Pharmacoepidemiology and Drug Safety最新文献

{"title":"Correction to \"Hospital Discharge Prescription of Drugs That May Raise Blood Pressure in Patients With Hypertension\".","authors":"","doi":"10.1002/pds.70171","DOIUrl":"https://doi.org/10.1002/pds.70171","url":null,"abstract":"","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 6","pages":"e70171"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144326504","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":"Correction to \"An Open-Source Implementation of Tree-Based Scan Statistics\".","authors":"","doi":"10.1002/pds.70167","DOIUrl":"https://doi.org/10.1002/pds.70167","url":null,"abstract":"","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 6","pages":"e70167"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144216522","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":"Correction to \"Adapting the European Concerted Action on Congenital Anomalies and Twins (EUROCAT) Guide 1.5 for Use in Post-Authorisation Safety Studies Using US Data\".","authors":"","doi":"10.1002/pds.70170","DOIUrl":"10.1002/pds.70170","url":null,"abstract":"","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 6","pages":"e70170"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12416966/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144226154","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":"Clarithromycin Versus Azithromycin for Community-Acquired Pneumonia and the Risk of Major Adverse Cardiovascular Events: A Multicentre Cohort Study Using Data From Canada and Denmark.","authors":"Theis Skovsgaard Itenov, Anthony D Bai, Tor Biering-Sørensen, Amol Verma, Fahad Razak, Ajay Bhasin, Henning Bundgaard, Pradeesh Sivapalan, Kasper Iversen, Christian Rasmussen, Jens Rasmussen, Lotte Klitfod, Kathrine Dircks, Jens-Ulrik S Jensen, Mike Fralick","doi":"10.1002/pds.70163","DOIUrl":"10.1002/pds.70163","url":null,"abstract":"<p><strong>Background: </strong>Studies suggest that clarithromycin is associated with an increased risk of major adverse cardiovascular events (MACE) among adults with coronary artery disease. However, data comparing clarithromycin to other macrolides, such as azithromycin, in a broader population are lacking.</p><p><strong>Methods: </strong>A multicenter study was conducted in 33 hospitals in Ontario, Canada, and Copenhagen, Denmark, using the Target Trial framework. Adults hospitalized with community-acquired pneumonia (CAP) who received either clarithromycin or azithromycin were included. The primary outcome was MACE, defined as the one-year risk of nonfatal myocardial infarction, nonfatal stroke, or all-cause mortality. Propensity score matching and Cox proportional hazards models were used for analysis.</p><p><strong>Results: </strong>In Ontario, we identified 23 081 patients with CAP, and 11 164 received oral macrolides. After propensity score matching, the primary outcome occurred in 7.8% of clarithromycin patients and 9.1% of azithromycin patients (HR 0.85, 95% CI 0.60-1.21). In Copenhagen, there were 11 280 patients with CAP and 3924 received oral macrolides. After propensity score matching, 19% of clarithromycin patients and 12% of azithromycin patients experienced the primary outcome for oral macrolides (HR 1.7, 95% CI 1.2-2.4, p = 0.002). Meta-analysis of the point estimate from each country provided an overall HR of 1.21 (95% CI 0.61-2.39). For intravenous macrolides in Copenhagen, the HR was 1.15 (95% CI 1.0-1.3, p = 0.007) for clarithromycin compared to azithromycin.</p><p><strong>Conclusion: </strong>This study did not consistently observe an increased risk of cardiovascular events with clarithromycin among adults hospitalized with CAP. However, the observational nature of the study may introduce selection bias and unmeasured confounding.