Drug Safety最新文献

{"title":"Assessment of Pharmacovigilance Across University Hospitals in Morocco.","authors":"Hind Hamzaoui, Anna Shaum, Imad Cherkaoui, Latifa Ait Moussa, Houda Sefiani, Ismail Talibi, Ghita Benabdallah, Omar Salman, Seth Ferrey, Rachida Soulaymani Bencheikh","doi":"10.1007/s40264-025-01517-w","DOIUrl":"10.1007/s40264-025-01517-w","url":null,"abstract":"<p><strong>Introduction: </strong>Despite the increased scrutiny on vaccine safety following the coronavirus disease 2019 (COVID-19) pandemic, Morocco's Centre of Antipoison and Pharmacovigilance (CAPM) remained concerned that the pharmacovigilance system in Morocco was insufficiently implemented, including limited adverse event (AE) reporting, poor data use, and inconsistent training nationwide.</p><p><strong>Objectives: </strong>We sought to assess the status of pharmacovigilance activities (PAs) prior to formally institutionalizing them across university hospital centers (UHCs), given their position as the main providers of healthcare in Morocco and key sources for reporting serious AEs.</p><p><strong>Methods: </strong>We assessed seven UHCs (housing 30 hospitals) in 2023 using a structured questionnaire with pharmacovigilance focal points developed from the World Health Organization's indicators of pharmacovigilance and the Global Benchmarking Tool. Data were grouped into 28 PAs and scored from 0 (not implemented) to 3 (fully implemented). We then calculated an implementation rate for each site on the basis of percent of PAs fully implemented (≥ 70%, well established; > 40% to < 70%, partially implemented; and ≤ 40%, not implemented). A desk review was also performed at the sites. Using the results of the assessment, three working groups of pharmacovigilance stakeholders developed recommendations to be formally adopted by UHCs.</p><p><strong>Results: </strong>Basic elements of pharmacovigilance (notification forms and VigiFlow^® or Excel databases) were present at all the UHCs assessed. In total, 14 hospitals (47%) had well-established PAs, including advanced activities such as signal detection of adverse events following the use of medicines and vaccines, as well as causality assessment; 9 hospitals (30%) were partially implementing pharmacovigilance, and 7 hospitals (23%) had no established activities or very basic activities. Within four UHCs, activities had not been implemented at the same level from one hospital to another and vaccine vigilance was largely deprioritized. The working groups made recommendations for improving collaboration, standardizing procedures, and outlining a new organizational structure for pharmacovigilance, which was institutionalized by a formal agreement among UHCs in July 2023.</p><p><strong>Conclusions: </strong>The assessment revealed a subgroup of centers with well-established AE signal detection and causality assessment abilities, which could play a leading role in the country. After the site assessment, our collaborative approach of bringing together focal points to identify next steps and generate buy-in helped to formalize pharmacovigilance across centers.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":"527-539"},"PeriodicalIF":4.0,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11981840/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143406395","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of Batoclimab Treatment on LDL-C with and Without Coadministration of Atorvastatin: Results from a Phase I Randomized Study in Healthy Participants.","authors":"Thomas Hardy, Su Liang, Philip Tedeschi, E Lin, Eliot A Brinton, Michael H Davidson","doi":"10.1007/s40264-025-01549-2","DOIUrl":"https://doi.org/10.1007/s40264-025-01549-2","url":null,"abstract":"<p><strong>Introduction: </strong>Batoclimab is an anti-neonatal fragment crystallizable receptor monoclonal antibody in clinical development for the treatment of autoimmune diseases. In phase II trials, batoclimab resulted in dose-dependent reductions in pathogenic immunoglobulin G autoantibodies; however, dose-related increases in low-density lipoprotein cholesterol and other lipids were observed.</p><p><strong>Objective: </strong>This study examined the relationship between batoclimab treatment and lipid levels, and whether increases in low-density lipoprotein cholesterol could be mitigated by coadministration with atorvastatin, a widely used cholesterol-lowering agent.</p><p><strong>Methods: </strong>In this phase I, randomized, fixed-sequence, single-blind trial, 70 healthy participants received subcutaneous injections of batoclimab at various doses or placebo for 6 weeks. Open-label oral atorvastatin was coadministered in a subset of participants receiving batoclimab 340 mg or 680 mg weekly, starting 14 days before the first dose of the study drug, and continuing through the 6-week treatment period and 8-week safety follow-up. Key endpoints included changes in lipid parameters and atorvastatin pharmacokinetics.