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Table 1 Trial design

From: Heterogeneity amongst GLP-1 RA cardiovascular outcome trials results: can definition of established cardiovascular disease be the missing link?

  ELIXA [21] LEADER [23] SUSTAIN-6 [25] EXSCEL [26] Harmony Outcomes [29] PIONEER 6 [31] REWIND [33]
NCT number NCT01147250 NCT01179048 NCT01720446 NCT01144338 NCT02465515 NCT02692716 NCT01394952
Drug Lixisenatide Liraglutide Semaglutide Exenatide Albiglutide Semaglutide Dulaglutide
Posology Daily Subcutaneous Daily Subcutaneous Once-weekly Subcutaneous Once-weekly Subcutaneous Once-weekly Subcutaneous Daily
Oral
Once-weekly
Subcutaneous
Trial phase III (pre-approval) IIIb (post-approval) III (pre-approval) III/IV (post-approval) IV (post-approval) III (pre-approval) III/IV (post-approval)
Primary analysis Non-inferiority (upper range of the two-sided 96% CI < 1.3) Non-inferiority (upper range of the two-sided 95% CI < 1.3) Non-inferiority (upper limit of the 95% CI  < 1.8) Superiority (upper limit of the 95% CI is < 1.00) Non-inferiority (upper range of the two-sided 95% CI < 1.3) Non-inferiority (upper limit of the 95% CI
 < 1.8)
Superiority
Primary outcome 4-point MACE: CV death, MI, stroke, or hospitalization for UA 3-point MACE: CV death, MI, or stroke 3-point MACE: CV death, MI, or stroke 3-point MACE: CV death, MI, or stroke 3-point MACE: CV death, MI, or stroke 3-point MACE:
CV death, MI, or stroke
3-point MACE:
CV death, MI, or stroke
  1. CI confidence interval, CV cardiovascular, MACE major adverse cardiovascular outcome, MI myocardial infarction, UA unstable angina