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Data from the REWIND trial suggests men receiving dulaglutide had an 8% lower risk for incident erectile dysfunction than their counterparts who were randomized to placebo therapy.
An exploratory analysis of data from the REWIND trial suggests use of dulaglutide could help reduce the incidence of erectile dysfunction in men with type 2 diabetes.
Results of the analysis, which was published in The Lancet Diabetes and Endocrinology, suggest use of dulaglutide was associated with an 8% reduction in the incidence of moderate to severe erectile dysfunction.
“These findings support the hypothesis that dulaglutide 4 reduced the incidence of moderate or severe erectile dysfunction in the REWIND trial and provide further support for its overall beneficial effect on the vasculature,” wrote investigators.
A randomized, double-blind, placebo-controlled, 12,133-person trial, REWIND was designed to assess the cardiovascular safety of dulaglutide in patient with type 2 diabetes. Randomizing patients in a 1:1 ratio to 1.5 mg dulaglutide once weekly or placebo, results of the study demonstrated dulaglutide was associated with a 12% reduction in risk of the primary composite outcome of cardiovascular death, MI, or stroke.
With erectile dysfunction a common condition among patients with type 2 diabetes, participants in the REWIND trial were offered the opportunity to complete the International Index of Erectile Function (IIEF) questionnaire at baseline, 2 years, 5 years, and conclusion of the study. Using this data, investigators sought to explore whether use of the GLP-1 RA impacted the incidence, prevalence, or progression of erectile dysfunction and whether these effects were consistent with its effects on other diabetes-related outcomes.
Of the 5312 male participants included in REWIND, 3725 were assessed in the current analyses. This group of men had a mean age of 65.5 (SD, 6.4) years, 39.9% had a history of cardiovascular disease, and 56.5% reported moderate or severe erectile dysfunction at baseline.
The crude incidence rate of moderate or severe erectile dysfunction was 21.3 per 100 person-years in the dulaglutide group compared to 22.0 per 100 person-years in the placebo group (HR, 0.92; 95% CI, 0.85-0.99; P=.021). Additionally, men in the dulaglutide arm of the trial had a lesser fall in erectile function subscore compared with those in the placebo arm, with a least-square mean difference of 0.61 (95% CI, 0.18-1.05; P=.006).
In a related comment, Sten Madsbad, MD, PhD, of the Department of Endocrinology at Hvidovre Hospital in Denmark, noted an important next step for research is to determine the mechanisms through which dulaglutide might reduce incidence of erectile dysfunction, but results of the current study were a positive addition to the current knowledge base surrounding erectile dysfunction in men with type 2 diabetes.
“Erectile dysfunction should be considered by physicians when choosing pharmacological treatment including glucose-lowering medications for men with type 2 diabetes. In their study, Bajaj and colleagues present new and useable information about the benefits of dulaglutide on the incidence of moderate or severe erectile dysfunction in men with type 2 diabetes, particularly for those with cardiovascular disease,” wrote Madsbad.
This study, “Erectile function in men with type 2 diabetes treated with dulaglutide: an exploratory analysis of the REWIND placebo-controlled randomised trial,” was published in The Lancet Diabetes and Endocrinology.