Pharmacoepidemiology and Drug Safety最新文献

{"title":"Benzodiazepine Initiation Effect on Mortality Among Medicare Beneficiaries Post-Acute Ischemic Stroke.","authors":"Madhav Sankaranarayanan, Maria A Donahue, Shuo Sun, Julianne D Brooks, Lee H Schwamm, Joseph P Newhouse, John Hsu, Deborah Blacker, Sebastien Haneuse, Lidia M V R Moura","doi":"10.1002/pds.70194","DOIUrl":"10.1002/pds.70194","url":null,"abstract":"<p><strong>Purpose: </strong>Despite guideline warnings and concerns for increased mortality, acute ischemic stroke (AIS) survivors older than 66 years of age still receive benzodiazepines (BZDs). We examined the BZD-associated effect on mortality within 30 days post-discharge on survival among older Medicare beneficiaries after an AIS.</p><p><strong>Methods: </strong>We analyzed a sample of Medicare beneficiaries enrolled for at least 12 months before hospitalization for AIS. Our primary exposure was BZD initiation within 30 days post-discharge, and its primary outcome was 90 days mortality risk differences (RDs) from discharge using trial emulation with methods to address confounding (i.e., cloning, weighting, censoring, and inverse-probability-of-censoring weighting).</p><p><strong>Results: </strong>Of 47 421 beneficiaries, 826 (1.74%) initiated BZD 30 days post-discharge, and 6392 (13.48%) died within 90 days. The median age was 79 (IQR: 12), with 55.3% female, 82.9% White, 10.1% Black, 1.7% Hispanic, 2.2% Asian, and 0.4% American Native. After standardization (based on age, sex, race/ethnicity, length of stay, and baseline dementia), the 90-day mortality risk revealed an RD of 26 events per 1000 (95% CI: 22, 33). Subgroup analyses revealed higher RDs in older age groups, particularly those aged 86 or older, with an RD of 84 events per 1000 (95% CI: 73, 106), and for patients with baseline dementia, with an RD of 87 events per 1000 (95% CI: 63, 112).</p><p><strong>Conclusion: </strong>Initiating BZDs within 30 days post-AIS discharge was associated with increased 90 days mortality risk, especially in older adults 76 years and older and those with baseline dementia, highlighting their vulnerability to BZD adverse effects.</p><p><strong>Plain language summary: </strong>This study looked at how starting to take benzodiazepines (BZDs) affects survival in older adults after a stroke. BZDs are medications typically used for anxiety, insomnia, and seizures. The study focused on patients 66 years old and older on Medicare and determined whether taking BZDs within 30 days after leaving the hospital increased their risk of dying within 90 days. The study analyzed over 47,000 patients, selecting those with more favorable outcomes, and found that 1.74% began taking BZDs after their stroke. After adjusting for factors like age, gender, race, hospital stay, and dementia, we found that starting BZDs was associated with a higher risk of death. The risk was particularly high in patients 86 years and older and those with dementia. The study concluded that prescribing BZDs to older stroke survivors could substantially raise the risk of death, especially in the oldest and most vulnerable patients.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 8","pages":"e70194"},"PeriodicalIF":2.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144708418","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 Biologic and Targeted-Synthetic DMARDs in Patients With Rheumatoid Arthritis: A Multi-Database Real-World Cohort Study.","authors":"Yinzhu Jin, Jun Liu, Rishi J Desai","doi":"10.1002/pds.70193","DOIUrl":"10.1002/pds.70193","url":null,"abstract":"<p><strong>Objectives: </strong>To examine the comparative risk of malignancy, venous thromboembolism (VTE), and heart failure (HF) associated with biologic/targeted synthetic disease-modifying antirheumatic drugs (b/ts DMARDs) in patients with rheumatoid arthritis (RA).