</p><p><strong>Results: </strong>Dose-dependent increases in total cholesterol and low-density lipoprotein cholesterol were observed with batoclimab doses ≥ 255 mg weekly, comparable to previous observations, whereas coadministration of atorvastatin 10 mg or 40 mg daily mitigated these changes. Batoclimab had little effect on atorvastatin pharmacokinetics. Dose-dependent decreases in serum albumin up to 37% were observed with batoclimab doses ≥ 255 mg weekly, returning to near-baseline levels 4 weeks after stopping batoclimab. As expected, coadministration of atorvastatin did not meaningfully impact the albumin level. The majority of adverse events were mild in severity.</p><p><strong>Conclusions: </strong>Atorvastatin can mitigate clinically significant increases in low-density lipoprotein cholesterol that may occur with batoclimab treatment.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-04-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143982662","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Mixed-Methods Evaluation to Identify Industry Knowledge Needs and Challenges in Health Product Defect and Recall Reporting in Singapore.","authors":"Pei San Ang, Michelle Sau Yuen Ng, Desmond Chun Hwee Teo, Sreemanee Raaj Dorajoo, Filina Meixuan Tan, Alice Qunyuan Mai, Wayne Guo Wei Ng, Jalene Wang Woon Poh, Chih Tzer Choong","doi":"10.1007/s40264-025-01544-7","DOIUrl":"https://doi.org/10.1007/s40264-025-01544-7","url":null,"abstract":"<p><strong>Introduction: </strong>Health product defects are complex issues affecting the quality standards of health products and indirectly impact public health outcomes. It is crucial for the pharmaceutical industry to be clear of the reporting and case management requirements for such issues. The Health Sciences Authority of Singapore used a mixed-methods evaluation strategy, combining an online questionnaire and face-to-face focus group discussions to identify areas for knowledge enhancement and challenges faced by the industry regarding product defect reporting and recall procedures. These findings were used to plan training workshops.</p><p><strong>Methods: </strong>A self-administered online survey was emailed to representatives of all pharmaceutical companies with registered medicines and/or vaccines, or cell, tissue and gene therapy products (CTGTPs) in Singapore. The aim was to find out the challenges faced with product defect reporting and recall procedures. Two face-to-face focus group discussions were conducted with selected companies, specifically those that conducted product recalls between September 2022 and August 2024. A two-day online industry training workshop was held in October 2024. Pre- and post-workshop quizzes, including self-rating questions, were conducted to quantify the participants' baseline knowledge and what they gained from the workshop.</p><p><strong>Results: </strong>In total, 136 out of 463 individuals (29.4%) completed the online survey questionnaire for medicines and vaccines, while 24 out of 42 individuals (57.1%) completed the survey for CTGTPs. Seventeen industry professionals were invited for two focus group discussions. Participants provided feedback on existing processes, and requested clearer guidelines and examples on reportable defects, to aid their internal decision-making. The training workshop saw 318 and 271 industry professionals in attendance over two days, respectively, with 160 participating in both pre- and post-workshop quizzes. There was an improvement in average quiz scores ranging from 4.5% to 25.0% post-workshop. Participants' self-ratings also improved from a median of 3 (out of 5) to median of 4 from pre- to post-workshop.</p><p><strong>Conclusions: </strong>The series of evaluations revealed an enhanced understanding of regulatory requirements in industry professionals through a combination of surveys, focus group discussions and tailored training workshops. These initiatives can equip the industry with knowledge to make informed decisions and enhance overall compliance with product defect reporting and recall procedures. The findings would be used to streamline our processes related to defect and recall.