{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,23]],"date-time":"2026-01-23T08:07:44Z","timestamp":1769155664619,"version":"3.49.0"},"reference-count":33,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2006,9,1]],"date-time":"2006-09-01T00:00:00Z","timestamp":1157068800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2006,9,1]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n               <jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Aims<\/jats:title>\n                  <jats:p>To evaluate the safety and efficacy of flexible-dose vardenafil therapy in a prospective randomized study in phosphodiesterase 5 inhibitor-na\u00efve subjects with type 1 diabetes and ED.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>In this multicenter, double-blind, placebo-controlled clinical trial, phosphodiesterase-5 inhibitor-na\u00efve patients were randomized to receive placebo (N = 149) or flexible-dose (5\u201320 mg) (N = 153) vardenafil.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Main Outcome Measure<\/jats:title>\n                  <jats:p>Sexual Encounter Profile diary questions 2 and 3, concerning success rates of vaginal insertion and maintenance of erection to allow successful intercourse, respectively.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>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 &amp;lt; 0.0001, intention to treat and last observation carried forward). These rates were unaffected by stratification into distinct subsets according to the level of HbA1c (HbA1c &amp;lt; 7%, good glycemic control; HbA1c &amp;gt;7\u2013\u22648%, moderate glycemic control; and HbA1c &amp;gt; 8%, poor glycemic control). Vardenafil treatment also significantly improved the Erectile Function domain score (P &amp;lt; 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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1111\/j.1743-6109.2006.00295.x","type":"journal-article","created":{"date-parts":[[2006,8,21]],"date-time":"2006-08-21T17:47:47Z","timestamp":1156182467000},"page":"883-891","source":"Crossref","is-referenced-by-count":62,"title":["Efficacy and Safety of Flexible-Dose Vardenafil in Men with Type 1 Diabetes and Erectile Dysfunction"],"prefix":"10.1093","volume":"3","author":[{"given":"Dan","family":"Ziegler","sequence":"first","affiliation":[{"name":"Deutsche Diabetes-Klinik Deutsches-Diabetes\u2013Zentrum Leibniz-Institut an der Heinrich-Heine Universit\u00e4t , D\u00fcsseldorf , Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frank","family":"Merfort","sequence":"additional","affiliation":[{"name":"Diabetologic Office , Grevenbroich , Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hermann","family":"Van Ahlen","sequence":"additional","affiliation":[{"name":"Klinikum Osnabr\u00fcck , Osnabr\u00fcck , Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aksam","family":"Yassin","sequence":"additional","affiliation":[{"name":"Office Norderstedt , Noderstedt , Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tjark","family":"Reblin","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline , Munich , Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marcus","family":"Neureither","sequence":"additional","affiliation":[{"name":"Aachen , Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2006,9,1]]},"reference":[{"key":"2024032600173339700_bib1","doi-asserted-by":"crossref","first-page":"135","DOI":"10.2337\/diacare.19.2.135","article-title":"Prevalence of self-reported erectile dysfunction in people with long-term IDDM","volume":"19","author":"Klein","year":"1996","journal-title":"Diabetes Care"},{"key":"2024032600173339700_bib2","doi-asserted-by":"crossref","first-page":"837","DOI":"10.1016\/0002-9343(86)90355-4","article-title":"Non-insulin-dependent diabetes in older patients. 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