The effects of cholesterol lowering with simvastatin on cause-specific mortality and on cancer incidence in 20,536 high-risk people: a randomised placebo-controlled trial [ISRCTN48489393].

Despite concerns about possible adverse effects of statin therapy on heart failure [ 31 ], the non-significant trend toward fewer heart failure deaths due to any cause (70 [0.7%] vs 86 [0.8%]; RR 0.81 [0.59–1.10]; p = 0.2) is supported by a marginally significant reduction in first hospital admission for worsening heart failure or heart failure death (354 [3.4%] vs 405 [3.9%]; RR 0.86 [0.75–1.00]; p = 0.05).

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This difference is not conventionally significant (p = 0.06), even before allowing for the multiple comparisons involved.

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Results There was a highly significant 17% (95% CI 9–25) proportional reduction in vascular deaths, along with a non-significant reduction in all non-vascular deaths, which translated into a significant reduction in all-cause mortality (p = 0.0003).

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