To the Editor.
—Hulley et al1 question the approval by the Food and Drug Administration of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, because trials with mortality end points have not yet been completed and because "a preliminary trial of lovastatin showed a three-fold increase in total mortality in the treated groups (P=.08)." With regard to the first point, all lipid-lowering agents available today were approved many years before end point studies were completed. Furthermore, Food and Drug Administration advisory panels have twice in recent years rejected the proposal that data from such trials should be required before approval. Several end point studies with HMG-CoA reductase inhibitors are under way.With regard to the second point, the trial in question is the Expanded Clinical Evaluation of Lovastatin (EXCEL) study,2 which randomized 8245 patients into five equal groups taking lovastatin 20 mg daily, 40 mg daily, 20 mg twice
Tobert JA. Blood Cholesterol Measurement in Young Adults. JAMA. 1993;270(8):936. doi:10.1001/jama.1993.03510080040016