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August 17, 1994

Safety and Side Effects of Sustained-Release Niacin-Reply

JAMA. 1994;272(7):514-515. doi:10.1001/jama.1994.03520070031019

In Reply.  —Niacin remains a valuable agent for the treatment of dyslipidemias and is properly categorized as a "major" drug for managing hypercholesterolemia in the new Adult Treatment Panel (ATPII) guidelines.1 As a "grandfathered" drug, it has not been subjected to the rigorous, systematic study the Food and Drug Administration requires for approval and marketing of modern drugs, and we must continue to learn about it unless and until it becomes displaced by newer and safer drugs.Dr Keenan and colleagues are critical of the 1500 mg twice-daily dosing schedule we used. This dose is not excessive by current standards.2 We do not find any reports supporting the notion that thrice-daily dosing of niacin is safer, more effective, or more physiologic. Optimal dosing of niacin may not be achieved until we have a better understanding of its pharmacokinetics. Contrary to his suggestion that it was intentional, the frequency