Cardiovascular safety for once-weekly dulaglutide in type 2 diabetes: a pre-specified meta-analysis of prospectively adjudicated cardiovascular events

Table 5 Time-to-event analysis of other cardiovascular (CV) endpoints—all randomized patients (ITT population)

Endpoint component	All comparators (N = 2125) n (%)	All dulaglutide (N = 3885) n (%)	HR^a Est. (95 % CI)	p value^a
All cause mortality	8 (0.38)	7 (0.18)	0.50 (0.18, 1.38)	0.181
3-Component MACE endpoint^b	21 (0.99)	23 (0.59)	0.60 (0.33, 1.08)	0.090
6-Component MACE endpoint^c	37 (1.74)	39 (1.00)	0.57 (0.37, 0.90)	0.016
Heart failure requiring hospitalization	2 (0.09)	7 (0.18)	2.02 (0.41, 9.88)	0.378
Coronary revascularization	16 (0.75)	13 (0.33)	0.44 (0.21, 0.92)	0.029
Percutaneous coronary intervention	14 (0.66)	11 (0.28)	0.43 (0.19, 0.95)	0.036
Coronary artery bypass grafting	2 (0.09)	2 (0.05)

AWARD Assessment of Weekly AdministrRation of LY2189265 (dulaglutide) in Diabetes, CV cardioavascular, HR Est estimated hazard ratio, MACE major adverse CV event, MI myocardial infarction
^aCalculated from a stratified Cox Proportional Hazards regression model: response = treatment. Strata = studies. All Phase 2 studies form one stratum, AWARD-3 and AWARD-5 form one stratum. When the total number of outcomes is <10, survival analysis is not performed. Instead when the total number of outcomes is <10 and ≥5, Mantel–Haenszel odds ratio and p value by Cochran–Mantel–Haenszel test are reported; When the total number of outcomes is <5, ratio and p-value are not reported
^bComposite endpoint of death from CV causes, nonfatal MI, or nonfatal stroke
^cComposite endpoint of death from CV causes, nonfatal MI, nonfatal stroke, hospitalization for unstable angina, coronary revascularization, or heart failure requiring hospitalization

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