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Statins: Still on Track for OTC Sales

KEY POINT

As medications with initial concerns about hepatotoxicity, HMG-CoA reductase inhibitors would seem unlikely candidates for an Rx-to-OTC switch. However, as the lay media focus on the nonprescription possibilities for loratadine (Claritin—Schering) and other second- generation antihistamines, manufacturer-sponsored OTC applications for lovastatin (Mevacor—Merck) and pravastatin (Pravachol—Bristol-Myers Squibb) continue on cat paws through FDA’s regulatory framework. If approved, the OTC statins would be indicated for reducing low-density lipoprotein cholesterol (LDL-C) levels only in primary prevention patients. People with preexisting heart disease require medical care and frequently need more potent statins or higher doses of these agents to achieve larger reductions in LDL-C.

SOURCES

Juhl RP, ed. OTC statins: primary prevention in pharmaceutical care. American Pharmaceutical Association Highlights Newsletter. July 2001.

Larouche SJ et al. Lovastatin 10 mg efficacy in nonprescription studies. Paper presented at: Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics; March 7, 2001; Orlando, Fla.

Struble WE et al. Long-term persistence and compliance with lovastatin 10 mg in a naturalistic nonprescription use study. Paper presented at: Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics; March 8, 2001; Orlando, Fla.

Downs JR et al., for the AFCAPS/TexCAPS Research Group. Primary prevention of acute coronary events with lovastatin in men and women with average cholesterol levels: results of AFCAPS/TexCAPS. JAMA. 1998;279:1615–22.

Cohen JD. PREDICT study—results of a simulated study with OTC Pravachol. Paper presented at: Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics; March 24, 2002; Atlanta, Ga.

Tolman KG. Lovastatin hepatotoxicity revisited: much ado about nothing. Paper presented at: Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics; March 24, 2002; Atlanta, Ga.