</p><p><strong>Methods: </strong>We conducted an observational cohort study using 3 US insurance claims databases: Medicare (2009-2019), MarketScan (2009-2020), and Optum's de-identified Clinformatics Data Mart Database (CDM, 2009-2022). We included adults with RA initiating abatacept (reference), tumor necrosis factor inhibitors (TNFi), rituximab, interleukin-6 inhibitors (IL-6i), or Janus kinase inhibitors (JAKi). We used an as-treated approach as the primary analysis to estimate outcome incidence. Inverse probability of treatment weighting was applied to adjust for confounding. Database-specific hazard ratios (HR) with 95% confidence intervals (CI) were estimated using Cox-proportional hazard models, then combined through random-effects meta-analysis.</p><p><strong>Results: </strong>We identified 26 908 abatacept, 11 176 IL-6i, 115 437 TNFi, 14 045 JAKi, and 12 097 rituximab initiators. Weighted HR (95% CI) of malignancy was 0.73 (0.60-0.88) for IL-6i, 0.85 (0.60-1.19) for JAKi, 1.30 (1.14-1.49) for rituximab, and 0.93 (0.85-1.02) for TNFi, compared to abatacept. Weighted HR (95% CI) for VTE was 0.92 (0.62-1.35), 1.17 (0.73-1.86), 1.43 (1.50-1.95), and 1.16 (0.93-1.46), respectively. Weighted HR (95% CI) for HF was 1.00 (0.69-1.46), 1.24 (0.62-2.51), 1.52 (1.04-2.22), and 1.54 (1.22-1.94), respectively.</p><p><strong>Conclusion: </strong>We observed increased risks of malignancy, VTE, and HF among rituximab initiators; an increased risk of HF among TNFi initiators; and a lower risk of malignancy among IL-6i initiators, all compared to abatacept initiators. These findings should be interpreted with caution due to the potential influence of residual confounding.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 8","pages":"e70193"},"PeriodicalIF":2.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144732647","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":"Abstracts of ISPEs 2025, 41st International Conference, 22-26 August 2025, Washington DC.","authors":"","doi":"10.1002/pds.70186","DOIUrl":"10.1002/pds.70186","url":null,"abstract":"","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 Suppl 1 ","pages":"e70186"},"PeriodicalIF":2.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144883403","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":"Glucagon-like Peptide-1 Receptor Agonists in Asthma Exacerbations: An Application of High-Dimensional Iterative Causal Forest to Identify Subgroups.","authors":"Tiansheng Wang, Jeanny H Wang, Alan C Kinlaw, Richard Wyss, Virginia Pate, Zhuoyue Gou, John B Buse, Corinne A Keet, Michael R Kosorok, Til Stürmer","doi":"10.1002/pds.70192","DOIUrl":"10.1002/pds.70192","url":null,"abstract":"<p><strong>Background: </strong>Glucagon-like Peptide-1 Receptor Agonists (GLP1RA) may reduce asthma exacerbation (AE) risk, but it is unclear which populations benefit most. Recent pharmacoepidemiologic studies have employed iterative causal forest (iCF), a machine learning (ML) algorithm, to identify subgroups with heterogeneous treatment effects (HTEs). While iCF does not rely on prior knowledge of treatment-variable interactions, it may be constrained by missing or poorly defined variables in pharmacoepidemiologic studies.</p><p><strong>Methods: </strong>We applied the high-dimensional iterative causal forest (hdiCF)-a causal ML algorithm requiring predefined variables-to MarketScan 2016-2020 claims data to identify populations with asthma that might benefit most from GLP1RA in reducing AE risk. We built a GLP1RA vs. sulfonylurea new-user cohort with ≥ 1 inpatient or two outpatient asthma encounters, excluding patients with nonasthma indications for systemic steroids. The outcome was acute AE (hospital admission or emergency department visit for asthma), assessed over 6 months using 599 high-dimensional features from inpatient/outpatient services and pharmacy claims.</p><p><strong>Results: </strong>In the overall population, GLP1RA decreased AE risk relative to sulfonylurea: aRD -1.4% (-2.0%, -0.8%). hdiCF identified three subgroups based on the quantity of systemic steroid prescription fills (0, 1, and ≥ 2): patients with ≥ 2 prescriptions (GLP1RA: 34 events/1367 individuals; sulfonylurea: 53/1013) benefited most from GLP1RA: aRD -3.8% (-5.3%, -2.2%).