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| Efficacy and safety of vardenafil in men with erectile dysfunction caused by spinal cord injury |
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| Author(s): Giuliano F, Rubio-Aurioles E, Kennelly M, Montorsi F, Kim ED, Finkbeiner AE, Pommerville PJ, Colopy MW, Wilkins HJ, Wachs BH |
| Source: NEUROLOGY Volume: 66 Issue: 2 Pages: 210-216 Published: JAN 24 2006 |
| Times Cited: 18 References: 28 |
| Abstract: Objective: To assess the efficacy and tolerability of vardenafil in men with erectile dysfunction (ED) due to traumatic spinal cord injury (SCI). Methods: In this multicenter, double-blind, placebo-controlled, parallel-group 12-week study, 418 men aged 18 years and older with ED for more than 6 months consequent to SCI were randomized to vardenafil (n = 207) or placebo (n = 211) (10 mg for 4 weeks, then maintained or titrated to 5 or 20 mg at weeks 4 and 8). Efficacy assessments included the erectile function (EF) domain score of the International Index of Erectile Function questionnaire and diary questions regarding penetration, maintenance of erection to completion of intercourse, and ejaculation. Results: Baseline patient characteristics were similar in the vardenafil (mean age 40 years) and placebo (mean age 39 years) groups. Mean baseline EF domain scores were 11.6 in the vardenafil group and 12.1 (moderate ED) in the placebo group. EF domain score in the vardenafil group improved to 22.0 (mild ED) at last observation carried forward vs 13.5 in the placebo group (p < 0.001). Over 12 weeks of treatment, mean per-patient penetration (76% vs 41%), maintenance (59% vs 22%), and ejaculation (19% vs 10%) success rates were significantly greater vs placebo (all p < 0.001). The most frequently reported drug-related adverse events were headache (vardenafil 15%, placebo 4%), flushing (vardenafil 6%, placebo 0%), nasal congestion (vardenafil 5%, placebo 0%), and dyspepsia (vardenafil 4%, placebo 0%). Conclusion: Vardenafil significantly improved erectile and ejaculatory function and was generally well tolerated in men with erectile dysfunction due to spinal cord injury. |
| Document Type: Article |
| Language: English |
| Reprint Address: Giuliano, F (reprint author), Acad Hosp Bicetre, AP HP, Dept Urol, 78 Rue Gen Leclerc, F-94270 Le Kremlin Bicetre, France |
Addresses:
1. Acad Hosp Bicetre, AP HP, Dept Urol, F-94270 Le Kremlin Bicetre, France
2. Asoc Mexicana Para Salud Sexual, Mexico City, DF Mexico
3. McKay Urol, Charlotte, NC USA
4. Univ Vita Salute San Raffaele, Dept Urol, Milan, Italy
5. UT Med Ctr, Knoxville, TN USA
6. Univ Arkansas Med Sci, Dept Urol, Little Rock, AR USA
7. Can Med Clin Res Inc, Victoria, BC Canada
8. GlaxoSmithKline Inc, Res Triangle Pk, NC USA
9. GlaxoSmithKline Inc, King Of Prussia, PA USA
10. Atlantic Urol Med Grp, Long Beach, CA USA |
| Publisher: LIPPINCOTT WILLIAMS & WILKINS, 530 WALNUT ST, PHILADELPHIA, PA 19106-3261 USA |
| Subject Category: Clinical Neurology |
| IDS Number: 005SA |
| ISSN: 0028-3878 |
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