Vardenafil Allows Successful Intercourse initiated Rapidly after Dosing in Japanese Patients with Diabetes Mellitus and Erectile Dysfunction |
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| Authors: | Koichi Nagao Hideyuki Kobayashi Keita Fujikawa Takashi Tachibana Yasuhiko Iwamoto Nobuhisa Ishii Paul J. Turek William O. Brant Sadao Kamidono |
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| Affiliation: | 2. Bayer Yakuhin Ltd—Product Development Division, Osaka, Japan;3. Tokyo Women''s Medical University—Diabetes Center, Tokyo, Japan;4. The Turek Clinic—San Francisco, CA, USA;5. University of Utah—Department of Surgery (Urology), Salt Lake City, UT, USA;1. Université Paris-Diderot, Sorbonne Paris Cité, Paris, France;2. INSERM U-698, Paris, France;3. Département Hospitalo-Universitaire FIRE, Hôpital Bichat, Assistance Publique – Hôpitaux de Paris, Paris, France;4. Deparment of Cardiology, Isala Klinieken, Zwolle, The Netherlands;5. Department of Cardiology, University of Copenhagen, The Heart Center, Copenhagen, Denmark;6. SAMU 93 - UF Recherche-Enseignement-Qualité, Paris, France;7. Hôpital Avicenne, Bobigny, France;8. Université Paris 13, Sorbonne Paris Cité, Paris, France;9. Jagiellonian University Medical College, Krakow, Poland;10. Universite de Caen, France and INSERM U 744, Institut Pasteur de Lille, Caen, France;11. Ospedale S. Maria della Misericordia, Azienda Ospedaliera, Perugia;12. Rianimazione-118, Ospedale Maggiore - Azienda USL di Bologna, Italy;13. 3rd Department of Medicine, Cardiology and Emergency Medicine, Wilhelminen Hospital, Vienna, Austria;14. Cardiology Hospital, University of Bordeaux, Bordeaux, France;15. University Hospital of Bordeaux, SAMU, Bordeaux, France;p. Department of Nephrology and Medical Intensive Care, Charité - Campus Virchow, Universitätsmedizin, Berlin, Germany;q. Department of Anaesthesia 4231, HOC, Rigshospitalet, Copenhagen, Denmark;r. St Antonius Hospital, Nieuwegein, The Netherlands;s. RAV IJsselvecht, Zwolle (EMS Service Zwolle area), The Netherlands;t. Klinikum Ludwigshafen, Ludwigshafen, Germany;u. Department of Cardiology, Kerckhoff Clinic and Thoraxcenter, Benekestr. Bad Nauheim, Germany;v. Cardiology and Angiology Department, University Medical Centre Maribor, Maribor, Slovenia;w. The Medicines Company Ltd., Parsippany, NJ;x. The Medicines Company Ltd., Abingdon, Oxfordshire, United Kingdom;y. Emergency Department and SAMU, Lille University Hospital, Lille, France |
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| Abstract: | IntroductionVardenafil is reported to improve success rates in the maintenance of an erection sufficient for completion of intercourse (SEP-3) compared with placebo in erectile dysfunction (ED) patients who attempted intercourse from as early as 15 minutes after dosing. However, these data were based on general ED patients, using time from administration to initiation of intercourse. It is unclear whether the results can be applied to difficult-to-treat ED patients, such as those with diabetes mellitus (DM), with the time between dosing and insertion into vagina.AimTo determine whether early onset of activity with vardenafil is also achievable in ED patients with DM.MethodsData from a 12-week Phase III clinical trial (randomized, placebo-controlled, double-blind, parallel-group comparison) in Japanese men with ED and DM was used for analysis. In this study, patients received vardenafil 10 mg, 20 mg, or placebo, and were instructed to start sexual activity 1 hour after dosing. Mean per-patient SEP-3 success rates (intent-to-treat; ITT population), based on patient diary question, were calculated by the time between dosing and insertion. The least-squares means and nominal P values for differences versus placebo were derived by analysis of covariance with terms for baseline.Main Outcome MeasuresSEP-3 success rates in each time interval.ResultsThe majority of inserts occurred between 60–90 minutes after dosing, but 100 of inserts in 52 patients occurred in the first 30 minutes. SEP-3 success rates in patients who inserted in each interval from 0–15 minutes (P = 0.0268), 15–30 minutes (P = 0.0094) through > 120 minutes were all higher in vardenafil-treated patients than those in placebo.ConclusionsIn this retrospective analysis, a rapid onset of activity was also demonstrated in difficult-to-treat ED patients. Vardenafil improved successful intercourse rates compared with placebo in Japanese DM patients who inserted from as early as 15 minutes to >120 minutes after dosing. Nagao K, Kobayashi H, Fujikawa K, Tachibana T, Iwamoto Y, Ishii N, Turek PJ, Brant WO, and Kamidono S. Vardenafil allows successful intercourse initiated rapidly after dosing in Japanese patients with diabetes mellitus and erectile dysfunction. J Sex Med 2009;6:2851–2857. |
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