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Journal Cover Drugs
  [SJR: 1.601]   [H-I: 139]   [159 followers]  Follow
    
   Full-text available via subscription Subscription journal
   ISSN (Print) 0012-6667 - ISSN (Online) 1179-1950
   Published by Adis Homepage  [20 journals]
  • Acalabrutinib: First Global Approval
    • Abstract: Acerta Pharma is developing the Bruton’s tyrosine kinase inhibitor acalabrutinib (Calquence®) for the treatment of various haematological and solid malignancies. The drug has received accelerated approval from the US FDA for the treatment of mantle cell lymphoma based on the results of a phase II study, and phase III trials in mantle cell lymphoma and chronic lymphocytic leukaemia are currently underway. This article summarizes the milestones in the development of acalabrutinib leading to this first approval for mantle cell lymphoma.
      PubDate: 2017-12-05
       
  • Preservative-Free Prostaglandin Analogs and Prostaglandin/Timolol Fixed
           Combinations in the Treatment of Glaucoma: Efficacy, Safety and Potential
           Advantages
    • Abstract: Glaucoma therapy-related ocular surface disease (OSD) is a serious pathology with a broad spectrum of insidious clinical presentations and complex pathogenesis that undermines long-term glaucoma care. Preservatives, especially benzalkonium chloride (BAK), contained in topical intraocular pressure-lowering medications frequently cause or aggravate OSD in glaucoma. Management of these patients is challenging, and to date often empirical due to the scarcity of controlled long-term clinical trials. Most of the available data are extracted from case series and retrospective analysis. Preservative-free prostaglandins and prostaglandin/timolol fixed combinations are novel options developed to remove the harmful impact of preservatives, especially BAK, upon ocular tissues. Based on what is currently known on the value of preservative-free antiglaucoma therapies it is tempting to speculate how these new therapies may affect the future medical management of all glaucoma patients. This article provides a comprehensive and critical review of the current literature on preservative-free prostaglandins and preservative-free prostaglandin/timolol fixed combinations.
      PubDate: 2017-12-01
       
  • Current and New Therapeutic Strategies for Relapsed and Refractory
           Multiple Myeloma: An Update
    • Abstract: Although survival of multiple myeloma patients has at least doubled during recent years, most patients eventually relapse, and treatment at this stage may be particularly complex. At the time of relapse, the use of alternative drugs to those given upfront is current practice. However, many new options are currently available for the treatment of relapsed multiple myeloma, including recently approved drugs, such as the second- and third-generation proteasome inhibitors carfilzomib and ixazomib, the immunomodulatory agent pomalidomide, the monoclonal antibodies daratumumab and elotuzumab and the histone deacetylase inhibitor panobinostat, but also new targeted agents are under active investigation (e.g. signal transduction modulators, kinesin spindle protein inhibitors, and inhibitors of NF-kB, MAPK, AKT). We here describe a new paradigm for the treatment of relapsed multiple myeloma. The final goal should be finding a balance among efficacy, toxicity, and cost and, at the end of the road, achieving long-lasting control of the disease and eventually even cure in a subset of patients.
      PubDate: 2017-11-29
       
  • Aripiprazole Lauroxil: A Review in Schizophrenia
    • Abstract: Aripiprazole lauroxil long-acting injectable (LAI) [Aristada®] is an intramuscularly administered, extended-release prodrug of aripiprazole, an established atypical antipsychotic agent that, in terms of its relative position within the class, is at the low end of the risk spectrum for metabolic side effects. In the USA, aripiprazole lauroxil LAI is indicated for the treatment of schizophrenia; approved doses of the drug can be injected once-monthly (q4w), every 6 weeks (q6w) or every 2 months (q8w). The efficacy of the 441 and 882 mg q4w dosages in the treatment of acute exacerbations of schizophrenia and as long-term maintenance therapy in stable schizophrenia has been directly demonstrated in a phase III clinical trial and extension, while the efficacy of the 662 mg q4w, 882 mg q6w and 1064 mg q8w dosing regimens has been established on the basis of pharmacokinetic bridging studies. Aripiprazole lauroxil LAI therapy was generally well tolerated, with an adverse event profile consistent with that of oral aripiprazole (with the exception of injection-site reactions), including a low propensity to cause metabolic disturbances. Thus, aripiprazole lauroxil LAI extends the treatment regimen options for patients with schizophrenia; as with other LAI formulations of antipsychotic agents, it can be particularly recommended for patients with recurrent relapses related to nonadherence to oral preparations and for those who prefer this mode of administration. Moreover, unlike aripiprazole monohydrate LAI, the only other commercially available long-acting formulation of aripiprazole, aripiprazole lauroxil LAI offers more than one dosing interval option, which may be a potential advantage in terms of tailoring therapy to the needs of individual patients.
      PubDate: 2017-11-25
       