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-04-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143958839","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Major Adverse Cardiovascular Events Related to JAK Inhibitors: A Disproportionality Analysis Using the WHO Global Individual Case Safety Database.","authors":"Raffaella Di Napoli, Christophe Richez, Cristina Scavone, Allison Singier, Maxime Demourgues, Annamaria Mascolo, Annalisa Capuano, Francesco Salvo","doi":"10.1007/s40264-025-01552-7","DOIUrl":"https://doi.org/10.1007/s40264-025-01552-7","url":null,"abstract":"","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143988060","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Drug Similarity-Based Bayesian Method for Early Adverse Drug Event Detection.","authors":"Yi Shi, Yuedi Yang, Ruoqi Liu, Anna Sun, Xueqiao Peng, Lang Li, Ping Zhang, Pengyue Zhang","doi":"10.1007/s40264-025-01545-6","DOIUrl":"https://doi.org/10.1007/s40264-025-01545-6","url":null,"abstract":"<p><strong>Introduction: </strong>Biochemical drug similarity-based methods demonstrate successes in predicting adverse drug events (ADEs) in preclinical settings and enhancing signals of ADEs in real-world data mining. Despite these successes, drug similarity-based ADE detection shall be expanded with false-positive control and evaluated under a time-to-detection setting.</p><p><strong>Methods: </strong>We tested a drug similarity-based Bayesian method for early ADE detection with false-positive control. Under the tested method, prior distribution of ADE probability of a less frequent drug could be derived from frequent drugs with a high biochemical similarity, and posterior probability of null hypothesis could be used for signal detection and false-positive control. We evaluated the tested and reference methods by mining relatively newer drugs in real-world data (e.g., the US Food and Drug Administration (FDA)'s Adverse Event Reporting System (FAERS) data) and conducting a simulation study.</p><p><strong>Results: </strong>In FAERS analysis, the times to achieve a same probability of detection for drug-labeled ADEs following initial drug reporting were 5 years and ≥ 7 years for the tested method and reference methods, respectively. Additionally, the tested method compared with reference methods had higher AUC values (0.57-0.79 vs. 0.32-0.71), especially within 3 years following initial drug reporting. In a simulation study, the tested method demonstrated proper false-positive control, and had higher probabilities of detection (0.31-0.60 vs. 0.11-0.41) and AUC values (0.88-0.95 vs. 0.69-0.86) compared with reference methods. Additionally, we identified different types of drug similarities had a comparable performance in high-throughput ADE mining.</p><p><strong>Conclusion: </strong>The drug similarity-based Bayesian ADE detection method might be able to accelerate ADE detection while controlling the false-positive rate.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143985825","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Signal Monitoring for Adverse Events Following Immunisation with COVID-19 Vaccines During the SARS-CoV-2 Pandemic: An Evaluation of the South African Surveillance System.","authors":"Chenoa Sankar, Stephen Evans, Johanna Catharina Meyer, Hannah May Gunter, Victoria Sekiti, Kerrigan McCarthy","doi":"10.1007/s40264-025-01547-4","DOIUrl":"https://doi.org/10.1007/s40264-025-01547-4","url":null,"abstract":"<p><strong>Introduction: </strong>Monitoring of adverse events following immunisation (AEFI) is recommended for post-licensure surveillance. We investigated whether the South African surveillance system could detect signals of disproportionate reporting and whether these signals aligned with globally identified AEFI and adverse events of special interest (AESI) post-coronavirus disease-2019 (COVID-19) vaccination.</p><p><strong>Methods: </strong>This retrospective pharmacovigilance study undertook disproportionality analysis of the National Department of Health AEFI database from the start of the COVID-19 vaccine rollout on 17 May 2021 to 31 December 2022. We complemented this with AEFI reports for vaccines not on the routine Expanded Programme on Immunisation schedule, to address potential masking of signals due to the high reporting rate of COVID-19 vaccine AEFI.</p><p><strong>Results: </strong>During the study period, 3846 AEFI were reported for 37,537,009 doses of COVID-19 vaccines (BNT162b2 and Ad26.COV2.S) administered. The overall reporting rate was 10.2 per 100,000 doses, 18.1/100,000 and 7.9/100,000 for Ad26.COV2.S and BNT162b2, respectively. Comparison with other countries suggests underreporting. Disproportionate reporting signals were obtained for three and seven AEFI following BNT162b2 and Ad26.COV2.S vaccines, respectively. An additional three AEFI signals from Ad26.COV2.S emerged in the augmented dataset, indicating masking. All Ad26.COV2.S signals, and one BNT162b2 signal, appear in the vaccines' product information. Among nine AESI evaluated, myocarditis/pericarditis presented as a signal of disproportionate reporting following BNT162b2 vaccination.