medwireNews: Long-term dulaglutide use may reduce the incidence of moderate or severe erectile dysfunction in men with type 2 diabetes, particularly those with underlying cardiovascular disease (CVD), shows an exploratory analysis of REWIND data.
Writing in The Lancet Diabetes & Endocrinology, Hertzel Gerstein (McMaster University, Hamilton, Ontario, Canada) and co-authors say their findings reflect “the salutary vascular effects that were responsible for reducing cardiovascular outcomes, stroke, renal disease, and cognitive decline in the REWIND trial.”
“These salutary effects include dulaglutide’s effect on glucose, systolic blood pressure, and weight, and a possible direct effect on small vessels and endothelial function,” they add.
The analysis included data for 3725 male REWIND participants (mean age 65.5 years) with type 2 diabetes who completed the standardized International Index of Erectile Function questionnaire at baseline and at least one follow-up visit (2 years, 5 years, and study end).
The men were randomly assigned to receive either dulaglutide or placebo for the duration of the trial (up to 8 years). At baseline, 56.5% had moderate or severe erectile dysfunction (erectile function subscore ≤16) and 39.9% had a history of CVD.
During follow-up, moderate or severe erectile dysfunction was identified in 73.8% of men in the dulaglutide group and 75.7% of those in the placebo group. This corresponded to a significant 8% lower risk with dulaglutide and crude incidence rates of 21.3 versus 22.0 cases per 100 person–years, respectively.
The researchers also report that, after adjustment for baseline scores, men in the dulaglutide arm had a smaller reduction in erectile function subscore over time than those in the placebo arm, with the score falling by a mean 0.61 points less in the dulaglutide arm.
However, subgroup analyses indicated that the reduced risk for moderate or severe erectile dysfunction may be limited to men with a history of CVD. In this subgroup, dulaglutide use was associated with a significant 19% lower risk versus placebo whereas there was no significant risk difference in between the two treatment arms among the men with no CVD.
Gerstein et al note: “Clinical practice guidelines suggest that evidence for prevention of diabetes-related chronic consequence should be considered when choosing glucose lowering medications.”
They therefore believe their findings “suggest that erectile dysfunction, which is a common consequence of type 2 diabetes in men, should be included among these considerations.”
In an accompanying comment, Sten Madsbad, from Hvidovre Hospital in Copenhagen, Denmark says: “Although the finding in relation to the primary endpoint was statistically significant, the modest 8% reduction in hazard and the small absolute risk reduction plus absence of an effect when erectile dysfunction was defined as more sustained erectile dysfunction raise questions regarding the clinical significance in the overall study population.”
Nonetheless, he adds that the analysis provides “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.”
medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2021 Springer Healthcare Ltd, part of the Springer Nature Group
Lancet Diabetes Endocrinol 2021; doi:10.1016/S2213-8587(21)00115-7
Lancet Diabetes Endocrinol 2021; doi:10.1016/S2213-8587(21)00142-X