  • Triptorelin: A Review of its Use as an Adjuvant Anticancer Therapy in
           Early Breast Cancer
    • Abstract: A 1-month formulation of the gonadotrophin-releasing hormone agonist (GnRHa) triptorelin (Decapeptyl®) has been approved in the EU as an adjuvant treatment in combination with tamoxifen or an aromatase inhibitor (AI), of endocrine-responsive, early-stage breast cancer in women at high risk of recurrence who are confirmed as premenopausal after completion of chemotherapy. This indication reflects the results of the 5-year SOFT and TEXT studies, especially SOFT, in which ovarian function suppression (OFS; mainly achieved with triptorelin) added to tamoxifen provided a significant benefit in the overall study population of premenopausal patients only after adjusting for prognostic factors. It emerged that adding OFS to tamoxifen produced more pronounced benefits in terms of disease control and, furthermore, increased overall survival in the cohort of higher-risk patients who had previously received chemotherapy. Also, compared with tamoxifen alone, the combination of OFS plus exemestane produced more pronounced benefits in terms of disease control than OFS plus tamoxifen. OFS induces premature menopause; when combined with either tamoxifen or exemestane, it increased the endocrine symptom burden. Nonetheless, the two combinations had distinct tolerability profiles (e.g. vasomotor symptoms and thromboembolic events were more frequent with OFS plus tamoxifen, whereas musculoskeletal symptoms, decreased libido, osteoporosis and fractures were more frequent with OFS plus exemestane). Thus, the combinations of OFS (with triptorelin) plus either tamoxifen or an AI are valid options for the adjuvant treatment of endocrine-responsive, early-stage breast cancer in women at sufficiently high risk of relapse to warrant receiving chemotherapy and who remain premenopausal thereafter. Individualized weighing of the potential benefits and adverse effects of treatment is required.
      PubDate: 2017-11-25
       
  • Correction to: Opicapone: A Review in Parkinson’s Disease
    • Abstract: Parkinson’s disease (PD) is the most common chronic, progressive, neurodegenerative disease, with a mean age of onset of 57 years [1, 2].
      PubDate: 2017-11-21
       
  • Correlation of Opioid Mortality with Prescriptions and Social
           Determinants: A Cross-sectional Study of Medicare Enrollees
    • Abstract: Background The opioid epidemic is an escalating health crisis. We evaluated the impact of opioid prescription rates and socioeconomic determinants on opioid mortality rates, and identified potential differences in prescription patterns by categories of practitioners. Methods We combined the 2013 and 2014 Medicare Part D data and quantified the opioid prescription rate in a county level cross-sectional study with data from 2710 counties, 468,614 unique prescribers and 46,665,037 beneficiaries. We used the CDC WONDER database to obtain opioid-related mortality data. Socioeconomic characteristics for each county were acquired from the US Census Bureau. Results The average national opioid prescription rate was 3.86 claims per beneficiary that received a prescription for opioids (95% CI 3.86–3.86). At a county level, overall opioid prescription rates (p < 0.001, Coeff = 0.27) and especially those provided by emergency medicine (p < 0.001, Coeff = 0.21), family medicine physicians (p = 0.11, Coeff = 0.008), internal medicine (p = 0.018, Coeff = 0.1) and physician assistants (p = 0.021, Coeff = 0.08) were associated with opioid-related mortality. Demographic factors, such as proportion of white (p white < 0.001, Coeff = 0.22), black (p black < 0.001, Coeff = − 0.19) and male population (p male < 0.001, Coeff = 0.13) were associated with opioid prescription rates, while poverty (p < 0.001, Coeff = 0.41) and proportion of white population (p white < 0.001, Coeff = 0.27) were risk factors for opioid-related mortality (p model < 0.001, R 2 = 0.35). Notably, the impact of prescribers in the upper quartile was associated with opioid mortality (p < 0.001, Coeff = 0.14) and was twice that of the remaining 75% of prescribers together (p < 0.001, Coeff = 0.07) (p model = 0.03, R 2 = 0.03). Conclusions The prescription opioid rate, and especially that by certain categories of prescribers, correlated with opioid-related mortality. Interventions should prioritize providers that have a disproportionate impact and those that care for populations with socioeconomic factors that place them at higher risk.
      PubDate: 2017-11-20
       
