sought to characterize the context and concrete considerations of when to use Medical Data Vision (MDV) and JMDC databases, the main Japanese real-world data (RWD) sources accessible by pharmaceutical companies. Use cases for these databases, and related issues and considerations, were identified and summarized based on a literature search and experience-based knowledge. Studies conducted using MDV or JMDC were mostly descriptive in nature, or explored potential risk factors by evaluating associations with a target outcome. Considerations such as variable ascertainment at different time points, including issues relating to treatment identification and missing data, were highlighted for these two databases. Although several issues were commonly shared (e.g., only month of event occurrence reported), some database-specific issues were also identified and need to be accounted for. In conclusion, MDV and JMDC present limitations that are relatively typical of RWD sources, though some of them are unique to Japan, such as the identification of event occurrence and the inability to track patients visiting different healthcare settings. Addressing study design and careful result interpretation with respect to the specificities and uniqueness of the Japanese healthcare system is of particular importance. This aspect is especially relevant with respect to the growing global interest of conducting RWD studies in Japan.
      PubDate: 2022-03-18
       
  • The Sex-Specific Impact of the FORTA (Fit-fOR-The-Aged) List on Medication
           Quality and Clinical Endpoints in Older Hospitalized Patients: Secondary
           Analysis of a Randomized Controlled Trial

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      Abstract: Background Little is known about the sex-specific impact of drug optimization tools such as the Fit fOR The Aged (FORTA) list on drug use and relevant clinical endpoints in older people. Objective We aimed to detect gender differences of interventional effects on medication quality and related clinical effects in the VALFORTA trial. Patients and methods A sex-specific analysis of data from 409 patients (147 men and 262 women, mean age 79.4 and 82.7 years, respectively) in acute geriatric care comparing the control and FORTA intervention groups was performed. Changes of the FORTA score (sum of over- and undertreatment errors per patient), the incidence of adverse drug events (ADEs) during hospitalization, and several clinically relevant endpoints [e.g., the Barthel index (BI)] were tested for equivalence at a 20% margin. “Success” or “failure” for the development of these clinical endpoints was defined and their frequencies compared by a risk reduction analysis. Results Sex differences were insignificant for the reduction of the FORTA score, the improvement of BI, or over- and undertreatment errors (p > 0.05). In women only, the FORTA intervention significantly increased the number of patients without an ADE (p = 0.010). Statistical sex equivalence was found for the improvement of the FORTA scores, BI, and the number of prevented events (e.g., falls, confusion, or renal failure) (p < 0.05), but not for the improvement of specific mistreatments or over- and undertreatment scores under altered inclusion criteria (p > 0.05). Conclusions Both sexes benefit equally from the FORTA intervention regarding the amelioration of the quality of drug treatment as well as several clinically relevant outcomes. In addition, the positive impact of the FORTA intervention on the number of adverse drug events appears to be greater in women. Trial Registration Number DRKS00000531.
      PubDate: 2022-03-16
       
  • Indapamide-Induced Rhabdomyolysis: An Evaluation of Case Reports in
           VigiBase Using the Bradford Hill Criteria

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      Abstract: Background Indapamide can cause hypokalaemia and hyponatraemia. Rhabdomyolysis associated with these electrolyte abnormalities has been reported. Objective The aim of this study was to assess causal association between the use of indapamide and the occurrence of rhabdomyolysis using the Bradford Hill criteria. Methods Variables in the rhabdomyolysis case reports and literature were reviewed. Bradford Hill criteria were used in the assessment of causal association. Results Up to 11 November 2020, there were 28 unique cases in VigiBase from 13 countries reporting indapamide-associated rhabdomyolysis. In 18 of these cases, hypokalaemia (n = 14) or hyponatremia (n = 8) was a co-reported event, including four cases where both of these events were reported. Indapamide was the only suspected drug in nine of these 18 cases and positive dechallenge was mentioned in 13 of them. In addition, there were risk factors such as falls, concomitant drugs with risk of hypokalaemia, or muscle injury. In two cases, liquorice (containing glycyrrhizin) was concomitantly used with indapamide before hypokalaemia and rhabdomyolysis occurred. Thiazide diuretics, known to cause hypokalaemia, showed similar disproportionality patterns as indapamide regarding rhabdomyolysis and myopathy, while calcium channel blockers (not causing hypokalaemia), had lower disproportionality values than indapamide. Conclusions Based on the review of case series and causality assessment using Bradford Hill criteria, indapamide may cause rhabdomyolysis due to hypokalaemia or hyponatremia. Considering the seriousness of the reported cases, health care professionals should be aware of this potential risk following indapamide intake, particularly when there are risk factors for hypokalaemia and hyponatremia such as excessive liquorice consumption. A similar risk of muscle injuries may apply to thiazide diuretics as well.
      PubDate: 2022-03-02
       
