Effect of Extended-Release Niacin on New-Onset Diabetes Among Hyperlipidemic Patients Treated With Ezetimibe/Simvastatin in a Randomized Controlled Trial
- John R. Guyton, MD1⇓,
- Sergio Fazio, MD, PHD2,
- Adeniyi J. Adewale, PHD3,
- Erin Jensen, MS3,
- Joanne E. Tomassini, PHD3,
- Arvind Shah, PHD3 and
- Andrew M. Tershakovec, MD, MPH3
- 1Department of Medicine, Division of Endocrinology, Duke University, Durham, North Carolina
- 2Division of Cardiovascular Medicine, Vanderbilt University Medical Center, Nashville, Tennessee
- 3Merck Sharp and Dohme Corporation, Whitehouse Station, New Jersey
- Corresponding author: John R. Guyton, .
OBJECTIVE To determine the effect of niacin on fasting glucose (FG) and new-onset diabetes in statin/ezetimibe-treated patients.
RESEARCH DESIGN AND METHODS Prespecified secondary analysis among 942 hyperlipidemic patients randomized to ezetimibe/simvastatin (E/S; 10/20 mg) or E/S + extended-release niacin (N; titrated to 2 g) over 64 weeks.
RESULTS FG levels peaked by 8–12 weeks, then declined even without antidiabetic medication. At 64 weeks, 3.5% taking E/S+N versus 2.6% taking E/S met criteria for new-onset diabetes (P = 0.66). An additional 1.4% taking E/S+N versus 0.4% taking E/S transiently met criteria for diabetes and then remitted (P = 0.46). Of 28 new-diabetes diagnoses in the E/S+N group, 25 occurred by 24 weeks. Among patients with baseline diabetes, 13.9% taking E/S+N and 11.6% taking E/S underwent antidiabetic treatment modification.
CONCLUSIONS Increased FG and new-onset diabetes with E/S+N occurred mainly around the time of initial uptitration of N and often improved or remitted without specific treatment.
- Received July 20, 2011.
- Accepted December 19, 2011.
- © 2012 by the American Diabetes Association.
Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/licenses/by-nc-nd/3.0/ for details.