Efficacy and Safety of Dulaglutide in Older Patients: A Post-hoc Analysis of the REWIND trial.

CONTEXT Dulaglutide reduced major adverse cardiovascular events (MACE) in the REWIND Trial. Its efficacy and safety in older versus younger patients have not been explicitly analyzed. OBJECTIVE To assess efficacy and safety of dulaglutide versus placebo in REWIND by age subgroups (≥65 and <65 years). DESIGN Post-hoc subgroup analysis of the REWIND trial. SETTING Trial conducted at 371 sites in 24 countries. PATIENTS Type 2 diabetes patients aged ≥50 years with established CV disease or multiple CV risk factors, and a wide range of glycemic control. INTERVENTIONS Patients randomized (1:1) to dulaglutide 1.5 mg or placebo as add-on to country-specific standard of care.Main Outcome Measure: MACE (first occurrence of the composite of non-fatal myocardial infarction, non-fatal stroke, or death from CV or unknown causes). RESULTS 5,256 randomized patients were ≥65 years (mean=71.0) and 4645 were <65 years (mean=60.7). Baseline characteristics were similar in randomized treatment groups. Dulaglutide treatment showed a similar reduction in the incidence (11% vs 13%) of MACE in older versus younger patients. The rate of permanent study drug discontinuation, incidence of all-cause mortality, hospitalizations for heart failure, severe hypoglycemia, severe renal or urinary events, and serious gastrointestinal events were similar between randomized treatment groups within each age subgroup. The incidence rate of serious cardiac conduction disorders was numerically higher in the dulaglutide group compared to placebo within each age subgroup but the difference was not statistically significant. CONCLUSIONS Dulaglutide had similar efficacy and safety in REWIND in patients aged ≥65 years and those aged <65 years.