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 6","pages":"e70163"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12144676/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144248987","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":"Corrigendum to \"A Brief Report on Proposed Areas of International Harmonization of Real-World Evidence Relevance, Reliability and Quality Standards Among Medical Product Regulators\".","authors":"","doi":"10.1002/pds.70169","DOIUrl":"10.1002/pds.70169","url":null,"abstract":"","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 6","pages":"e70169"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12416973/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144216523","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":"Drug Interactions With Tamoxifen and Treatment Effectiveness in Premenopausal Breast Cancer Patients: A Bayesian Joint Modeling Approach.","authors":"Kirsten M Woolpert, Deirdre P Cronin-Fenton, Per Damkier, Anders Kjærsgaard, Stephen Hamilton-Dutoit, Bent Ejlertsen, Richard F MacLehose, Peer Christiansen, Rebecca A Silliman, Timothy L Lash, Thomas P Ahern, Lindsay J Collin","doi":"10.1002/pds.70157","DOIUrl":"10.1002/pds.70157","url":null,"abstract":"<p><strong>Purpose: </strong>Tamoxifen is guideline treatment for premenopausal women with estrogen receptor-positive (ER+) breast cancer. Therapeutic efficacy relies partly on tamoxifen biotransformation by CYP2D6, CYP2C19, and CYP3A4 enzymes. We conducted a cohort study to evaluate whether concomitant prescription of drugs that inhibit these enzymes impacted breast cancer recurrence.</p><p><strong>Methods: </strong>We enrolled 4493 premenopausal women with stage I-III ER+ breast cancer (2002-2011) treated with tamoxifen. We defined time-varying CYP-inhibiting drug exposures as the proportion of overlapping days during the tamoxifen treatment period. We estimated associations of concomitant medication use with recurrence using: (1) Bayesian joint modeling (hazard ratio [HR] and 95% credible intervals [95% CrI]), (2) traditional Cox regression (HR and 95% confidence intervals [95% CI]).</p><p><strong>Results: </strong>During tamoxifen therapy, 13% of the cohort used strong CYP2D6 inhibitors, 31% weak CYP2D6 inhibitors, 37% CYP2C19 inhibitors, and 12% CYP3A4/5 inhibitors. Bayesian joint models showed that women with ≥ 50% overlap between tamoxifen and CYP2D6 inhibitors had increased recurrence risk compared with 0% overlap (HR: 1.24, 95% CrI: 0.96, 1.58). No recurrence association was seen for CYP2C19 inhibitors (≥ 50% vs. 0%, HR = 1.0, 95% CrI: 0.69, 1.40), but traditional Cox models yielded positive associations for CYP2C19 overlap (≥ 50% vs. 0%, HR = 1.45, 95% CI: 1.07, 1.96). With Bayesian joint models, we observed no association between ≥ 50% versus 0% overlap with CYP3A4/5 inhibitors (HR: 0.84, 95% CrI: 0.32, 1.93).</p><p><strong>Conclusions: </strong>With Bayesian joint modeling, we saw a slight increase in recurrence among CYP2D6-inhibitor users, but no increase among CYP2C19- or CYP3A4-inhibitor users. Results from Cox regression models were less plausible.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 5","pages":"e70157"},"PeriodicalIF":2.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12076038/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144005143","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":"Hospital Discharge Prescription of Drugs That May Raise Blood Pressure in Patients With Hypertension.","authors":"Sarasa Miyake, Atsushi Miyawaki, Hiroki Matsui, Yuya Kimura, Hideo Yasunaga","doi":"10.1002/pds.70150","DOIUrl":"10.1002/pds.70150","url":null,"abstract":"<p><strong>Purpose: </strong>This study aimed to determine the frequency of discharge prescriptions of drugs that may raise blood pressure (BP) in hospitalized patients with hypertension and identify factors associated with these prescriptions.</p><p><strong>Methods: </strong>A retrospective cross-sectional analysis was conducted using a nationwide inpatient database in Japan, focusing on adults with hypertension discharged from acute care hospitals between April 2021 and March 2022. The primary outcome was the prescription of drugs that may raise BP at discharge. A multivariable linear probability model was employed to assess the relationship between patient and hospital characteristics and the likelihood of receiving these prescriptions.</p><p><strong>Results: </strong>Among 979 234 patients with hypertension (mean age: 75.3 years, standard deviation: 13.2), 230 792 (23.6%) received at least one drug that may elevate BP at discharge. Non-steroidal anti-inflammatory drugs (NSAIDs) were the most frequently prescribed (46.6%), followed by glucocorticoids (35.3%), atypical antipsychotics (15.1%), antidepressants (7.9%), and Japanese herbal medicines (6.1%). Prescription prevalence was higher among female patients, younger adults, those admitted for medical conditions, non-emergency hospitalizations, patients with disabilities, and those with a Charlson Comorbidity Index of 1. Patients hospitalized for musculoskeletal or skin conditions, transferred to another hospital, or discharged from high-volume hospitals were also more likely to receive these prescriptions.