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Table 2 Characteristics of GLP-1RA trials [100, 135138]

From: GLP-1RAs in type 2 diabetes: mechanisms that underlie cardiovascular effects and overview of cardiovascular outcome data

  EXSCEL ELIXA LEADER SUSTAIN-6 HARMONY REWIND
GLP-1RA Exenatide Lixisenatide Liraglutide Semaglutide (SC) Albiglutide Dulaglutide
N 14,752 6068 9340 3297 9463 9901
Inclusion criteria T2DM
With prior cardiovascular events and/or with or without known cardiovascular risk factors
T2DM
Acute coronary event within 180 days prior to randomization
T2DM
Previous CVD or CKD
High risk CVD
T2DM
Previous CVD or CKD
High-risk CVD
T2DM
Previous CVD
High-risk CVD
T2DM
Previous CVD
High-risk CVD
Study design Phase 3/4 multicentre, randomised, double-blind, placebo-controlled, parallel-group; non-inferiority, superiority (hierarchical analysis) Multicentre, randomised, double-blind, placebo-controlled; non-inferiority, superiority Multicentre, double-blind, placebo-controlled; non-inferiority, superiority (hierarchical analysis) Multicentre, double-blind, placebo-controlled; non-inferiority, superiority testing was not part of the pre-specified analysis Multicentre, randomised, double-blind, placebo-controlled; non-inferiority, superiority testing was pre-specified Multicentre, randomised, double-blind, placebo-controlled; non-inferiority, superiority testing was pre-specified
Primary outcome 3-point MACE: cardiovascular death, non-fatal MI, non-fatal stroke 4-point MACE: cardiovascular death, non-fatal MI, non-fatal stroke, hospitalisation for unstable angina 3-point MACE: cardiovascular death, non-fatal MI, non-fatal stroke 3-point MACE: cardiovascular death, non-fatal MI, non-fatal stroke 3-point MACE: cardiovascular death, non-fatal MI, non-fatal stroke 3-point MACE: cardiovascular death, non-fatal MI, non-fatal stroke
Results Exenatide group: 11.4%
Placebo group: 12.2%
HR 0.91; 95% CI 0.83–1.00
P < 0.001 for non-inferiority, P = 0.06 for superiority
Lixisenatide group: 13.4%
Placebo group: 13.2%
HR 1.02; 95% CI 0.89–1.17
P < 0.001 for non-inferiority, P = 0.81 for superiority
Liraglutide group: 13.0%
Placebo group: 14.9%
HR 0.87; 95% CI 0.78–0.97
P < 0.001 for non-inferiority, P = 0.01 for superiority
Semaglutide group: 6.6%
Placebo group: 8.9%
HR 0.74; 95% CI 0.58–0.95
P < 0.001 for non-inferiority, P = 0.02 for superiority
Albiglutide group: 7.1%
Placebo group: 9.0%
HR 0.78; 95% CI 0.68–0.90
P < 0.001 for non-inferiority, P = 0.0006 for superiority
Preliminary results reported as a positive trial
Additional findings    Reduction in all-cause mortality in the liraglutide group (8.2% vs. 9.6% in placebo group; HR 0.85; 95% CI 0.74–0.97; P = 0.02)
Reduction in CV death in the liraglutide group (4.7% vs. 6.0% in the placebo group; HR 0.78; 95% CI 0.66–0.93; P = 0.007)
Reduction in nonfatal stroke:
Semaglutide group: 1.6%
Placebo group: 2.7%
HR 0.61; 95% CI, 0.38–0.99
P = 0.04
  
  1. CI, confidence interval; CKD, chronic kidney disease; CVD, cardiovascular disease; GLP-1RA, glucagon-like peptide-1 receptor agonist; HR, hazard ratio; MACE, major adverse cardiovascular event; SC, subcutaneous; T2DM, type 2 diabetes mellitus