</p><p><strong>Conclusions: </strong>This study demonstrates how automated feature identification can pinpoint clinically relevant subgroups with HTEs. The quantity of systemic steroid prescriptions, as a proxy for severe asthma, may guide personalized predictions of GLP1RA's short-term benefits on acute AE.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 8","pages":"e70192"},"PeriodicalIF":2.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144732648","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":"Review of Mother-Infant Linkage Algorithms in Health Care Data Sources.","authors":"Melanie H Jacobson, Alexis A Krumme, Dina M Gifkins, Andrea V Margulis, James Weaver, Kourtney J Davis","doi":"10.1002/pds.70189","DOIUrl":"https://doi.org/10.1002/pds.70189","url":null,"abstract":"<p><strong>Introduction: </strong>Studies that use health care data to assess infant outcomes following maternal medication use in pregnancy require linkage of maternal and infant records. While such linkage is increasing among established and emerging data sources, linkage methods are heterogeneous and have not been thoroughly reviewed or evaluated to inform fitness for use. The objective of this study was to describe methods used to link maternal and infant records in health care databases for pharmacoepidemiology research.</p><p><strong>Methods: </strong>Multiple Medline searches were conducted using structured terms and known mother-infant linked data sources. Reference sections of identified key papers were also reviewed. From each publication, we abstracted information on the type(s) of data sources, data fields used for the linkage, linkage methodology, and any results of record linkage evaluation.</p><p><strong>Results: </strong>We reviewed 114 publications describing mother-infant linkages published from 1990 to 2025 that used data from North and South America, Europe, Asia, and Oceania. Linkage methods using administrative claims data only primarily relied on family ID and estimated dates of maternal delivery and infant birth; proportions of mothers linked with infants were 56%-90%. Use of vital records, such as birth certificates, alongside claims data resulted in higher linkage proportions (> 86% of deliveries); examples were identified in Taiwan, Europe, and several US states. Utilization of birth records together with hospital discharge data resulted in linkages of over 90% of deliveries. Linkages involving additional data types, such as electronic health records, were identified in Europe and the US. Mother-infant linkages were straightforward in regions with national birth registers that include identifiers for mother and infant, such as the Nordic countries, and within integrated delivery networks in the US that provide both health insurance and care. Although most mother-infant linkages used deterministic methods, probabilistic methods typically achieved greater linkage proportions while requiring more data fields. Validations were uncommon; two studies demonstrated high positive predictive value (> 95%) but lower sensitivity (20%-88%).</p><p><strong>Discussion: </strong>Successful mother-infant data linkage occurs throughout the world and is enabled by aligned health care and technology infrastructure and policy. To increase trust in evidence generated from linked data, we encourage researchers and journals to include a description of linking methods, a quantification of linkage success, and, when possible, an assessment of linkage validity in peer-reviewed publications.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 8","pages":"e70189"},"PeriodicalIF":2.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144799858","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":"Use of Valproic Acid Among Women of Childbearing Age and Its Concomitant Use With Contraceptives in Colombia.","authors":"Jorge E Machado-Alba, Andrés Gaviria-Mendoza, Manuel E Machado-Duque, Luis F Valladales-Restrepo, Albert Figueras","doi":"10.1002/pds.70208","DOIUrl":"https://doi.org/10.1002/pds.70208","url":null,"abstract":"<p><strong>Purpose: </strong>Valproic acid is a known teratogen. The aim was to identify contraceptive use in a group of women using valproic acid.