International Journal of Clinical Pharmacy最新文献

{"title":"Disproportionality analysis of flutamide- or bicalutamide-induced liver injury with and without steroids by using the Japanese Adverse Drug Event Report database.","authors":"Tomoyuki Yamada, Saori Tanaka, Takumi Noda, Kazuya Urashima, Ayumi Fujimoto, Yuka Kohda, Ryuji Kato","doi":"10.1007/s11096-024-01814-x","DOIUrl":"10.1007/s11096-024-01814-x","url":null,"abstract":"<p><strong>Background: </strong>Although the mechanism underlying flutamide- or bicalutamide-induced liver injury may be immune related, the details remain unclear. If this mechanism is immune related, steroid use may be considered as a treatment option.</p><p><strong>Aim: </strong>Disproportionality analysis was conducted to evaluate the effect of concomitant steroid use on flutamide- and bicalutamide-induced liver injury.</p><p><strong>Method: </strong>Male patients aged 20 years or older who were receiving nonsteroidal anti-androgens from April 2004 to October 2023 were screened from the Japanese Adverse Drug Event Report database. Data on liver injury, age, weight, height, steroid use, obesity, hepatic stenosis, alcohol-related hepatic disorders, hepatitis B and C, and common drugs known to cause drug-induced liver injury were analyzed. Liver injury was defined by the Standardized Medical Dictionary for Regulatory Activities query index (code 20000006, version 27.0).</p><p><strong>Results: </strong>Among 142,430 patients, 2,316 were administered nonsteroidal anti-androgens. Reports of liver injury were disproportionate depending on the agents used (reporting odds ratio [ROR], 1.29; 95% confidence intervals [CI], 1.13-1.46), especially among flutamide or bicalutamide users (flutamide: ROR, 6.09; 95% CI, 4.51-8.23; bicalutamide: ROR, 1.24; 95% CI, 1.05-1.48). Multivariable logistic regression analysis correlated steroid use with a lower risk of flutamide- or bicalutamide-induced liver injury (flutamide: odds ratio, 0.07; 95% CI, 0.01-0.52; bicalutamide: odds ratio, 0.45; 95% CI, 0.21-0.96).</p><p><strong>Conclusion: </strong>Our findings suggest that flutamide and bicalutamide may increase the risk of liver injury compared to enzalutamide, apalutamide, and darolutamide. Furthermore, our study indicated that steroid use could aid in the management of liver injury.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"128-135"},"PeriodicalIF":2.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142464595","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":"Desprescribing antihypertensives in older people in primary care: subgroup analysis of the MINOR randomised clinical trial.","authors":"Igor Matheus Silva, Pablo Maciel Moreira, Alessa Maria Santos, Priscila Ribeiro Castro, Erlan Canguçu Aguiar, Marcio Galvão Oliveira","doi":"10.1007/s11096-024-01805-y","DOIUrl":"10.1007/s11096-024-01805-y","url":null,"abstract":"<p><strong>Background: </strong>Polypharmacy is often required for older adults with hypertension, and excessive treatment is associated with a high risk of adverse reactions, including hypotension.</p><p><strong>Aim: </strong>To evaluate the deprescribing of antihypertensive medications guided by pharmacists using home blood pressure monitoring in older adults with hypotension.</p><p><strong>Method: </strong>A subgroup of older adults with signs or symptoms of hypotension, included in the MINOR clinical trial, was analysed. In the MINOR procedures, each patient was provided with a device to conduct blood pressure measurement at home for 1 week, following which a report was generated and shared with pharmacists (intervention group) or family physicians (control group). In the intervention group, a pharmacist suggested optimising pharmacotherapy; meanwhile, in the control group, a family physician alone determined the necessary treatment adjustments. Differences in mean blood pressure, the patients with symptoms/signs of hypotension, and the antihypertensive medication deprescribing between both groups were analysed.</p><p><strong>Results: </strong>Seventy-two patients were evaluated (35, control group; 37, intervention group). The intervention group showed a significant reduction in medication prescriptions (- 28.6%; P < 0.001), especially beta-blockers (- 74.2%), loop diuretics (- 83.3%), and aldosterone antagonists (- 80%). The mean office blood pressure in the intervention group increased (14.1 mmHg systolic and 6.9 mmHg diastolic), remaining below the target range (140/90 mmHg). The intervention group showed a significantly reduction in hypotensive symptoms than the control group (64.9% vs. 20%) (P < 0.001).</p><p><strong>Conclusion: </strong>The data highlight an important role for pharmacists in optimizing hypertension management in older people. Deprescribing antihypertensives can limit symptomatic hypotension.