ACP Journal Club. Review: Statins reduce mortality and major vascular events in patients with no history of CV disease.

In patients with no history of cardiovascular disease (CVD), what are the benefits and harms of statins? Review scope Included studies compared statins with placebo or usual care in adults ≥ 18 years of age, and had treatment duration ≥ 12 months and follow-up ≥ 6 months. Studies in which > 10% of patients had previous CVD or in which statins were used to treat or control chronic conditions were excluded. Outcomes included all-cause mortality, coronary heart disease (CHD), CVD, stroke, revascularizations, type 2 diabetes, and adverse events. were searched for randomized controlled trials (RCTs); reference lists of review articles and included RCTs were also reviewed. 18 RCTs with 19 groups (n = 56 934, mean age 57 y [range 28 to 97 y]) met the inclusion criteria. Sample size ranged from 47 to 17 802 patients, and duration of follow-up ranged from 1 to 5.3 years. 16 RCTs adequately reported random sequence generation, 15 used double-blinding of outcome assessment, and 13 used intention-to-treat analyses. Meta-analysis showed that statins reduced all-cause mortality, CHD, CVD, stroke, and revascularizations (Table). Statins increased risk for type 2 diabetes but not other adverse events (Table). Conclusion In patients with no history of cardiovascular disease, statins reduce mortality and major vascular events and increase the risk for diabetes without increasing other adverse events. Commentary The meta-analysis by Taylor and colleagues found that statins reduce risk for mortality and CVD in patients with no history of CVD. The relative risk reductions (RRRs) in this primary prevention review are similar to the RRRs found in studies of secondary prevention of CVD and mortality (1), although the numbers needed to treat (NNTs) are very different. To avoid 1 additional death, about 30 persons would need to be treated with statins for 5 years in secondary prevention (1) but, as shown in this review, 138 patients would need to be treated in primary prevention. The cost-effectiveness also differs. A UK report estimated costs equivalent to approximately $20 000 to $34 000/quality-adjusted life-year (QALY) in secondary prevention, but $20 000 to $96 000/QALY in primary prevention (1), although this would probably be less with generic statins. In secondary prevention, such interventions as exercise-based cardiac rehabilitation are as clinically effective (2) and cost-effective (3) as statins, yet do not receive the attention or funding that statins do. Some lifestyle interventions are probably as cost-effective as statins in primary prevention as well. …