Pharmacoepidemiology and Drug Safety最新文献

{"title":"A European, Observational, 3-Year Cohort Comparative Study on the Safety of the Fixed Dose Combination Pravastatin 40 mg/Fenofibrate 160 mg vs. Statin Alone in Real Clinical Practice: The POSE Study.","authors":"Nikolaos Papadopoulos, Eleni Arvaniti, Theodoros Angelopoulos, Konstantinos Tziomalos, Manuel Suarez Tembra, Jose Luis Diaz, Sophie De Niet, Stéphanie Da Silva, John Doupis","doi":"10.1002/pds.70047","DOIUrl":"10.1002/pds.70047","url":null,"abstract":"<p><strong>Background and purpose: </strong>The aim of the study was to provide valuable real-world long-term safety data of the fixed pravastatin 40 mg/fenofibrate 160 mg combination in comparison of monotherapy with statins of moderate intensity.</p><p><strong>Materials and methods: </strong>POSE study was an observational, comparative study conducted in three European countries. Patients treated or planned to be treated with pravastatin 40 mg/fenofibrate 160 mg or with a moderate-intensity statin in monotherapy were assessed over 3 years. The main safety endpoints included the incidence of renal or urinary disorder, musculoskeletal or connective tissue disorder, hepatobiliary disorder and cardiovascular events.</p><p><strong>Results: </strong>The study included 3075 patients treated for dyslipidaemia, with diabetes mellitus (47%), hypertension (56%) and/or established cardiovascular disease (61%). Over the 3 years of follow-up, the difference in incidence rate of safety events between the pravastatin 40 mg/fenofibrate 160 mg group and the statin group was not statistically significant (RR = 1.366 [95% CI = 0.967-1.929]). The most frequently occurring events were musculoskeletal and connective tissue disorders (AR = 0.030 in the pravastatin 40 mg/fenofibrate 160 mg group and 0.024 in the statin group), renal and urinary disorders (AR = 0.019 vs. 0.016, respectively) and aggravated diabetes mellitus (0.021 vs. 0.014). Most events occurred during the first year, then incidence decreased over the 3-year period. No statistically significant difference was observed between treatment groups regarding the cardiovascular events (RR = 1.209 [95% CI = 0.596-2.453]) and no new signal emerged from the long-term follow-up.</p><p><strong>Conclusions: </strong>This study demonstrates a reassuring long-term safety profile of the fixed pravastatin 40 mg/fenofibrate 160 mg combination in routine clinical practice, with low and similar incidence of events over the 3 years follow-up compared to a monotherapy with statins of moderate intensity.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"33 11","pages":"e70047"},"PeriodicalIF":4.6,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142569266","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 2024, 40th international conference, 24-28 August 2024, Germany.","authors":"","doi":"10.1002/pds.5893","DOIUrl":"https://doi.org/10.1002/pds.5893","url":null,"abstract":"","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"33 Suppl 2 ","pages":"e5893"},"PeriodicalIF":2.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142676412","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 2024, 40th international conference, 24-28 August 2024, Germany.","authors":"","doi":"10.1002/pds.5892","DOIUrl":"https://doi.org/10.1002/pds.5892","url":null,"abstract":"","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"33 Suppl 2 ","pages":"e5892"},"PeriodicalIF":2.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142676410","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":"Mental Health and Medicine Use for Headache: A Nationally Representative Study of Adolescents in Denmark.","authors":"Bjørn Evald Holstein, Mette Toftager, Julie Ellegaard Ibáñez Román, Katrine Rich Madsen","doi":"10.1002/pds.70031","DOIUrl":"10.1002/pds.70031","url":null,"abstract":"<p><strong>Purpose: </strong>This study examined the prevalence of headache medicine use among Danish adolescents and explores the link between mental health, frequent headaches, and medicine use for headache. We hypothesized that poor mental health increases headache occurrence, leading to greater medicine use.</p><p><strong>Methods: </strong>The 2022 Danish Health Behaviour in School-aged Children (HBSC) study surveyed 5292 students aged 11, 13, and 15. Self-reported data included headache frequency, medicine use for headache, and five mental health indicators: life satisfaction, emotional symptoms, loneliness, self-efficacy, and self-esteem. Multivariate logistic regression analyses assessed the association between mental health indicators and headache medicine use, adjusting for headache frequency.