</p><p><strong>Trial registration: </strong>Registered on ClinicalTrials.gov under number NCT04861727.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"53-59"},"PeriodicalIF":2.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142582784","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":"Pharmacists' empathy after a postgraduate course in narrative medicine: an observational study.","authors":"Trine Graabæk, Anders Juhl Rasmussen, Anne-Marie Mai, Charlotte Rossing, Merethe Kirstine Kousgaard Andersen, Ulla Hedegaard","doi":"10.1007/s11096-024-01815-w","DOIUrl":"10.1007/s11096-024-01815-w","url":null,"abstract":"<p><strong>Background: </strong>Narrative medicine is a recent cross-disciplinary approach which through aesthetic activities such as reading fiction and creative writing aims to encourage empathy, reflection, professionalism, and trustworthiness in the encounter between patients and health care professionals.</p><p><strong>Aim: </strong>The aim of this study was to evaluate changes in level of empathy after a postgraduate course in narrative medicine among pharmacists conducting medication counselling.</p><p><strong>Method: </strong>During 2020-2021, three courses in narrative medicine among pharmacists with the aim to enhance empathy were held in Odense, Denmark. The primary outcome was the pharmacists' self-reported level of empathy before and after the course measured with Jefferson Scale of Empathy (JSE), which is a validated 20 item scale with higher scores indicating higher levels of cognitive empathy.</p><p><strong>Results: </strong>A total of 33 community and hospital pharmacists participated in the three courses. The pharmacists' median age was 41 years, 91% were female, 76% were working in community pharmacy, and 47% were, according to themselves, rare readers. The pharmacists completed the JSE scale before and after the course. A statistically significant increase was found in mean total JSE score from 109.9 ± 17.1 before the course to 115.7 ± 14.6 after the course (p = 0.0362).</p><p><strong>Conclusion: </strong>Following the course in narrative medicine the level of empathy for the pharmacists according to JSE was enhanced. We recommend that future studies also use patient-reported outcomes to explore if the self-experienced enhanced empathy among pharmacists affects the patients' experience of their encounters.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"224-231"},"PeriodicalIF":2.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142464596","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 cross-sectional study of recent patterns of psychotropic medication use in children and adolescents in Ireland.","authors":"Rebecca Parkin, Kathleen Bennett, Fiona Mc Nicholas, John C Hayden","doi":"10.1007/s11096-024-01817-8","DOIUrl":"10.1007/s11096-024-01817-8","url":null,"abstract":"<p><strong>Background: </strong>There has been a global rise in prescribing of psychotropic medications. Variations in patterns of use, according to age, gender and drug class type, have also been reported.</p><p><strong>Aim: </strong>This study aimed to analyse patterns of psychotropic medication use in Ireland according to age group, gender and drug class type, to determine if variations exist, and identify specific nuances to be addressed in future research.</p><p><strong>Method: </strong>A retrospective, repeated, cross-sectional study of the Irish pharmacy claims database (community setting dispensing data) was conducted. Yearly prevalence of children/adolescents receiving dispensed psychotropic medications was analysed from January 2017 to December 2021, across years, age groups (5-15, 5-11 and 12-15 years), gender and drug class type. All available data were used. Yearly prevalence was the mean number of patients receiving medication per month per 1000 eligible population during a given year. Negative binomial regression was used to examine association of year, age group and gender on prevalence.</p><p><strong>Results: </strong>In the 12-15 years group, prevalence for all selected psychotropic medications in 2021 in males was almost twice that in females (19.92/1000 vs 10.62/1000). In the 5-11 years group, prevalence was three times higher in males than females (7.56/1000 vs 2.49/1000). Overall, there was a higher rate of increase in females and higher usage in older children.</p><p><strong>Conclusion: </strong>This study found variations in psychotropic medication use in children/adolescents, depending on age, gender and drug class type. Further research is needed to determine whether variations have resulted in treatment disparities for certain cohorts.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"146-156"},"PeriodicalIF":2.