Pharmacoepidemiology and Drug Safety最新文献

{"title":"Real-World Data and Real-World Evidence in Regulatory Decision Making: Report Summary From the Council for International Organizations of Medical Sciences (CIOMS) Working Group XIII.","authors":"Sean Hennessy, Yoshiko Atsuta, Sanna Hill, Lembit Rägo, Juhaeri Juhaeri","doi":"10.1002/pds.70117","DOIUrl":"10.1002/pds.70117","url":null,"abstract":"<p><p>Data from sources other than traditional randomized clinical trials are known as real-world data (RWD), and the evidence derived from the review and analysis of RWD is known as real-world evidence (RWE). RWD and RWE are used increasingly throughout the lifecycle of medicinal products to provide evidence about their effectiveness and safety. Recent regulatory guidance about RWE and approvals based on the use of RWE to demonstrate beneficial effects of products have created an urgency to develop generally accepted processes that promote trust in the evidence-generation process. A recent report from a working group of the Council for International Organizations of Medical Science (CIOMS) describes the use of RWE for decision making in the lifecycle of medical products, describes RWD and data sources, discusses key scientific considerations in the generation of RWE, and discusses ethical and governance issues related to the use of RWD. This paper provides a high-level summary of this report. More work remains to be done to globally harmonize practices and guidance for using RWD and RWE for regulatory decision making, thereby maximizing the benefits they can bring to patient care and public health.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 3","pages":"e70117"},"PeriodicalIF":2.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11897686/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143606052","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":"High-Throughput Screening for Prescribing Cascades Among Real-World Angiotensin-Converting Enzyme Inhibitor Initiators.","authors":"Asinamai M Ndai, Kayla Smith, Shailina Keshwani, Jaeyoung Choi, Michael Luvera, Julia Hunter, Rebecca Galvan, Tanner Beachy, Matt Molk, Shannon Wright, Marianna Calvet, Carl J Pepine, Stephan Schmidt, Scott M Vouri, Earl J Morris, Steven M Smith","doi":"10.1002/pds.70132","DOIUrl":"10.1002/pds.70132","url":null,"abstract":"<p><strong>Purpose: </strong>Angiotensin-converting enzyme inhibitors (ACEIs) are commonly prescribed, but their adverse effects may prompt new drug prescription(s), known as prescribing cascades (PCs). We aimed to identify potential ACEI-induced PCs using high-throughput sequence symmetry analysis.</p><p><strong>Methods: </strong>Using claims data from a national sample of Medicare beneficiaries (2011-2020), we identified new ACEI users aged ≥ 66 years with continuous enrollment ≥ 360 days before and ≥ 180 days after ACEI initiation. We screened for initiation of 446 other (non-antihypertensive) \"marker\" drug classes within ±90 days of ACEI initiation, generating sequence ratios (SRs) reflecting proportions of ACEI users starting the marker class after versus before ACEI initiation. Adjusted SRs (aSRs) accounted for prescribing trends over time. For significant aSRs, we calculated the naturalistic number needed to harm (NNTH), and significant signals underwent clinical review for plausibility.</p><p><strong>Results: </strong>We identified 308 579 ACEI initiators (mean age 76.1 ± 7.5 years; 59.6% female; 88.6% with hypertension). Of 446 marker classes evaluated, 81 signals were significant, and 42 (52%) classified as potential PCs after clinical review. The strongest signals ranked by lowest NNTH included corticosteroids (NNTH 313; 95% CI, 262-392) and serotonin type 3 (5-HT₃) antagonists (NNTH 496; 95% CI, 392-689); the strongest signals ranked by highest aSR included sympathomimetics (aSR, 1.97; 95% CI, 1.10-3.53) and other antianemic preparations (aSR, 1.87; 95% CI, 1.31-2.67).</p><p><strong>Conclusion: </strong>Identified prescribing cascade signals were indicative of known and possibly underrecognized ACEI adverse events in this Medicare cohort. The findings are hypothesis-generating and require further investigation to determine the extent and impact of the identified PCs on health outcomes.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 3","pages":"e70132"},"PeriodicalIF":2.