Daniel Muñoz, MD, MPA; Christopher B. Granger, MD
In patients with low cardiovascular (CV) risk, are statins effective and safe for primary prevention?
Included studies compared a statin with no statin (placebo or standard care) in patients ≥ 16 years of age with low CV risk (extrapolated observed 10-y risk for CV-related death or nonfatal myocardial infarction [MI] < 20% in control group), had ≥ 6 months of follow-up, and ≥ 30 patients per study group. Outcomes included all-cause mortality, acute MI, stroke or transient ischemic attack, unstable angina, revascularization, and serious adverse events (as defined by each study's authors or if led to treatment or study withdrawal).
MEDLINE and EMBASE/Excerpta Medica (2003 to Jan 2011), health technology assessment and clinical trial registries, and reference lists of reviews* were searched for parallel-group randomized controlled trials (RCTs). Canadian manufacturers of statins were contacted for published and unpublished studies. 29 RCTs (n = 80 711, median age 58 y, median 62% men, median follow-up 2 y [range 0.5 to 5.3 y]) met inclusion criteria: 9 evaluated pravastatin, 6 evaluated atorvastatin, 4 each evaluated fluvastatin and rosuvastatin, and 3 each evaluated lovastatin and simvastatin. 10 RCTs had adequate allocation concealment, and 22 were described as double-blind; overall risk for bias was moderate.
In a low-risk study population, statins reduced all-cause mortality, nonfatal MI, nonfatal stroke, unstable angina, and revascularization more than placebo or standard care (Table). Groups did not differ for serious adverse events (Table).
In patients with low cardiovascular risk, statins reduced mortality and cardiovascular morbidity and did not increase adverse events more than no statins.
Statins vs no statins (placebo or standard care) in patients with low cardiovascular risk†
† MI = myocardial infarction; other abbreviations defined in Glossary. RRR, RRI, CI, and weighted event rates calculated from control event rates and relative risks in article using a random-effects model. Only studies with ≥ 1 event were included in the analysis.
‡Value provided by authors.
Muñoz D, Granger CB. Review: Statins reduce mortality and cardiovascular (CV) morbidity in patients with low CV risk. Ann Intern Med. ;156:JC4–7. doi: 10.7326/0003-4819-156-8-201204170-02007
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Published: Ann Intern Med. 2012;156(8):JC4-7.
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