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545314","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":"Exploring the impact of baseline platelet count on linezolid-induced thrombocytopenia: a retrospective single-center observation study.","authors":"Yuki Inoue, Hitoshi Kashiwagi, Yuki Sato, Shunsuke Nashimoto, Mitsuru Sugawara, Yoh Takekuma","doi":"10.1007/s11096-024-01810-1","DOIUrl":"10.1007/s11096-024-01810-1","url":null,"abstract":"<p><strong>Background: </strong>Patients treated with linezolid (LZD) frequently develop thrombocytopenia, and previous studies have identified the risk factors for this condition. However, the relationship between the development of LZD-induced thrombocytopenia and baseline platelet count has varied according to different reports.</p><p><strong>Aim: </strong>To explore the relationship between platelet count and the development of LZD-induced thrombocytopenia.</p><p><strong>Method: </strong>Patients who underwent LZD at Hokkaido University Hospital in Japan from September 2008 to March 2023 were included. We collected data on patient characteristics and platelet counts at baseline and during LZD therapy from the electronic medical records. Thrombocytopenia was defined as a decrease in platelet count by 30% or more from baseline, or a platelet level < 100,000/µL.</p><p><strong>Results: </strong>Two hundred and ninety-five patients who received LZD were included in this study, of whom 34.9% developed thrombocytopenia. In the early days of LZD treatment, the thrombocytopenia group showed a nearly 5% decrease in platelet count, while the non-thrombocytopenia group exhibited an increase of over 5%. Additionally, focusing on early onset thrombocytopenia (within 5 days), a baseline platelet count of < 150,000/µL was identified as a risk factor for early thrombocytopenia. Conversely, it was also observed that 24.7% of patients with a baseline platelet count ≥ 150,000/µL still developed early thrombocytopenia.</p><p><strong>Conclusion: </strong>Our findings suggest that while a baseline platelet count of < 150,000/µL is a risk factor for the early onset of thrombocytopenia, vigilant monitoring of platelet counts by clinical pharmacists in the early stages of LZD treatment is essential, regardless of baseline platelet levels.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"90-98"},"PeriodicalIF":2.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142371771","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":"Association of polypharmacy with clinical outcomes and healthcare utilization in older adults with cardiometabolic diseases: a retrospective cohort study.","authors":"Su Su, Xuelu Zhu, Shiqi Wu, Wenyao Ma, Suying Yan, Lan Zhang","doi":"10.1007/s11096-024-01809-8","DOIUrl":"10.1007/s11096-024-01809-8","url":null,"abstract":"<p><strong>Background: </strong>Limited knowledge exists on the association between polypharmacy among older patients diagnosed with cardiometabolic diseases and the risk of clinical outcomes and healthcare utilization.</p><p><strong>Aim: </strong>This study aimed to estimate the impact of polypharmacy on clinical outcomes and healthcare utilization in older adults with cardiometabolic diseases.</p><p><strong>Method: </strong>A retrospective cohort analysis was performed using data from the Beijing Municipal Medical Insurance Database. The study focused on polypharmacy prescribing patterns in community-dwelling adults 65 years and older with cardiometabolic diseases. Polypharmacy was defined as the use of five or more medications on the index date. The primary outcome included clinical outcomes, including hospitalizations and emergency department visits. The secondary outcome focuses on hospital utilization, specifically medication costs and length of stay.</p><p><strong>Results: </strong>The study included a cohort of 405,608 patients. Among these, the most frequently used drug classes in the polypharmacy and non-polypharmacy groups were HMG-CoA reductase inhibitors and dihydropyridines, respectively. After adjustment for covariates, polypharmacy was not associated with an increased risk of hospitalization (odds ratio [OR] 1.09, 95% confidence interval [CI] 0.95-1.26, p = 0.23) or ED visits (OR 1.28, 95% CI 0.97-1.68, p = 0.08). Similarly, no significant association was found with an increase in inpatient medication costs ($2,620.5, 95% CI $2387.3-$2894.3, p = 0.97) or length of stay (3.98 days, 95% CI 3.68-4.30 days, p = 0.79). However, polypharmacy was associated with higher medication costs in outpatient settings ($73.07, 95% CI $72-$74, p < 0.05) and ED visits ($51.2, 95% CI $44.5-$59.1, p < 0.05).</p><p><strong>Conclusion: </strong>Although polypharmacy is associated with increased healthcare costs in outpatient settings and ED visits, it does not significantly increase the risk of hospitalization or ED visits when properly managed.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"80-89"},"PeriodicalIF":2.