Table I.
Randomized Controlled Clinical Trials Assessing the Effects of Lifestyle Modification and Pharmacologic Therapy With Antidiabetic and Lipid‐Lowering Drugs on Risk of NOD
| Study | Patient Population | Interventions a | Prespecified End Point? | Results |
|---|---|---|---|---|
| Lifestyle intervention | ||||
| Finnish Diabetes Prevention Study 6 | 522 obese patients (mean BMI, 31 kg/m2) with IGT (2‐hour post‐challenge glucose, 140–200 mg/dL) | Individual counseling to reduce weight and increase physical activity or placebo for 3.2 years | Yes | NOD developed in 11% of patients in the intervention group and 23% in the placebo group (RR, 0.40; 95% CI, 0.30–0.70; P<.001) |
| DPP 7 | 3234 nondiabetic obese patients (mean BMI, 34 kg/m2) with IFG (FPG, 95–125 mg/dL) and IGT (2‐hour post‐challenge glucose, 140–199 mg/dL) | Lifestyle intervention (goal of ≥7% weight loss and ≥150 min physical activity/wk); metformin (850 mg 2 times/d); or placebo for 2.8 years | Yes | 58% reduction in risk of NOD with lifestyle intervention vs placebo (RR, 0.42; 95% CI, 0.34–0.52; P<.001); 31% reduction in risk of NOD with metformin vs placebo (RR, 0.69; 95% CI, 0.57–0.83; P<.001) |
| Antidiabetic drugs | ||||
| STOP‐NIDDM 8 | 1368 patients with IGT (140–199 mg/dL) and IFG (FPG, 100–140 mg/dL) with no history of CVD events within the previous 6 months | Acarbose (100 mg 3 times/d) or placebo for 3.3 years | Yes | 25% reduction in risk of NOD with acarbose vs placebo (RR, 0.75; 95% CI, 0.63–0.90; P=.0015) |
| TRIPOD 9 | 266 Hispanic women with previous gestational diabetes | Troglitazone (100 mg/d) or placebo for 2.5 years (median) | Yes | 65% reduction in risk of NOD with troglitazone vs placebo (RR, 0.45; 95% CI, 0.25–0.83; P<.01) |
| DREAM 10 | 5269 patients with IFG (FPG, 110–124 mg/dL) and/or IGT (2‐hour post‐challenge glucose, 140–199 mg/dL) but without CVD or renal disease | Rosiglitazone (8 mg/d) or placebo for 3.0 years (median) | Yes | 62% reduction in risk of NOD with rosiglitazone vs placebo (RR, 0.38; 95% CI, 0.33–0.44; P<.0001); Reversion to normoglycemia in 50.5% of rosiglitazone group vs 30.3% of placebo group (RR, 1.71; 95% CI, 1.57–1.87; P<.001) |
| Lipid‐lowering drugs | ||||
| WOSCOPS 11 | 5974 nondiabetic men aged 45–64 years with dyslipidemia, normal renal function, and no history of MI, UA, or coronary revascularization | Pravastatin (40 mg/d) or placebo for 4.9 years | No | 30% reduction in risk of NOD with pravastatin vs placebo (RR, 0.70; 95% CI, 0.50–0.99; P=.042) |
| Heart Protection Study 12 | 14,573 patients with occlusive arterial disease without MI, stroke, or hospitalization for angina within 6 months, or substantially impaired renal function | Simvastatin (40 mg/d) or placebo for 5.0 years | Yes | 15% increase in risk of NOD with simvastatin vs placebo (RR, 1.15; 95% CI, 0.99–1.34; P=NS) |
| LIPID 13 | 6997 patients with dyslipidemia and MI or hospitalization for UA within 3 to 36 months | Pravastatin (40 mg/d) or placebo for 6 years | No | 11% reduction in risk of NOD with pravastatin vs placebo (RR, 0.89; 95% CI, 0.70–1.13; P=NS) |
| ASCOT‐LLA 14 | 19,342 hypertensive patients with ≥3 other CVD risk factors | Atorvastatin (10 mg/d) or placebo for 3.3 years (median) | Yes | 15% increase in risk of NOD with atorvastatin vs placebo (RR, 1.15; 95% CI, 0.91–1.44; P=NS) |
Abbreviations: ASCOT‐LLA, Anglo‐Scandinavian Cardiac Outcomes Trial–Lipid Lowering Arm; BMI, body mass index; CI, confidence interval; CVD, cardiovascular disease; DPP, Diabetes Prevention Program; DREAM, Diabetes Reduction Assessment With Ramipril and Rosiglitazone Medication; FPG, fasting plasma glucose; IFG, impaired fasting glucose; IGT, impaired glucose tolerance; LIPID, Long‐Term Intervention With Pravastatin in Ischemic Disease; MI, myocardial infarction; NS, not significant; NOD, new‐onset diabetes; RR, relative risk; STOP‐NIDDM, Study to Prevent Non–Insulin‐Dependent Diabetes Mellitus; TRIPOD, Troglitazone in Prevention of Diabetes; UA, unstable angina; WOSCOPS, West of Scotland Coronary Prevention Study. aMean years of follow‐up unless indicated.