</p><p><strong>Methods: </strong>Descriptive study. A total of 22 855 women of childbearing age (15-49 years) with at least 1 month of valproic acid use from January 2022 to December 2023 were selected from a Colombian drug-dispensing database. Data on the dispensing of hormonal contraceptives were searched during the study period. The time and rate of coverage (% of the period during which women took contraceptives while using valproic acid/total period of valproic acid consumption) with contraceptives were calculated.</p><p><strong>Results: </strong>Among the women included, 71.4% (n = 16 308) used 250-mg valproic acid tablets. The mean age was 32.7 (standard deviation [SD]: 9.9) years, and the most common related diagnosis was migraine and headache (n = 5163, 22.6%). Only 8.0% (n = 1832) of the women had at least 1 day of coverage with some contraceptive while using valproate. For the patients with at least 1 day of coverage, the average duration of coverage was 72.5 (SD: 84.7) days (median: 30 days; IQR: 30-86 days). This represents an overall coverage rate of 5.3% (SD: 20.4%) (median: 0.0) and a coverage rate of 65.7% (SD: 35.1%) (median: 75.8%, IQR: 33.3-100%) for those with at least 1 day of coverage.</p><p><strong>Conclusions: </strong>A significant proportion of women of childbearing age are likely at risk of becoming pregnant while taking valproic acid.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 8","pages":"e70208"},"PeriodicalIF":2.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144964233","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":"Colectomy and Neoplasia Outcomes of Patients With Ulcerative Colitis Receiving Golimumab: A Post-Authorisation Safety Study Using the Spanish ENEIDA Registry.","authors":"Eugeni Domènech, Joan Fortuny, David Martínez, Anita Tormos, Zhiping Huang, Deanna D Hill, Cindy Weinstein, Suzan Esslinger, Alexis A Krumme, Marijo Otero-Lobato, Daniel Mines, Javier P Gisbert","doi":"10.1002/pds.70176","DOIUrl":"10.1002/pds.70176","url":null,"abstract":"<p><strong>Purpose: </strong>Golimumab (GLM), an anti-tumour necrosis factor alpha (anti-TNFα) agent, is indicated for moderate to severe ulcerative colitis (UC). This post-authorisation safety study evaluated the risk of colectomy due to intractable disease and advanced colonic neoplasia (high-grade dysplasia and/or colorectal cancer) under real-world conditions of GLM use.</p><p><strong>Methods: </strong>This bidirectional cohort study using Spanish ENEIDA registry data (2013-2022) included adults with UC who initiated GLM, other anti-TNFα agents, or thiopurines (TPs). Crude risk analyses-and, when feasible, multivariable models-in cohort and nested case-control designs were performed. For colectomy, we evaluated exposure to GLM only, other anti-TNFα agents, and both (i.e., overlapping exposure). For ACN, we evaluated exposure to GLM, other anti-TNFα agents, and TPs.</p><p><strong>Results: </strong>Sixty-four colectomy cases and 10 ACN cases were identified among patients exposed to GLM (N = 474), other anti-TNFα agents (N = 1737), or TPs (N = 1380). Incidence rates per 1000 person-years and 95% confidence intervals were reported for colectomy (GLM-only [4.4, 1.2-11.2] and other anti-TNFα agents only [12.4, 9.1-16.5]) and ACN (GLM [1.5, 0.2-5.4], other anti-TNFα agents [1.3, 0.5-2.8], and TPs [1.0, 0.3-2.6]). In comparisons excluding overlapping exposure, GLM was not associated with an increased risk of colectomy versus other anti-TNFα agents. GLM was also not associated with an increased risk of ACN versus either comparator. Observed events, especially for ACN, were limited for all exposures.</p><p><strong>Conclusions: </strong>Findings do not indicate an increased risk of colectomy due to intractable disease or ACN with GLM use versus other therapies for similar disease severity in routine UC care (EUPAS15752).</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 8","pages":"e70176"},"PeriodicalIF":2.