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The ADMIT Study: A Randomized Trial

Marshall B. Elam, PhD, MD; Donald B. Hunninghake, MD; Kathryn B. Davis, PhD; Rekha Garg, MD, MS; Craig Johnson, MS; Debra Egan, MSc, MPH; John B. Kostis, MD; David S. Sheps, MD; Eliot A. Brinton, MD; for the ADMIT Investigators

JAMA. 2000;284:1263-1270.

Context  Although niacin increases low levels of high-density lipoprotein cholesterol (HDL-C), which frequently accompany diabetes, current guidelines do not recommend use of niacin in patients with diabetes because of concerns about adverse effects on glycemic control; however, this is based on limited clinical data.

Objective  To determine the efficacy and safety of lipid-modifying dosages of niacin in patients with diabetes.

Design and Setting  Prospective, randomized placebo-controlled clinical trial conducted in 6 clinical centers from August 1993 to December 1995.

Participants  A total of 468 participants, including 125 with diabetes, who had diagnosed peripheral arterial disease.

Interventions  After an active run-in period, participants were randomly assigned to receive niacin (crystalline nicotinic acid), 3000 mg/d or maximum tolerated dosage (n = 64 with diabetes; n = 173 without diabetes), or placebo (n = 61 with diabetes; n = 170 without diabetes) for up to 60 weeks (12-week active run-in and 48-week double-blind).

Main Outcome Measures  Plasma lipoprotein, glucose, hemoglobin A_1c (HbA_1c), alanine aminotransferase, and uric acid levels; hypoglycemic drug use; compliance; and adverse events, in patients with diabetes vs without who were receiving niacin vs placebo.

Results  Niacin use significantly increased HDL-C by 29% and 29% and decreased triglycerides by 23% and 28% and low-density lipoprotein cholesterol (LDL-C) by 8% and 9%, respectively, in participants with and without diabetes (P<.001 for niacin vs placebo for all). Corresponding changes in participants receiving placebo were increases of 0% and 2% in HDL-C and increases of 7% and 0% in triglycerides, and increases of 1% and 1% in LDL-C. Glucose levels were modestly increased by niacin (8.7 and 6.3 mg/dL [0.4 and 0.3 mmol/L]; P = .04 and P<.001) in participants with and without diabetes, respectively. Levels of HbA_1c were unchanged from baseline to follow-up in participants with diabetes treated with niacin. In participants with diabetes treated with placebo, HbA_1c decreased by 0.3% (P = .04 for difference). There were no significant differences in niacin discontinuation, niacin dosage, or hypoglycemic therapy in participants with diabetes assigned to niacin vs placebo.

Conclusions  Our study suggests that lipid-modifying dosages of niacin can be safely used in patients with diabetes and that niacin therapy may be considered as an alternative to statin drugs or fibrates for patients with diabetes in whom these agents are not tolerated or fail to sufficiently correct hypertriglyceridemia or low HDL-C levels.

Author Affiliations: University of Tennessee Health Science Center (Dr Elam), Memphis Veterans Affairs Medical Center (Dr Elam), Memphis, Tenn; University of Minnesota, Minneapolis (Dr Hunninghake); University of Washington (Dr Davis), Axio Research Corp (Dr Davis and Mr Johnson), Seattle, Wash; Division of Epidemiology and Clinical Applications, National Heart, Lung, and Blood Institute, Bethesda, Md (Dr Garg and Ms Egan); Robert Wood Johnson School of Medicine, Robert Wood Johnson University, New Brunswick, NJ (Dr Kostis); University of North Carolina, Chapel Hill (Dr Sheps); and Bowman Gray School of Medicine, Wake Forest University, Winston-Salem, NC (Dr Brinton).
Dr Garg is now with Eli Lilly Co; Dr Sheps is now with the University of Florida College of Medicine, Gainesville; and Dr Brinton is now with the University of Arizona College of Medicine, Tucson.

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