Physician Care Particularly Important In Pediatric Statin Use – JAMA Editorial
This article was originally published in The Tan Sheet
Executive Summary
Familial hypercholesterolemia populations are not suitable targets for OTC statins, according to an editorial in the July 21 Journal of the American Medical Association
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Familial hypercholesterolemia populations are not suitable targets for OTC statins, according to an editorial in the July 21 Journal of the American Medical Association. "For a young adult with severe hypercholesterolemia, a physician's oversight is the wisest option," Antonio Gotto, MD, Cornell University, stresses. Nonprescription availability of cholesterol-lowering drugs in an "older, intermediate-risk population may be an appealing option," Grotto notes, although he observes that "data demonstrating the safety and efficacy of these agents come from clinical trials rather than from OTC-use studies." While Gotto supports OTC statin use in some instances, he maintains that "for the familial hypercholesterolemia community, OTC self-management seems sub-optimal" and says patients with this condition should seek a physician's care. The editorial responds to an accompanying study that evaluates the use of pravastatin 20 mg or 40 mg in children. Pravachol marketer Bristol-Myers Squibb funded the research. The double-blind, placebo-controlled trial included 214 children ages eight to 18 with familial hypercholesterolemia. Treatment dose was dependent on age; participants were encouraged to consume a fat-restricted diet and engage in regular physical activity. Albert Wiegman, MD/PhD, University of Amsterdam, et al., compared the intima-media thickness (IMT) of the subjects' carotid arteries as the primary outcome. "At the end of the two-year trial, all of the carotid artery wall segments showed a trend toward attenuation of IMT in the pravastatin group, while these segments exhibited a trend toward IMT increase in the placebo group," the investigators report. The difference between the groups was significant, they state. Wiegman et al. note that endocrine functions were comparable between the two groups, and determined that "the long-term tolerability of pravastatin was excellent in these children." They encourage further research on long-term safety and efficacy. |