ABSTRACT
Gemfibrozil (Lopid1) was developed by Parke-Davis, the pharmaceutical research division of Warner-Lambert, and approved by the FDA in 1981 for the treatment of adults with high triglyceride levels-those who were considered at risk of developing pancreatitis (inflammation of the pancreas) and who do not respond to a strict diet. Based upon data collected in the Helsinki Heart Study Primary Prevention (HHSPP) trial, Lopid was the first drug approved for the broader indication of reducing the risk of coronary heart disease (CHD) while increasing high-density lipoproteins (HDL)-cholesterol (the ‘‘good’’ component of total cholesterol) and lowering low-density lipoproteins (LDL)-cholesterol (the ‘‘bad’’ component of total cholesterol). The HHSPP trial was a landmark clinical trial in dyslipidemic, middle-
aged Finnish males, who were otherwise healthy and without a history of myocardial infarction (MI) [1]. Subjects who satisfied eligibility criteria were randomized in a balanced fashion to either Gemfibrozil or Placebo and followed in double-blind manner for 5 years. Subjects who exhibited symptoms or signs of possible CHD were eligible to participate in an ancillary treatment protocol [2,3]. Following completion of the 5-year double-blind study phase, all subjects
living at that time, including those who dropped out during the double-blind phase, were given the option of taking Gemfibrozil or no drug, and participate in open-label follow-up for up to 5 years [4,5]. This chapter presents an overview of the HHSPP trial and an analysis of data on major events occurring during the double-blind and open-label phases that attempts to adjust for differential exposure to study medication.