</p><p><strong>Conclusions: </strong>This study is one of the first from a lower-middle-income country, using a spontaneous reporting system for signal detection post-COVID-19 vaccination. Signals aligned with those reported globally. The study highlights the need to further investigate underreporting, masking, and system attributes for system strengthening.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143987243","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Investigating Risk of Cancer with Sodium-Glucose Cotransporter 2 Inhibitors: A Disproportionality Analysis in the WHO Global Pharmacovigilance Database Vigibase^®.","authors":"Paul Gautier, Meyer Elbaz, Frédéric Bouisset, Fabien Despas, François Montastruc","doi":"10.1007/s40264-025-01546-5","DOIUrl":"https://doi.org/10.1007/s40264-025-01546-5","url":null,"abstract":"<p><strong>Introduction: </strong>Use of sodium-glucose cotransporter 2 inhibitors (SGLT-2is) has significantly increased due to their cardiovascular benefits. Whether SGLT-2is increase risk of cancer has been of concern since first clinical trials, but this question remains unclear because of methodological limitations in previous studies.</p><p><strong>Methods: </strong>We conducted a disproportionality analysis using Vigibase^® between 2014 and 2023 to estimate the association between SGLT-2i use and the risk of reporting of different subtypes of cancers, compared with glucagon like peptide-1 (GLP-1) analogues and dipeptidyl peptidase-4 (DPP-4) inhibitors.</p><p><strong>Results: </strong>Among 644 reported cases of cancer associated with SGLT-2i use, 427 (66.3%) were male, with a mean age of 66.5 ± 9.7 years. Sodium-glucose cotransporter 2 inhibitors showed increased reporting odds ratio for bladder cancer (ROR 4.46, 95% CI 3.23-6.17) and kidney cancer (ROR 1.84, 95% CI 1.25-2.69), but not for all other cancer subtypes.</p><p><strong>Conclusion: </strong>In this disproportionality analysis with a hypothesis-generating approach, SGLT-2is are associated with an increased risk of reporting bladder and kidney cancer. There is a need of an urgent clarification of this signal with further long-term observational studies.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143977716","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Interplay of Spontaneous Reporting and Longitudinal Healthcare Databases for Signal Management: Position Statement from the Real-World Evidence and Big Data Special Interest Group of the International Society of Pharmacovigilance.","authors":"Salvatore Crisafulli, Andrew Bate, Jeffrey Stuart Brown, Gianmario Candore, Rebecca E Chandler, Tarek A Hammad, Samantha Lane, Judith Christina Maro, G Niklas Norén, Antoine Pariente, Mulugeta Russom, Maribel Salas, Andrej Segec, Saad Shakir, Andrea Spini, Sengwee Toh, Marco Tuccori, Eugène van Puijenbroek, Gianluca Trifirò","doi":"10.1007/s40264-025-01548-3","DOIUrl":"https://doi.org/10.1007/s40264-025-01548-3","url":null,"abstract":"<p><p>Signal management, defined as the set of activities from signal detection to recommendations for action, is conducted using different data sources and leveraging data from spontaneous reporting databases (SRDs), which represent the cornerstone of pharmacovigilance. However, the exponentially increasing generation and availability of real-world data collected in longitudinal healthcare databases (LHDs), along with the rapid evolution of artificial intelligence-based algorithms and other advanced analytical methods, offers a wide range of opportunities to complement SRDs throughout all stages of signal management, especially signal detection. Integrating information derived from SRDs and LHDs may reduce their respective limitations, thus potentially enhancing post-marketing surveillance. The aim of this position statement is to critically evaluate the complementary role of SRDs and LHDs in signal management, exploring the potential benefits and challenges in integrating information coming from these two data sources. Furthermore, we presented successful cases of the interplay between SRDs and LHDs for signal management, along with future opportunities and directions to improve such interplay.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143972875","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Risk Minimisation Measures of Advanced Therapy Medicinal Products Authorised in the EU Between 2009 and 2023: A Cross-Sectional Study.","authors":"Sharon C M Essink, Inge M Zomerdijk, Sabine M J M Straus, Helga Gardarsdottir, Marie L De Bruin","doi":"10.1007/s40264-025-01550-9","DOIUrl":"https://doi.org/10.1007/s40264-025-01550-9","url":null,"abstract":"<p><strong>Introduction: </strong>Because of the novelty of advanced therapy medicinal products (ATMPs), pro-active risk management is needed post-authorisation; for example, through implementation of additional risk minimisation measures (aRMMs).