Pharmacoepidemiology and Drug Safety最新文献

{"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":"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":"","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":"","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":"Quantitative Benefit-Risk Assessment of Vaccination Against COVID-19: A Systematic Review.","authors":"E Claire Newbern, Lea Wildisen, Rita Verstraeten, Corinne Willame, Kevin Haynes, Bennett Levitan, Nicolas Praet","doi":"10.1002/pds.70099","DOIUrl":"10.1002/pds.70099","url":null,"abstract":"<p><strong>Purpose: </strong>With the introduction of COVID-19 vaccines, there has been a proliferation of quantitative benefit-risk assessments (qBRAs). Prior work on other types of vaccines has found that published qBRAs have not always clearly reported methods and/or results needed to assist in the application of the qBRA findings. The aim was to systematically identify, review, and critically assess published COVID-19 vaccine qBRA. The ultimate goal is to support the future development of robust qBRA for existing, new, and updated vaccines.</p><p><strong>Methods: </strong>We systematically reviewed COVID-19 vaccine qBRAs identified from multiple sources through April 17, 2023, including literature databases, selected Health Authority websites, and a grey literature search. We critically assessed whether key features typical of qBRA were presented in these reports.</p><p><strong>Results: </strong>We identified 37 COVID-19 vaccine qBRAs from screening 2220 publications and 18 other sources. The qBRAs were conducted on two mRNA and two adenoviral vector COVID-19 vaccines. Only one qBRA represented low- and middle-income countries. Although many qBRAs used simple calculations (n = 25), more complex models were presented in 15 reports. Simple approaches were able to employ stratification by age and/or sex to highlight safety issues affecting specific demographic groups and scenarios to account for changes in viral transmission and vaccine effectiveness over time. Details regarding data sources and analytic methods were missing or limited in some reports.</p><p><strong>Conclusions: </strong>This comprehensive description and critical assessment of COVID-19 vaccine qBRAs together with available guidance can be used to support the development of robust and transparent future vaccine qBRAs.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 2","pages":"e70099"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11779546/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143067099","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":"Expanding the OMOP Common Data Model to Support Perinatal Research in Network Studies.","authors":"Alicia Abellan, Edward Burn, Nhung T H Trinh, Theresa Burkard, Alison Callahan, Sergio Fernández-Bertolín, Eimir Hurley, Clara Rodriguez, Elena Segundo, Daniel R Morales, Hedvig M E Nordeng, Talita Duarte-Salles","doi":"10.1002/pds.70106","DOIUrl":"10.1002/pds.70106","url":null,"abstract":"<p><strong>Objectives: </strong>The Observational Medical Outcomes Partnership common data model (OMOP-CDM) is a useful tool for large-scale network analysis but currently lacks a structured approach to pregnancy episodes. We aimed to develop and implement a perinatal expansion for the OMOP-CDM to facilitate perinatal network research.</p><p><strong>Methods: </strong>We collaboratively developed a perinatal expansion with input from domain experts and stakeholders to reach consensus. The structure and vocabularies followed the OMOP-CDM ontological framework principles. We tested the expansion using SIDIAP and Norwegian databases. We developed a diagnostics package for quality control assessment and conducted a descriptive analysis on the captured perinatal data mapped to the OMOP-CDM.</p><p><strong>Results: </strong>The perinatal expansion consists of a pregnancy table and an infant table, each with required and optional variables incorporated into standardized vocabularies. Quality assessment of the perinatal expansion table in SIDIAP and Norwegian databases demonstrated accurate capture of perinatal characteristics. Descriptive analysis measured the number of pregnancies (SIDIAP: 646 530; Norway: 746 671), pregnancy outcomes (e.g., 0.5% stillbirths in SIDIAP and 0.4% in Norway), gestational length (median [IQR] in days, SIDIAP: 273 [56-280]; Norway: 280 [273-286]), number of infants (Norway: 758 806), and birth weight (median [IQR] in grams, Norway: 3520 [3175-3860)], among other relevant variables.</p><p><strong>Discussion and conclusion: </strong>We developed and implemented a perinatal expansion that captures important variables for perinatal research and allows interoperability with existing tables in the OMOP-CDM, which is expected to facilitate future network studies. The publicly available diagnostics package enables testing the implementation of the extension table and the quality and completeness of available data on pregnancy and pregnancy-related outcomes in databases mapped to the OMOP CDM.