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Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: A Systematic Review for the U.S. Preventive Services Task Force

Evidence Synthesis, No. 219

Investigators: , M.D., , M.D., M.P.H., , M.L.S., , M.A., , B.A., , Ph.D., and , M.D., Ph.D.

Rockville (MD): Agency for Healthcare Research and Quality (US); .
Report No.: 22-05291-EF-1

Structured Abstract

Background:

Cardiovascular disease (CVD) is the leading cause of mortality and morbidity in the United States. A 2016 review for the US Preventive Services Task Force (USPSTF) found statin therapy associated with decreased risk of all-cause and cardiovascular mortality and CVD events in adults at increased CVD risk but without prior CVD events.

Purpose:

To update the 2016 review on statins for primary prevention in adults to inform an updated USPSTF recommendation.

Data Sources:

We searched the Cochrane Central Register of Controlled Trials, the Cochrane Database of Systematic Reviews, and Ovid MEDLINE, from May, 2016 to November 12 2021, and reference lists; with surveillance through May 20, 2022.

Study Selection:

Randomized controlled trials (RCTs) on the benefits and harms of statin therapy versus placebo or no statin and large cohort studies on harms of statin therapy in adults without prior cardiovascular events.

Data Extraction:

One investigator abstracted data and a second investigator checked data abstraction for accuracy. Two investigators independently assessed study quality using methods developed by the USPSTF.

Data Synthesis (Results):

22 trials (N=90,624) with followup from 6 months to 6 years compared statin therapy versus placebo or no statin, one additional trial compared statins of different intensities (N=5,144) and three cohort studies (N=417,523) cohort study reported harms. Compared to the 2016 USPSTF review, additional data were available from three trials (1 new trial and 2 older trials that reported results for the primary prevention population) and one large cohort study (n=261,032). Statin therapy was associated with decreased risk of all-cause mortality (relative risk [RR] 0.92, 95% confidence interval [CI], 0.87 to 0.98; absolute risk difference [ARD], −0.35%; number needed to treat [NNT] 286), stroke (RR 0.78, 95% CI, 0.68 to 0.90; ARD −0.39%; NNT 256), myocardial infarction (RR 0.67, 95% CI, 0.60 to 0.75; ARD −0.85%; NNT 118), and composite cardiovascular outcomes (RR 0.72, 95% CI, 0.64 to 0.81; ARD −1.28%; NNT 78); though the estimate for all-cause mortality was mildly attenuated compared to the 2016 USPSTF review. With the inclusion of additional data, the estimate for cardiovascular mortality was no longer statistically significant (RR 0.91, 95% CI, 0.81 to 1.02; ARD −0.13%; NNT 769). Overall, relative benefits appeared to be consistent in groups defined by demographic and clinical characteristics, including populations with cardiovascular risk factors without marked dyslipidemia. Data for older persons remains sparse and imprecise, particularly for persons >75 years of age. Statin therapy was not associated with significantly increased risk of serious adverse events (RR 0.97, 95% CI, 0.93 to 1.01), myalgia (RR 0.98, 95% CI, 0.86 to 1.11), or liver-related harms (RR 0.94, 95% CI, 0.78 to 1.13). Statin therapy was not associated with increased risk of diabetes (RR 1.04, 95% CI, 0.92 to 1.19), though statistical heterogeneity was present (I2=52%), and one trial found that high-intensity statins were associated with increased risk (RR 1.25, 95% CI, 1.05 to 1.49). Otherwise, there were no clear differences in benefits or harms based on intensity of statin therapy.

Limitations:

Restricted to English language, statistical heterogeneity in some pooled analyses, methodological limitations in some trials, and limited ability to assess for publication bias.

Conclusions:

In adults at increased CVD risk but without prior CVD events, statin therapy is associated with reduced risk of all-cause mortality and CVD events; with the inclusion of additional data, effects on cardiovascular mortality are not statistically significant. Benefits of statin therapy appear to be present across diverse demographic and clinical populations, with greater absolute benefits in patients at higher baseline risk, and do not appear to be restricted to patients with marked dyslipidemia.

Contents

Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services, 5600 Fishers Lane, Rockville, MD 20857; www.ahrq.gov Contract No. HHSA-290-2015-00007-I, Task Order No. 75Q80119F32009 Prepared by: Pacific Northwest Evidence-Based Practice Center, Oregon Health & Science University, Mail Code: BICC, 3181 SW Sam Jackson Park Road, Portland, OR 97239, www.ohsu.edu/epc

Suggested citation:

Chou R, Cantor A, Dana T, Wagner J, Ahmed A, Fu R, Ferencik M. Statin Use for the Primary Prevention of Cardiovascular Disease in Adults: A Systematic Review for the U.S. Preventive Services Task Force. Evidence Synthesis No. 219. AHRQ Publication No. 22-05291-EF-1. Rockville, MD: Agency for Healthcare Research and Quality; 2022.

This report is based on research conducted by the Pacific Northwest Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (HHSA-290-2015-00007-I, Task Order No. 75Q80119F32009). The findings and conclusions in this document are those of the authors, who are responsible for its contents, and do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.

The information in this report is intended to help healthcare decision makers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of healthcare services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information (i.e., in the context of available resources and circumstances presented by individual patients).

This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.

None of the investigators has any affiliations or financial involvement that conflicts with the material presented in this report.

Bookshelf ID: NBK583661PMID: 36067345

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