Table 1.

Rates of the Primary Composite Outcome and Key Secondary Outcomes.^*

Outcome	Exenatide (N = 7356)		Placebo (N = 7396)		Hazard Ratio (95% CI)†
	Patients with Event	Incidence Rate of First Event	Patients with Event	Incidence Rate of First Event
	no. (%)	no. of events/100 patient-yr	no. (%)	no. of events/100 patient-yr
Primary composite outcome	839 (11.4)	3.7	905 (12.2)	4.0	0.91 (0.83–1.00)
Secondary outcomes
Death from any cause	507 (6.9)	2.0	584 (7.9)	2.3	0.86 (0.77–0.97)
Death from cardiovascular causes‡	340 (4.6)	1.4	383 (5.2)	1.5	0.88 (0.76–1.02)
Fatal or nonfatal myocardial infarction	483 (6.6)	2.1	493 (6.7)	2.1	0.97 (0.85–1.10)
Fatal myocardial infarction§	17 (0.2)	—	13 (0.2)	—	1.29 (0.63–2.66)
Fatal or nonfatal stroke	187 (2.5)	0.8	218 (2.9)	0.9	0.85 (0.70–1.03)
Fatal stroke§	18 (0.2)	—	25 (0.3)	—	0.71 (0.39–1.30)
Hospitalization for heart failure	219 (3.0)	0.9	231 (3.1)	1.0	0.94 (0.78–1.13)
Hospitalization for acute coronary syndrome	602 (8.2)	2.6	570 (7.7)	2.5	1.05 (0.94–1.18)

^*The primary outcome was the first occurrence of any component of the composite outcome of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, in a time-to-event analysis. This analysis was conducted in the intention-to-treat population, which consisted of all patients who underwent randomization.

^†Hazard ratios (exenatide vs. placebo) and confidence intervals were estimated with the use of a Cox proportional-hazards regression model, stratified according to history of cardiovascular disease, with trial regimen as the sole explanatory variable.

^‡Death from cardiovascular causes includes death from unknown cause.

^§The incidence rate was not calculated because this outcome was not prespecified in the statistical analysis plan as a trial outcome.