  • Use of Drugs with Anticholinergic Properties at Hospital Admission
           Associated with Mortality in Older Patients: A Danish Nationwide
           Register-Based Cohort Study

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      Abstract: Background Use of drugs with anticholinergic properties (DAP) has a negative impact on older people. Objective Our aim was to examine the association between DAP at hospital admission and mortality in older patients. Patients and Methods We performed a nationwide population-based cohort study including patients aged ≥ 65 years admitted to Danish geriatric medicine departments during 2005–2014. National health registers were used to link with individual-level data. Patients were followed to emigration, death, or study termination (31 December 2015). DAP was defined as medications included in the anticholinergic cognitive burden (ACB) scale, which assigns each DAP a score between 1 and 3. The individual ACB score was calculated and the number of DAP counted. We used Cox proportional-hazard regressions to estimate the crude and adjusted hazard ratios adjusting for age, activities of daily living, marital status, index admission period, BMI, and prior hospitalizations (model 1), and additionally Charlson Comorbidity Index (model 2). Results We included 74,589 patients aged (median [IQR]) 83 (77–88) years. Use of one or more DAP (62.5%) was associated with increased mortality compared with those with no use (p < 0.001). In the fully adjusted model 2, compared with no use, higher mortality risks (HR [95% CI]) were seen with ACB score of 2 and number of DAP ≥ 5 for 30-day (1.46 [1.32–1.61] and 1.46 [1.09–1.95]), 1-year (1.34 [1.28–1.41] and 1.48 [1.29–1.70]), and overall mortality (1.27 [1.23–1.31] and 1.44 [1.31–1.59]), respectively. Conclusions Use of DAP at hospital admission is associated with short- and long-term mortality in geriatric patients. Deprescribing studies are warranted to study whether the impact on mortality can be attenuated.
      PubDate: 2022-03-01
      DOI: 10.1007/s40801-021-00270-7
       
  • Effectiveness and Tolerability of Fondaparinux vs Enoxaparin in a
           Population of Indian Patients with Symptomatic Deep Vein Thrombosis: A
           Retrospective Real-World Study

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      Abstract: Background Fondaparinux is the first approved anticoagulant drug among factor Xa inhibitors, with proven effectiveness and safety in preventing deep vein thrombosis. However, limited data are available supporting the benefit-risk profile of fondaparinux vs enoxaparin in a real-world group of Indian patients with deep vein thrombosis. Objective To compare the effectiveness and tolerability of fondaparinux vs enoxaparin in patients with symptomatic deep vein thrombosis in a long-term real-world setting. Methods Data from the electronic medical records of adult patients diagnosed with deep vein thrombosis prescribed fondaparinux (n = 503) or enoxaparin (n = 508) as monotherapy were analyzed. Effectiveness was analyzed in terms of recurrence, duration, and type of deep vein thrombosis event, and tolerability as bleeding events at initial hospitalization and follow-up visits up to 3 months duration. Appropriate statistical methods were used to determine the significance (p < 0.05) between the two groups. Results The deep vein thrombosis recurrence in the fondaparinux group was non-inferior (2.78%) when compared with enoxaparin (3.76%), with a mean duration of 47 and 48 days, respectively. The number of events and mean duration of events (in days) were not significant (p > 0.05). Major bleeding events were higher in the enoxaparin group at 3.17% than the fondaparinux group at 2.19%, and the difference was not statistically significant (p > 0.05). Conclusions The weight-based, once-daily subcutaneous fondaparinux dose showed non-inferior effectiveness and a comparable tolerability profile when compared with the twice-daily enoxaparin dose for the management of symptomatic deep vein thrombosis.
      PubDate: 2022-03-01
      DOI: 10.1007/s40801-021-00273-4
       
