Serious Adverse Events Among SPRINT Trial Participants Taking Statins at Baseline.

Publisher: Adis, Springer International Country of Publication: New Zealand NLM ID: 100883647 Publication Model: Print Cited Medium: Internet ISSN: 1179-6901 (Electronic) Linking ISSN: 11745886 NLM ISO Abbreviation: Drugs R D Subsets: MEDLINE

Publication: Auckland : Adis, Springer International
Original Publication: Auckland ; Philadelphia : Adis International, c1999-

Randomized Controlled Trials as Topic*/statistics & numerical data; Blood Pressure/*drug effects ; Cardiovascular Diseases/*drug therapy ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/*adverse effects ; Myalgia/*chemically induced; Cohort Studies ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosage ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use

Background: Real-world evidence of statin side effects is potentially biased because statin use is neither randomized nor unblinded. An innovative study design can mitigate these biases. For example, in the recent ASCOT-LLA trial, patient-reported adverse events such as muscle pain and weakness were higher in the non-randomized and non-blinded setting than in the randomized, blinded setting. Less optimally, secondary re-analysis of clinical trials in which statin use is recorded and in which serious adverse events (SAEs) are adjudicated may be conducted.
Objective: The objective of this study was to evaluate SAEs by statin use at baseline among participants in the SPRINT blood pressure (BP) management trial.
Methods: Unadjusted overall SAE and treatment-related SAE rates by statin use as well as adjusted hazard ratios for statin use were computed in four cohorts [by baseline clinical cardiovascular disease (CVD), by intervention arm].
Results: Statin use at baseline was not associated with higher overall or treatment-related SAE rates among (1) those without pre-existing CVD, regardless of BP arm, nor among (2) those randomized to standard BP management, regardless of pre-existing CVD. Among higher risk patients with existing clinical CVD randomized to intensive BP management, a small but significant increase in overall SAE rate was found among those taking statin at baseline.
Conclusions: In SPRINT, generally statin use was not associated with increased risk of reporting SAEs. Only statin use by higher risk patients was associated with more overall SAEs. Confounding by clinical CVD and the polytherapy of intensive BP management may explain this.

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0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)

Date Created: 20171024 Date Completed: 20180629 Latest Revision: 20240604

20240604

PMC5694426

10.1007/s40268-017-0213-9

29058304