Statin Use for the Primary Prevention of Cardiovascular Disease in Adults

Abstract

IMPORTANCE A 2016 review for the US Preventive Services Task Force (USPSTF) found use of statins for primary prevention of cardiovascular disease (CVD) was associated with reduced mortality and cardiovascular outcomes. OBJECTIVE To update the 2016 review on statins for primary prevention of CVD to inform the USPSTF DATA SOURCES Ovid MEDLINE, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews (to November 2021); surveillance through May 20, 2022.STUDY SELECTION Randomized clinical trials on statins vs placebo or no statin and statin intensity in adults without prior cardiovascular events; large cohort studies on harms.DATA EXTRACTION AND SYNTHESIS One investigator abstracted data; a second checked accuracy. Two investigators independently rated study quality. MAIN OUTCOMES AND MEASURESAll-cause and cardiovascular mortality, myocardial infarction, stroke, composite cardiovascular outcomes, and adverse events. RESULTS Twenty-six studies were included: 22 trials (N = 90 624) with 6 months to 6 years of follow-up compared statins vs placebo or no statin, 1 trial (n = 5144) compared statin intensities, and 3 observational studies (n = 417 523) reported harms. Statins were significantly associated with decreased risk of all-cause mortality (risk ratio [RR], 0.

Statin Use for the Primary Prevention of Cardiovascular Disease in Adults

“…To update its 2016 recommendation statement, the USPSTF commissioned a systematic review of the evidence on the benefits and harms of statins in reducing CVD-related morbidity or mortality or all-cause mortality. The evidence review also investigated whether the benefits or harms of statin treatment vary in populations of interest defined by demographic, clinical, or socioeconomic characteristics, by statin intensity, or by titration of statin therapy to a target LDL-C level vs use of a fixed statin dose.…”

“…All trials enrolled persons with at least 1 cardiovascular risk factor, and a few required the presence of multiple cardiovascular risk factors at baseline. The most common risk factors were dyslipidemia (which was variably defined), diabetes, and hypertension …”

“…In several trials, primary outcome was reported as a composite of CVD events, with the exact components of this end point varying across trials. In a pooled analysis of 15 trials, statin therapy was also associated with a decreased risk of composite cardiovascular outcomes (n = 74 390; RR, 0.72 [95% CI, 0.64 to 0.81]; ARD, −1.28%) …”

“…Only 1 trial, WOSCOPS (West of Scotland Coronary Prevention Study; n = 6595), reported a statistically significant difference between statin and placebo in risk of cardiovascular mortality (RR, 0.68 at 6 years [95% CI, 0.48 to 0.98]; ARD, −0.70% [95% CI, −1.36% to −0.05%]) . In pooled analyses of all 12 trials, statin therapy was associated with a slight reduction in cardiovascular mortality risk at 2 to 6 years that was not statistically significant (RR, 0.91 [95% CI, 0.81 to 1.02]; ARD, −0.13%; [95% CI, −0.25% to −0.02%]) …”

Statin Recommendations for Primary Prevention

“…In 2016, the US Preventive Services Task Force (USPSTF) issued its first recommendations for statin therapy for the primary prevention of cardiovascular disease based on an evidence review that included 19 randomized clinical trials (RCTs) . In this issue of JAMA , the USPSTF presents an update of the 2016 recommendations based on an updated evidence report and systematic review using the same 19 RCTs plus a single new RCT (TRACE-RA), as well as additional data from 2 previous RCTs that included patients treated for both primary and secondary prevention (PROSPER and ALLHAT-LLT) . Given the overlap in the contributing studies, the USPSTF updated evidence summary and resulting treatment recommendations for statin use in primary prevention remained largely unchanged.…”