  • Adverse Drug Reactions with HER2-Positive Breast Cancer Treatment: An
           Analysis from the Italian Pharmacovigilance Database

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      Abstract: Background Anti-HER2 therapy has evolved in the last years and an important role in this transformation was that of monoclonal antibodies and tyrosine kinase inhibitors. Considering their extended use in clinical practice, some toxicity problems have been highlighted around these drugs. Objective To analyze the onset of adverse drug reactions (ADRs) related to the use of HER2-positive breast cancer treatments through a spontaneous reporting system (SRS) database. Methods All ADR reports having as suspected drug trastuzumab, pertuzumab, lapatinib, or trastuzumab emtansine (TDM-1), recorded into the Report Reazioni Avverse dei Medicinali (RAM) system database for national data and into the Italian SRS database for Sicilian data and collected from 2006 to 2020 have been evaluated. A descriptive analysis of basal demographic and drug-related characteristics was performed. A case-by-case methodology was conducted paying particular attention to the serious ADR reports collected in Sicily, focusing on type of seriousness, age, sex, concomitant drugs, comorbidities, time to onset (TTO), and time to resolution (TTR). Results Of the 3609 Italian reports, 65.6% were related to trastuzumab (n = 2367), followed by pertuzumab, TDM-1, and lapatinib. Almost all reports occurred in female patients (94.3%) and were most frequent in the age group 18–65 years (69.6%). A higher number of cases were related to general disorders and administration site conditions (n = 1079; 29.9%), gastrointestinal disorders (n = 1037; 28.7%), skin disorders (n = 821; 22.7%), and blood disorders (n = 599; 16.6%). Cases involving trastuzumab and pertuzumab mainly reported general disorders (n = 788; 33.3% and n = 194; 32.1%, respectively) while more than half of the reports associated with lapatinib were related to gastrointestinal (n = 184; 59.7%) and skin diseases (n = 146; 47.4%). Regarding TDM-1, 40% of reports had at least one ADR belonging to blood and lymphatic system disorders. The case-by-case assessment of Sicilian ADR reports showed that 40 cases were serious (33.3%), with a median TTO of 37 (6–97) days. Serious ADR reports mainly involved the onset of thrombocytopenia (n = 8; 20.0%), diarrhea (n = 6; 15.0%), asthenia and cardiac failure (both with n = 5; 12.5%), vomiting, hypersensitivity, and ejection fraction decreased (all with n = 4; 10.0%) and stomatitis (n = 3: 7.5%). Conclusion This study is fundamentally consistent with results from the literature. Given the serious clinical condition of breast cancer and taking into account the importance of preventing some clinically relevant ADRs related to the use of anti-HER2 therapy, further analyses are essential to better describe the safety profile of these target therapies.
      PubDate: 2022-03-01
      DOI: 10.1007/s40801-021-00278-z
       
  • Anti-Epileptic Medication Exposure Influences Functional Status in New
           Zealand Stroke Patients: A Retrospective Population-Level Study

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      Abstract: Background Patients who develop seizures after stroke have disproportionately poorer outcomes and increased mortality. Objective Our objective was to investigate whether exposure to anti-epileptic medications influenced long-term functional status after stroke. Methods We used linked health administrative data from a cohort of adult stroke patients in New Zealand. Demographics and prescription information were obtained from the National Minimum Dataset and Pharmaceutical Collection, respectively. Activities of daily living (ADL) scores for the same patients were obtained using the International Resident Assessment Instrument. Beta regression was used to investigate the relationship between anti-epileptic drug (AED) exposure and functional status. Results The study included 3606 patients with a single ischaemic stroke between 2012 and 2017. In total, 15% were dispensed an AED in the 3 months before or after stroke. The adjusted odds ratio (OR) for AED exposure was 1.29 (95% confidence interval [CI] 1.15–1.45). Overall AED exposure, categorical body mass index (BMI), ethnicity, length of hospital stay, and exposure to paracetamol, opioids, anti-psychotics, and anti-nausea medications were significantly associated with changes in the mean ADL score percentages. Considering the exposure timeframe, the ORs for AED exposure only after stroke and for exposure both before and after stroke were 1.52 (95% CI 1.31–1.78) and 1.09 (95% CI 0.93–1.27), respectively. Conclusion Stroke patients with AED exposure had greater odds of a higher ADL score, indicating a poorer long-term functional status than those unexposed to AEDs. The timeframe of exposure impacted on functional status, with patients exposed only after stroke having increased odds of higher ADL scores than those exposed both before and after stroke.
      PubDate: 2022-03-01
      DOI: 10.1007/s40801-021-00280-5
       
