Dulaglutide lowers erectile dysfunction risk in men with type 2 diabetes: Lancet
Canada: The long-term use of dulaglutide, a GLP-1 receptor agonist, may reduce the risk of severe erectile dysfunction in men with type 2 diabetes, show results from an analysis of the REWIND trial. The findings of which are published in The Lancet Diabetes & Endocrinology.
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 done at 371 sites in 24 countries.
About two-thirds of men with type 2 diabetes are affected by erectile dysfunction. In diabetic men, ED is 3·5-times more prevalent, has greater severity, and is less responsive to phosphodiesterase-5 (PDE5) inhibitors 2 than in men without diabetes.
Harpreet S Bajaj, LMC Diabetes & Endocrinology, Brampton, ON, Canada, and colleagues 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.
The study included men and women with type 2 diabetes and aged older than 50 years and had either a previous cardiovascular event or cardiovascular risk factors. They were randomly assigned in the ratio of 1:1 to receive either dulaglutide or placebo.
Participating men were made to complete the standardized International Index of Erectile Function (IIEF) questionnaire at baseline, 2 years, 5 years, and study end. The researchers did an exploratory analysis in which participants who completed a baseline and at least 1 follow-up IIEF questionnaire were included.
The primary outcome for these analyses was the first occurrence of moderate or severe erectile dysfunction following randomization, assessed by the erectile function subscores on IIEF. This analysis was part of the REWIND trial.
Key findings of the study include:
· Between Aug 18, 2011, and Aug 14, 2013, 3725 (70·1%) of 5312 male participants with a mean age of 65·5 years were analysed, of whom 1487 (39·9%) had a history of cardiovascular disease, and 2104 (56·5%) had moderate or severe erectile dysfunction at baseline.
· The incidence of erectile dysfunction following randomization was 21·3 per 100 person-years in the dulaglutide group and 22·0 per 100 person-years in the placebo group (HR 0·92).
· 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 0·61.
"Our findings suggest that long-term use of dulaglutide might reduce the incidence of moderate or severe erectile dysfunction in men with type 2 diabetes," concluded the authors.
The study titled, "Erectile function in men with type 2 diabetes treated with dulaglutide: an exploratory analysis of the REWIND placebo-controlled randomised trial," is published in the journal