Pharmacoepidemiology and Drug Safety最新文献

{"title":"Psychiatric Medication Adherence in the United States Before and During the COVID-19 Pandemic.","authors":"Rebecca C Rossom, Hsueh-Han Yeh, Robert B Penfold, Gregory E Simon, Stephanie A Hooker, Lisiyu Ma, Lisa Miller-Matero, Ashli Owen-Smith, Brian K Ahmedani","doi":"10.1002/pds.70229","DOIUrl":"https://doi.org/10.1002/pds.70229","url":null,"abstract":"<p><strong>Objective: </strong>The COVID-19 pandemic caused disruptions in in-person mental health (MH) care and a rapid uptake of virtual MH care, but there is little research on the impacts of this on patients' ability to continue their MH medications. This study used population-level data to examine the impact of the pandemic on MH medication nonadherence.</p><p><strong>Methods: </strong>This retrospective study used electronic health record and claims data to identify 149,977 patients with MH diagnoses at three U.S. health systems who filled at least one MH medication in the 9 months before and after 3/14/2020. The primary outcome was nonadherence to MH medications (i.e., a disruption in coverage ≥ 25%) during the pandemic.</p><p><strong>Results: </strong>Pre-pandemic, 39% of patients had MH medication nonadherence, while 35% had nonadherence during the pandemic. Nonadherence during the pandemic improved for nearly all patient subgroups, with the exception of Black patients, for whom MH medication nonadherence increased from 47% to 49%. Asian, Black, and Hispanic patients were less adherent to MH medications during the pandemic than White patients, and patients with lower education or income were less adherent than patients with higher education or income. Non-rural patients were less adherent to MH medication than rural patients.</p><p><strong>Conclusions: </strong>Adherence to MH medications improved during the pandemic for all subgroups except Black patients. Despite these improvements, disparities in MH medication adherence persisted for Asian, Black, and Hispanic patients and for patients with lower education or income, suggesting these populations may need additional outreach and support.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 10","pages":"e70229"},"PeriodicalIF":2.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145207358","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comment on \"Association of Quinolone Exposure in the First Trimester of Pregnancy and the Risk of Major Congenital Malformations: A Health Administrative Database Study in Japan\" by Morishita K. Et Al.","authors":"Mesut Gungor, Cagri Caglayan Kuragi, Deniz Ceyda Karagulle, Yusuf Cem Kaplan","doi":"10.1002/pds.70228","DOIUrl":"https://doi.org/10.1002/pds.70228","url":null,"abstract":"","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 10","pages":"e70228"},"PeriodicalIF":2.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145207367","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Documentation of Compounded GLP-1 Receptor Agonists in a Large Primary Care Dataset.","authors":"Nathaniel Hendrix, Esther E Velásquez, Harry Pham, Andrew Bazemore","doi":"10.1002/pds.70227","DOIUrl":"https://doi.org/10.1002/pds.70227","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Purpose: &lt;/strong&gt;Large telehealth companies and smaller aesthetic medicine providers used compounded semaglutide and tirzepatide to meet consumer demand for these drugs during their shortages. In this study, we estimate the documentation rate of compounded formulations of these drugs in the US primary care and characterize differences between users of compounded and brand-name formulations of these drugs.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We conducted a retrospective cohort study using data from the American Family Cohort, a nationwide US database of electronic health records from primary care practices, spanning January 1, 2021, to December 31, 2024. Patients with documented semaglutide and/or tirzepatide use were included. Brand-name drug prescriptions were identified from structured data; compounded formulation use was identified from clinical notes. Outcomes included the proportion of patients using compounded formulations and their characteristics.