  • Safety and Effectiveness of Plerixafor for Peripheral Blood Stem Cell
           Mobilization in Autologous Stem Cell Transplantation: Results of a
           Post-Marketing Surveillance Study

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      Abstract: Background Plerixafor was approved in Japan in 2016 for peripheral blood stem cell (PBSC) mobilization in autologous stem cell transplantation (A-SCT). Objective Our objective was to evaluate the safety and effectiveness of plerixafor in Japanese patients undergoing A-SCT for various indications in real-world practice. Patients and Methods This post-marketing surveillance study included Japanese patients initiating PBSC mobilization with plerixafor for A-SCT. Safety assessments included the incidence of adverse events (AEs) including serious AEs, adverse drug reactions (ADRs), and laboratory variables. Effectiveness assessments were the proportion of patients with the target CD34+ cell yield (≥2 × 106 cells/kg) ≤4 days after plerixafor administration and the number of days required to reach the target CD34+ cell yield. Results In total, 785 patients were registered, and the safety and effectiveness analysis sets comprised 764 and 717 patients, respectively. ADRs occurred in 12.2% of patients, with gastrointestinal disorders (5.5%), laboratory investigations (4.5%), and blood and lymphatic system disorders (3.0%) being the most common. A total of 71.1% of patients had the target CD34+ cell yield within ≤4 days of treatment, with a mean (standard deviation) of 1.3 (0.7) days to reach the target CD34+ cell yield. Over 80% of patients with a baseline CD34+ cell count >2 cells/μL had a target CD34+ cell yield within ≤4 days of treatment. Conclusions This large post-marketing surveillance study provided real-world evidence detailing the safety and effectiveness of plerixafor for PBSC mobilization in Japanese patients undergoing A-SCT. Importantly, no new safety concerns were identified, and the safety profile of plerixafor was consistent with the established profile of this drug.
      PubDate: 2022-03-01
      DOI: 10.1007/s40801-021-00276-1
       
  • Real-World Use and Outcomes of Oral Antiplatelets Among Patients with
           Acute Coronary Syndrome: A Retrospective Cohort Study

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      Abstract: Background Acute coronary syndrome (ACS)-related readmission is an important hospital quality measure. Medication management therapy, especially adherence to antiplatelet agents post discharge, could play an important role in reducing readmission rates. Newer agents such as ticagrelor and prasugrel have been shown, in randomized control trials, to have superior effectiveness to cardiovascular outcomes compared to clopidogrel, but they are more expensive and have more common adverse events such as bleeding and dyspnea. Objective We compared real-world readmission rates and adherence to antiplatelet agents among patients who initiated these agents post discharge. Methods This was a retrospective cohortstudy of patients with an index ACS-related hospitalization between 1 July 2017 and 31 December 2018. Using integrated pharmacy and medical claims data from a large national pharmacy benefits manager for commercially insured adults aged ≥ 18 years, we compared ACS-related readmission and medication adherence (as medication possession ratio (MPR)) among the three agents. ANOVA and logistic regression, controlling for demographics such as age, gender, and Charlson Comorbidity Index, were used to estimate any association between the agents and 365-day readmission rates. Results Of the 948 eligible patients, 86, 342, and 520 were initiated on prasugrel, ticagrelor, and clopidogrel (PTC), respectively. There were 4.7%, 5.3%, and 8.5% readmissions rates in the PTC cohorts, respectively, but these were not statistically significant in either the ANOVA or the logistic regression analyses. MPR was highest in the ticagrelor (88.1%) cohort, followed by the prasugrel (79.1%) and clopidogrel (76.4%) cohorts. Conclusion Ticagrelor cohort had the highest medication adherence. Clopidogrel cohort had the highest readmission rate but the difference with the other cohorts was statistically insignificant.
      PubDate: 2022-03-01
      DOI: 10.1007/s40801-021-00283-2
       
