Harpreet S Bajaj1, Hertzel C Gerstein2, Purnima Rao-Melacini3, Jan Basile4, Helen Colhoun5, Ignacio Conget6, William C Cushman7, Gilles R Dagenais8, Edward Franek9, Markolf Hanefeld10, Matyas Keltai11, Mark Lakshmanan12, Fernando Lanas13, Lawrence A Leiter14, Patricio Lopez-Jaramillo15, Valdis Pirags16, Nana Pogosova17, Jeffrey Probstfield18, Peter Raubenheimer19, Lars Ryden20, Jonathan E Shaw21, Wayne H-H Sheu22, Denis Xavier23. 1. LMC Diabetes & Endocrinology, Brampton, ON, Canada. 2. Population Health Research Institute, McMaster University Medical Centre-Hamilton Health Sciences, Hamilton, ON, Canada. Electronic address: gerstein@mcmaster.ca. 3. Population Health Research Institute, McMaster University Medical Centre-Hamilton Health Sciences, Hamilton, ON, Canada. 4. Ralph H Johnson VA Medical Center, Medical University of South Carolina, Charleston, SC, USA. 5. Medical Informatics and Epidemiology, Institute of Genetics and Molecular Medicine, University of Edinburgh, Edinburgh, UK. 6. Endocrinology and Nutrition Department, University of Barcelona, Barcelona, Spain. 7. Preventive Medicine and Medicine, University of Tennessee Health Science Center, Memphis, TN, USA. 8. Clinical Research Center, Laval University, Quebec Heart and Lung Institute, Quebec City, QC, Canada. 9. Mossakowski Clinical Research Centre, Polish Academy of Sciences, Warsaw, Poland. 10. Department of Internal Medicine, Dresden Technical University, Dresden, Germany. 11. Hungarian Institute of Cardiology, Semmelweis University, Budapest, Hungary. 12. Eli Lilly and Company, Indianapolis, IN, USA. 13. Department of Internal Medicine, Universidad de La Fontera, Temuco, Chile. 14. Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, ON, Canada. 15. Masira Research Institute, Medical School, Universidad de Santander, Bucaramanga, Colombia. 16. Department of Internal Medicine, University of Latvia, Riga, Latvia. 17. National Medical Research Center of Cardiology, Moscow, Russia. 18. Department of Medicine, University of Washington, Seattle, WA, USA. 19. Department of Medicine, University of Cape Town, Cape Town, South Africa. 20. Department of Medicine, Karolinska University, Solna, Sweden. 21. Baker Heart and Diabetes Institute, Melbourne, VIC, Australia. 22. Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan. 23. St John's Medical College, St John's National Academy of Health Sciences, Bangalore, India.
Abstract
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 withplacebo, 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.
RCT Entities:
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.
Authors: Giuseppe Defeudis; Alfonso Maria Di Tommaso; Claudia Di Rosa; Danilo Cimadomo; Yeganeh Manon Khazrai; Antongiulio Faggiano; Raffaele Ivan Cincione; Nicola Napoli; Rossella Mazzilli Journal: J Clin Med Date: 2022-06-13 Impact factor: 4.964
Authors: Haifa Maalmi; Christian Herder; Gidon J Bönhof; Klaus Strassburger; Oana-Patricia Zaharia; Wolfgang Rathmann; Volker Burkart; Julia Szendroedi; Michael Roden; Dan Ziegler Journal: Diabetologia Date: 2021-11-20 Impact factor: 10.460