</p><p><strong>Results: </strong>Weekly headaches were reported by 33.1%, and 43.6% used headache medicine in the past month. Poor mental health correlated with higher headache and medicine use rates. Analyses adjusted for sex, age group, and occupational social class found significantly increased odds ratios (95% confidence interval) for medicine use for headache among students with low life satisfaction (2.27; 1.88-2.75), among students with 2+ emotional symptoms (2.28; 1.92-2.69), students who often felt lonely (2.08; 1.69-2.55), students with low self-efficacy (1.37; 1.16-1.61) and students with low self-esteem (1.59; 1.36-1.85). When accounting for headache frequency, the association between poor mental health and medicine use diminished and became nonsignificant.</p><p><strong>Conclusions: </strong>Poor mental health was linked to increased medicine use for headache. The findings suggest that frequent headaches may explain the association between poor mental health and the use of headache medicine. Promoting rational medicine use and enhancing mental health among adolescents is essential.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"33 10","pages":"e70031"},"PeriodicalIF":4.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142471908","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":"A Real-World Study on Adverse Reactions of Belimumab Based on the FDA Adverse Event Reporting System Database.","authors":"Le Hai, Jiaojiao Wu, Yingying Xie","doi":"10.1002/pds.70037","DOIUrl":"10.1002/pds.70037","url":null,"abstract":"<p><strong>Background and objectives: </strong>This investigation leverages data derived from the United States Food and Drug Administration Adverse Event Reporting (FAERS) to real-world adverse reactions associated with Belimumab, with the intention of providing guidance for safe clinical pharmacotherapy.</p><p><strong>Methods: </strong>Data encompassing adverse drug event (ADE) reports relating to Belimumab from Q1 2011 to Q4 2023 within the FAERS were extracted and analyzed using methodologies such as the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS).</p><p><strong>Results: </strong>The study identified a total of 19 825 ADE reports where Belimumab was the primary suspect medication, with the United States constituting the majority of reporting countries (16 312 cases, or 82.28%). Patients aged 18 to 64.9 years accounted for the largest demographic (36.29%), while the proportion of female patients (77.91%) significantly surpassed that of male patients (5.03%). The analysis uncovered 184 unique Preferred Terms (PTs) across 21 System Organ Classes (SOCs). Following selection through ROR, the SOC signal strength was prioritized as follows: Systemic disorders and administration site conditions, infections and infestations, a variety of musculoskeletal and connective tissue disorders, and conditions related to pregnancy, puerperium, and the perinatal period. The top five PTs for ADE reports not included in the product's labeling were hypersensitivity reactions, immunosuppression, non-vascular diseases, herpes virus infections, and Sjögren's syndrome. The top five PTs for ADE signal strength not included in the labeling were disseminated cutaneous herpes zoster, herpes zoster meningitis, onycholysis, cyclothymic disorder, and mixed connective tissue disease.</p><p><strong>Discussion: </strong>Based on pharmacovigilance research utilizing the FAERS database, it is recommended that clinical monitoring of Bevacizumab should be intensified to support effective pharmaceutical care and ensure rational clinical medication use.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"33 10","pages":"e70037"},"PeriodicalIF":4.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142471882","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":"Dexamethasone Dose for COVID-19 in a Large U.S. Hospital Network From April 2020 to May 2023.","authors":"Marie C Bradley, Ashish Rai, Austin Cosgrove, Silvia Perez-Vilar, Candace Fuller, Edward Rosen, Efe Eworuke, Laura E McLean, Jeffrey S Guy, Russell E Poland, Kenneth E Sands, Gerald J Dal Pan","doi":"10.1002/pds.70018","DOIUrl":"10.1002/pds.70018","url":null,"abstract":"<p><strong>Purpose: </strong>While potential harm from high doses of systemic dexamethasone for clinical management of COVID-19 is an important concern, little is known about real world dexamethasone dosing in patients hospitalized with COVID-19 in the United States.</p><p><strong>Methods: </strong>Descriptive study to assess dexamethasone daily dose in adults with COVID-19 in a large US hospital network, overall and by respiratory support requirements, extracted using semi- structured nursing notes.