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 (70·1%) of 5312 male participants with a mean age of 65·5 years (SD 6·4 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 randomisation 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, 95% CI 0·85–0·99, p=0·021). 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 (95% CI 0·18–1·05, p=0·006).

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.

中文翻译：

---

度拉糖肽治疗男性 2 型糖尿病患者的勃起功能：REWIND 安慰剂对照随机试验的探索性分析

背景

糖尿病是勃起功能障碍的主要危险因素，然而，GLP-1 受体激动剂对勃起功能障碍的影响尚不清楚。我们旨在评估与安慰剂相比，接受度拉糖肽治疗的男性勃起功能障碍的发生率、患病率和进展情况，并确定度拉糖肽对勃起功能障碍的影响是否与其对其他糖尿病相关结局的影响一致。

方法

糖尿病患者每周肠促胰岛素研究心血管事件 (REWIND) 试验是一项关于度拉糖肽对心血管结局影响的双盲、安慰剂对照随机试验。REWIND 在 24 个国家的 371 个站点完成。50 岁以上患有 2 型糖尿病的男性和女性，之前有心血管事件或心血管危险因素，被随机分配 (1:1) 接受度拉糖肽或安慰剂。参与的男性有机会在基线、2 年、5 年和研究结束时完成标准化的国际勃起功能指数 (IIEF) 问卷。我们进行了一项探索性分析，其中包括完成基线调查和至少 1 个后续 IIEF 调查问卷的参与者。这些分析的主要结果是随机化后首次出现中度或重度勃起功能障碍，通过 IIEF 的勃起功能子评分进行评估。该分析是 REWIND 试验的一部分，该试验在 ClinicalTrials.gov 注册，NCT01394952。

发现

2011 年 8 月 18 日至 2013 年 8 月 14 日期间，对 5312 名平均年龄为 65·5 岁（SD 6·4 岁）的男性参与者中的 3725 名（70·1%）进行了分析，其中 1487 名（39·9%） ) 有心血管疾病史，2104 (56·5%) 人在基线时有中度或重度勃起功能障碍。度拉糖肽组随机分组后勃起功能障碍的发生率为每 100 人年 21·3，安慰剂组为每 100 人年 22·0（HR 0·92，95% CI 0·85–0·99， p=0·021）。与安慰剂组相比，度拉糖肽组男性的勃起功能子评分下降幅度较小，最小二乘均差为 0·61（95% CI 0·18–1·05，p=0·006）。

解释

长期使用度拉糖肽可能会降低 2 型糖尿病男性中度或重度勃起功能障碍的发生率。

资金

礼来公司。