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March 24, 2003

Safety and Statin Therapy: Reconsidering the Risks and Benefits

Arch Intern Med. 2003;163(6):657-659. doi:10.1001/archinte.163.6.657

THE FIRST 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor, lovastatin, obtained Food and Drug Administration approval in the United States in 1987.1 Now, after a little more than 15 years of clinical availability, the statins have emerged at the forefront of pharmacological treatment of hypercholesterolemia.2-7 As one large-scale statin trial after another reported significant relative risk reductions—of 24% to 37%—for coronary disease, and adverse event rates that rarely differed from placebo, these agents quickly became the "gold standard" for drugs affecting lipid metabolism. The enthusiasm for statins was so great, even a few years ago, that the suggestion of adding statins to the drinking water as their next logical application was a common joke among those in the field.

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