</p><p><strong>Conclusions: </strong>Drugs that may raise BP are commonly prescribed at discharge for patients with hypertension. This highlights the need for targeted interventions to optimize medication management at discharge, aiming to improve BP control and patient outcomes.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 5","pages":"e70150"},"PeriodicalIF":2.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144013785","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":"Treatment Persistence and Variations in Prescribing Oral, Injectable, and Inhaled Corticosteroids: A Population-Based Drug Utilisation Study.","authors":"Eleni Domzaridou, Matthew J Carr, David M Williams, Anthony J Avery, Tjeerd van Staa, D Aled Rees, Darren M Ashcroft","doi":"10.1002/pds.70153","DOIUrl":"https://doi.org/10.1002/pds.70153","url":null,"abstract":"<p><strong>Purpose: </strong>To examine variation in oral, injectable, and inhaled corticosteroid (CS) prescribing in primary care, exploring treatment persistence and coverage.</p><p><strong>Methods: </strong>We examined patient-level electronic health records from English general practices in the Clinical Practice Research Datalink Aurum database. We delineated a cohort of new users of oral, injectable, or inhaled CS with prescriptions issued between January 1, 2000, and June 30, 2021. Lorenz curves assessed potential prescribing skewness, and Kaplan-Meier (KM) plots estimated treatment persistence. The Proportion of Patients Covered (PPC) method estimated the proportion of patients still covered by treatment 1 year after initiation.</p><p><strong>Results: </strong>We observed 1 942 571 CS users across 1471 general practices, with 20% of oral and inhaled CS users accounting for almost 80% of total CS use. Older patients with comorbidities including respiratory diseases (13.5%), skin conditions (5.8%), or inflammatory bowel diseases (1.6%) were more likely to be prescribed higher doses. The KM plots showed that 20% of oral and 50% of inhaled CS users were persistent after one and 2 months, respectively. The PPC method indicated that 30% of oral and 60% of inhaled CS users were covered by treatment 6 months post-initiation. Some variation was observed when different grace periods were applied. Combined use of oral and inhaled CS was observed for 6.9% of patients.</p><p><strong>Conclusion: </strong>A fifth of patients receiving CS accounted for over 80% of oral and inhaled CS prescribing in primary care. Identifying these patients is crucial for targeting future interventions to promote patient safety and cost-effective CS use.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 5","pages":"e70153"},"PeriodicalIF":2.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12042156/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144036998","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":"Proton Pump Inhibitor Use Exceeding the U.S. Food and Drug Administration Approved Treatment Duration for Patients With Peptic Ulcer Disease: A Retrospective Cohort Study.","authors":"Jordan A Villars, Timothy S Anderson, Jonathan G Yabes, Robert E Schoen, Ravy K Vajravelu","doi":"10.1002/pds.70152","DOIUrl":"https://doi.org/10.1002/pds.70152","url":null,"abstract":"<p><strong>Background: </strong>Proton-pump inhibitors (PPIs) are effective in treating peptic ulcer disease (PUD), but they are often prescribed beyond the approved duration. Because PPIs are associated with adverse effects, there is a need for effective stewardship.</p><p><strong>Objective: </strong>To identify the frequency of and healthcare factors associated with PPI prescriptions exceeding the approved eight-week treatment duration for PUD.