Statin use provide effective primary prevention against cardiovascular disease in high-risk patients – US Preventive Services Task Force

1. Statin use in patients at increased risk of cardiovascular disease without prior history of cardiovascular disease events was significantly associated with lower risk of all-cause mortality, stroke, and myocardial infarction compared to placebo in a meta-analysis of the included studies.

2. Statin therapy was not significantly associated with an increased risk of adverse events including myalgias, transaminitis and cancer.

Level of Evidence Rating: 1 (Excellent)

Study Rundown: Cardiovascular disease is the leading cause of morbidity and mortality in North America. Guidelines established in 2016 recommend statin medications for the primary prevention of cardiovascular disease (CVD) in elevated-risk adults aged 40-75. The present study reviews relevant evidence for the efficacy of statin therapy as a primary prevention intervention gathered over the past five years.

A total of 26 studies were analyzed, including 23 randomized trials and 3 observational studies. With regards to study quality, 7 were considered “good” and 15 were “fair”. Statins were compared to either placebo, or no statin and found to significantly lower all-cause mortality as well as the risk of stroke. These findings were robust to sensitivity analyses which controlled for the quality and intent of trials (i.e. specific to primary prevention of CVD) and no differences were found between different racial/ethnic groups. With regards to adverse events, statins were not associated with a significant increase in the rate of serious adverse events, myalgias/myopathy, cancer or transaminitis.

This review study by Chou et al concluded that statin therapy is definitively beneficial for primary prevention of CVD in adults with risk factors. A thorough analysis of the evidence found that the benefits of statin therapy outweigh the drawbacks and the risk of adverse events is not increased with statins. This work represents high-quality evidence for statin therapy, particularly given the inclusion of many randomized controlled trials and the assessment of individual study quality which was performed. A major limitation of this work is the stringent inclusion criteria for placebo-controlled trials of statins for primary prevention only which may limit the external validity of these findings.

Click here to read this study in JAMA

Click to read an accompanying editorial in JAMA

Relevant reading: Statins for prevention of cardiovascular disease in adults: evidence report and systematic review for the US Preventive Services Task Force

In Depth [systematic review and meta-analysis]: A systematic review and meta-analysis was completed. A search of English-language studies published in three databases (MEDLINE, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic) was conducted and studies were assessed for inclusion by two independent reviewers. The population of interest was adults aged 40 years or older who had not previously had a CVD event. Observational and experimental studies were included for the outcome analysis but only randomized controlled trials were analyzed to understand the harm profile of statins.

18 trials assessed all-cause mortality and statins were found to play a significantly beneficial role: the relative risk (RR) for mortality in the statin group versus the comparator was 0.92 (95% confidence interval 0.87 to 0.98). The RR for stroke (fatal or nonfatal) in the statin versus comparator group was 0.78 (0.68 to 0.90) and for myocardial infarction was 0.67 (95% CI, 0.60 to 0.75). Statin therapy was not found to increase the risk of various adverse outcomes as illustrated by the following relative risk values: serious adverse events (0.97, 95% confidence interval 0.93 to 1.01), cancer (0.98, 0.91 to 1.04), myalgia (0.98, 0.86 to 1.11), elevated alanine aminotransferase (0.94, 0.78 to 1.13), elevated aspartate aminotransferase (1.30, 0.78 to 2.17) and myopathy (1.49, 0.48 to 2.47).

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