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Among 153 044 included patients (64.0% female, mean age 55.0 years), 8.2% used compounded formulations, which made up an increasing share of semaglutide and tirzepatide use over time. Users of compounded formulations had longer mean therapy durations (compounded only: 10.0 months vs. brand-name only: 7.8 months) and were more likely to be female, non-Hispanic White, nondiabetic, and to live in areas of lower socioeconomic deprivation compared to patients who used only brand-name drugs.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Between January 2021 and December 2024, documentation of compounded semaglutide and tirzepatide use in US primary care settings appeared lower than surveys reporting that approximately 23% of patients using these medications received them from compounders. This suggests that many patients may access these medications outside of coordinated care.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Plain language summary: &lt;/strong&gt;During drug shortages from 2022 to 2024, many patients turned to compounded formulations of popular weight-loss medications semaglutide (Ozempic/Wegovy) and tirzepatide (Mounjaro/Zepbound) made by specialty pharmacies. We analyzed medical records from over 153 000 patients across the United States who used these medications to understand how often primary care doctors knew their patients were using compounded formulations. We found that only 8.3% of patients had documented use of compounded formulations in their medical records, far lower than previous surveys suggesting 23% of users get these medications from nontraditional sources like telehealth companies or aesthetic clinics. Patients using compounded formulations were more likely to be white, female, nondiabetic, and live in wealthier areas compared to those using brand-name versions. They also used the medications for longer periods. This gap between documented use and actual use suggests many patients are getting these medications outside their regular healthcare system, which could create safet","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 10","pages":"e70227"},"PeriodicalIF":2.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145192335","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Potential Bias in Self-Controlled Case Series Design: Impact of Incident Versus Prevalent Scenarios of Exposure and Outcome.","authors":"Kyungyeon Jung, Seong Jun Byun, Gyeongmin Lim, Jeong-Eun Lee, Hyesung Lee, Ju Hwan Kim, Ju-Young Shin","doi":"10.1002/pds.70234","DOIUrl":"https://doi.org/10.1002/pds.70234","url":null,"abstract":"<p><strong>Purpose: </strong>To assess changes in study results in self-controlled case series (SCCS) studies and explore potential biases when applying incident and prevalent exposure and outcome scenarios.</p><p><strong>Methods: </strong>We used the National Health Insurance Service database in South Korea to conduct two SCCS studies: (1) the risk of retinal detachment following fluoroquinolone use (expected elevated risk), and (2) the risk of acute cardiovascular disease following ranibizumab use (expected null association). Exposure and outcome scenarios were classified based on a washout period of 2 and 1 year, respectively, before the observation period: incident exposure-incident outcome, incident exposure-prevalent outcome, prevalent exposure-incident outcome, and prevalent exposure-prevalent outcome. For each scenario, conditional Poisson regression models, adjusted for time-varying age, estimated incidence rate ratios (IRRs) with 95% confidence intervals (CIs).</p><p><strong>Results: </strong>In the fluoroquinolone study, IRRs of retinal detachment were as follows: 1.83 (95% CI 1.72-1.96) for incident exposure-incident outcome, 1.83 (1.71-1.95) for incident exposure-prevalent outcome, 1.71 (1.62-1.80) for prevalent exposure-incident outcome, and 1.70 (1.62-1.79) for prevalent exposure-prevalent outcome scenario. In the ranibizumab study, IRRs of acute cardiovascular disease were 0.91 (0.84-0.99), 0.89 (0.82-0.97), 1.02 (0.94-1.10), and 1.00 (0.93-1.08), respectively.</p><p><strong>Conclusions: </strong>In prevalent exposure scenarios, IRRs in both studies were attenuated, consistent with prevalent user bias. In prevalent outcome scenarios, where survivor bias was anticipated, no notable shifts in IRRs were observed, possibly due to the high severity and low recurrence of the outcomes associated with the respective exposures. Further consideration of prevalent user and survivor bias is important when interpreting SCCS results. Additional research is needed to quantify the impact of varying exposure and outcome definitions on SCCS estimates.