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12319186/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144732637","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":"Evaluating the Impact of Data Standardization on Real-World Data.","authors":"Elizabeth M Garry, Aidan Baglivo, Priya Govil, Jennifer L Duryea, Wei Liu, Tamar Lasky, Aloka Chakravarty, Donna R Rivera, Marie C Bradley","doi":"10.1002/pds.70191","DOIUrl":"https://doi.org/10.1002/pds.70191","url":null,"abstract":"<p><strong>Purpose: </strong>To understand the impact of standardizing administrative healthcare data to the Sentinel common data model for cohort selection and descriptive findings.</p><p><strong>Methods: </strong>Among patients with an outpatient COVID-19 diagnosis (January 2021-December 2022) in HealthVerity using the data in its native and the standardized format, we descriptively compared cohort attrition and sample size, patient characteristics, and healthcare resource utilization during baseline and incidence of selected conditions after COVID-19 diagnosis.</p><p><strong>Results: </strong>The standardized cohort included fewer patients than the native (164 445 vs. 198 317), but age (median 48 years) and sex (70% female) were the same. The distribution of race was similar; however, the standardized cohort mapped patients with \"Other\" race to the \"Unknown/Missing\" race category, which created differences among those categories. Distributions were similar, albeit slightly lower for comorbidities (differences < 1%), and lower for SARS-CoV-2 diagnostic tests (59% vs. 70%). Medical encounter counts were also lower, with substantial differences that were attenuated after limiting encounter counts to one event per day (e.g., mean count of 6.0 vs. 27.7 specialty care visits reduced to 2.9 vs. 3.5). Incidence rates were lower, with the greatest difference for hepatotoxicity (29.6 vs. 37.1 per 1000 person-years).</p><p><strong>Conclusions: </strong>The data standardization refines the data (e.g., removes duplicate claims and variables or variable categories), which may reduce outliers and errors but yield lower distributions and counts of certain variables than observed in native format data. Therefore, it is critical to understand how standardization impacts the data and subsequently its fitness for use.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 8","pages":"e70191"},"PeriodicalIF":2.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144784958","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":"How COVID-19 Treatment in Pregnancy Reflects Healthcare Utilization During a Pandemic: A Two-Stage Individual Participant Data Meta-Analysis Combining Case-Based Registries.","authors":"Emeline Maisonneuve, Odette De Bruin, Guillaume Favre, Erin Oakley, Jenny Yeon Hee Kim, Fouzia Farooq, Nouf Al-Fadel, Abdulaali Almutairi, Maria Del Mar Gil, Irene Fernandez Buhigas, Silvia Visentin, Erich Cosmi, Fernanda Surita, Renato T Souza, José G Cecatti, Maria Laura Costa, Jose Sanin-Blair, Jorge E Tolosa, Eran Hadar, Anna Goncé, Christophe Poncelet, Fabienne Forestier, Thibaud Quibel, Begoña Martinez de Tejada, Béatrice Eggel-Hort, Romina Capoccia Brugger, Daniel Surbek, Luigi Raio, Anda-Petronela Radan, Monya Todesco-Bernasconi, Cécile Monod, Leonard Schäffer, Anett Harnadi, Sayed Hamid Mousavi, Diogo Ayres-de-Campos, Léo Pomar, Joanna Sichitiu, Laurent J Salomon, Yves Ville, Andrea Papadia, Marie-Claude Rossier, Lavinia Schuler-Faccini, Natalya Goncalves Pereira, Adolfo Etchegaray, Albaro Jose Nieto-Calvache, Michael Geary, Javiera Fuenzalida, Claudia Grawe, Albert I Ko, Silke Johann, Marco De Santis, Cora Alexandra Voekt, Najeh Hcini, Karin Nielsen-Saines, Charles Garabedian, Loïc Sentilhes, Otto H May Feuerschuette, Grit Vetter, Manggala Pasca Wardhana, Irida Dajti, Kitty W M Bloemenkamp, Satu J Siiskonen, Emily R Smith, David Baud, Alice Panchaud, Miriam C J M Sturkenboom","doi":"10.1002/pds.70180","DOIUrl":"10.1002/pds.70180","url":null,"abstract":"<p><strong>Purpose: </strong>To describe an international response to the COVID-19 pandemic by estimating the prevalence of medication use for COVID-19 treatment in pregnancy, stratified by hospitalization, trimester of pregnancy, and country.