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142365159","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":"Adverse drug reactions in older people following hospitalisation: a qualitative exploration of general practitioners' perspectives.","authors":"Justin M Cousins, Bonnie Bereznicki, Nibu Parameswaran Nair, Elizabeth Webber, Colin Curtain","doi":"10.1007/s11096-024-01806-x","DOIUrl":"10.1007/s11096-024-01806-x","url":null,"abstract":"<p><strong>Background: </strong>Older people have greater comorbidity and medication burden. Adverse drug reactions occur in up to 30% of older people within one month of hospital discharge. General practitioners are key stakeholders in transitions of care from hospital to the community.</p><p><strong>Aim: </strong>The study aimed to explore general practitioner perspectives of adverse drug reactions in older people after hospitalisation, investigating the medication-related issues encountered and possible approaches to reduce the risk.</p><p><strong>Method: </strong>An invitation to participate in the study was sent to general practitioners in Southern Tasmania, Australia. A semi-structured interview occurred in person at their practice or online. The questions covered experiences with managing medication in older people after hospital discharge, challenges and risks involving adverse drug reactions and suggestions to prevent adverse drug reactions. The interviews were transcribed and analysed through thematic analysis.</p><p><strong>Results: </strong>Twelve general practitioners were interviewed, revealing four themes describing challenges, including (i) complex patients and acceptance of risk, (ii) patient confusion and decline in hospital, (iii) time taken to manage older patients and (iv) communication challenges. Three themes describing recommendations were identified, including (i) clear communication on discharge, (ii) patient involvement and (iii) roles for pharmacists.</p><p><strong>Conclusion: </strong>Prevention of adverse drug reactions after hospital discharge may require clear and timely communication to general practitioners, patients and families to be educated and empowered to help manage their own health and risk, and pharmacists to support both patients and general practitioners in managing the risks.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"60-67"},"PeriodicalIF":2.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142464594","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":"Pharmacist-led interventions at hospital discharge: a scoping review of studies demonstrating reduced readmission rates.","authors":"Carole Weber, Carla Meyer-Massetti, Nicole Schönenberger","doi":"10.1007/s11096-024-01821-y","DOIUrl":"10.1007/s11096-024-01821-y","url":null,"abstract":"<p><strong>Background: </strong>Substantial numbers of hospital readmissions occur due to medication-related problems. Pharmacists can implement different interventions at hospital discharge that aim to reduce those readmissions. It is unclear which pharmacist-led interventions at hospital discharge are the most promising in reducing readmissions.</p><p><strong>Aim: </strong>This scoping review aimed to summarise pharmacist-led interventions conducted at hospital discharge that demonstrated a reduction in readmissions.</p><p><strong>Method: </strong>We searched the MEDLINE, EMBASE and CINAHL databases up to February 2024. We included studies that focused on pharmacist-led interventions at hospital discharge and reported significant readmission reductions. Two reviewers independently screened titles, abstracts and full texts. Data extracted included study characteristics, populations and the type of implemented pharmacist-led interventions along with the reduction in readmission rates achieved.</p><p><strong>Results: </strong>We included 25 articles for data synthesis. Many of the studies included either implemented at least two interventions concurrently or were part of broader programmes involving other healthcare professionals. The most common pharmacist-led interventions associated with reduced readmission rates included medication reconciliation, counselling and post-discharge follow-up by telephone. Follow-up primarily aimed to improve patients' treatment adherence through education about their medications. Furthermore, many studies reported on multi-component interventions that began at hospital admission or during inpatient stays, not only at discharge.</p><p><strong>Conclusion: </strong>Successfully reducing readmissions through pharmacist-led interventions at hospital discharge suggests the effectiveness of a holistic approach incorporating multiple interventions. While these findings offer insights for pharmacists, further research should focus on conducting high-quality studies using a multifaceted approach to identify the most appropriate timing and combination.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"15-30"},"PeriodicalIF":2.