Efficacy and Safety of Flexible-Dose Vardenafil in Men with Type 1 Diabetes and Erectile Dysfunction

doi:10.1111/j.1743-6109.2006.00295.x

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Wiley InterScience

Journal of Sexual Medicine

Volume 3 Issue 5, Pages 883 - 891

Published Online: 21 Aug 2006

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ORIGINAL RESEARCH—ED PHARMACOTHERAPY

Efficacy and Safety of Flexible-Dose Vardenafil in Men with Type 1 Diabetes and Erectile Dysfunction

Dan Ziegler, FRCP,* Frank Merfort, MD, ^† Hermann van Ahlen, MD, ^‡ Aksam Yassin, MD, ^§ Tjark Reblin, MD, ^¶ and Marcus Neureither, MD**

*Deutsche Diabetes-Klinik, Deutsches-Diabetes–Zentrum, Leibniz-Institut an der Heinrich-Heine Universität, Düsseldorf, Germany; ^† Diabetologic Office, Grevenbroich, Germany; ^‡ Klinikum Osnabrück, Osnabrück, Germany; ^§ Office Norderstedt, Noderstedt, Germany; ^¶ GlaxoSmithKline, Munich, Germany; **Aachen, Germany

Correspondence to Tjark Reblin, MD, GlaxoSmithKline, 80339 Munich, Germany. Tel: +49 89 36044 8678; E-mail: tjark.reblin@gsk.com

KEYWORDS

Vardenafil • Type 1 Diabetes • Erectile Dysfunction • Glycemic Control • Oral Phosphodiesterase 5 Inhibitor • Clinical Trial

ABSTRACT

Introduction. Erectile dysfunction (ED) affects up to 70% of men with diabetes, occurring with a higher prevalence in those with type 1 diabetes than with type 2 diabetes. Studies investigating treatment of ED in men with diabetes have largely been conducted in a total male population with diabetes. Limited data are available on the efficacy and safety of the potent oral phosphodiesterase-5 inhibitor vardenafil in men with ED and type 1 diabetes.

Aims. To evaluate the safety and efficacy of flexible-dose vardenafil therapy in a prospective randomized study in phosphodiesterase 5 inhibitor-naïve subjects with type 1 diabetes and ED.

Methods. In this multicenter, double-blind, placebo-controlled clinical trial, phosphodiesterase-5 inhibitor-naïve patients were randomized to receive placebo (N = 149) or flexible-dose (5–20 mg) (N = 153) vardenafil.

Main Outcome Measure. Sexual Encounter Profile diary questions 2 and 3, concerning success rates of vaginal insertion and maintenance of erection to allow successful intercourse, respectively.

Results. Vardenafil significantly improved mean success rates for Sexual Encounter Profile 2 and 3 compared with baseline and placebo at 4, 8, and 12 weeks (P < 0.0001, intention to treat and last observation carried forward). These rates were unaffected by stratification into distinct subsets according to the level of HbA_1c (HbA_1c < 7%, good glycemic control; HbA_1c >7–≤8%, moderate glycemic control; and HbA_1c > 8%, poor glycemic control). Vardenafil treatment also significantly improved the Erectile Function domain score (P < 0.0001) of the International Index of Erectile Function compared with placebo, in addition to scores for the other individual domains of the International Index of Erectile Function. The most commonly reported treatment-emergent adverse events were headache (3.1%) and flushing (2.5%), which were mild to moderate and transient in nature.

Conclusion. These data suggest that vardenafil significantly improves erectile function in men with type 1 diabetes and is well tolerated, regardless of the level of glycemic control. Ziegler D, Merfort F, van Ahlen H, Yassin A, Reblin T, and Neureither M. Efficacy and safety of flexible-dose vardenafil in men with type 1 diabetes and erectile dysfunction. J Sex Med 2006;3:883–891.

DIGITAL OBJECT IDENTIFIER (DOI)

10.1111/j.1743-6109.2006.00295.x About DOI