{"title":"吲达帕胺诱发横纹肌溶解症的真实证据:对电子健康记录的回顾性分析。","authors":"Raseel Alroba, Almaha Alfakhri, Hisham Badreldin, Adel Alrwisan, Ohoud Almadani","doi":"10.1002/pds.70053","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>Previous research and pharmacovigilance monitoring activities have suggested a potential association between indapamide use and rhabdomyolysis. This study aims to investigate the potential causal relationship between the use of indapamide and rhabdomyolysis.</p><p><strong>Methods: </strong>A case-control study conducted using electronic health records data, between July 1, 2016 and December 31, 2022. Patients who have rhabdomyolysis event (cases) were matched to four controls bases on age, gender, and date. We examined the odds for indapamide exposure through three risk periods: current use, recent use, and former. The study outcome was ascertained through the presence of CK level over 1000 U/L (i.e., rhabdomyolysis event). Subsequently, a multivariable conditional logistic regression analysis was utilized to assess the causal association of indapamide exposure on the likelihood of developing rhabdomyolysis, while accounting for potential confounding variables.</p><p><strong>Results: </strong>The study population consisted of 2965 cases and 11 860 controls. The results of the conditional logistic regression analysis indicated a lack of association between exposure to indapamide for the current users with an odds ratio (OR) of 0.6 (95% confidence intervals (CI): 0.39-1.05). The odds of recent indapamide use among cases was lower than controls (OR 0.2; 95% CI: 0.14-0.47). Lastly, the OR for former use of indapamide was 0.1 (95% CI: 0.07-0.23).</p><p><strong>Conclusions: </strong>In this study, we did not find association between indapamide use and rhabdomyolysis regardless timing of exposure.</p>","PeriodicalId":19782,"journal":{"name":"Pharmacoepidemiology and Drug Safety","volume":"33 11","pages":"e70053"},"PeriodicalIF":2.4000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Real-World Evidence of Indapamide-Induced Rhabdomyolysis: A Retrospective Analysis of Electronic Health Records.\",\"authors\":\"Raseel Alroba, Almaha Alfakhri, Hisham Badreldin, Adel Alrwisan, Ohoud Almadani\",\"doi\":\"10.1002/pds.70053\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>Previous research and pharmacovigilance monitoring activities have suggested a potential association between indapamide use and rhabdomyolysis. This study aims to investigate the potential causal relationship between the use of indapamide and rhabdomyolysis.</p><p><strong>Methods: </strong>A case-control study conducted using electronic health records data, between July 1, 2016 and December 31, 2022. Patients who have rhabdomyolysis event (cases) were matched to four controls bases on age, gender, and date. We examined the odds for indapamide exposure through three risk periods: current use, recent use, and former. The study outcome was ascertained through the presence of CK level over 1000 U/L (i.e., rhabdomyolysis event). Subsequently, a multivariable conditional logistic regression analysis was utilized to assess the causal association of indapamide exposure on the likelihood of developing rhabdomyolysis, while accounting for potential confounding variables.</p><p><strong>Results: </strong>The study population consisted of 2965 cases and 11 860 controls. The results of the conditional logistic regression analysis indicated a lack of association between exposure to indapamide for the current users with an odds ratio (OR) of 0.6 (95% confidence intervals (CI): 0.39-1.05). The odds of recent indapamide use among cases was lower than controls (OR 0.2; 95% CI: 0.14-0.47). Lastly, the OR for former use of indapamide was 0.1 (95% CI: 0.07-0.23).</p><p><strong>Conclusions: </strong>In this study, we did not find association between indapamide use and rhabdomyolysis regardless timing of exposure.</p>\",\"PeriodicalId\":19782,\"journal\":{\"name\":\"Pharmacoepidemiology and Drug Safety\",\"volume\":\"33 11\",\"pages\":\"e70053\"},\"PeriodicalIF\":2.4000,\"publicationDate\":\"2024-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Pharmacoepidemiology and Drug Safety\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1002/pds.70053\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmacoepidemiology and Drug Safety","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/pds.70053","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Real-World Evidence of Indapamide-Induced Rhabdomyolysis: A Retrospective Analysis of Electronic Health Records.
Purpose: Previous research and pharmacovigilance monitoring activities have suggested a potential association between indapamide use and rhabdomyolysis. This study aims to investigate the potential causal relationship between the use of indapamide and rhabdomyolysis.
Methods: A case-control study conducted using electronic health records data, between July 1, 2016 and December 31, 2022. Patients who have rhabdomyolysis event (cases) were matched to four controls bases on age, gender, and date. We examined the odds for indapamide exposure through three risk periods: current use, recent use, and former. The study outcome was ascertained through the presence of CK level over 1000 U/L (i.e., rhabdomyolysis event). Subsequently, a multivariable conditional logistic regression analysis was utilized to assess the causal association of indapamide exposure on the likelihood of developing rhabdomyolysis, while accounting for potential confounding variables.
Results: The study population consisted of 2965 cases and 11 860 controls. The results of the conditional logistic regression analysis indicated a lack of association between exposure to indapamide for the current users with an odds ratio (OR) of 0.6 (95% confidence intervals (CI): 0.39-1.05). The odds of recent indapamide use among cases was lower than controls (OR 0.2; 95% CI: 0.14-0.47). Lastly, the OR for former use of indapamide was 0.1 (95% CI: 0.07-0.23).
Conclusions: In this study, we did not find association between indapamide use and rhabdomyolysis regardless timing of exposure.
期刊介绍:
The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report.
Particular areas of interest include:
design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology;
comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world;
methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology;
assessments of harm versus benefit in drug therapy;
patterns of drug utilization;
relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines;
evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.