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Jonathan A. Tobert, MD, PhD
Merck Research Laboratories Rahway, NJ

JAMA. 1993;270(8):936.

	Since this article does not have an abstract, we have provided the first 150 words of the full text PDF and any section headings.

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 . . . [Full Text PDF of this Article]

Footnotes
Edited by Drummond Rennie, MD, Deputy Editor (West), and Margaret A. Winker, MD, Senior Editor.

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