October 1990

Deaths due to Accidents and Violence in Two Recent Trials of Cholesterol-Lowering Drugs

Author Affiliations

From the Division of Epidemiology and Surveillance, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Md.

Arch Intern Med. 1990;150(10):2169-2172. doi:10.1001/archinte.1990.00390210125027

• The Helsinki Heart Study and the Lipid Research Clinics Coronary Primary Prevention Trial both reported higher rates of deaths due to homicides, suicides, and accidents in the groups receiving cholesterol-lowering agents compared with the groups receiving placebos. We examined these deaths in the active treatment arms of the two trials to determine if there were some readily explainable causes or if the cholesterol-lowering agents might be a factor. Our examination showed that the two homicides were victims, not offenders, and one had stopped treatment because of myocardial infarction 1 year before his death. Five of the eight suicides had dropped out of the trials and had not taken the cholesterol-lowering drugs for periods of months to years prior to committing suicide. Of the 10 deaths due to accidents, two were dropouts from the trials, three others had high blood alcohol concentrations detectable at autopsy, and another three reported a history of psychiatric symptoms and/or treatment prior to entry. When dropouts and known risk factors for these deaths such as alcohol intoxication and psychiatric histories are considered, little evidence remains to support the hypothesis that cholesterol-lowering drugs are causally associated with deaths due to homicides, suicides, and accidents in these trials.

(Arch Intern Med. 1990;150:2169-2172)