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 10","pages":"e70234"},"PeriodicalIF":2.4,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145244695","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety of BNT162b2 mRNA COVID-19 Vaccine Batches: A Nationwide Cohort Study.","authors":"Anders Hviid, Ingrid Bech Svalgaard","doi":"10.1002/pds.70207","DOIUrl":"10.1002/pds.70207","url":null,"abstract":"<p><strong>Objectives: </strong>The safety of the BNT162b2 mRNA COVID-19 vaccine has been extensively evaluated since the global rollout began. While serious adverse events are rare, safety issues continue to arise. This study evaluates the claim that earlier small vaccine batches were associated with higher rates of serious adverse events compared to later batches.</p><p><strong>Design, participants, setting: </strong>A nationwide cohort study was conducted in Denmark, comprising individuals vaccinated with the BNT162b2 vaccine from 52 pre-defined batches classified into three pre-defined groups. Vaccinated individuals were matched 1:1 between batch groups on age, sex, and vaccination priority group. The study outcomes included 27 serious adverse events, two negative control outcomes, and all-cause mortality. Cox regression was used to estimate hazard ratios (HRs) comparing rates between batch groups in the 28 days following vaccination. We conducted two comparisons of the early small batches to two groups of larger batches used later in the pandemic.</p><p><strong>Results: </strong>In the study period, 9 983 728 vaccinations were administered from batches in the three pre-defined groups. Slightly increased rates of arrhythmia were observed in both study comparisons, HRs 1.25 (95% CI, 1.05-1.50) and 1.15 (1.00-1.31), respectively, but sensitivity analyses did not robustly support these associations. For the remaining outcomes, increased rates in both study comparisons were not observed.</p><p><strong>Conclusion: </strong>This nationwide cohort study provides reassurance regarding the safety of the BNT162b2 vaccine across different batches used in Denmark. The findings support the overall safety of the vaccine, with no clinically relevant variations in serious adverse event rates between batches.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 9","pages":"e70207"},"PeriodicalIF":2.4,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12355449/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144855980","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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 Long-Acting Beta-Agonists on Progressive Risk of Lung Cancer in Patients With Chronic Obstructive Pulmonary Disease: A Nationwide Cohort Study.","authors":"Shih-Hsun Lin, Yu-Chun Lin, Tsai-Hui Lin, Hung-Jen Lin, Mei-Chen Lin, Sheng-Teng Huang","doi":"10.1002/pds.70204","DOIUrl":"10.1002/pds.70204","url":null,"abstract":"<p><strong>Purpose: </strong>Chronic obstructive lung disease (COPD) is a common comorbid disease in lung cancer causing disability. A long-acting β2-agonist (LABA) is commonly given to patients with moderate to very severe COPD. This study aims to evaluate the relationship between LABA treatment and the risk of lung cancer in patients with COPD using a national representative database.</p><p><strong>Methods: </strong>We conducted the analyses using the Longitudinal Health Insurance Database. Patients with at least two outpatient visits or one hospitalization due to COPD diagnosis (ICD-9-CM: 491, 492, 494, 496) from 1997 to 2012 were identified. Patients in the LABA cohort had regularly used LABA during the study period, while the non-LABA cohort was those without receiving LABA treatment. A 1:2 propensity score matching by COPD diagnosis year, index year, sex, age, occupation, comorbidities, and medication usage was applied.</p><p><strong>Results: </strong>A total of 3924 patients with COPD were enrolled in the study, 1308 patients with regular LABA treatment and 2616 patients without LABA treatment. Approximately half of the study subjects were male (54.8%), with a mean age of 63.1 years. Those with LABA treatment who were male (aHR = 2.15, 95% CI = 1.09-4.22) had an increased risk of lung cancer.