</p><p><strong>Results: </strong>Of 332 430 hospitalizations with a COVID-19 diagnosis, 201 637 (60.7%) hospitalizations included dexamethasone administration. The mean age of recipients was 63 years, 53.0% were male, and 64.5% White. Median time from admission to dexamethasone administration was 0 day (interquartile range [IQR], 0-1 days) and median duration of use was 5 (IQR, 3-9) days. Almost 80% of hospitalizations received standard daily doses (≤ 6 mg daily), 12.7% moderately high daily doses (> 6- ≤ 10 mg daily), and 8.1% high (> 10- ≤ 20 mg daily) or very high daily dose (> 20 mg daily). Over 20% of COVID-19 hospitalizations requiring no oxygen or simple oxygen received high doses of systemic dexamethasone.</p><p><strong>Conclusions: </strong>Given the findings from the UK RECOVERY trial, and the general uncertainty around safety of higher dexamethasone doses in those requiring more intense respiratory support, standard daily dexamethasone doses of 6 mg or less for hospitalized COVID-19 requiring supplemental oxygen are recommended.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"33 10","pages":"e70018"},"PeriodicalIF":4.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142471885","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":"Core Concepts in Pharmacoepidemiology: Quantitative Bias Analysis.","authors":"Jeremy P Brown, Jacob N Hunnicutt, M Sanni Ali, Krishnan Bhaskaran, Ashley Cole, Sinead M Langan, Dorothea Nitsch, Christopher T Rentsch, Nicholas W Galwey, Kevin Wing, Ian J Douglas","doi":"10.1002/pds.70026","DOIUrl":"10.1002/pds.70026","url":null,"abstract":"<p><p>Pharmacoepidemiological studies provide important information on the safety and effectiveness of medications, but the validity of study findings can be threatened by residual bias. Ideally, biases would be minimized through appropriate study design and statistical analysis methods. However, residual biases can remain, for example, due to unmeasured confounders, measurement error, or selection into the study. A group of sensitivity analysis methods, termed quantitative bias analyses, are available to assess, quantitatively and transparently, the robustness of study results to these residual biases. These approaches include methods to quantify how the estimated effect would be altered under specified assumptions about the potential bias, and methods to calculate bounds on effect estimates. This article introduces quantitative bias analyses for unmeasured confounding, misclassification, and selection bias, with a focus on their relevance and application to pharmacoepidemiological studies.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"33 10","pages":"e70026"},"PeriodicalIF":4.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142392228","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":"Liver Injury in People With HIV on Antituberculosis and/or Antiretroviral Therapy-Assessing Causality Using the Updated Roussel Uclaf Causality Assessment Method.","authors":"H M Gunter, G Tatz, G Maartens, C W Spearman, U Mehta, K Cohen","doi":"10.1002/pds.5883","DOIUrl":"10.1002/pds.5883","url":null,"abstract":"<p><strong>Purpose: </strong>We compared performance of the Roussel Uclaf Causality Assessment Method (RUCAM) with multidisciplinary expert panel review in identifying a drug-induced liver injury (DILI) due to antituberculosis therapy (ATT) and/or antiretroviral therapy (ART).</p><p><strong>Methods: </strong>Cases were drawn from a prospective registry of hospitalised adults with suspected DILI due to ATT and/or ART in Cape Town, South Africa. Participants had to fulfil American Thoracic Society criteria for ATT interruption (alanine transaminase [ALT] ≥5 times upper limit of normal [ULN]/ALT ≥3 times [ULN] and symptomatic). Causality assessment by expert panel review served as reference standard. The panel ranked potentially implicated drugs as certain, probable, possible or unlikely causes guided by World Health Organization Uppsala Monitoring Centre criteria. The RUCAM was performed for each potentially implicated drug. We calculated sensitivity and specificity of the RUCAM in identifying a probable/certain drug cause for liver injury.</p><p><strong>Results: </strong>We included 48 participants. All were people with HIV (PWH). Twenty-seven were on concomitant ART and ATT, with a median of six potentially hepatotoxic drugs per case. Sensitivity and specificity of the RUCAM in identifying a probable/certain drug cause of liver injury compared with expert panel review was 7% and 100% respectively. Implicated drugs (times ranked probable/certain by panel) were isoniazid (18/0), pyrazinamide (17/0), rifampicin (15/1), efavirenz (6/4) and lopinavir/ritonavir (1/0).</p><p><strong>Conclusions: </strong>PWH with liver injury received multiple potentially implicated drugs, which may increase liver injury risk and complicate causality assessment. Compared with expert panel review, the RUCAM had low sensitivity in detecting probable or certain drug causes of liver injury.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"33 10","pages":"e5883"},"PeriodicalIF":4.