  • Ticagrelor: A Review in Long Term Secondary Prevention of Cardiovascular
           Events
    • Abstract: Ticagrelor (Brilique®) is an orally administered P2Y12 inhibitor. A long-term (maintenance) regimen of ticagrelor 60 mg twice daily is indicated in the EU for coadministration with low-dose aspirin 75–150 mg/day for the secondary prevention of atherothrombotic events in high-risk patients with a history of myocardial infarction (MI) of at least 1 year. Approval is based on the results of the PEGASUS-TIMI 54 trial that compared ticagrelor with placebo (in conjunction with low-dose aspirin) in stable patients who had had a spontaneous MI 1–3 years prior to enrolment and were at high risk of atherothrombotic events. At 3 years, the composite primary efficacy endpoint of cardiovascular (CV) death, MI or stroke occurred in significantly fewer ticagrelor 60 mg twice daily than placebo recipients. Long-term ticagrelor had a manageable tolerability and safety profile. The risk of TIMI major bleeding (primary safety endpoint) was significantly increased in ticagrelor 60 mg twice daily versus placebo recipients; however, the risk appeared to decline after the first year of therapy. Landmark analyses have demonstrated that patients with a history of MI remain at a persistent high risk of the composite primary endpoint up to 5 years after the event. Furthermore, these analyses demonstrated that the efficacy of ticagrelor 60 mg twice daily was maintained over time, with less excess in bleeding after the first year. Thus, long-term dual antiplatelet therapy with ticagrelor 60 mg twice daily and low-dose aspirin is a valuable new option for the secondary prevention of atherothrombotic events in stable, high-risk patients with a history of MI of at least 1 year.
      PubDate: 2017-11-18
       
  • Middle East Respiratory Syndrome and Severe Acute Respiratory Syndrome:
           Current Therapeutic Options and Potential Targets for Novel Therapies
    • Abstract: No specific antivirals are currently available for two emerging infectious diseases, Middle East respiratory syndrome (MERS) and severe acute respiratory syndrome (SARS). A literature search was performed covering pathogenesis, clinical features and therapeutics, clinically developed drugs for repurposing and novel drug targets. This review presents current knowledge on the epidemiology, pathogenesis and clinical features of the SARS and MERS coronaviruses. The rationale for and outcomes with treatments used for SARS and MERS is discussed. The main focus of the review is on drug development and the potential that drugs approved for other indications provide for repurposing. The drugs we discuss belong to a wide range of different drug classes, such as cancer therapeutics, antipsychotics, and antimalarials. In addition to their activity against MERS and SARS coronaviruses, many of these approved drugs have broad-spectrum potential and have already been in clinical use for treating other viral infections. A wealth of knowledge is available for these drugs. However, the information in this review is not meant to guide clinical decisions, and any therapeutic described here should only be used in context of a clinical trial. Potential targets for novel antivirals and antibodies are discussed as well as lessons learned from treatment development for other RNA viruses. The article concludes with a discussion of the gaps in our knowledge and areas for future research on emerging coronaviruses.
      PubDate: 2017-11-15
       