</p><p><strong>Conclusions: </strong>This study indicated that LABA treatment in patients with COPD was associated with lung cancer in older men; those with high cumulative daily doses.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 9","pages":"e70204"},"PeriodicalIF":2.4,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144874483","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preregistration: A Key to Credible Real-World Evidence Generation.","authors":"Emma Simonsen, Shirley V Wang, Helene Kildegaard, Anton Pottegård","doi":"10.1002/pds.70215","DOIUrl":"https://doi.org/10.1002/pds.70215","url":null,"abstract":"<p><strong>Background: </strong>Preregistration of study protocols in a public repository promotes transparency and reproducibility in pharmacoepidemiological research. Despite its clear benefits, preregistration remains underutilized.</p><p><strong>Purpose: </strong>Here, we discuss the advantages of preregistration, explore barriers to its implementation, and highlight existing repositories for preregistering real-world evidence study protocols. A relatively new option is the Real-World Evidence Registry within the Open Science Framework (OSF), which we briefly introduce.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 9","pages":"e70215"},"PeriodicalIF":2.4,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12397443/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144964215","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Aioli: Standardising Drugs in the FDA Adverse Event Reporting System (FAERS) to RxNorm and Anatomical Therapeutic Chemical (ATC) Codes.","authors":"Rowan E Parry, Victor Pera, Katia M C Verhamme, Marcel de Wilde, Erik M van Mulligen, Jan A Kors","doi":"10.1002/pds.70216","DOIUrl":"10.1002/pds.70216","url":null,"abstract":"<p><strong>Purpose: </strong>The Food and Drug Administration Adverse Event Reporting System (FAERS) is an important source of information on suspected adverse drug reactions, but does not standardise drugs. The Adverse Event Open Learning Through Universal Standardization (AEOLUS) System Provides Standardisation of drugs in FAERS to RxNorm, but its coverage leaves room for improvement and mapping accuracy has not been established. Furthermore, drugs are not mapped to the Anatomical Therapeutic Chemical (ATC) Classification System, which is frequently used in pharmacovigilance studies. Here we develop and evaluate the Aioli system, an extension of AEOLUS, to increase the mapping of drugs in FAERS to RxNorm, and to provide mappings to the ATC coding system.</p><p><strong>Methods: </strong>Several changes and extensions were made to the AEOLUS mapping process to increase the number of drugs standardized to RxNorm. Information in FAERS fields about ingredient, route, dose amount, dose form, and dose unit was used to map to the most appropriate ATC code. Mapping accuracy was assessed on an evaluation set of 122 FAERS records.</p><p><strong>Results: </strong>Aioli mapped 94.1% of drug names in FAERS to RxNorm, compared to 90.4% by AEOLUS. In addition, Aioli mapped 80.4% of drug names to ATC codes. Evaluation showed high accuracies, with 92.2% correct mappings to RxNorm and 94.0% to ATC.</p><p><strong>Conclusions: </strong>We have developed and evaluated the Aioli system that maps drugs in the FAERS database to RxNorm and ATC codes. With increased coverage of drugs and the mapping to ATC, Aioli further improves the usability of FAERS data in pharmacovigilance studies.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 9","pages":"e70216"},"PeriodicalIF":2.4,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12411121/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145001247","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adverse Events Associated With Dabrafenib, Trametinib, and Their Combination Therapy: A Disproportionality Analysis of the FDA Adverse Event Reporting System (FAERS) Database.","authors":"Zhenpo Zhang, Qimin Wu, Yuting Wang, Yankun Liang, Jingping Zheng, Chufeng Ding, Lin Ma, Ling Su","doi":"10.1002/pds.70200","DOIUrl":"https://doi.org/10.1002/pds.70200","url":null,"abstract":"<p><strong>Objective: </strong>Based on the FAERS database, this study aims to compare the safety of dabrafenib, trametinib, and their combination therapy, providing a reference for clinically safe medication.