Pharmacoepidemiology and Drug Safety最新文献

{"title":"Comparative Effectiveness of Oral Fluoropyrimidines Versus FOLFOX as Adjuvant Therapy for Stage III Colon Cancer: A Retrospective Cohort Study Using Overlap-Weighted Restricted Mean Survival Time Analysis.","authors":"Shih-Feng Huang, Chao-Wen Hsu, Chih-Chien Wu, Yu-Hsun Chen","doi":"10.1002/pds.70427","DOIUrl":"10.1002/pds.70427","url":null,"abstract":"<p><strong>Purpose: </strong>Oxaliplatin-based chemotherapy is the standard adjuvant treatment for stage III colon cancer, but oral fluoropyrimidines remain widely used for patients unsuitable for combination therapy. Real-world data comparing these strategies are limited.</p><p><strong>Methods: </strong>We conducted a retrospective cohort study of patients with stage III colon cancer who received adjuvant chemotherapy at Kaohsiung Veterans General Hospital (2017-2021). Using a 12-month landmark design, we compared disease-free survival (DFS) between patients receiving FOLFOX (IV-Only) versus oral fluoropyrimidines (PO-Only). The primary analysis used overlap-weighted restricted mean survival time (RMST) differences to quantify absolute treatment effects. Cox proportional hazards regression provided complementary hazard ratio estimates.</p><p><strong>Results: </strong>Of 157 patients included, 58 (36.9%) received FOLFOX and 99 (63.1%) received oral fluoropyrimidines. During median follow-up of 36 months, 22 DFS events occurred. The 3-year DFS was 93.1% versus 76.5% for IV-Only and PO-Only groups, respectively. The primary analysis showed that patients receiving FOLFOX had 4.0 additional months of disease-free time over 48 months (RMST difference: 4.0 months; 95% CI, 0.6-7.9; p = 0.014) and 2.4 months over 36 months (RMST difference: 2.4 months; 95% CI, 0.2-4.7; p = 0.024). The hazard ratio from overlap-weighted Cox regression with covariate adjustment was 0.37 (95% CI 0.09-1.45; p = 0.154), directionally consistent with the RMST findings but not reaching statistical significance. Hazard ratio estimates were directionally consistent across sensitivity analyses but varied in statistical significance, likely reflecting limited power: unadjusted (HR 0.23; p = 0.019), stabilized weighting with covariates (HR 0.19; p = 0.046), and multivariable adjustment (HR 0.44; p = 0.249).</p><p><strong>Conclusions: </strong>In this real-world cohort, oral fluoropyrimidines were associated with 4.0 fewer months of disease-free time compared with FOLFOX at 48 months among patients for whom both treatment options were appropriate. As a single-center study with limited events, these findings should be confirmed in larger multicenter cohorts. The combination of RMST with overlap weighting provides an interpretable framework for comparative effectiveness questions where treatment selection is strong.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 7","pages":"e70427"},"PeriodicalIF":2.6,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13355949/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148361739","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":"Age, Age-Related Comorbidities and Survival in Palbociclib, Ribociclib and Abemaciclib Users With Advanced Breast Cancer: A Nation-Wide Retrospective Cohort Study.","authors":"Blair Rajamaki, Olli Tenhunen, Liisa Pylkkänen, Thuan Vo, Anne Paakinaho, Miia Turpeinen, Sirpa Hartikainen, Anna-Maija Tolppanen","doi":"10.1002/pds.70416","DOIUrl":"10.1002/pds.70416","url":null,"abstract":"<p><strong>Purpose: </strong>Prevalence of breast cancer (BC) increases with age, but the external validity of data obtained from pivotal trials of medicinal products remains a concern due to the underrepresentation of frail and older adults. Cyclin-dependent kinase inhibitors (CDKi), palbociclib, abemaciclib, and ribociclib are considered an essential part of the standard-of-care in the management of advanced/metastatic breast cancer. We investigated age, comorbidities, and survival in a nationwide real-world cohort of CDKi users.</p><p><strong>Methods: </strong>Data from the Finnish Cancer Registry, reimbursed dispensed prescriptions, Electronic Prescription Database, Care Register for Health Care (CRHC), and Causes of Death Register were combined and analysed.</p><p><strong>Results: </strong>Altogether 1921 women with BC initiated CDKi treatment in 2018-2022. The median age at initiation was 66.9 years, with 43.2% of the study cohort being < 65 years of age, 36.1% 65-74 years, 19.0% 75-84 years, and 1.7% 85 years or older. The prevalence of age or frailty-related comorbidities in individuals ≥ 65 years was low, highest for cardiovascular diseases, 32.3%, and diabetes, 16.9%. The median survival was 25.3 months, with longer median survival times in younger age groups (27.7 months in < 65 year-olds, 25.1 months in aged 65-74, 21.4 months in aged 75-84 years, and 15.4 months in 85 years or older).