Deaths from Injury, Violence, and Suicide in Secondary Prevention Trials of Cholesterol Lowering

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Abstract
There may not be any excess of noncardiovascular, noncancer deaths (including deaths from injury, violence, and suicide) in secondary prevention trials of cholesterol lowering. Our previously reported odds ratio of 2.10 (95 percent confidence interval, 1.33 to 3.34) was derived from a meta-analysis of the small number of noncardiovascular, noncancer events in eight secondary prevention trials.1 The analysis relied heavily on the results of the largest trial, the Coronary Drug Project. It has come to our attention that the in-trial mortality data for the project2 that were used in the meta-analysis had been updated and revised in an appendix to a subsequent report.3 As compared with the primary report by the Coronary Drug Project, the numbers of deaths from noncardiovascular, noncancer causes decreased from 19 to 12 in patients taking clofibrate and from 21 to 13 in those taking niacin, while increasing from 30 to 31 in those taking placebo. The excess mortality in this category was no longer present when the meta-analysis was repeated with the revised numbers (odds ratio, 1.16; 95 percent confidence interval, 0.70 to 1.92).

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