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142392229","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":"Monitoring Pregnancies Exposed to Galcanezumab for Migraine in a United States Administrative Claims Database.","authors":"Sarah R Hoffman, Francis Mawanda, Christopher L Crowe, Dustin D Ruff, Stephan Lanes, Krista Schroeder","doi":"10.1002/pds.70015","DOIUrl":"10.1002/pds.70015","url":null,"abstract":"<p><strong>Purpose: </strong>Galcanezumab is a calcitonin gene-related peptide monoclonal antibody indicated for migraine prevention in adults. Due to the long half-life of galcanezumab and the prevalence of migraine in women of childbearing age, galcanezumab exposure may occur during pregnancy. However, real-world use and safety of galcanezumab during pregnancy has not been fully described. To help fill this gap, galcanezumab has two ongoing pregnancy safety studies, one of which is an insurance claims database study.</p><p><strong>Methods: </strong>This database study is actively identifying and following pregnancies exposed to galcanezumab using commercial claims from the Healthcare Integrated Research Database (HIRD). Patient accrual is planned from September 2018 to June 2026, with a final study report planned for December 2027. This study requires 430 galcanezumab-exposed pregnancies with linked infants to reach power for comparative analysis of major congenital malformations.</p><p><strong>Results: </strong>Recent monitoring of patient accrual, including data from 28 September 2018 to 31 January 2023, identified 207 galcanezumab-exposed pregnancies in women with migraine in the HIRD, of which 110 were live births and 73 of which were linked to an infant. This represents an annual accrual rate of approximately 17 pregnancies linked to infants, which is substantially lower than the 55 required annually to reach target size within current regulatory-committed study timelines.</p><p><strong>Conclusions: </strong>The accrual of a sufficient number of galcanezumab-exposed pregnancies represents a substantial, but not uncommon, barrier to conducting comparative analyses in pregnancy studies. Potential solutions that would allow for timely dissemination of important safety information to patients and providers may be available.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"33 10","pages":"e70015"},"PeriodicalIF":4.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142392230","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":"The Use of Japanese Traditional (Kampo) Medicines Before and During Pregnancy in Japan: The Tohoku Medical Megabank Project Birth and Three-Generation Cohort Study.","authors":"Aoi Noda, Ryutaro Arita, Taku Obara, Satoko Suzuki, Minoru Ohsawa, Ryo Obara, Kei Morishita, Fumihiko Ueno, Fumiko Matsuzaki, Genki Shinoda, Keiko Murakami, Masatsugu Orui, Mami Ishikuro, Akiko Kikuchi, Shin Takayama, Tadashi Ishii, Shinichi Kuriyama","doi":"10.1002/pds.70033","DOIUrl":"10.1002/pds.70033","url":null,"abstract":"<p><strong>Purpose: </strong>Japanese traditional (Kampo) medicines are often used for pregnant women in Japan. However, no comprehensive studies have been conducted regarding the self-reported use of these medicines during pregnancy. This study investigated the use of Kampo medicines during pregnancy in Japan using the Tohoku Medical Megabank Project Birth and Three-Generation Cohort Study (TMM BirThree Cohort Study).</p><p><strong>Methods: </strong>Questionnaires were distributed to pregnant women participating in the TMM BirThree Cohort Study (July 2013 to March 2017) at approximately 12 weeks (early pregnancy) and 26 weeks (middle pregnancy). We analysed Kampo medicines use over three periods: (1) 12 months before pregnancy diagnosis, (2) the period between pregnancy diagnosis and around Week 12 of pregnancy and (3) from around Week 12 of pregnancy.</p><p><strong>Results: </strong>In total, 19 220 women were included in the analysis. The proportions using prescribed Kampo medicines were 4.1% before pregnancy diagnosis, 4.5% from diagnosis to Week 12% and 4.5% after Week 12 of pregnancy. The most frequently prescribed Kampo medicines were tokishakuyakusan (1.0%) before pregnancy diagnosis, shoseiryuto (1.3%) from diagnosis to Week 12 and shoseiryuto (1.5%) Post-week 12. Sixty of the pregnant women used Kampo medicines containing crude drugs, which should be administered cautiously during pregnancy.</p><p><strong>Conclusion: </strong>The proportion of Kampo medicines use before and during pregnancy was 4%-5%. Some pregnant women used Kampo medicines containing crude drugs that should be administered cautiously during pregnancy. Further research is required to determine the safety of Kampo medicines during pregnancy.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"33 10","pages":"e70033"},"PeriodicalIF":4.6,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142392246","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}