VARDENAFIL RESCUE RATES OF SILDENAFIL NONRESPONDERS: OBJECTIVE ASSESSMENT OF 327 PATIENTS WITH ERECTILE DYSFUNCTION THEODORE E. BRISSON, GREGORY A. BRODERICK, DAVID D. THIEL, MICHAEL G. HECKMAN, AND DAVID M. PINKSTAFF ABSTRACT Objectives. To prospectively investigate whether vardenafil can effectively treat patients for whom sildenafil (100 mg) has failed. The introduction of two new oral phosphodiesterase type 5 inhibitors (tadalafil and vardenafil) raises the question of whether the new agents will permit us to treat sildenafil nonresponders with another oral agent. Methods. Patients were seen at one institution during a 5-year period. A total of 327 patients complaining of sildenafil-refractory erectile dysfunction underwent intracavernous pharmacologic injection and color duplex Doppler ultrasonography. Subsequently 59 of these men tried vardenafil home dosing. Results. Of the 327 men in whom sildenafil failed, 16% were younger than 50, 21% were 51 to 60, 34% were 61 to 70, and 28% were older than 70 years. The Doppler diagnoses were arterial insufficiency in 154 (47%), mixed vascular insufficiency in 73 (22%), and cavernous venous occlusive disease in 57 (17%). Forty-three men (13%) had normal erectile responses to prostaglandin E 1 (10 to 20 g). Of the 59 men who tried vardenafil, 19% were younger than 50, 17% were 51 to 60, 40% were 61 to 70, and 23% were older than 70 years. The Doppler diagnoses were arterial insufficiency in 28 (42%), mixed vascular insufficiency in 10 (19%), and cavernous venous occlusive disease in 15 (29%). Six men (8%) had normal erectile responses to prostaglandin E 1 . Only 7 (12%) of the 59 men reported that home vardenafil dosing resulted in successful intercourse. Conclusions. An appropriate diagnostic evaluation and subsequent treatment algorithm have yet to be established for those for whom phosphodiesterase type 5 inhibitors fail. We found that most sildenafil nonresponders had severe arterial insufficiency and were older, with 62% older than 60 years. Our preliminary experience suggests that only a small percentage (12%) of sildenafil nonresponders can be salvaged with vardenafil. UROLOGY 68: 397–401, 2006. © 2006 Elsevier Inc. E rectile dysfunction (ED) is a common urologic problem affecting as many as 30 million men in the United States. 1 Epidemiologic data have sug- gested that its prevalence will only increase with an aging society. The Massachusetts Male Aging Study showed an increase in the risk of severe ED of 5% to 15% and an increase in the risk of mild ED of 17% to 34% between 40 and 70 years of age. 2 This increased risk is believed to result from nor- mal aging with exacerbation by underlying comor- bidities such as cardiovascular disease and diabetes mellitus. The Cologne Male Survey also demon- strated that ED is often associated with chronic diseases and that a steep age-related increase in the prevalence of ED exists. 3 The introduction of the first oral phosphodiesterase type 5 inhibitor revo- lutionized the treatment of ED. No longer were patients limited only to the option of cumbersome and invasive pharmacologic measures or surgery. The early clinical trials with sildenafil showed a remarkably high efficacy rate compared with pla- cebo. 4,5 Seven years of postmarket data have con- firmed this high efficacy rate. 6 Not all men with ED, however, have been effec- G. A. Broderick is a study investigator partially funded by Antigen- ics, GlaxoSmithKline, Lilly/ICOS, and Ortho-Urology/Johnson & Johnson. From the Department of Urology, Mayo Clinic Jacksonville, Jacksonville, Florida Reprint requests: Gregory A. Broderick, M.D., Department of Urology, Mayo Clinic Jacksonville, 3 East Davis Building, 4500 San Pablo Road, Jacksonville, FL 32224. E-mail: broderick. gregory@mayo.edu Submitted: November 9, 2005, accepted (with revisions): March 7, 2006 ADULT UROLOGY © 2006 ELSEVIER INC. 0090-4295/06/$32.00 ALL RIGHTS RESERVED doi:10.1016/j.urology.2006.03.005 397