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12067835/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143649899","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":"Mixed Impact of Direct Healthcare Professional Communications When Considering Proximal Outcomes and the Targeted Population: A Systematic Review.","authors":"Esther de Vries, Petra Denig, Taco B M Monster, Peter G M Mol","doi":"10.1002/pds.70135","DOIUrl":"10.1002/pds.70135","url":null,"abstract":"<p><strong>Background: </strong>Direct Healthcare Professional Communications (DHPCs) are an important risk minimisation measure. Their effect has been shown to be variable and has been measured using different outcomes and study populations. Depending on the content of the message, the optimal outcome to measure a direct effect of the DHPC can differ. This systematic review investigates whether the effects of DHPCs differ according to the use of proximal outcomes and the inclusion of the targeted population.</p><p><strong>Methods: </strong>EMBASE and MEDLINE were searched for European DHPC effectiveness studies performed up to April 6, 2022, evaluating the impact of DHPCs issued from 2008. Outcomes and their impact were extracted, together with a classification of the message. The outcomes were categorised as knowledge/awareness, self-reported behaviour (prescribing/monitoring), prescribing of medication (including dosage changes), monitoring, or adverse events/other health outcomes, including hospitalisation. The outcomes closest to the message of the DHPC were defined as proximal. Outcomes were coded 1 when effective and 0 if not. If multiple outcomes were reported in a study, a composite outcome was created ranging from 0 to 1. Chi-square or Fisher exact tests were performed.</p><p><strong>Results: </strong>From 7063 (scientific) publications identified in our literature search, 60 publications evaluating 31 different DHPCs were selected for our review. As publications could study multiple messages with an outcome, from the 60 scientific publications, 103 outcomes were generated for the messages, of which 30 had a high impact on the composite outcome, with the proportion of analyses with a significant association between 0.75 and 1. When taking the target population into account, some messages were studied in more than one population, resulting in 115 outcomes, of which 33 had a high impact, that is, a composite outcome between 0.75 and 1.</p><p><strong>Conclusion: </strong>Neither the use of proximal outcomes nor the restriction of the analysis to the targeted population significantly influenced the impact observed of the DHPC. These results stress the need for improving drug safety communication.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 3","pages":"e70135"},"PeriodicalIF":2.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11930567/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143693091","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":"Effect of Deregulation of the Brazilian National Controlled Products Management System on Antidepressants' Sales Data Deregulation of a Brazilian Drug Electronic System.","authors":"Vanessa Gomes Lima, Marcus Tolentino Silva, Tayanny Margarida Menezes Almeida Biase, Taís Freire Galvão","doi":"10.1002/pds.70136","DOIUrl":"10.1002/pds.70136","url":null,"abstract":"<p><strong>Purpose: </strong>To assess the effect of deregulating the national sales reporting system on Brazilian pharmacoepidemiologic data on antidepressants.</p><p><strong>Methods: </strong>This was a time series analysis to assess the trends in antidepressant sales in Brazilian drugstores from January 2014 to December 2022 using the Brazilian National Controlled Products Management System (SNGPC) and to predict sales records for 2022 after the deregulation of the mandatory record in December 2021. Antidepressant sales were converted to defined daily doses per 1000 inhabitants per day (DID). The seasonal autoregressive integrated moving average (SARIMA) was used to predict sales records for 2022. All analyses were conducted in Stata v.14.2.</p><p><strong>Results: </strong>Sales of patients taking antidepressants increased significantly from 2014 (mean: 14.7 DID/month) to 2020 (mean: 33.5 DID/month; β = 0.231; p < 0.001). After the start of the COVID-19 pandemic, the increasing trend continued, but the change was not significant (β = 0.330; p = 0.130). After the deregulation, a sharp decrease was observed (β = -1.032; p < 0.001). The monthly antidepressant sales forecasted for 2022 were 36.5 DID, while the observed value was 2.5 DID.