</p><p><strong>Objective: </strong>We described which aRMMs were introduced at marketing authorisation (MA) for ATMPs authorised in the European Union (EU), and for what safety concerns.</p><p><strong>Methods: </strong>We included all ATMPs ever authorised in the EU until December 31, 2023. Data on safety concerns and aRMMs was collected from the European public assessment reports (EPARs) related to initial MA for each ATMP. Safety concerns were categorised using the Medical Dictionary for Regulatory Activities (MedDRA^®) or context of use, where appropriate.</p><p><strong>Results: </strong>Of the 25 included ATMPs, most (n = 23, 92.0%) were authorised with aRMMs. Of these 23 ATMPs, all (100%) had educational material for healthcare professionals. Additionally, educational material for patients/caregivers was in place for 18 (78.3%) ATMPs and a controlled distribution or controlled access programme for 16 (69.6%). Safety concerns related to 'Long term effects' (n = 23, 92.0%), 'Injury, poisoning and procedural complications' (n = 22, 88.0%), and 'Use in special populations' (e.g., use in pregnancy) (n = 20, 80.0%) were common among all 25 ATMPs. ATMPs often had aRMMs introduced that addressed safety concerns related to 'Injury, poisoning and procedural complications' (n = 19/23; 82.6%), 'General disorders and administration site conditions' (n = 8, 34.8%), and/or 'Immune system disorders' (n = 8, 34.8%).</p><p><strong>Conclusion: </strong>The majority of ATMPs were authorised with aRMMs. Whilst educational materials were most prevalent, controlled distribution or controlled access programmes were also commonly introduced. For many ATMPs, aRMMs addressed risks related to 'Injury, poisoning and procedural complications'.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143988062","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of Mortality in Users of Pimavanserin Compared with Other Atypical Antipsychotics in Patients with Parkinson's Disease Psychosis: An Update.","authors":"Sapna Rao, Lisa J McQuay, Joan Forns, Rebecca MacKay, Heather E Danysh, Dilesh Doshi, Victor Abler, Mary S Anthony, J Bradley Layton","doi":"10.1007/s40264-025-01543-8","DOIUrl":"https://doi.org/10.1007/s40264-025-01543-8","url":null,"abstract":"<p><strong>Introduction: </strong>Pimavanserin is the only antipsychotic medication approved in the USA to specifically treat hallucinations and delusions associated with Parkinson's disease psychosis (PDP).</p><p><strong>Objective: </strong>To compare mortality risk in patients with PDP after initiation of pimavanserin or comparator atypical antipsychotics in an overall PDP cohort and in a subcohort of patients residing in long-term care or skilled nursing facilities (LTC/SNFs).</p><p><strong>Methods: </strong>This cohort study identified patients aged ≥ 65 years with PDP initiating pimavanserin or a comparator antipsychotic in US Medicare claims (2016-2021). Cox proportional hazards models were used to estimate hazard ratios (HRs) comparing all-cause mortality in the propensity score-matched treatment groups. Cumulative incidence curves, time period-specific relative risk, and risk difference estimates evaluated risk over time.</p><p><strong>Results: </strong>In this follow-up analysis, we identified 4384 pimavanserin initiators and 28,042 comparator initiators in the overall PDP cohort, and 921 pimavanserin initiators and 7963 comparator initiators in the LTC/SNF subcohort. After matching, the overall PDP cohort had 4381 patients in each treatment group, and the LTC/SNF subcohort had 905 patients in each group. The matched HR for mortality (pimavanserin versus comparator) was 0.76 (95% CI 0.68-0.85) in the overall PDP cohort and 0.90 (95% CI 0.74-1.10) in the LTC/SNF subcohort. In the overall PDP cohort, time period-specific relative risks and risk differences showed that pimavanserin initiators had a lower risk of mortality throughout the first 365 days of follow-up.</p><p><strong>Conclusion: </strong>In the overall PDP cohort, mortality risk was lower among pimavanserin initiators than comparator antipsychotic initiators.</p>","PeriodicalId":11382,"journal":{"name":"Drug Safety","volume":" ","pages":""},"PeriodicalIF":4.0,"publicationDate":"2025-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143986737","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}