</p><p><strong>Methods: </strong>We conducted a retrospective cohort study of patients diagnosed with acute PUD without other indications for PPI use using data from the Veterans Health Administration in the United States. Exposures were patient, provider, and facility factors that could influence PPI prescribing. The outcome was time to a filled PPI prescription exceeding the approved treatment duration for PUD. Associations were assessed using a multivariable time-to-recurrent-event model to calculate adjusted hazard ratios (aHR) and population-attributable fractions. Patients who developed indications for long-term PPI use were censored.</p><p><strong>Results: </strong>We identified 7708 patients with PUD who met eligibility criteria and received PUD treatment (median age 79 [IQR 71-85], 7% female). Thirty-five percent had PPI prescriptions exceeding the approved duration for a median of 346 days (IQR 165-643) of overuse. On the patient level, inpatient PUD diagnosis (aHR 1.32, 95% CI 1.25-1.39), use of nonsteroidal anti-inflammatory drugs (NSAIDs) (aHR 1.26, 95% CI 1.18-1.34), use of anticoagulants (aHR 1.25, 95% CI 1.13-1.38), and moderate frailty (1.15, 95% CI 1.06-1.26) had the strongest associations with filled PPI prescriptions exceeding the approved duration. On the health-system level, inpatient PUD diagnosis had the highest peak population attributable fraction at 0.26, followed by NSAIDs and anticoagulants at 0.18.</p><p><strong>Conclusions: </strong>Markers of patient complexity and medication use not meeting gastroprotection guidelines are associated with inappropriate PPI persistence among patients with PUD. These data may inform future targeted PPI deprescribing programs.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 5","pages":"e70152"},"PeriodicalIF":2.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12038380/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144006873","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":"Implementing Negative Control Outcomes to Assess Comparability of Treatments for Psoriasis and Psoriatic Arthritis.","authors":"Mary E Horner, Alexis Ogdie, Kate K Orroth, Shia T Kent, Kathy V Tran, Cynthia Deignan, Myriam Cordey, M Alan Brookhart","doi":"10.1002/pds.70156","DOIUrl":"10.1002/pds.70156","url":null,"abstract":"<p><strong>Purpose: </strong>Treatment selection is typically associated with prognosis, leading to potential confounding in comparative studies. We used negative control outcomes (NCOs) to identify potential residual confounding when comparing apremilast initiators to other psoriasis (PsO) or psoriatic arthritis (PsA) treatment initiators.</p><p><strong>Methods: </strong>Adults with PsO/PsA who initiated treatment from September 23/March 21, 2016, respectively, with apremilast, topicals, methotrexate, interleukin (IL)-17 inhibitor (i), IL-12/23i, or tumor necrosis factor inhibitor (TNFi) were identified in the OPTUM Clinformatics DataMart database. Follow-up ended at treatment switch/discontinuation, NCO, end of enrollment, or September 30, 2022. NCOs addressed confounding for healthy users (wellness visit, herpes zoster vaccine, colon cancer screening, pelvic screening), functional status (accidents), and channeling. The 1-year relative risk (RR) for each NCO was estimated for all treatment comparisons using an inverse probability of treatment and censoring weighted estimator.</p><p><strong>Results: </strong>In PsO, potential healthy user bias was detected in apremilast vs. IL-17i initiators, with a higher likelihood of herpes zoster vaccine and colon cancer screening (RR [95% CI]: 2.01 [1.41, 2.88] and 1.42 [1.13, 1.77], respectively). Wellness visits and pelvic exams were less likely among apremilast vs. topical initiators (0.84 [0.72, 0.98] and 0.83 [0.70, 0.98], respectively). The wellness visit RR was attenuated in individuals with ≥ 1 pre-index topical prescription (0.90 [0.78, 1.04]). In PsA, minimal residual confounding was observed between apremilast and other treatments.</p><p><strong>Conclusions: </strong>Eligibility criteria (prior topicals) and weighting reduced residual confounding when comparing apremilast vs. other treatments for PsO and PsA. Integration of NCOs into comparative effectiveness/safety studies of PsO/PsA treatments may help identify unmeasured confounding.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 5","pages":"e70156"},"PeriodicalIF":2.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12087269/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144094545","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}