</p><p><strong>Conclusion: </strong>Deregulation of SNGPC registration significantly decreased the number of antidepressant sales records. This measure affected the availability of pharmacoepidemiological data and research in Brazil.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 3","pages":"e70136"},"PeriodicalIF":2.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143664127","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":"Ten Must-Read Papers on Transparency and Reproducibility in Pharmacoepidemiology.","authors":"Anton Pottegård","doi":"10.1002/pds.70119","DOIUrl":"https://doi.org/10.1002/pds.70119","url":null,"abstract":"","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 3","pages":"e70119"},"PeriodicalIF":2.4,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143516274","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":"Opioid Use After Hip Fracture and Subsequent Fracture Outcomes: A Self-Controlled Case Series Design.","authors":"Meghan A Cupp, Kaleen N Hayes, Sarah D Berry, Francesca L Beaudoin, Melissa R Riester, Richa Joshi, Andrew R Zullo","doi":"10.1002/pds.70118","DOIUrl":"10.1002/pds.70118","url":null,"abstract":"<p><strong>Purpose: </strong>Hip fractures in older adults cause severe pain that often necessitates opioid use. However, opioids may trigger falls that result in subsequent fractures. Studies examining the effects of opioids on subsequent fractures are often limited by unmeasured confounding between opioid-treated and untreated persons. To overcome this limitation, we used a self-controlled case series (SCCS) design to investigate subsequent fracture risk during periods of opioid use after hip fracture.</p><p><strong>Methods: </strong>The retrospective cohort included Medicare beneficiaries aged > 65 years who had a subsequent hip fracture within one year after an incident hip fracture (2012-2018). We estimated the risk of subsequent hip fracture in three exposure intervals according to the duration of opioid exposure: (1) The first 0-14 days of opioid exposure, (2) days 15-42 of exposure, and (3) opioid use beyond 42 days. We employed several approaches to modify the SCCS design to be more robust to assumptions, including adjustment for event-dependent exposures.</p><p><strong>Results: </strong>The rate of subsequent fracture was greatest during opioid use across a variety of approaches. The effect within the first 14 days after initiating opioids was robust to SCCS design choices, ranging from IRR 1.12 (95%CLs 0.98, 1.28) to IRR 1.77 (95%CLs 1.52, 2.07). The effect of extended opioid use (> 42 days) ranged from IRR 2.49 (95%CLs 1.95, 3.18) to IRR 4.08 (95%CLs 3.06, 5.46).</p><p><strong>Conclusions: </strong>Analyses indicate a consistent increased risk of subsequent fracture associated with opioid use and demonstrate the importance that SCCS assumptions must be carefully investigated for real-world applications.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 2","pages":"e70118"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11899599/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143414788","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":"Lessons Learned From Characterizing Long COVID Among US Medicare Beneficiaries.","authors":"Yun Lu, Arnstein Lindaas, Hector S Izurieta, Myrna Cozen, Mikhail Menis, Xiangyu Shi, Whitney R Steele, Michael Wernecke, Yoganand Chillarige, Jeffrey A Kelman, Richard A Forshee","doi":"10.1002/pds.70101","DOIUrl":"10.1002/pds.70101","url":null,"abstract":"<p><strong>Purpose: </strong>To characterize long-term effects of COVID-19 among older adults (aged ≥ 65 years).</p><p><strong>Methods: </strong>This retrospective descriptive study utilized Medicare Fee-for-Service beneficiaries' claims to characterize post-COVID condition diagnosis code usage, long COVID (defined as post-COVID condition diagnoses made ≥ 28 days after an initial COVID-19 diagnosis) incidence, patient demographics, and concurrent diagnoses.