Background Diabetes is a major risk factor for erectile dysfunction, however, the
effect of GLP-1 receptor agonists on erectile dysfunction is unknown. We aimed to
assess the incidence, prevalence, and progression of erectile dysfunction in men treated
with dulaglutide compared with placebo, and to determine whether dulaglutide's effect
on erectile dysfunction was consistent with its effect on other diabetes-related outcomes.
Methods The Researching Cardiovascular Events with a Weekly Incretin in Diabetes (REWIND)
trial was a double-blind, placebo-controlled randomised trial of the effect of dulaglutide
on cardiovascular outcomes. REWIND was done at 371 sites in 24 countries. Men and
women aged older than 50 years with type 2 diabetes, who had either a previous cardiovascular
event or cardiovascular risk factors, were randomly assigned (1:1) to receive either
dulaglutide or placebo. Participating men were offered the opportunity to complete
the standardised International Index of Erectile Function (IIEF) questionnaire at
baseline, 2 years, 5 years, and study end. We did an exploratory analysis, in which
we included participants who completed a baseline and at least 1 follow-up IIEF questionnaire.
The primary outcome for these analyses was the first occurrence of moderate or severe
erectile dysfunction following randomisation, assessed by the erectile function subscores
on IIEF. This analysis was part of the REWIND trial, which is registered with ClinicalTrials.
gov, NCT01394952. Findings Between Aug 18, 2011, and Aug 14, 2013, 3725 (70middot1%)
of 5312 male participants with a mean age of 65middot5 years (SD 6middot4 years) were
analysed, of whom 1487 (39middot9%) had a history of cardiovascular disease, and 2104
(56middot5%) had moderate or severe erectile dysfunction at baseline. The incidence
of erectile dysfunction following randomisation was 21middot3 per 100 person-years
in the dulaglutide group and 22middot0 per 100 person-years in the placebo group (HR
0middot92, 95% CI 0middot85-0middot99, p=0middot021). Men in the dulaglutide group
also had a lesser fall in erectile function subscore compared with the placebo group,
with a least square mean difference of 0middot61 (95% CI 0middot18-1middot05, p=0middot006).
Interpretation Long-term use of dulaglutide might reduce the incidence of moderate
or severe erectile dysfunction in men with type 2 diabetes. Funding Eli Lilly and
Company. Copyright (c) 2021 Elsevier Ltd. All rights reserved.