</p><p><strong>Conclusions: </strong>Real-world CDKi users are older than women included in the pivotal trials, and the survival differences between age groups imply challenges in the generalisability of data from pivotal trials. The real-world CDKi user population is characterised by a low prevalence of major comorbidities.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 7","pages":"e70416"},"PeriodicalIF":2.6,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13270987/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148259141","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":"Mortality in Castration Resistant Prostate Cancer Patients With and Without Pre-Existing Cardiovascular Disease Receiving Oral Androgen Receptor Pathway Inhibitors.","authors":"Ibrahim M Asiri, Ronald C Chen, Viraj Master, Lanyu Mi, Sarah E James, Cassandra Moore, Alan H Bryce, Jon C Tilburt, Irbaz B Riaz, Syed Arsalan Ahmed Naqvi, Umar Afzal, Steven R H Beach, Ewan K Cobran","doi":"10.1002/pds.70405","DOIUrl":"10.1002/pds.70405","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Men with castration-resistant prostate cancer (CRPC) who have a pre-existing history of cardiovascular disease (CVD) or other comorbidities are often excluded from clinical trials involving oral androgen receptor pathway inhibitors (ARPi). In this study, we compared all-cause and prostate cancer-specific mortality among CRPC patients, with and without a pre-existing history of CVD, receiving ARPi compared to chemotherapy.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Men with CRPC were identified using the Surveillance, Epidemiology, and End Results-Medicare Linked Database from 2004 to 2015. Patients were grouped into two analytical cohorts by drug use. Inverse probability treatment weights (IPTW)-adjusted Cox models and Fine-Gray subdistribution hazards models were used to evaluate associations between ARPi and chemotherapy, and between ENZ and AA for all-cause mortality and cancer-specific mortality separately.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The study cohort included 1438 men with CRPC. Nearly 54.4% of patients had a pre-existing history of CVD. Patients with a pre-existing history of CVD had a higher incidence of all-cause and prostate cancer-specific mortality compared to patients without a history of CVD (all-cause mortality: 69.7% vs. 59.3%, prostate cancer-specific mortality: 56.0% vs. 49.5%, respectively). In the pre-existing history of CVD cohort, the IPTW-adjusted Cox model showed a significantly lower all-cause mortality in patients who received APRi, enzalutamide, and abiraterone, versus chemotherapy (IPTW-adjusted hazard ratio [AHR], 0.56; 95% Confidence Interval [CI], 0.48-0.64; p-value &lt; 0.001). Further, the IPTW-adjusted competing risk model showed significantly lower prostate cancer-specific mortality in patients who received ARPi compared with those who received chemotherapy (IPTW-AHR, 0.48; 95% CI, 0.41 to 0.57; p-value &lt; 0.001). In the without pre-existing history of CVD cohort, the adjusted Cox model showed significantly lower all-cause mortality in patients who received APRi than those who received chemotherapy (IPTW-AHR, 0.49; 95% CI, 0.41-0.60; p-value &lt; 0.001). Whereas the IPTW-adjusted competing risk model showed significantly lower prostate cancer-specific mortality in patients who received ARPi compared with those who received chemotherapy (IPTW-AHR, 0.52; 95% CI, 0.42-0.64; p-value &lt; 0.001).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;In this population-based cohort of older men with castration-resistant prostate cancer, treatment with oral androgen receptor pathway inhibitors was associated with lower estimated risks of all-cause and prostate cancer-specific mortality compared with chemotherapy in patients with and without pre-existing CVD. These findings add real-world comparative effectiveness evidence for patient populations not well represented in randomized clinical trials; however, given the observational design and limitations of administrative data, residual confounding and unmeasured clinical diff","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 7","pages":"e70405"},"PeriodicalIF":2.6,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13356235/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148284100","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":"Nationwide Trends in Opioid Consumption in Costa Rica, 2017-2024: Implications for Regulatory Policy and Public Health.","authors":"Esteban Zavaleta-Monestel, Sebastián Arguedas-Chacón, Jeaustin Mora-Jiménez, Carlos Wu-Chin, Roberto Rodríguez-Miranda","doi":"10.1002/pds.70421","DOIUrl":"10.1002/pds.70421","url":null,"abstract":"<p><strong>Introduction: </strong>The global opioid crisis has highlighted substantial differences in prescribing, monitoring, and regulatory practices across health systems. In Costa Rica, comprehensive national data on opioid use have been limited. This study aimed to describe temporal trends in legally prescribed opioid consumption between 2017 and 2024 using nationwide administrative data.