  • Human Papillomavirus Vaccination and Premature Ovarian Failure: A
           Disproportionality Analysis Using the Vaccine Adverse Event Reporting
           System

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      Abstract: Introduction There have been public health concerns about a potential association between human papillomavirus (HPV) vaccines and premature ovarian failure (POF) in young women. Objective To identify a potential safety signal of POF after HPV vaccination using the United States (US) Vaccine Adverse Event Reporting System (VAERS) database. Methods We manually selected relevant MedDRA preferred terms related to POF and identified in VAERS all POF reports in women less than 40 years of age between 2 July 1990 and 14 May 2018, followed by a review of narratives to confirm the cases. We conducted descriptive analyses on age, POF type, HPV vaccine type (HPV2, HPV4, HPV9), time to onset of POF, and dose rank. We described trends in reporting over time and assessed a potential safety signal using the proportional reporting ratio (PRR). Results Of the 228,341 eligible POF reports, 281 (0.1%) were suspected to be associated with HPV vaccines. Median patient age was 15 years (range 11–39 years). POF events consisted mainly of amenorrhea (80.4%) and premature menopause (15.3%). Mean number of reported POF events significantly increased after the first HPV vaccine launch in 2006 with 22.2 POF cases/year up from 1.4 POF cases/year before the launch. PRR was 46.1 (95% confidence interval: 31.7–67.2) and sensitivity analyses yielded similar estimates. Conclusion Our study suggests the presence of a potential safety signal of POF associated with HPV vaccination, which may only be partly attributed to notoriety bias. Due to the well-known limitations of spontaneous reporting data, further investigations are warranted.
      PubDate: 2022-03-01
      DOI: 10.1007/s40801-021-00271-6
       
  • Unintentional Medication Discrepancies at Admission Among Elderly
           Inpatients with Chronic Medical Conditions in Vietnam: A Single-Centre
           Observational Study

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      Abstract: Background Elderly patients are at high risk of unintentional medication discrepancies during transition of care as they are more likely to have multiple comorbidities and chronic diseases that require multiple medications. Objective The aim of the study was to assess the frequency of unintentional medication discrepancies and identify the associated risk factors and potential clinical impact of them in elderly inpatients during hospital admission. Patients and Methods A prospective observational study was conducted from July to December 2018 in an 800-bed geriatric hospital in Hanoi, North Vietnam. Patients over 60 years of age, admitted to one of selected internal medicine wards, taking at least one chronic medication before admission, and staying at least 48 h were eligible for enrollment. Medication discrepancies of chronic medications before and after admission of each participant were identified by a pharmacist using a step-by-step protocol for the medication reconciliation process. The identified discrepancies were then classified as intentional or unintentional by an assessment group comprising a pharmacist and a physician. A logistic regression model was used to identify risk factors of medication discrepancies. Results Among 192 enrolled patients, 328 medication discrepancies were identified, with 87 (26.5%) identified as unintentional. Nearly a third of enrolled patients (32.3%) had at least one unintentional medication discrepancy. The most common unintentional medication discrepancy was omission of drugs (75.9% of 87 medication discrepancies). The logistic regression analysis revealed a positive association between the number of discrepancies at admission and the type of treatment wards. Conclusions Medication discrepancies are common at admission among Vietnamese elderly inpatients. This study highlights the importance of obtaining a comprehensive medication history at hospital admission and supports implementing a medication reconciliation program to reduce the negative impact of medication discrepancy, especially for the elderly population.
      PubDate: 2022-03-01
      DOI: 10.1007/s40801-021-00274-3
       
  • Adverse Drug Reactions in Japanese Patients with End-Stage Heart Failure
           Receiving Continuous Morphine Infusion: A Single-Center Retrospective
           Cohort Study