</p><p><strong>Results: </strong>During April 1, 2020 to May 21, 2022, 193 691 (0.6%) of 31 847 927 Medicare beneficiaries were diagnosed with post-COVID conditions using ICD-10-CM diagnosis codes U09.9 and B94.8, regardless of prior COVID-19 diagnosis. Post-COVID condition diagnosis rate was higher among nursing home residents (18.7 per 1000 person-years) than community-dwelling beneficiaries (2.8). Among community-dwelling beneficiaries with a post-COVID condition diagnosis, 17.5% did not have any prior COVID-19 diagnosis code U07.1 recorded. Among beneficiaries with COVID-19 diagnosis, there were no significant sex, age, or race/ethnicity differences between those with post-COVID conditions ≥ 28 days after COVID-19 (i.e., long COVID) and those without post-COVID conditions. Certain myopathies and interstitial pulmonary disease codes were disproportionately present concurrently with long COVID compared to COVID-19.</p><p><strong>Conclusions: </strong>In this large study of 32 million Medicare beneficiaries, we found approximately 194 000 post-COVID condition diagnoses. Post-COVID condition diagnosis rate was higher among nursing home residents, highlighting the substantial burden of COVID-19 in this vulnerable population. Community-dwelling beneficiaries were less likely to seek medical care for COVID-19 events than nursing home residents, which may suggest differences in COVID-19 severity and respiratory disease detection between these populations. Long COVID risk after COVID-19 infection may be similar across demographic groups.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 2","pages":"e70101"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11753895/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143024288","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":"The Clinical Practice Research Datalink (CPRD) Mother-Baby Links: A Data Resource Profile.","authors":"Sonia Coton, Stephen Welburn, Rachael Williams, Jennifer Campbell","doi":"10.1002/pds.70091","DOIUrl":"10.1002/pds.70091","url":null,"abstract":"<p><strong>Purpose: </strong>Maternal exposures before, during and after pregnancy can affect the infant. It is therefore important that researchers study mothers and their children. The CPRD GOLD Mother-Baby Link (MBL) algorithm was applied to the CPRD Aurum database, to extend the useful tool. Here, we present the algorithm and data resource profiles of the CPRD MBLs.</p><p><strong>Methods: </strong>Records of female patients registered with a CPRD practice between the 1st January 1987 and the 1st June 2023 were searched for evidence of delivery. Infants born and registered between 1st January 1987 and 1st June 2023 were matched to mothers on practice and household indicators. The resulting MBLs were characterised.</p><p><strong>Results: </strong>The CPRD MBL algorithm was applied to the CPRD databases resulting in nearly four-million mother-baby pairs: 2.4-million in CPRD Aurum. Mothers in the CPRD GOLD and CPRD Aurum MBL's were similar in terms of age; mean age 29.6 years (SD = 5.7) vs. 30.2 years (SD = 5.7), and length of GP registration; mean = 14.4 years (SD = 10.9) vs. mean = 13.7 (SD = 10.9). The median number of matches was slightly higher in the CPRD GOLD MBL; 2 (IQR = 1, 2) vs. 1 (IQR = 1, 2). The number of matches in both databases peaked in 2008-2011, followed by a steady decline to 2023.</p><p><strong>Conclusion: </strong>The CPRD MBL's offer a valuable tool for researchers to study the mother-infant relationship. Extending the CPRD MBL algorithm to CPRD Aurum has increased the capacity for researchers to investigate rarer exposures and outcomes.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 2","pages":"e70091"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11792100/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143190034","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 Antibiotic Shortages on Antibiotic Utilisation in the Community.","authors":"Maarten Lambert, Katja Taxis, Lisa Pont","doi":"10.1002/pds.70107","DOIUrl":"10.1002/pds.70107","url":null,"abstract":"<p><strong>Background: </strong>Drug shortages are an increasing and worldwide problem. Oral antibiotics are one of the most used medicines worldwide and have recently been affected by drug shortages. Despite this, little is known about the impact of antibiotic shortages on prescribing practices.</p><p><strong>Aim: </strong>To explore the impact of oral antibiotic shortages on national antibiotic utilisation.