</p><p><strong>Methods: </strong>A nationwide, retrospective, population-based analysis was conducted using data from the Costa Rican Ministry of Health's narcotics registry. Dispensation records for morphine, methadone, fentanyl, oxycodone, and tapentadol were included. Opioid consumption was standardized to Morphine Milligram Equivalents (MME) using NIH HEAL conversion factors. Temporal trends were assessed using descriptive statistics and simple linear regression.</p><p><strong>Results: </strong>A total of 31.9 million opioid dispensations were recorded during the study period. National opioid consumption peaked in 2018 (395.1 million MME), followed by an approximate 70% decline through 2023 and a modest increase in 2024. Consumption of morphine and methadone declined substantially (-72.2% and -82.4%, respectively), while oxycodone and tapentadol showed moderate increases over time. These findings indicate a marked reduction in overall opioid consumption alongside changes in the distribution of use across opioid agents.</p><p><strong>Conclusions: </strong>Between 2017 and 2024, Costa Rica experienced a sustained decline in total opioid dispensing and a redistribution of opioid use across substances. These trends occurred in the context of strengthened regulatory oversight and expanded digital monitoring of controlled substances. While causal relationships cannot be established, the findings provide relevant population-level evidence to support opioid stewardship and inform regulatory and public health strategies in middle-income health systems.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 7","pages":"e70421"},"PeriodicalIF":2.6,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13356230/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148345367","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":"Direct Oral Anticoagulant Consumption and the Risk of Acute Interstitial Lung Diseases: A Case-Crossover Study Using Japanese Administrative Data.","authors":"Keisuke Anan, Takahiro Itaya, Yuki Kataoka, Kazuya Ichikado, Kodai Kawamura, Yosuke Yamamoto","doi":"10.1002/pds.70398","DOIUrl":"10.1002/pds.70398","url":null,"abstract":"<p><strong>Background: </strong>Direct oral anticoagulants (DOACs) offer advantages over warfarin; however, concerns exist regarding their association with acute interstitial lung diseases (ILDs). This study investigated the risk of acute-onset ILDs associated with DOAC use.</p><p><strong>Methods: </strong>We conducted a case-crossover study to assess the risk of hospitalization for acute-onset ILDs following DOAC initiation using the JMDC database, a Japanese administrative claims database. Patients aged ≥ 18 years hospitalized for acute-onset ILDs (April 2011-February 2023) were included. DOAC exposure was defined as ≥ 14 days within predefined 30-day windows: 1-30 days before admission (exposure period) and 60-90 and 120-150 days before admission (reference periods). The primary outcome was hospitalizations for acute-onset ILD, identified using a validated algorithm. Conditional logistic regression estimated odds ratios (ORs). Sensitivity analyses included a bidirectional case-crossover design, a case-crossover analysis with warfarin as an active comparator, weighted case-crossover analysis, and a case-case-time-control design. A descriptive cohort analysis of new DOAC and warfarin users examined ILD frequency and prognosis.</p><p><strong>Results: </strong>The main case-crossover analysis included 178 patients, showing an association between DOAC use and acute-onset ILDs (adjusted OR, 4.44 [95% CI, 1.58-12.5]). Sensitivity analyses demonstrated a consistent direction of association (adjusted ORs: 3.37-6.85). In descriptive cohort analysis (52 021 DOAC and 12 026 warfarin initiators), ILD incidence was low (0.24% vs. 0.20%), but 90-day mortality was higher in the DOAC group (21% vs. 0%).</p><p><strong>Conclusions: </strong>DOAC use was associated with an increased risk of hospitalization for acute-onset ILDs. Clinicians should monitor patients on DOACs for ILD symptoms.