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 2","pages":"e70106"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11826376/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143414782","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 Lookback Duration on the Performance of a Claims-Based Frailty Proxy in Women With Stage I-III Breast Cancer.","authors":"Emilie D Duchesneau, Til Stürmer, Katherine Reeder-Hayes, Dae Hyun Kim, Jessie K Edwards, Keturah R Faurot, Jennifer L Lund","doi":"10.1002/pds.70103","DOIUrl":"10.1002/pds.70103","url":null,"abstract":"<p><strong>Background: </strong>Frailty is an important prognostic indicator in older women with breast cancer. The Faurot frailty index, a validated claims-based frailty proxy measure, uses healthcare billing codes during a user-specified ascertainment window to predict frailty. We assessed how the duration of frailty ascertainment affected the ability of the Faurot frailty index to predict one-year mortality in women with stage I-II breast cancer.</p><p><strong>Methods: </strong>We included 128 857 women (66+ years) with stage I-III breast cancer in the SEER-Medicare database (2003-2019). The Faurot frailty index was calculated using 3-, 6-, 8-, and 12-month ascertainment windows prior to diagnosis or using all-available lookback. Associations between the Faurot frailty index using each window and one-year all-cause mortality were estimated using Kaplan-Meier curves. Discrimination of one-year mortality risk was assessed using C-statistics.</p><p><strong>Results: </strong>Five percent of women died during the year following diagnosis. Higher Faurot scores were associated with increased mortality risk for all frailty ascertainment windows. Differences in one-year mortality risk for women with high vs. low Faurot frailty scores were reduced when using all-available lookback (16% vs. 2%, difference = 15%, 95% CI 0.14-0.15) compared to shorter windows (e.g., 8 months: 25% vs. 2%, difference = 23%, 95% CI 0.22-0.24). C-statistics ranged from 0.758 (all-available lookback) to 0.770 (12 months) and were robust in subgroups defined by age, race, ethnicity, region, stage, and cancer subtype.</p><p><strong>Conclusions: </strong>The Faurot frailty index performed well across 3- to 12-month frailty ascertainment windows in women with breast cancer. Researchers should employ this index to address confounding by frailty in studies of cancer populations.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 2","pages":"e70103"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11912347/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143009445","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":"Successful Linkage of Electronic Medical Records and National Health Data System in Type 2 Diabetes Research: Methodological Insights and Implications.","authors":"Romane Le Goff, Sandrine Brice, Andrea Contini, Marjorie Boussac, Arnaud Souche, Fabien Belloc, Nicolas Coulombel, Cédric Collin, Amandine Gouverneur, Mathieu Molimard","doi":"10.1002/pds.70095","DOIUrl":"10.1002/pds.70095","url":null,"abstract":"<p><strong>Purpose: </strong>This study assesses success and methodological implications of linking IQVIA's Electronic Medical Records (EMR) of type 2 diabetes (T2D) patients with the National Health Data System (SNDS) database, a cornerstone process in healthcare research.</p><p><strong>Methods: </strong>The OREOT cohort was constituted by T2D patients identified in the IQVIA EMR from 2014 to 2018 and linked indirectly to SNDS database. The EMR database contains clinical records from general practitioner consultations, representing ~2.8% of the French population and the SNDS claims database covers over 99% of the French population's healthcare activities. Linkage success was evaluated by the linkage rate. Baseline patients' characteristics were described for both linked and non-linked patients.</p><p><strong>Results: </strong>Of the 291 408 T2D patients identified in the EMR, 244 656 (84%) were successfully linked. After technical data cleaning, 239 141 (82%) were finally linked. Linked and non-linked patients (n = 52,267) were aged 65 years and more frequently male (57% and 59%); half were obese, and most of comorbidities were consistent. Linked patients had more EMR consultations (median 32 vs 16), and more cardiovascular events (12% vs 7%) or chronic kidney disease (10% vs 7%).</p><p><strong>Conclusions: </strong>The successful linkage of EMR and SNDS databases provides valuable insights for future research in T2D and other chronic diseases requiring clinical data. This study demonstrates the feasibility of such data alignments, particularly in patients with complex health profiles or extensive medical records, and linkage potential to enhance real-world research quality. Despite higher prevalence of baseline comorbidities among linked patients, patients' characteristics were consistent with French T2D population.