  • Effects of Allopurinol on Endothelial Function: A Systematic Review and
           Meta-Analysis of Randomized Placebo-Controlled Trials
    • Abstract: Introduction Uric acid (UA), the final product of purine catabolism, may be associated with an increased risk of cardiovascular disease. Aim The aim of this meta-analysis of randomized placebo-controlled trials was to evaluate whether lowering serum UA (SUA) levels with allopurinol is associated with improved flow-mediated dilation (FMD), a validated marker of early vascular damage. Methods A literature search was carried out from inception until 20 June 2017. Meta-analysis was performed using an inverse variance-weighted, random-effects model with standardized mean difference (SMD) as the effect size estimate. Results Meta-analysis of data from the ten eligible randomized controlled trials (RCTs), with 670 subjects, suggested a significant increase in FMD following allopurinol treatment (weighted mean difference [WMD] 1.79%, 95% confidence interval [CI] 1.01–2.56, p < 0.001; I 2: 86.77%). The effect size was robust and remained significant after omission of each single study. Subgroup analyses of RCTs based on the administered dose or duration of treatment did not reveal any significant impact of these variables on FMD change. Nor was a significant association found between allopurinol-induced changes in SUA levels and FMD (slope 0.46, p = 0.253), whereas baseline FMD significantly influenced the degree of FMD improvement following allopurinol treatment (slope 0.52, p = 0.022). Nitroglycerin-mediated dilation was not altered by allopurinol treatment (WMD 0.88%, 95% CI − 1.15–2.91, p = 0.395; I 2: 80.88%). Conclusion This meta-analysis of available RCTs suggests a significant benefit from allopurinol intake in increasing FMD in humans, independent of its effect on SUA levels.
      PubDate: 2017-11-14
       
  • Tofacitinib: A Review in Rheumatoid Arthritis
    • Abstract: Tofacitinib (Xeljanz®) is a potent, selective JAK inhibitor that preferentially inhibits Janus kinase (JAK) 1 and JAK3. In the EU, oral tofacitinib 5 mg twice daily is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to, or who are intolerant of, one or more DMARDs. Several clinical studies of ≤ 24 months’ duration showed that tofacitinib monotherapy (as first- or second-line treatment) and combination therapy with a conventional synthetic DMARD (csDMARD; as second- or third-line treatment) was effective in reducing signs and symptoms of disease and improving health-related quality of life (HR-QOL), with benefits sustained during long-term therapy (≤ 96 months). Tofacitinib monotherapy inhibited progression of structural damage in methotrexate-naïve patients during ≤ 24 months’ treatment, with beneficial effects also seen in patients receiving tofacitinib plus methotrexate as second-line therapy for 12 months. Tofacitinib was generally well tolerated during ≤ 114 months’ treatment, with most adverse events of mild or moderate severity. The tolerability profile of tofacitinib was generally similar to that of biological DMARDs (bDMARDs), with infections and infestations the most common adverse events (AEs) in tofacitinib recipients. However, the incidence of herpes zoster (HZ) was higher with tofacitinib than in the general RA population, although infections were clinically manageable. When added to background methotrexate, tofacitinib was noninferior to adalimumab in terms of efficacy, and both combination therapies had generally similar tolerability profiles. Although additional comparative studies are needed to more definitively position tofacitinib relative to bDMARDs and other targeted synthetic DMARDs, current evidence indicates that oral tofacitinib is a useful option for the treatment of patients with RA.
      PubDate: 2017-11-14
       
  • Pharmacological Approach to the Management of Crohn’s Disease
           Patients with Perianal Disease
    • Abstract: Perianal localization of Crohn’s disease involves significant morbidity, affects quality of life and results in an increased use of healthcare resources. Medical and surgical therapies contribute to its management. The objective of this review is to address the current understanding in the management of perianal Crohn’s disease, with the main focus in reviewing pharmacological therapies, including stem cells. In complex fistulas, once local sepsis has been controlled by surgical drainage and/or antibiotics, anti-TNF drugs (infliximab, adalimumab) are the first-line therapy, with or without associated immunomodulators. Combining surgery and anti-TNF therapy has additional benefits for healing. However, response is inadequate in up to half of cases. A possible role of new biological drugs in this context (vedolizumab, ustekinumab) is an area of ongoing investigation, as is the local application of autologous or allogeneic mesenchymal stem cells. These are non-hematopoietic multipotent cells with anti-inflammatory and immunomodulatory properties, the use of which may successfully treat refractory patients, and seem to be a promising and safe alternative to achieving fistula healing in Crohn’s disease, without known systemic effects.
      PubDate: 2017-11-14
       
