Ezetimibe vs. niacin added to statins for secondary prevention of CAD

Penelitian ini membandingkan efektivitas NIACIN vs EZETIMIBE dalam hal meningkatkan kadar kolesterol HDL dan menurunkan kadar kolesterol LDL serta perbedaan rerata ketebalan carotid intima media setelah 14 bulan intervensi pada pasien yang mendapatkan preparat statin.

 

Hasilnya pada kelompok niacin terjadi peningkatan HDL, penurunan LDL dan trigliserida secara signifikan. Kelompok ezetimibe terjadi penurunan HDL, LDL dan trigliserida. Dalam hal ketebalan carotid intima media niacin lebih unggul.

Anehnya pada kelompok ezetimibe penurunan LDL berhubungan signifikan dengan penebalan carotid intima media (R=–0.31, P<0.001).

Insiden kejadian kardiovaskuler mayor pada kelompok niacin lebih rendah dibanding kelompok ezetimibe (1% vs. 5%, P=0.04 by the chi-square test).

 

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N Engl J Med 361(22):2113-2122, 26 November 2009. © 2009 to the Massachusetts Medical Society
Extended-Release Niacin or Ezetimibe and Carotid Intima-Media Thickness. Allen J. Taylor, Todd C. Villines, Eric J. Stanek, et al. 

ABSTRACT

Background Treatment added to statin monotherapy to further modify the lipid profile may include combination therapy to either raise the high-density lipoprotein (HDL) cholesterol level or further lower the low-density lipoprotein (LDL) cholesterol level.

Methods We enrolled patients who had coronary heart disease or a coronary heart disease risk equivalent, who were receiving long-term statin therapy, and in whom an LDL cholesterol level under 100 mg per deciliter (2.6 mmol per liter) and an HDL cholesterol level under 50 mg per deciliter for men or 55 mg per deciliter for women (1.3 or 1.4 mmol per liter, respectively) had been achieved. The patients were randomly assigned to receive extended-release niacin (target dose, 2000 mg per day) or ezetimibe (10 mg per day). The primary end point was the between-group difference in the change from baseline in the mean common carotid intima–media thickness after 14 months. The trial was terminated early, on the basis of efficacy, according to a prespecified analysisconducted after 208 patients had completed the trial.

Results The mean HDL cholesterol level in the niacin group increased by 18.4% over the 14-month study period, to 50 mg per deciliter (P<0.001), and the mean LDL cholesterol level in the ezetimibe group decreased by 19.2%, to 66 mg per deciliter (1.7 mmol per liter) (P<0.001). Niacin therapy significantly reduced LDL cholesterol and triglyceride levels; ezetimibe reduced the HDL cholesterol and triglyceride levels. As compared with ezetimibe,niacin had greater efficacy regarding the change in mean carotid intima–media thickness over 14 months (P=0.003), leading to significant reduction of both mean (P=0.001) and maximal carotid intima–media thickness (P0.001 for all comparisons). Paradoxically, greater reductions in the LDL cholesterol level in association with ezetimibe were significantly associated with an increase in the carotid intima–media thickness (R=–0.31, P<0.001). The incidence of major cardiovascular events was lower in the niacin group than in the ezetimibe group (1% vs. 5%, P=0.04 by the chi-square test).

Conclusions This comparative-effectiveness trial shows that the use of extended-release niacin causes a significant regression of carotid intima–media thickness when combined with a statin and that niacin is superior to ezetimibe.