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 6","pages":"e70398"},"PeriodicalIF":2.6,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148006359","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":"Letter to the Editor Regarding \"Safety of Short-Term Trimethoprim-Sulfamethoxazole Use for Uncomplicated Cystitis: A Nationwide Retrospective Cohort Study\".","authors":"Toshiki Fukasawa, Hisashi Urushihara, Takayuki Okura, Koji Kawakami","doi":"10.1002/pds.70401","DOIUrl":"10.1002/pds.70401","url":null,"abstract":"","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 6","pages":"e70401"},"PeriodicalIF":2.4,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148016859","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":"Transportability Analyses in Comparative Effectiveness Research: A Conceptual Framework and Methodological Principles Endorsed by the International Society for Pharmacoepidemiology.","authors":"Blythe Adamson, Wei Liu, Stephen Duffield, Anouk Déruaz-Luyet, Dimitri Bennett, Montse Soriano Gabarró, Mehmet Burcu, Daniela Claudia Moga, Sarah Welby, Tianze Jiao, Xuerong Wen, Grammati Sarri","doi":"10.1002/pds.70396","DOIUrl":"10.1002/pds.70396","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;The problem: &lt;/strong&gt;Transportability considerations are increasingly important to answer research questions in comparative effectiveness research (CER) to support the transfer of evidence on medicinal products across countries or settings. As drug development costs rise and healthcare systems and professionals face economic and resource pressures, leveraging existing data and evidence generated across borders or settings can improve efficiency and inform decisions in product development and decision-making (regulatory, health technology assessment [HTA] and clinical care). Differences in population characteristics, healthcare systems, and data availability, including coding discrepancies, may present significant challenges to the transportability of CER evidence. Without rigorous methodological approaches, the utility of transportability analyses is limited.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;What we did: &lt;/strong&gt;This article provides a structured framework for considering transportability exercises in CER analyses. We outlined key methodological principles, when and why to use transportability exercises in CER, feasibility assessments including effect modifier identification and causal inference techniques such as weighting, outcome regression, and combined methods to guide transportability analytical approaches in CER. By synthesizing existing literature and expert insights, we identified opportunities and trade-offs in applying transportability methods to support decisions across the product lifecycle.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Strategies to disseminate and facilitate use: &lt;/strong&gt;To enhance the adoption of transportability analyses, we proposed best practices for researchers, regulators, HTA bodies, and industry stakeholders. These include early engagement with regulatory agencies and HTA bodies, transparent documentation of data assumptions, quality, fitness, and comparability assessments while ensuring robust analytical approaches. We also emphasized the need for standardized reporting guidelines and cross-country collaborations to validate transportability methods in real-world settings and communicate uncertainty in transported evidence.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Transportability analyses offer a powerful tool for extending the applicability of CER findings across healthcare systems, improving evidence generation efficiency, and supporting global drug development and evaluation. By implementing best practices that promote a rigorous and transparent approach to the design and conduct of such analyses, stakeholders can maximize the value of transported treatment effects while ensuring scientific rigor and decision-making relevance. Future research should focus on empirical testing and validation of transportability methods targeting different questions across the product lifecycle and the development of harmonized regulatory and HTA methodological standards. \"This manuscript is endorsed by the International Society for Pharmacoepidemiology (ISPE).\"","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 6","pages":"e70396"},"PeriodicalIF":2.6,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13180502/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147964503","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":"Response to the Letter \"Safety of Short-Term Trimethoprim-Sulfamethoxazole Use for Uncomplicated Cystitis: A Nationwide Retrospective Cohort Study\".","authors":"Jumpei Taniguchi, Shotaro Aso, Hideo Yasunaga","doi":"10.1002/pds.70400","DOIUrl":"10.1002/pds.70400","url":null,"abstract":"","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 6","pages":"e70400"},"PeriodicalIF":2.4,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147942418","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 Effectiveness and Safety of Three Oral Antihypertensive Therapies on Maternal and Infant Outcomes in a California Medicaid Population, 2016-2020.","authors":"Catherine Psaras, Erin Delker, Rebecca J Baer, Clare M Cutri-French, Gretchen Bandoli","doi":"10.1002/pds.70406","DOIUrl":"10.1002/pds.70406","url":null,"abstract":"<p><strong>Purpose: </strong>To extend the Chronic Hypertension and Pregnancy (CHAP) trial findings, this study compared labetalol, nifedipine, and methyldopa initiation at or before 23 weeks' gestation in pregnant patients with chronic hypertension, examining effects on a composite effectiveness outcome and on small for gestational age birth (SGA).