</p><p><strong>Methods: </strong>We conducted a two-stage individual participant data meta-analysis of proportions from primary data on medications used to treat COVID-19 during pregnancy. A common data model was developed to pool the data from single-country and international registries. Data from pregnant individuals with COVID-19 between February 2020 and October 2022 were included in study platforms across 9 data sources. Patient information was abstracted from medical records.</p><p><strong>Results: </strong>Among 24 937 pregnant individuals, the pooled prevalences of individuals receiving medications to treat COVID-19 were: 34.7% heparin, 9.8% antibiotics, 4.9% corticosteroids, 2.2% antivirals, 0.8% antimalarials, 0.3% convalescent plasma, 0.2% immunosuppressants, and 0.02% monoclonal antibodies. Prevalence of medication use was higher in hospitalized individuals than in non-hospitalized individuals: 58.4% versus 17.9% for heparin, 26.9% versus 5.7% for antibiotics, 17.5% versus 1.3% for corticosteroids, 10.3% versus 0.3% for antivirals, and 4.5% versus 0.1% for antimalarials. The prevalence of corticosteroid use was lower in the first trimester (0.1%) compared with the second (7.2%) and third (4.9%) trimesters of pregnancy. The prevalence of medications differed widely across countries.</p><p><strong>Conclusion: </strong>Medication to treat COVID-19 was more frequently used in pregnant individuals hospitalized for COVID-19. Corticosteroids were used less in the first trimester of pregnancy. The differences in use between countries could reflect differences in the clinical management and access to medications for this population at risk of severe disease.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 7","pages":"e70180"},"PeriodicalIF":2.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12418691/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144643066","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":"Modeling Versus Balancing Approaches to Addressing Instrumental Variables in Weighting: A Comparison of the Outcome-Adaptive Lasso, Stable Balancing Weighting, and Stable Confounder Selection.","authors":"Byeong Yeob Choi, M Alan Brookhart","doi":"10.1002/pds.70173","DOIUrl":"10.1002/pds.70173","url":null,"abstract":"<p><strong>Background: </strong>Variable selection is essential for propensity score (PS)-weighted estimators. Recent work shows that including instrumental variables (IVs), associated with only treatment but not with the outcome, can impact both the bias and precision of the PS-weighted estimators.</p><p><strong>Methods: </strong>The outcome-adaptive lasso (OAL) is an innovative model-based method adapting the popular adaptive lasso variable selection to causal inference. It attempts to identify IVs, so one can exclude them from the PS model. Unlike the model-based approach, stable balancing weighting (SBW) estimates inverse probability weights directly while minimizing the variance of the weights and covariate imbalance simultaneously. Based on its variance optimization algorithm, SBW may provide some protection against the impact of IVs. Lastly, we considered stable confounder selection (SCS), which assesses the stability of model-based effect estimates.</p><p><strong>Results: </strong>The authors present the results of simulation studies to investigate which method performs the best when moderate or strong IVs are used. The simulation studies consider IVs and spurious variables to generate extreme PSs. In simulations, SBW generally outperformed OAL and SCS in terms of reducing mean squared error, notably when the IVs were strong, and many covariates were highly correlated. Our empirical application to the effect of abciximab treatment demonstrates that SBW is a robust method to effectively handle limited overlap.</p><p><strong>Conclusions: </strong>Our numerical results support the use of SBW in situations where IVs or near-IVs may lead to practical violations of positivity assumptions.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 7","pages":"e70173"},"PeriodicalIF":2.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12203767/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144507330","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}