FRIDAY, Feb. 26 (HealthDay News) -- The triple combination therapy of ezetimibe/simvastatin (E/S) plus niacin safely improves several lipoprotein parameters better than E/S alone, according to a study in the Feb. 15 American Journal of Cardiology.
Sergio Fazio, M.D., of Vanderbilt University in Nashville, Tenn., and colleagues randomized patients with hyperlipidemia to either niacin, E/S, or E/S plus niacin. After 24 weeks, patients taking E/S and E/S plus niacin continued those therapies, while those taking niacin were switched to E/S alone or E/S plus niacin for 40 more weeks. Study end points included changes in total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), non-high-density lipoproteins (non-HDL), triglycerides, and adverse events (AEs).
The researchers found that E/S plus niacin and E/S alone reduced total cholesterol comparably (35.4 and 34.0 percent, respectively). However, E/S plus niacin improved constituent lipid levels compared to E/S: for HDL, 30.5 and 9.0 percent, respectively; for LDL, 54.0 and 49.3 percent; for non-HDL, 52.4 and 45.1 percent; and for triglycerides, 44.5 and 26.8 percent. Four patients experienced gall bladder AEs, two had cholecystectomy, and the incidence of new diabetes was 3.1 percent in the E/S group and 4.9 percent in the E/S plus niacin group. The authors note that the most common cause of discontinuation was flushing.
"In conclusion, the combination of E/S plus niacin was generally well tolerated, aside from niacin-associated flushing, and was significantly superior to E/S alone in improving several lipoprotein parameters during a 64-week trial in patients with hyperlipidemia," the authors write.
Merck/Schering-Plough Pharmaceuticals Inc. funded the study, and five authors reported being employees of Merck and holding stock and stock options in the company. Also, several authors reported financial relationships with various pharmaceutical companies.
Sergio Fazio, M.D., of Vanderbilt University in Nashville, Tenn., and colleagues randomized patients with hyperlipidemia to either niacin, E/S, or E/S plus niacin. After 24 weeks, patients taking E/S and E/S plus niacin continued those therapies, while those taking niacin were switched to E/S alone or E/S plus niacin for 40 more weeks. Study end points included changes in total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), non-high-density lipoproteins (non-HDL), triglycerides, and adverse events (AEs).
The researchers found that E/S plus niacin and E/S alone reduced total cholesterol comparably (35.4 and 34.0 percent, respectively). However, E/S plus niacin improved constituent lipid levels compared to E/S: for HDL, 30.5 and 9.0 percent, respectively; for LDL, 54.0 and 49.3 percent; for non-HDL, 52.4 and 45.1 percent; and for triglycerides, 44.5 and 26.8 percent. Four patients experienced gall bladder AEs, two had cholecystectomy, and the incidence of new diabetes was 3.1 percent in the E/S group and 4.9 percent in the E/S plus niacin group. The authors note that the most common cause of discontinuation was flushing.
"In conclusion, the combination of E/S plus niacin was generally well tolerated, aside from niacin-associated flushing, and was significantly superior to E/S alone in improving several lipoprotein parameters during a 64-week trial in patients with hyperlipidemia," the authors write.
Merck/Schering-Plough Pharmaceuticals Inc. funded the study, and five authors reported being employees of Merck and holding stock and stock options in the company. Also, several authors reported financial relationships with various pharmaceutical companies.
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