</p><p><strong>Methods: </strong>Adverse event data for dabrafenib, trametinib, and their combination were extracted from the FAERS database. Descriptive statistical analysis was performed, and adverse event signals were mined using the Reporting Odds Ratio (ROR) method and the Bayesian Confidence Propagation Neural Network (BCPNN) method.</p><p><strong>Results: </strong>The dabrafenib group yielded 11 048 adverse event reports with 311 positive signals across 22 organ systems. The trametinib group had 7848 reports with 249 positive signals across 21 organ systems. The combination therapy group had 13 544 reports with 418 positive signals across 23 organ systems. Signals were primarily concentrated in investigations, while adverse event reports mainly focused on general disorders and administration site conditions. The distribution of adverse events within System Organ Classes (SOCs) differed among the three groups.</p><p><strong>Conclusion: </strong>Dabrafenib was associated with stronger reporting signals for adverse events such as fever, hyperpyrexia, and tumor progression. Trametinib was associated with skin-related or infectious adverse events like rash, acneiform dermatitis, and paronychia. The combination therapy increased the risk of ocular and cardiovascular adverse events. These signals indicate potential risks but require clinical confirmation. Clinical practice should prioritize monitoring different adverse events based on patient characteristics and drug type.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 9","pages":"e70200"},"PeriodicalIF":2.4,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145081177","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative Safety of Glucagon-Like Peptide 1 Receptor Agonists (GLP-1-RAs) in Type 2 Diabetes and Chronic Weight Management: A Real-World Data Study.","authors":"Sarah Ruth Hurwitz, Stephan Lanes, Tracey Quimbo, Anahit Papazian, Jeff White, Vicki Fisher, Mark J Cziraky, Matthew J Crowley, Vincent J Willey","doi":"10.1002/pds.70214","DOIUrl":"10.1002/pds.70214","url":null,"abstract":"<p><strong>Purpose: </strong>This study assessed serious clinical outcomes comparing glucagon-like peptide 1 receptor agonists (GLP-1-RAs) with sodium glucose co-transporter 2 inhibitors (SGLT2-Is) in patients with type 2 diabetes (T2DM) and patients without diabetes using two chronic weight management (CWM) regimens.</p><p><strong>Methods: </strong>We performed a new user, active comparator cohort study in a large, national U.S. claims database. Adults who initiated GLP-1-RAs, SGLT2-Is, naltrexone/bupropion (NalBup), or phentermine/topiramate (PhenTop) from 1 January 2016 to 31 December 2023 were included. Potential confounding was controlled using propensity score weighting for 82 clinical and demographic covariates, and risk ratios (RRs) were estimated.</p><p><strong>Results: </strong>This study included 330,684 GLP-1-RA users and 264,277 SGLT2-I users with T2DM. Among CWM patients without diabetes, we studied over 25,000 GLP-1-RA users, 5019 NalBup users, and 3841 PhenTop users. In both indications, GLP-1-RA users had higher rates of hospitalizations for gallbladder and biliary diseases with RRs ranging from 1.14 (95% CI: 1.06-1.22) in T2DM patients to 3.32 (95% CI: 1.44-7.64) in CWM patients. No reduction in the rate of cardiovascular events was observed for GLP-1-RA users with RRs ranging from 0.92 (95% CI: 0.37-2.25) in CWM patients to 1.03 (95% CI: 0.99-1.08) in T2DM patients. In T2DM patients, GLP-1-RA users had a lower rate of acute liver injury (RR: 0.76; 95% CI: 0.64-0.91).</p><p><strong>Conclusions: </strong>This study corroborates an increased risk of hospitalization for gall bladder and biliary conditions among users of GLP-1-RAs and found similar rates as comparators of MI or stroke when GLP-1-RAs were used for T2DM or CWM. This real-world study complements placebo-controlled trials and can further inform prescribing decisions.</p><p><strong>Protocol registration: </strong>The study protocol was pre-registered at the Center for Open Science's Real-World Evidence Registry and is publicly accessible online (https://doi.org/10.17605/OSF.IO/PSY74).</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 9","pages":"e70214"},"PeriodicalIF":2.4,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12433752/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145065439","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}