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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: Roger Chou, M.D., Amy Cantor, M.D., M.P.H., Tracy Dana, M.L.S., Jesse Wagner, M.A., Azrah Ahmed, B.A., Rongwei Fu, Ph.D., and Maros Ferencik, M.D., Ph.D.
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
- Acknowledgments
- Chapter 1. Introduction and Background
- Chapter 2. Methods
- Chapter 3. Results
- Key Question 1a. What Are the Benefits of Statins in Reducing the Incidence of CVD-Related Morbidity or Mortality or All-Cause Mortality in Asymptomatic Adults Without Prior CVD Events?
- Key Question 1b. Do the Benefits of Statin Treatment Vary in Groups Defined by Demographic, Clinical, or Socioeconomic Characteristics?
- Key Question 1c. What Are the Benefits of Statin Treatment Titrated to Achieve Target Low-Density Lipoprotein Cholesterol Levels vs. a Fixed Dose Strategy?
- Key Question 2a. What Are the Harms of Statins in Adults Without Prior CVD Events?
- Key Question 2b. Do the Harms of Statin Treatment Vary in Groups Defined by Demographic, Clinical, or Socioeconomic Characteristics?
- Key Question 3. How Do the Benefits and Harms of Statin Treatment Vary According to Its Intensity?
- Contextual Question 1. What Are the Effects of Initiating Statins for Primary Prevention at Different Cardiovascular Risk Thresholds on the Number of Persons Eligible for Treatment and Potential Benefits and Harms (Including Modeling Studies)?
- Contextual Question 2. How Do Patient Preferences Regarding Use of Statins for Primary Prevention Vary at Different Cardiovascular Risk Thresholds?
- Contextual Question 3. What Are the Effects on Mortality and Cardiovascular Events of Use of the Coronary Artery Calcium Score Alone or in Addition to the Pooled Cohort Equations vs. the Pooled Cohort Equations Alone to Guide Decisions Regarding Use of Statins for Primary Prevention?
- Contextual Question 4. What Are the Effects of Consideration of Coronary Artery Calcium Score, C-Reactive Protein, Ankle-Brachial Index, Lipoprotein(a), Socioeconomic Status, Race and Ethnicity, or Family History in Addition to the Pooled Cohort Equations vs. the Pooled Cohort Equations Alone on Patient Preferences Regarding Use of Statins for Primary Prevention?
- Contextual Question 5. In Persons With Similar Assessed Cardiovascular Risk, How Does Use of Statins for Primary Prevention Differ According to Demographic, Clinical, or Socioeconomic Characteristics?
- Chapter 4. Discussion
- References
- Abbreviations and Acronyms
- Appendixes
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.
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