Abstract 15052: Cardiovascular Event Reduction Versus New-Onset Diabetes During Atorvastatin Therapy: Effect of Baseline Risk Factors for Diabetes

Abstract

Background: Statins reduce cardiovascular (CV) events but increase the incidence of new-onset diabetes (NOD). We previously reported that in each of 3 large randomized trials using atorvastatin 80 mg/day, 4 risk factors were independent predictors of NOD: baseline fasting glucose >100 mg/dl, fasting triglycerides >150 mg/dl, body-mass index >30 kg/m², and a history of hypertension. We sought to compare CV event reduction and NOD in 15,056 non-diabetic patients with coronary disease in the TNT (n=7,595) and IDEAL (n=7,461) trials.

Methods and Results: Patients were randomized to atorvastatin 80 vs 10 mg/day (TNT) or atorvastatin 80 vs simvastatin 20-40 mg/day (IDEAL) and followed for a median of 5 years in both trials. CV events included coronary heart disease death, myocardial infarction, stroke and resuscitated cardiac arrest. High-dose atorvastatin was associated with an increased odds of NOD among participants with 2-4 risk factors (OR 1.24, 95% CI 1.08-1.42, P=0.003), but not in those with 0-1 risk factors for NOD (OR 0.97, 95% CI 0.77-1.22, P=0.77), when compared with low-dose atorvastatin or simvastatin (Figure). In contrast, high-dose atorvastatin was associated with a decreased odds of CV events regardless of the number of NOD risk factors present (Figure). There was a suggestive interaction between treatment and risk factor group in the prediction of NOD (P=0.07).

Conclusion: Compared to low-dose statin therapy, treatment with atorvastatin 80 mg/day was not associated with an increased risk of NOD in patients with 0-1 NOD risk factors. Among patients with 2-4 NOD risk factors, atorvastatin 80 mg was associated with a 24% increase in NOD. CV events were significantly reduced with atorvastatin 80 mg regardless of NOD risk factors.