  • Abemaciclib: First Global Approval
    • Abstract: Abemaciclib (Verzenio™) is an orally administered inhibitor of cyclin-dependent kinases 4 and 6 that is being developed by Eli Lilly and Company. Abemaciclib has been approved in the USA for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, in combination with fulvestrant in women with disease progression following endocrine therapy, and as monotherapy in adult patients with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting. In addition, abemaciclib is in various stages of development internationally for a variety of cancers. This article summarizes the milestones in the development of abemaciclib leading to its first approval for the treatment of patients with HR-positive, HER2-negative advanced or metastatic breast cancer.
      PubDate: 2017-11-11
       
  • Copanlisib: First Global Approval
    • Abstract: Bayer are developing copanlisib (Aliqopa™)—a pan-class I phosphoinositide 3-kinase (PI3K) inhibitor—as a treatment for various haematological and solid malignancies. The US FDA has granted copanlisib accelerated approval for the treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies based on the results of a phase II trial. Phase III trials are underway evaluating copanlisib as treatment for relapsed/refractory diffuse large B-cell lymphoma and in combination with rituximab or rituximab-based chemotherapy or standard immunochemotherapy in patients with relapsed indolent B-cell non-Hodgkin’s lymphoma. Phase I/II studies are underway in relapsed or refractory peripheral T-cell or NK/T-cell lymphoma, advanced cholangiocarcinoma, hormone receptor-positive HER2-negative stage I-IV breast cancer, HER2-positive breast cancer and recurrent and/or metastatic head and neck squamous cell carcinomas harbouring a PI3KCA mutation/amplification and/or a PTEN loss. This article summarizes the milestones in the development of copanlisib leading to this first approval for relapsed follicular lymphoma.
      PubDate: 2017-11-10
       
  • Acknowledgement to Referees
    • PubDate: 2017-11-10
       
  • Daratumumab: A Review in Relapsed and/or Refractory Multiple Myeloma
    • Abstract: Intravenous daratumumab (DARZALEX®) is a first-in-class human IgG1κ monoclonal antibody against CD38 available for use in patients with relapsed and/or refractory multiple myeloma. In phase I/II and II trials and a pooled analysis of these studies, daratumumab monotherapy induced an overall response (partial response or better) in approximately one-third of patients; responses were rapid, deep and durable. An overall survival (OS) benefit was seen with daratumumab monotherapy, including in patients with a minimal response or stable disease. In phase III trials, daratumumab in combination with either bortezomib plus dexamethasone or lenalidomide plus dexamethasone significantly prolonged progression-free survival and induced deep and durable responses compared with bortezomib plus dexamethasone or lenalidomide plus dexamethasone. An OS benefit with daratumumab triple combination therapy is yet to be demonstrated (as the OS data were not mature at the time of the last analysis). Daratumumab was generally well tolerated when used as monotherapy and had a generally manageable tolerability profile when used in combination therapy. Infusion-related reactions (IRRs) were the most common adverse events; these were predominantly grade 1 or 2 and mostly occurred during the first infusion. The most common grade 3–4 adverse events associated with daratumumab triple combination therapy were thrombocytopenia, neutropenia and anaemia. Although final OS data are awaited, current evidence indicates that daratumumab is a valuable addition to the treatment options currently available for patients with relapsed or refractory multiple myeloma.
      PubDate: 2017-11-10
       
