Hello. I'm Bret Stetka, Editorial Director at Medscape. Welcome to the F1000 Practice-Changing Minute, where we report commentaries from the Faculty of 1000 on highly rated studies that may change clinical practice.
Today's commentary covers the study "Effects of Extended-Release Niacin With Laropiprant in High-Risk Patients," by the HPS2-THRIVE Collaborative Group and published in the New England Journal of Medicine.[1] Our commentator has given this study a ranking of "Changes Clinical Practice," with the conclusion that extended-release niacin-laropiprant should no longer be given to statin-treated patients.
The following F1000 commentary is from Dr. Wilbert Aronow, Professor of Medicine in the Division of Cardiology at New York Medical College in Valhalla, New York.
Statins are the only lipid-lowering drugs that have been demonstrated to lower cardiovascular events and mortality in secondary prevention and primary prevention trials. The AIM-HIGH trial,[2] which included 3414 patients with stable coronary artery disease and a low serum high-density lipoprotein (HDL) level, was stopped by National Heart, Lung, and Blood Institute data and safety monitoring board at 3 years because the primary endpoint of myocardial infarction, ischemic stroke, death due to coronary artery disease, hospitalization for an acute coronary syndrome, or symptom-driven revascularization was 16.4% in patients randomly assigned to niacin vs. 16.2% in patients assigned to placebo, and because niacin non-significantly increased ischemic stroke by 61% (P = 0.11). On the basis of these data, I have not used niacin to treat patients with dyslipidemia. The present study randomly assigned 25,673 adults with vascular disease treated with simvastatin or simvastatin plus ezetimibe if needed as serum low-density lipoprotein (LDL) cholesterol-lowering therapy to 2 gm extended-release niacin and 40 mg laropiprant therapy or matching placebo. Median follow-up was 3.9 years. Compared with placebo, niacin reduced serum LDL cholesterol level by an average of 10 mg/dl, increased serum HDL cholesterol by an average of 6 mg/dl, and decreased serum triglycerides by an average of 33 mg/dl. The primary outcome of first major vascular event (nonfatal myocardial infarction, death from coronary artery disease, stroke, or arterial revascularization) was similar in both treatment groups. However, niacin was associated with a significant increase in serious adverse events. These data confirm that the use of niacin in statin-treated patients is not associated with a reduction in cardiovascular events but is associated with a significant increase in serious adverse events.
This concludes today's commentary from Dr. Aronow. For the F1000 Practice-Changing Minute, I am Bret Stetka. Thank you for listening.
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