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Real-World Evidence of Indapamide-Induced Rhabdomyolysis: A Retrospective Analysis of Electronic Health Records
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  • Raseel Alroba,
  • Almaha Alfakhri,
  • Hisham A. Badreldin,
  • Adel Alrwisan,
  • Ohoud A. Almadani
Raseel Alroba
Saudi Food and Drug Authority
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Almaha Alfakhri
Saudi Food and Drug Authority
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Hisham A. Badreldin
King Saud bin Abdulaziz University for Health Sciences College of Pharmacy
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Adel Alrwisan
Saudi Food and Drug Authority
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Ohoud A. Almadani
Saudi Food and Drug Authority

Corresponding Author:oal-madani@hotmail.com

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Abstract

Purpose: This study aims to investigate the potential causal relationship between the use of indapamide and rhabdomyolysis. Previous research and pharmacovigilance monitoring activities have suggested a potential association between indapamide use and rhabdomyolysis. However, limited information is available on this association. Methods: A case-control study conducted using EHR 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 1,000 U/L (i.e. rhabdomyolysis event). Subsequently, a multivariable conditional logistic regression analysis was utilized to assess the causal impact of indapamide exposure on the likelihood of developing rhabdomyolysis, while accounting for potential confounding variables. Results: The study population consisted of 2,965 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 the OR was 0.7 (95% CI: 0.49 - 0.92) and the AOR was 0.6 (95% CI: 0.39 - 1.05). The recent users showed OR of 0.9 (95% CI: 0.56 - 1.50) and AOR of 0.2 (95% CI: 0.14 - 0.47). Lastly, the former users demonstrated an OR of 0.8 (95% CI: 0.47 - 1.26), and AOR of 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.
29 Apr 2024Submitted to Pharmacoepidemiology and Drug Safety
29 Apr 2024Submission Checks Completed
29 Apr 2024Assigned to Editor
29 Apr 2024Review(s) Completed, Editorial Evaluation Pending
16 May 2024Reviewer(s) Assigned
07 Jul 2024Editorial Decision: Revise Major
24 Aug 20241st Revision Received
24 Aug 2024Submission Checks Completed
24 Aug 2024Assigned to Editor
24 Aug 2024Review(s) Completed, Editorial Evaluation Pending
31 Aug 2024Reviewer(s) Assigned
26 Sep 2024Editorial Decision: Revise Major
15 Oct 20242nd Revision Received
15 Oct 2024Submission Checks Completed
15 Oct 2024Assigned to Editor
15 Oct 2024Review(s) Completed, Editorial Evaluation Pending
16 Oct 2024Editorial Decision: Revise Minor
22 Oct 20243rd Revision Received
22 Oct 2024Submission Checks Completed
22 Oct 2024Assigned to Editor
22 Oct 2024Review(s) Completed, Editorial Evaluation Pending
25 Oct 2024Editorial Decision: Accept