We sought to examine the incidence and clinical predictors of new-onset type 2 diabetes
mellitus (T2DM) within 3 large randomized trials with atorvastatin.
Statin therapy might modestly increase the risk of new-onset T2DM.
We used a standard definition of diabetes and excluded patients with prevalent diabetes
at baseline. We identified baseline predictors of new-onset T2DM and compared the
event rates in patients with and without new-onset T2DM.
In the TNT (Treating to New Targets) trial, 351 of 3,798 patients randomized to 80
mg of atorvastatin and 308 of 3,797 randomized to 10 mg developed new-onset T2DM (9.24%
vs. 8.11%, adjusted hazard ratio [HR]: 1.10, 95% confidence interval [CI]: 0.94 to
1.29, p = 0.226). In the IDEAL (Incremental Decrease in End Points Through Aggressive
Lipid Lowering) trial, 239 of 3,737 patients randomized to atorvastatin 80 mg/day
and 208 of 3,724 patients randomized to simvastatin 20 mg/day developed new-onset
T2DM (6.40% vs. 5.59%, adjusted HR: 1.19, 95% CI: 0.98 to 1.43, p = 0.072). In the
SPARCL (Stroke Prevention by Aggressive Reduction in Cholesterol Levels) trial, new-onset
T2DM developed in 166 of 1,905 patients randomized to atorvastatin 80 mg/day and in
115 of 1,898 patients in the placebo group (8.71% vs. 6.06%, adjusted HR: 1.37, 95%
CI: 1.08 to 1.75, p = 0.011). In each of the 3 trials, baseline fasting blood glucose,
body mass index, hypertension, and fasting triglycerides were independent predictors
of new-onset T2DM. Across the 3 trials, major cardiovascular events occurred in 11.3%
of patients with and 10.8% of patients without new-onset T2DM (adjusted HR: 1.02,
95% CI: 0.77 to 1.35, p = 0.69).
High-dose atorvastatin treatment compared with placebo in the SPARCL trial is associated
with a slightly increased risk of new-onset T2DM. Baseline fasting glucose level and
features of the metabolic syndrome are predictive of new-onset T2DM across the 3 trials.
Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier
Inc. All rights reserved.