  • Nonacog Beta Pegol: A Review in Haemophilia B
    • Abstract: Nonacog beta pegol [Refixia® (EU)] is an intravenously-administered, glycoPEGylated recombinant factor IX (FIX), with an extended terminal half-life. It is approved in the EU for the treatment and prophylaxis of bleeding in patients aged ≥ 12 years with haemophilia B. The therapeutic efficacy and safety of nonacog beta pegol was demonstrated in the phase 3 Paradigm trials in previously treated adolescents and adults with haemophilia B. In Paradigm 2, nonacog beta pegol showed good haemostatic effects when treating bleeds on-demand, and reduced annualized bleeding rates when used as a once-weekly prophylaxis. It also improved some health-related quality of life measures in adult patients. The longer-term efficacy of nonacog beta pegol was demonstrated in the open-label extension Paradigm 4 trial. In Paradigm 3, nonacog beta pegol effectively maintained intraoperative and postoperative haemostasis. Nonacog beta pegol was well tolerated in phase 3 clinical trials in patients with haemophilia B, with no evidence of FIX inhibitor formation, allergic reactions or thromboembolic complications. In conclusion, nonacog beta pegol is effective and well tolerated in the on-demand, prophylaxis and perioperative settings in adolescent and adults with haemophilia B. Its extended half-life allows for once-weekly prophylaxis. Therefore, nonacog beta pegol is a useful additional treatment option for patients with haemophilia B.
      PubDate: 2017-11-09
       
  • Ciclosporin Ophthalmic Emulsion 0.1%: A Review in Severe Dry Eye Disease
    • Abstract: Ciclosporin ophthalmic emulsion 0.1% (hereafter referred to as ciclosporin 0.1%) [Ikervis®] is an unpreserved cationic emulsion formulation containing an 0.1% concentration of ciclosporin. It has been approved in various countries worldwide, including those of the EU, for the treatment of severe keratitis in adults with dry eye disease, which has not improved despite treatment with tear substitutes. In a multinational, phase III study in this patient population, once-daily ciclosporin 0.1% was associated with statistically significant and clinically relevant improvements in the signs (corneal surface damage and ocular surface inflammation) of dry eye disease relative to vehicle during the first 6-month treatment period. These beneficial effects were maintained or improved in a subsequent 6-month period, with data suggesting sustainability following treatment discontinuation in a 24-month, phase III extension study. Ciclosporin 0.1% was well tolerated in these studies, with instillation-site pain (which was mostly mild in severity) being the most frequently reported ocular treatment-related adverse event. There were no findings to suggest the systemic absorption of ciclosporin. Thus, once-daily ciclosporin 0.1% is an effective and well tolerated option for the treatment of severe keratitis in adults with dry eye disease.
      PubDate: 2017-11-06
       
  • Progress in Elucidating Biomarkers of Antidepressant Pharmacological
           Treatment Response: A Systematic Review and Meta-analysis of the Last 15
           Years
    • Abstract: Background Antidepressant drugs are widely prescribed, but response rates after 3 months are only around one-third, explaining the importance of the search of objectively measurable markers predicting positive treatment response. These markers are being developed in different fields, with different techniques, sample sizes, costs, and efficiency. It is therefore difficult to know which ones are the most promising. Objective Our purpose was to compute comparable (i.e., standardized) effect sizes, at study level but also at marker level, in order to conclude on the efficacy of each technique used and all analyzed markers. Methods We conducted a systematic search on the PubMed database to gather all articles published since 2000 using objectively measurable markers to predict antidepressant response from five domains, namely cognition, electrophysiology, imaging, genetics, and transcriptomics/proteomics/epigenetics. A manual screening of the abstracts and the reference lists of these articles completed the search process. Results Executive functioning, theta activity in the rostral Anterior Cingular Cortex (rACC), and polysomnographic sleep measures could be considered as belonging to the best objectively measured markers, with a combined d around 1 and at least four positive studies. For inter-category comparisons, the approaches that showed the highest effect sizes are, in descending order, imaging (combined d between 0.703 and 1.353), electrophysiology (0.294–1.138), cognition (0.929–1.022), proteins/nucleotides (0.520–1.18), and genetics (0.021–0.515). Conclusion Markers of antidepressant treatment outcome are numerous, but with a discrepant level of accuracy. Many biomarkers and cognitions have sufficient predictive value (d ≥ 1) to be potentially useful for clinicians to predict outcome and personalize antidepressant treatment.
      PubDate: 2017-11-02
       
  • Authors’ Reply to Yilmaz and Türk: “Targeting the PGD 2 /CRTH 2 /DP 1
           Signaling Pathway in Asthma and Allergic Disease: Current Status and
           Future Perspectives”
    • PubDate: 2017-10-04
       
 
 
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