European Primary Care Cardiovascular Society

Efficacy of statins in primary CVD prevention confirmed in large meta-analysis, but individual benefit-harm profiles vary

Comparative effectiveness and safety of statins as a class and of specific statins for primary prevention of cardiovascular disease: A systematic review, meta-analysis and network meta-analysis of randomized trials with 94,283 participants

Literature - Yebyo HG, Aschmann HE, Kaufmann M et al. - Am Heart J 2019;

Introduction and methods

The role of statins for primary prevention of CV events is highly debated [1-4]. Some see great potential for statins to reduce the burden of CVD and they recommend life-long use of statins for many healthy individuals [5-8]. Others argue that the evidence-base and decision support for individuals and health care professionals has not yet been developed enough.

Current guidelines used data obtained from systematic reviews and meta-analyses. However, these studies often suffer from limitations. Several meta-analyses reported effects of statins on composite outcomes only, while statins may have opposite effects for certain outcomes and their effect size on different outcomes may vary substantially [9-11]. Various systematic reviews examined statins as a class, which may conceal differences in efficacy and safety between individual statins [12]. Moreover, some of the systematic reviews mixed primary and secondary prevention populations, even though effects might differ between these groups. Plus, primary prevention populations are often prescribed low-dose statins [3,13,14].

To inform the debate on statins, a comprehensive systematic review, meta-analysis and drug-level network meta-analysis of RCTs was conducted (January 2013 – November 2018) to estimate the effectiveness and safety of statins as a class and of individual statins for primary prevention of CVD. Eligible open-label or double-blind RCTs (40 trials; n=94.283) compared a statin vs. placebo (33 trials) or a statin vs. another statin (7 trials) and reported results on at least one benefit or harm outcome in people without history of any CVD events at baseline (median age: 58.3 years). Six statins were considered: simvastatin, lovastatin, fluvastatin, atorvastatin, pravastatin, and rosuvastatin. Median follow-up was 1 year. Primary outcomes were CVD events or all-cause mortality.

Main results

Effects of statins on benefit outcomes

Effects of statins on harm outcomes


This systematic review, meta-analysis and network meta-analysis of RCTs on statins demonstrated efficacy both of statins as a class and of specific statins in prevention of CV events and all-cause mortality in primary prevention populations. However, increased risk of myopathy, renal dysfunction and hepatic dysfunction were observed. The benefit-harm profiles differed among individual statins. Atorvastatin and rosuvastatin appeared to be the most effective and atorvastatin the safest statin across most of the outcomes.


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