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      Abstract: Background Opioids have been reported to be effective for refractory dyspnea in patients with advanced heart failure (HF) in the palliative care setting. Objective The aim of this study was to evaluate the incidence of adverse drug reactions (ADRs) and their relationship with morphine dose/duration or renal insufficiency in patients with end-stage HF receiving continuous morphine infusion. Methods We retrospectively studied 38 patients with end-stage HF receiving continuous intravenous or subcutaneous morphine infusion for the relief of breathlessness between 2014 and 2019 (mean age 78 years). The endpoints were nausea/vomiting, respiratory depression, and drowsiness, which are common morphine-related ADRs. Results Of 38 patients with end-stage HF receiving continuous intravenous/subcutaneous morphine infusion, 14 (37%) experienced ADRs. The median estimated glomerular filtration rate (eGFR) was lower in patients with than in those without ADRs (16 [range 9–48] vs. 41 [range 8–133], respectively; p = 0.011). The ADRs with the highest incidence were drowsiness (n = 13), nausea/vomiting (n =5), and respiratory depression (n =3). There were no differences in the maintenance dose or duration of morphine administration between patients with and without ADRs. A baseline eGFR of 32 mL/min/1.73 m2 was a good cutoff value for ADR prediction (sensitivity 86%, specificity 96%). A baseline eGFR < 32 mL/min/1.73 m2 was significantly associated with the occurrence of morphine-related ADRs (odds ratio 6.63, 95% confidence interval 1.19–37.01). Conclusions Our results showed that 37% of patients with end-stage HF receiving continuous intravenous/subcutaneous morphine infusion experienced ADRs, especially drowsiness. Patients with eGFR < 32 mL/min/1.73 m2 were likely to experience morphine-related ADRs.
      PubDate: 2022-03-01
      DOI: 10.1007/s40801-021-00281-4
       
  • Sodium-Glucose Cotransporter-2 Inhibitor Use is Associated with a Reduced
           Risk of Heart Failure Hospitalization in Patients with Heart Failure with
           Preserved Ejection Fraction and Type 2 Diabetes Mellitus: A Real-World
           Study on a Diverse Urban Population

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      Abstract: Background Limited evidence-based therapies exist for the management of heart failure with preserved ejection fraction (HFpEF). Sodium-glucose cotransporter-2 inhibitor (SGLT2i) use in patients with systolic heart failure (HFrEF) and type-2-diabetes mellitus (T2DM) is associated with improved cardiovascular (CV) and renal outcomes. Objective We sought to examine whether there is an association of SGLT2i use with improved CV outcomes in patients with HFpEF. Patients and methods We conducted a single-center, retrospective review of patients with HFpEF and T2DM. The cohort was divided into two groups based on prescription of a SGLT2i or sitagliptin. The primary outcome was heart failure hospitalization (HFH); secondary outcomes were all-cause hospitalization and acute kidney injury (AKI). Results After propensity score matching, there were 250 patients (89 in the SGLT2i group, 161 in the sitagliptin group), with a mean follow-up of 295 days. Univariate Cox regression analysis showed that the SGLT2i group had a reduced risk of HFH versus the sitagliptin group (hazard ratio (HR) 0.13; 95% confidence interval (CI) (0.05–0.36); p < 0.001). The SGLT2i group had a decreased risk of all-cause hospitalization (HR 0.48; 95% CI (0.33–0.70); p < 0.001) and SGLT2i had a lower risk of AKI (HR 0.39; 95% CI (0.20–0.74); p = 0.004). Conclusions The use of SGLT2is is associated with a reduced incidence of HFH and AKI in patients with HFpEF and T2DM.
      PubDate: 2022-03-01
      DOI: 10.1007/s40801-021-00277-0
       
  • Falls and Fractures in Patients with Parkinson’s Disease-Related
           Psychosis Treated with Pimavanserin vs Atypical Antipsychotics: A Cohort
           Study

