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Long-term safety and efficacy of triple combination ezetimibe/simvastatin plus extended-release niacin in patients with hyperlipidemia.
Am J Cardiol. 2010 Feb 15; 105(4):487-94.AJ

Abstract

The safety and efficacy of combination ezetimibe/simvastatin (E/S) plus extended-release niacin was assessed in 942 patients with type IIa/IIb hyperlipidemia for 64 weeks in a randomized, double-blind study. Patients received E/S (10/20 mg) plus niacin (to 2 g) or E/S (10/20 mg) for 64 weeks, or niacin (to 2 g) for 24 weeks and then E/S (10/20 mg) plus niacin (2 g) or E/S (10/20 mg) for an additional 40 weeks. The primary end point, the safety of E/S plus niacin, included prespecified adverse events (ie, liver, muscle, discontinuations due to flushing, gallbladder-related, cholecystectomy, fasting glucose changes, new-onset diabetes). The secondary end points included the percentage of change from baseline in high-density lipoprotein (HDL) cholesterol, triglycerides, non-HDL cholesterol, and low-density lipoprotein cholesterol, other lipids, lipoprotein ratios and high-sensitivity C-reactive protein. The anticipated niacin-associated flushing led to a greater rate of study discontinuations with the E/S plus niacin regimen than with E/S alone (0.7%, p <0.001). The rate of liver and muscle adverse events was low (<1%) in both groups. Four patients had gallbladder-related adverse events; 1 patient in the E/S and 1 in the E/S plus niacin group underwent cholecystectomy. The occurrence of new-onset diabetes was 3.1% for the E/S and 4.9% for the E/S plus niacin group. The fasting glucose levels increased to greater than baseline during the first 12 weeks (E/S, 3.2 mg/dl; E/S plus niacin, 7.7 mg/dl) and gradually decreased to pretreatment levels by 64 weeks in both groups. E/S plus niacin significantly improved HDL cholesterol, triglycerides, non-HDL cholesterol, low-density lipoprotein cholesterol, apolipoprotein B and A-I, and lipoprotein ratios compared with E/S (p <or=0.004). The changes in high-sensitivity C-reactive protein were comparable for both groups. 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. E/S plus niacin provided a broad, lipid-altering therapeutic option for these patients, even in the presence of diabetes with glucose monitoring.

Authors+Show Affiliations

Division of Cardiovascular Medicine, Vanderbilt University, Nashville, Tennessee, USA. sergio.fazio@vanderbilt.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20152243

Citation

Fazio, Sergio, et al. "Long-term Safety and Efficacy of Triple Combination Ezetimibe/simvastatin Plus Extended-release Niacin in Patients With Hyperlipidemia." The American Journal of Cardiology, vol. 105, no. 4, 2010, pp. 487-94.
Fazio S, Guyton JR, Polis AB, et al. Long-term safety and efficacy of triple combination ezetimibe/simvastatin plus extended-release niacin in patients with hyperlipidemia. Am J Cardiol. 2010;105(4):487-94.
Fazio, S., Guyton, J. R., Polis, A. B., Adewale, A. J., Tomassini, J. E., Ryan, N. W., & Tershakovec, A. M. (2010). Long-term safety and efficacy of triple combination ezetimibe/simvastatin plus extended-release niacin in patients with hyperlipidemia. The American Journal of Cardiology, 105(4), 487-94. https://doi.org/10.1016/j.amjcard.2009.10.001
Fazio S, et al. Long-term Safety and Efficacy of Triple Combination Ezetimibe/simvastatin Plus Extended-release Niacin in Patients With Hyperlipidemia. Am J Cardiol. 2010 Feb 15;105(4):487-94. PubMed PMID: 20152243.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term safety and efficacy of triple combination ezetimibe/simvastatin plus extended-release niacin in patients with hyperlipidemia. AU - Fazio,Sergio, AU - Guyton,John R, AU - Polis,Adam B, AU - Adewale,Adeniyi J, AU - Tomassini,Joanne E, AU - Ryan,Nicholas W, AU - Tershakovec,Andrew M, Y1 - 2009/11/13/ PY - 2009/09/11/received PY - 2009/10/09/revised PY - 2009/10/09/accepted PY - 2010/2/16/entrez PY - 2010/2/16/pubmed PY - 2010/3/20/medline SP - 487 EP - 94 JF - The American journal of cardiology JO - Am. J. Cardiol. VL - 105 IS - 4 N2 - The safety and efficacy of combination ezetimibe/simvastatin (E/S) plus extended-release niacin was assessed in 942 patients with type IIa/IIb hyperlipidemia for 64 weeks in a randomized, double-blind study. Patients received E/S (10/20 mg) plus niacin (to 2 g) or E/S (10/20 mg) for 64 weeks, or niacin (to 2 g) for 24 weeks and then E/S (10/20 mg) plus niacin (2 g) or E/S (10/20 mg) for an additional 40 weeks. The primary end point, the safety of E/S plus niacin, included prespecified adverse events (ie, liver, muscle, discontinuations due to flushing, gallbladder-related, cholecystectomy, fasting glucose changes, new-onset diabetes). The secondary end points included the percentage of change from baseline in high-density lipoprotein (HDL) cholesterol, triglycerides, non-HDL cholesterol, and low-density lipoprotein cholesterol, other lipids, lipoprotein ratios and high-sensitivity C-reactive protein. The anticipated niacin-associated flushing led to a greater rate of study discontinuations with the E/S plus niacin regimen than with E/S alone (0.7%, p <0.001). The rate of liver and muscle adverse events was low (<1%) in both groups. Four patients had gallbladder-related adverse events; 1 patient in the E/S and 1 in the E/S plus niacin group underwent cholecystectomy. The occurrence of new-onset diabetes was 3.1% for the E/S and 4.9% for the E/S plus niacin group. The fasting glucose levels increased to greater than baseline during the first 12 weeks (E/S, 3.2 mg/dl; E/S plus niacin, 7.7 mg/dl) and gradually decreased to pretreatment levels by 64 weeks in both groups. E/S plus niacin significantly improved HDL cholesterol, triglycerides, non-HDL cholesterol, low-density lipoprotein cholesterol, apolipoprotein B and A-I, and lipoprotein ratios compared with E/S (p <or=0.004). The changes in high-sensitivity C-reactive protein were comparable for both groups. 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. E/S plus niacin provided a broad, lipid-altering therapeutic option for these patients, even in the presence of diabetes with glucose monitoring. SN - 1879-1913 UR - https://www.unboundmedicine.com/medline/citation/20152243/Long_term_safety_and_efficacy_of_triple_combination_ezetimibe/simvastatin_plus_extended_release_niacin_in_patients_with_hyperlipidemia_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-9149(09)02476-X DB - PRIME DP - Unbound Medicine ER -