</p><p><strong>Methods: </strong>We used California Medicaid claims from deliveries between 2016 and 2020, linked to the California Study of Outcomes in Mothers and Infants (SOMI). The exposure was defined as ≥ 1 paid Medicaid fill for labetalol, extended-release nifedipine, or methyldopa in the first 23 weeks of pregnancy among women who did not use oral antihypertensive therapy in the period starting 90 days prior to last menstrual period (LMP) through LMP. Like CHAP, the composite outcome was preeclampsia with severe features, preterm birth < 35 weeks (PTB), placental abruption, and/or fetal or neonatal death. SGA was modeled as a safety outcome.</p><p><strong>Results: </strong>The analysis included 2281 singleton births: 1496 labetalol initiators, 653 methyldopa initiators, and 132 nifedipine initiators. Composite outcome incidence varied by medication (labetalol: 23%; methyldopa: 19%; nifedipine: 24%). The adjusted risk ratio (aRR) comparing methyldopa versus labetalol was 0.82 (95% CI: 0.68, 1.00); nifedipine versus labetalol was 1.01 (95% CI: 0.72, 1.41); and nifedipine versus methyldopa was 1.22 (95% CI: 0.85, 1.76). For SGA, results were similar (aRR (95% CI): methyldopa vs. labetalol: 0.81 (0.62, 1.05); nifedipine vs. labetalol: 1.07 (0.65, 1.75); nifedipine vs. methyldopa: 1.32 (0.78, 2.24)).</p><p><strong>Conclusions: </strong>Nifedipine and labetalol were equivalent in effectiveness and safety. Methyldopa was associated with lower risks of adverse outcomes. Potential residual confounding and limited overlap between treatment groups warrant caution in interpretation of our findings. Future research is needed to clarify whether the apparent advantages of methyldopa reflect true therapeutic benefit or underlying biases.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 6","pages":"e70406"},"PeriodicalIF":2.4,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148157552","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":"Estimating the Gestational Age of Spontaneous Abortions Identified via Database Algorithms: An Empirical Analysis Using Interrupted Time Series.","authors":"Chaitra Srinivas, Jacqueline M Cohen","doi":"10.1002/pds.70417","DOIUrl":"https://doi.org/10.1002/pds.70417","url":null,"abstract":"<p><strong>Purpose: </strong>To estimate the average gestational age for algorithm-identified spontaneous abortions in Norway using interrupted time series analysis.</p><p><strong>Methods: </strong>We used an algorithm to identify pregnancies registered in Norway from 2010 to 2020 and restricted to spontaneous abortions identified from primary and specialist care registers, and births from the Medical Birth Registry of Norway. For births, we calculated the first day of the last menstrual period (LMP; start of pregnancy) by subtracting the recorded gestational age from the birth date. We assigned spontaneous abortions an LMP corresponding to gestational ages ranging from 7 to 11 weeks. We identified prescriptions from 70 days before to 97 days after LMP and calculated the number of antidepressant prescriptions per 10 000 pregnancies per day. We applied two-sample interrupted time series analysis to compare spontaneous abortions versus births. We compared antidepressant prescription trends between intervention points at 28 and 55 gestational days, the time when most pregnancies are recognized.</p><p><strong>Results: </strong>In our interrupted time series analysis including 122 495 spontaneous abortions and 631 929 births, the 7-week assumption showed no post-intervention trend, suggesting underestimation. The 9-week assumption closely matched the trend for births (-0.051 prescriptions/day, 95% CI -0.090 to -0.013 vs. -0.056, 95% CI: -0.067 to -0.046). The 8, 10, and 11-week assumptions showed less precise alignment. The best alignment occurred with the 64-day assumption (9.1 weeks).</p><p><strong>Conclusion: </strong>Our study provides an empirically derived 64-day average gestational age for algorithm-identified spontaneous abortions in Norway, supporting future research, and this approach could help inform assumptions in other contexts.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"35 6","pages":"e70417"},"PeriodicalIF":2.4,"publicationDate":"2026-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148252688","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}