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Table 3 Incidence rates and exposure-adjusted incidence rates for primary MACE and secondary CV endpoints

From: Cardiovascular safety of exenatide BID: an integrated analysis from controlled clinical trials in participants with type 2 diabetes

 

Primary MACE Endpoint

Secondary MACE Endpoint

 

Exenatide

(N = 2,316)

Pooled Comparator

(N = 1,629)

Exenatide

(N = 2,316)

Pooled Comparator

(N = 1,629)

Primary Analyses

    

Incidence (n)

20

18

46

42

Incidence (n/N)

0.009

0.011

0.020

0.026

   RR (95% CI)

0.70 (0.38, 1.31)

0.69 (0.46, 1.03)

Secondary Analysis

    

EAIR (per 1,000 years)

18.73

23.17

43.37

54.37

   RR (95% CI)

0.81 (0.43, 1.53)

0.80 (0.53, 1.21)

Event Rate (per 1,000 years)

22.40

28.21

54.13

66.67

   RR (95% CI)

0.79 (0.45, 1.42)

0.81 (0.56, 1.18)

  1. CI = confidence interval; CV = cardiovascular; EAIR = exposure-adjusted incidence rate; MACE = major adverse cardiovascular events; RR = risk ratio
  2. RR for the incidence was calculated using the Mantel-Haenszel estimate with study as a stratification factor
  3. EAIR and event rate were calculated based on the Exact method, with corresponding RR calculated using the log-normal approximation