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      Abstract: Background Parkinson’s disease-related psychosis increases patients’ risk of falls. Pimavanserin is an atypical antipsychotic approved in the USA in 2016 for the treatment of hallucinations and delusions associated with Parkinson’s disease-related psychosis. Objective We aimed to compare the risk of falls/fractures among patients with Parkinson’s disease-related psychosis treated with pimavanserin vs other atypical antipsychotics. Patients and Methods We identified a cohort of patients with Parkinson’s disease-related psychosis aged ≥ 40 years initiating either pimavanserin or a comparator antipsychotic (clozapine, quetiapine, risperidone, olanzapine, aripiprazole, brexpiprazole) in US commercial insurance and supplementary Medicare claims (2015–2019). Comparators were propensity score matched 2:1 with pimavanserin initiators; incidence rates of falls/fractures were compared using incidence rate ratios (IRRs) and 95% confidence intervals (CIs). Results We identified 112 eligible pimavanserin initiators and 982 comparators. Pimavanserin initiators were younger and had fewer severe comorbidities, indicators of impairment, and healthcare encounters, though they had higher Parkinson’s disease medication use. The crude incidence rates [cases/100 person-years] (95% CI) for composite falls/fractures were 17.8 (7.7–35.0) for pimavanserin and 40.8 (35.0–47.4) for comparators. Matching retained 108 pimavanserin initiators and 216 comparators—all characteristics were well balanced after matching—with a matched IRR (pimavanserin vs comparator) of 0.71 (95% CI 0.27–1.67). Sensitivity analysis IRR estimates were consistently below 1.00, with a sensitivity analysis not requiring a diagnosis of psychosis resulting in an IRR estimate of 0.55 (95% CI 0.34–0.86). Conclusions The results of this study do not suggest an increase in the risk of falls or fractures associated with pimavanserin compared with other antipsychotics in patients with Parkinson’s disease-related psychosis. Sensitivity analyses suggest a decreased risk.
      PubDate: 2022-03-01
      DOI: 10.1007/s40801-021-00284-1
       
  • Treatment Patterns in Patients with Locally Advanced or Metastatic
           Non-Small-Cell Lung Cancer Treated with Epidermal Growth Factor
           Receptor-Tyrosine Kinase Inhibitors: Analysis of US Insurance Claims
           Databases

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      Abstract: Background Most patients with epidermal growth factor receptor mutation-positive (EGFRm) non-small-cell lung cancer (NSCLC) acquire resistance to first-line (1L) first- or second-generation (1G/2G) EGFR-TKIs; therefore, it is important to optimize 1L treatment to improve patient outcomes. Objective To retrospectively examine treatment patterns in locally advanced/metastatic NSCLC using MarketScan® Commercial and Medicare Supplemental Databases (all US census regions). Patients and methods Adults with a lung cancer diagnosis code between 1 January 2015–31 March 2018 were analyzed from diagnosis (index) through a variable-length follow-up. Patients had ≥ 1 pharmacy claim for 1G/2G EGFR-TKIs on or within 60 days post-index. Data were stratified by presence or absence of central nervous system (CNS) metastases (30 days pre-index through study end). Results 578 patients were included (median age 63 years, 64% female). Median follow-up was 13.5 months. The most frequently prescribed 1L EGFR-TKI was erlotinib (414/578, 72%). Median time to 1L treatment discontinuation was 8.2 (95% confidence interval (CI) 6.9, 9.0) months in patients diagnosed with CNS metastases at any time, and 7.7 (95% CI 6.9, 8.9) months in patients without CNS metastases. 270/578 patients (47%) discontinued 1L EGFR-TKIs; 209/270 (77%) initiated second-line (2L) therapy, most frequently osimertinib (96/209, 46%). Conclusions In an analysis of US claims data, nearly half of patients discontinued 1L EGFR-TKIs, and 46% who initiated 2L received osimertinib. As nearly a quarter of patients who discontinued 1L EGFR-TKIs did not receive 2L treatment, this study highlights the need for optimal 1L treatment in EGFRm locally advanced/metastatic NSCLC.
      PubDate: 2022-03-01
      DOI: 10.1007/s40801-021-00272-5
       
  • Delirium Associations with Antibiotics: A Pharmacovigilance Study of the
           FDA Adverse Event Reporting System (FAERS)

