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

Table 4 Time-to-event analysis of the primary cardiovascular (CV) endpoint and individual components—all randomized patients (ITT population)

Endpoint component	All comparators (N = 2125) n (%)	All dulaglutide (N = 3885) n (%)	HR^a (adj. 98.02 % CI)	p value^a
Primary 4-component MACE endpoint	25 (1.18)	26 (0.67)	0.57 (0.30, 1.10)	0.046
Death from CV causes^b	5 (0.24)	3 (0.08)	0.35 (0.07, 1.87)	0.119
Nonfatal MI	14 (0.66)	9 (0.23)	0.35 (0.13, 0.95)	0.014
Nonfatal stroke	4 (0.19)	12 (0.31)	1.61 (0.42, 6.20)	0.411
Hospitalization for unstable angina	6 (0.28)	3 (0.08)	0.28 (0.05, 1.46)	0.054
Exposure (event specific person-years follow-up)	2211.31	3926.90	–	–
Incidence rate per 100 person-years	1.13	0.66	–	–

AWARD Assessment of Weekly AdministrRation of LY2189265 (dulaglutide) in Diabetes, CV cardioavascular, HR 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 formed one stratum, AWARD-3 and AWARD-5 formed one stratum. 2-sided p value to be compared to an alpha level of 0.0198 for test of superiority
^bDeath from CV causes is defined as a death resulting from an acute MI, sudden cardiac death, death due to heart failure, death due to stroke, and death due to other CV causes

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