</p><p><strong>Methods: </strong>A cross-sectional study of oral antibiotic shortages and antibiotic utilisation was conducted using Australian reimbursement and regulatory data from January 2022 to December 2023. All nationally reimbursed oral antibiotics were included in the study. The number and duration of reported antibiotic shortages per product were determined for each active ingredient. The clinical impact was assessed using national utilisation in Defined Daily Doses per 100 000 inhabitants. Changes in trends were analysed using Joinpoint regression.</p><p><strong>Results: </strong>Shortages were reported for eighteen of the twenty-one (86%) oral antibiotics reimbursed in Australia. For ten active ingredients, shortages did not coincide with changes in utilisation data. No clear relation between the number and duration of shortages and impact on utilisation was observed. Changes in utilisation coinciding with shortages were observed for eight active ingredients. For cefaclor (-20% decrease in utilisation) and roxithromycin (-26% decrease), the impact of shortages is most clearly reflected by decreases in utilisation. For the other six, minor changes in utilisation were observed coinciding with shortages.</p><p><strong>Conclusions: </strong>Antibiotic shortages were common in Australia during 2022 and 2023. The impact of shortages differs per antibiotic, for some antibiotics there are shortages coinciding with declines in utilisation. For others, shortages occur without apparent changes in utilisation.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 2","pages":"e70107"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11772095/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143053132","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":"The Effect of Isoniazid for Tuberculosis Prevention on Pregnancy Risk Among Women Living With HIV on Antiretroviral Treatment and Progestin-Based Hormonal Contraception.","authors":"Karen Diepstra, Daniel Westreich, Agatha Bula, Clara Lemani, John Chapola, Jennifer Winston, Katie Mollan, Jill Hagey, Sam Phiri, Jane Chiwoko, Lameck Chinula, Mina C Hosseinipour, Mackenzie Cottrell, Audrey Pettifor, Mollie E Wood, Jennifer H Tang","doi":"10.1002/pds.70105","DOIUrl":"10.1002/pds.70105","url":null,"abstract":"<p><strong>Purpose: </strong>Concomitant use of antiretroviral therapy (ART), hormonal contraception, and isonicotinic acid hydrazide (isoniazid) for tuberculosis prevention is common among women of reproductive age who are living with HIV in sub-Saharan Africa. We estimated the effect of isoniazid on 6-month pregnancy risk among Malawian women living with HIV in the Family Planning and Antiretroviral Therapy (FP-ART) prospective cohort study, overall and among subgroups defined by ART regimen type and hormonal contraceptive method.</p><p><strong>Methods: </strong>The analytic sample included visits contributed by participants who were currently using either efavirenz- or dolutegravir-based ART and either depot medroxyprogesterone acetate (DMPA) or levonorgestrel (LNG) implant contraception at the time of the visit. The exposure was self-reported, current isoniazid use (yes/no). The binary outcome measure, 6-month pregnancy, was defined as an estimated conception date 1-183 days after the study visit date. We used a marginal structural linear risk regression model with inverse probability of treatment weights, multiple imputation by chained equations, and bootstrapping to estimate risk differences (RD) and 95% confidence intervals (CI).</p><p><strong>Results: </strong>The analytic sample included 4709 study visits occurring between September 2017 and June 2021. The weighted 6-month pregnancy risk among isoniazid use visits was 3.0% compared with 2.3% among non-use visits (RD 0.7%, 95% CI: -0.7%, 2.1%), and the results were qualitatively similar for all subgroup estimates.</p><p><strong>Conclusions: </strong>We did not find a clinically significant effect of isoniazid use on 6-month pregnancy incidence among women concomitantly using ART and either DMPA or LNG implant contraception.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 2","pages":"e70105"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12210350/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143067102","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}