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11741998/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142800555","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":"Translation and validation of the CLEO tool in Vietnamese to assess the significance of pharmacist interventions.","authors":"An Thi-Truong Nguyen, Khanh Hoang-Phuong Nguyen, Hai Ba Le, Hong Tham Pham, Hai Thanh Nguyen, Nga Thi-Bich Nguyen, Phuong Thi-Xuan Dong, Trang Nguyen-Doan Dang, Van Thi-Thuy Pham, Dung Tuan Nguyen, Allenet Benoit, Pierrick Bedouch, Ha Thi Vo","doi":"10.1007/s11096-024-01813-y","DOIUrl":"10.1007/s11096-024-01813-y","url":null,"abstract":"<p><strong>Background: </strong>There is currently no validated tool available for assessing the potential significance of pharmacist interventions in Vietnam.</p><p><strong>Aim: </strong>This study aimed to translate the CLEO tool from French into Vietnamese, validate the Vietnamese version, and demonstrate its feasibility in daily practice.</p><p><strong>Method: </strong>The CLEO tool was translated into Vietnamese (CLEO_VN) using a 5-step process by bilingual experts. A total of 100 scenarios were compiled from clinical cases from nine hospitals evaluated by seven clinical pharmacists to determine inter-rater reliability and 30 out of 100 scenarios were re-evaluated one month later to determine test-retest reliability. Reliability was quantified using the intra-class correlation coefficient (ICC). A 20-item questionnaire on a 7-point Likert scale assessed the tool's appropriateness, acceptability, precision, and feasibility.</p><p><strong>Results: </strong>Inter-rater reliability was good for clinical dimension (ICC_A,1 = 0.71), excellent for economic dimension (ICC_A,1 = 0.86), and fair for organizational/operational dimension (ICC_A,1 = 0.56). Test-retest reliability scores were excellent for clinical (I̅C̅C̅_A,1 = 0.79), excellent for economic (I̅C̅C̅_A,1 = 0.84), and fair for organizational/operational (I̅C̅C̅_A,1 = 0.56). The tool was rated as appropriate (mean = 5.86; SD = 1.03), acceptable (mean = 5.19; SD = 1.12), precise (mean = 5.71; SD = 1.17), and feasible (mean = 5.05; SD = 1.24). The maximum time required to evaluate an intervention was three minutes.</p><p><strong>Conclusion: </strong>The CLEO_VN tool was successfully translated and validated for reliability, appropriateness, acceptability, precision, and feasibility. It will be suitable to evaluate the value of clinical pharmacy interventions.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"119-127"},"PeriodicalIF":2.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142371773","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":"Cardiac adverse events associated with statins in myocardial infarction patients: a pharmacovigilance analysis of the FDA Adverse Event Reporting System.","authors":"Chuanhuan Deng, Xiaofang Lin, Dan Ni, Ludong Yuan, Jing Li, Yuxuan Liu, Pengfei Liang, Bimei Jiang","doi":"10.1007/s11096-024-01804-z","DOIUrl":"10.1007/s11096-024-01804-z","url":null,"abstract":"<p><strong>Background: </strong>Despite the advent of new pharmacotherapies, statins remain a cornerstone in the secondary prevention of myocardial infarction (MI). However, the cardiac adverse events (AEs) linked to statins are not well-documented.</p><p><strong>Aim: </strong>This pharmacovigilance study used data from the FDA Adverse Event Reporting System (FAERS) to investigate the association between statin use and cardiac AEs in MI patients.</p><p><strong>Method: </strong>Reports from the FAERS database (2004-2023) identifying statins as the primary suspect in MI patients were analyzed. The study evaluated seven types of statins: atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, and simvastatin. Disproportionality analysis using four major indices, Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma-Poisson Shrinker (MGPS), was conducted to detect signals of statin-related cardiac AEs.</p><p><strong>Results: </strong>Of the 20,346,289 reports reviewed, 150 identified statins as the primary suspect drug in MI patients. The most common cardiac AEs were recurrent MI (50 reports), acute MI (14 reports), followed by tachycardia (10), angina pectoris (8), coronary artery occlusion (6), cardiac failure (6), and arrhythmia (6). The analysis revealed no significant signals of statin-induced cardiac AEs.</p><p><strong>Conclusion: </strong>The findings confirm that statin use in MI patients does not significantly increase the risk of cardiac adverse effects, supporting their safety profile in this context.</p>","PeriodicalId":13828,"journal":{"name":"International Journal of Clinical Pharmacy","volume":" ","pages":"46-52"},"PeriodicalIF":2.6,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142582774","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}