Table 2.
Randomized controlled trials of anti-hyperglycemic medications and cardiovascular outcomes
| ORIGIN | UGDP | NAVIGATOR | UKPDS 34 | STOP-NIDDM | RECORD | PROactive | EXAMINE | SAVOR- TIMI 53 |
|
|---|---|---|---|---|---|---|---|---|---|
| Drug assessed |
Insulin glargine |
Tolbutamide | Nateglinide | Metformin | Acarbose | Rosiglitazone | Pioglitazone | Alogliptin | Saxagliptin |
| Patient population |
N=12,537 IFG, IGT, T2DM + CV risk factors |
N= 823 newly diagnosed T2DM |
N=9,306 IGT + CVD or CV risk factors |
N=1,704 Newly diagnosed T2DM + obese |
N=1,368 IGT |
N= 4,447 T2DM on metformin or SU |
N=5,238 T2DM + macrovascular disease |
N=2701 T2DM + previous ACS |
N=16,492 T2DM + CVD or high CV risk |
| Primary outcome |
Composite: Nonfatal MI, nonfatal stroke, or death from CV causes |
CV death, all-cause mortality |
Composite: death from CV causes, nonfatal MI, nonfatal stroke, or hospitalization for CHF |
All-cause mortality |
Composite: coronary heart disease, CV death, congestive heart failure, cerebrovascular event, and peripheral vascular disease |
CV death/CV hospitalization, MI, CV death |
Composite: Death, MI, Stroke, ACS, vascular intervention, amputation |
Composite: Death from CV causes, nonfatal MI, or nonfatal stroke. |
Composite: CV death, MI, or ischemic stroke |
| Follow up | 6.2 years | 5 years | 5 years | 10.7 years | 3.3 years | 5.5 years | 2.9 years | 3.3 years | 2.1 years |
| Results | Composite: 1.02 (95% CI 0.94- 1.11) |
CV death: 12.7% TOL vs. 4.9% PLB All-cause mortality: 14.7% TOL vs. 10.2 PLB |
Composite: 0.94 (95% CI 0.82-1.09) |
All-cause mortality: 36% RRR vs. conventional therapy |
Composite: 0.51 (95% CI 0.28-0.95) |
CV death/CV hospitalization:0.99 (95% CI 0.85-1.16) MI: 1.14 (95% CI 0.80-1.63) CV death: 0.84 (95% CI 0.59-1.18) |
Composite: 0.90 (95% CI 0.80-1.02) |
Composite: 0.96; upper boundary of the one-sided repeated confidence interval, 1.16; p<0.001 for noninferiority |
Composite: 1.00(95% CI 0.89 - 1.12) |
Legend: All results are hazard ratios/95% confidence intervals unless otherwise noted. Abbreviations: IFG=impaired fasting glucose, IGT=impaired glucose tolerance, T2DM=type 2 diabetes, CV=cardiovascular, MI=myocardial infarction, CI=confidence intervals, TOL=tolbutamide, PLB=placebo, CVD=cardiovascular disease, CHF=congestive heart failure, SU=sulfonylurea, RRR=relative risk reduction, ACS=acute coronary syndromes.