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 2","pages":"e70095"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143024292","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":"Evaluating the Role of High-Dimensional Proxy Data in Confounding Adjustment in Multiple Sclerosis Research: A Case Study.","authors":"Mohammad Ehsanul Karim, Md Belal Hossain, Huah Shin Ng, Feng Zhu, Hanna A Frank, Helen Tremlett","doi":"10.1002/pds.70112","DOIUrl":"10.1002/pds.70112","url":null,"abstract":"<p><strong>Purpose: </strong>Given the historical use of limited confounders in multiple sclerosis (MS) studies utilizing administrative health data, this brief report evaluates the impact of incorporating high-dimensional proxy information on confounder adjustment in MS research. We have implemented high-dimensional propensity score (hdPS) and high-dimensional disease risk score (hdDRS) methods to assess changes in effect estimates for the association between disease-modifying drugs (DMDs) and all-cause mortality in an MS cohort from British Columbia (BC), Canada.</p><p><strong>Methods: </strong>We conducted a population-based retrospective study using linked administrative databases from BC, including health insurance registries, demographics, physician visits, hospitalizations, prescriptions, and vital statistics. The cohort comprised 19 360 individuals with MS, followed from January 1, 1996, to December 31, 2017. DMD exposure was defined as at least 180 days of use for beta-interferon or glatiramer acetate, or at least 90 days for other DMDs. The outcome was time to all-cause mortality. We compared Cox proportional hazards models adjusting for investigator-specified covariates with those incorporating additional empirical covariates using hdPS and hdDRS methods.</p><p><strong>Results: </strong>In the unadjusted analysis, DMD exposure was associated with a 69% lower risk of mortality (HR 0.31; 95% CI: 0.27-0.36). Adjusting for investigator-specified covariates, the adjusted hazard ratio (aHR) was 0.76 (95% CI: 0.65-0.89). HdPS analyses showed a 20%-23% lower mortality risk (aHRs: 0.77 to 0.80), while hdDRS analyses indicated a 19%-21% reduction (aHRs: 0.79 to 0.81).</p><p><strong>Conclusions: </strong>Incorporating high-dimensional proxy information resulted in minor variations in effect estimates compared to traditional covariate adjustment. These findings suggest that the impact of residual confounding in the question under consideration may be modest. Further research should explore additional data dimensions and replicate these findings across different datasets.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 2","pages":"e70112"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11791124/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143123363","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":"Hepatobiliary Adverse Events Associated With the KRAS p.G12C Inhibitor Sotorasib.","authors":"Connor Frey","doi":"10.1002/pds.70104","DOIUrl":"10.1002/pds.70104","url":null,"abstract":"<p><strong>Purpose: </strong>The p.G12C mutation in KRAS is commonly found in many cancers and was previously untreatable until drugs like sotorasib were developed. However, up to 15% of patients treated with sotorasib have experienced hepatobiliary adverse events. To investigate whether these side effects are more common among sotorasib users, a pharmacovigilance study is necessary.</p><p><strong>Methods: </strong>This study used the FDA adverse event reporting system (FAERS) database, a publicly available repository of reported drug adverse events, and AERSMine, an open-access pharmacovigilance tool, to investigate these adverse events.</p><p><strong>Results: </strong>A total of 428 hepatobiliary adverse events were linked to sotorasib. Hepatic cytolysis had the highest reported relative risk at 26.541 and a safety signal of 4.726. Elevated liver and biliary enzymes such as AST, ALT, ALP, and GGT were commonly observed, but with lower reported relative risk and safety signal values, which supports previous real-world reports.</p><p><strong>Conclusions: </strong>These findings highlight the hepatobiliary risks associated with sotorasib and underscore the importance of closely monitoring liver function in patients who are using the medication. This is particularly crucial for patients with hepatobiliary cancers, as disease progression and adverse events could be misinterpreted.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"34 2","pages":"e70104"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11753893/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143060144","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}