WHO cooperative trial on primary prevention of ischaemic heart disease with clofibrate to lower serum cholesterol: final mortality follow-up. Report of the Committee of Principal Investigators

Lancet. 1984 Sep 15;2(8403):600-4.

Abstract

This is the final report on mortality amongst men in the WHO cooperative trial of the prevention of ischaemic heart disease (IHD) by clofibrate and it takes the follow-up a further 4 years to the end of 1982. Mean observation was 13.2 years, 5.3 in the trial and 7.9 afterwards. 1788 deaths were recorded in 208 000 man-years. In the 877 new deaths reported here, there was an excess of 9 deaths in the high cholesterol control group compared with the clofibrate-treated group. In the whole period there were 70 (11%) more deaths in the clofibrate-treated group. Excess mortality in the clofibrate-treated group was much greater during the "treatment period" (there was an excess of 47% during treatment compared with 5% after treatment had ended) and was due to a wide variety of causes other than IHD. Thus, the excess mortality in the clofibrate-treated group has not continued after the end of treatment. The substantial excess previously reported remains unexplained.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Cholesterol / blood*
  • Clinical Trials as Topic
  • Clofibrate / therapeutic use*
  • Coronary Disease / mortality
  • Coronary Disease / prevention & control*
  • Follow-Up Studies
  • Humans
  • Male
  • Neoplasms / mortality

Substances

  • Cholesterol
  • Clofibrate