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      Abstract: Background Ertapenem, cefepime, imipenem, ofloxacin, ceftazidime, clarithromycin, cefaclor, levofloxacin, linezolid, moxifloxacin, azithromycin, piperacillin–tazobactam, trimethoprim–sulfamethoxazole, metronidazole, ciprofloxacin, and cefuroxime are known to be associated with delirium. Other antibiotics may also lead to delirium, but no study has systemically compared delirium associations for many available antibiotics. Objective The objective of this study was to evaluate the association between delirium and antibiotics using the FDA Adverse Event Reporting System (FAERS). Methods FAERS reports from January 1, 2004 to December 31, 2018 were included in the study. Reporting odds ratios (RORs) and corresponding 95% confidence intervals (95% CI) for the association between antibiotics and delirium were calculated. An association was considered to be statistically significant when the lower limit of the 95% CI was greater than 1.0. Results A total of 10,015,622 reports (including 16,982 delirium reports) were considered, after inclusion criteria were applied. Statistically significant delirium RORs (95% CI) for antibiotics were: ertapenem 21.07 (16.38–27.10), cefepime 9.8 (6.37–15.09), imipenem 9.68 (6.75–13.89), ofloxacin 7.73 (4.00–14.92), ceftazidime 6.09 (2.73–13.62), clarithromycin 5.34 (4.37–6.53), cefaclor 5.32 (1.71–16.58), ampicillin–sulbactam 4.49 (2.13–9.45), levofloxacin 4.47 (3.88–5.16), linezolid 4.33 (3.28–5.72), moxifloxacin 3.51 (2.81–4.38), azithromycin 2.76 (2.09–3.64), piperacillin–tazobactam 2.41 (1.47–3.93), trimethoprim–sulfamethoxazole 2.36 (1.61–3.47), metronidazole 1.85 (1.31–2.60), ciprofloxacin 1.83 (1.44–2.33), and cefuroxime 1.81 (1.03–3.20). Conclusion This study found statistically significant increased risk of reporting delirium with ertapenem, cefepime, imipenem, ofloxacin, ceftazidime, clarithromycin, cefaclor, ampicillin–sulbactam, levofloxacin, linezolid, moxifloxacin, azithromycin, piperacillin–tazobactam, trimethoprim–sulfamethoxazole, metronidazole, ciprofloxacin, and cefuroxime.
      PubDate: 2022-03-01
      DOI: 10.1007/s40801-021-00268-1
       
  • Reporting Rates of Opioid-Related Adverse Events Since 1965 in Canada: A
           Descriptive Retrospective Study

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      Abstract: Background Patients with chronic or acute/postoperative pain frequently use opioids. However, opioids may cause considerable adverse reactions (ARs), such as respiratory depression, which could be lethal. Unfortunately, only 5% of drug-related ARs (including those to opioids) are reported to health authorities. Therefore, little is known regarding the occurrence of opioid-related ARs at the population level. Objective The aim of this study was to investigate how the rates of reported opioid-related ARs have changed in Canada since 1965. Methods Our retrospective study examined trends of reported opioid-related ARs occurring in hospitalized and outpatients. Data on opioid-related ARs and mortality between 1965 and 2019 were obtained from the Canada Vigilance and Statistics Canada databases. Descriptive and Joinpoint regression analyses were performed. Results Oxycodone and normethadone were the most and least involved opioid agents, respectively, among the 18,407 reported ARs. The highest rate of reported opioid ARs (3.8 per 100,000 person-years) was recorded in 2012, whereas the lowest was recorded in 1965 (0.1 per 100,000 person-years). Between 1965 and 2019, annual rates climbed by 4.2% (95% confidence interval [CI] 3.1–5.2), and many fluctuations were observed: 1965–1974: +22.3% (95% CI 12.0–33.6); 1974–2000: − 4.1% (95% CI − 5.3 to − 2.9); 2000–2008: +30.3% (95% CI 22.6–38.4); 2008–2014: +4.1% (95% CI − 1.5 to 10.1); 2014–2017: −26.0% (95% CI − 44.7 to − 0.9); and, finally, 2017–2019: +35.4% (95% CI 3.8–76.7). Conclusion Reported opioid-related ARs have increased since 1965, although fluctuations were observed in recent decades. The absolute number of opioid-related ARs might be seriously underestimated. Future studies should look into how to close this gap.
      PubDate: 2022-03-01
      DOI: 10.1007/s40801-021-00275-2
       
 
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