PROSPECTIVE, RANDOMIZED, CROSSOVER COMPARISON OF SUBLINGUAL APOMORPHINE (3 mg) WITH ORAL SILDENAFIL (50 mg) FOR MALE ERECTILE DYSFUNCTION

Curto, F; Pavone-Macaluso, M

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Abstract

Purpose: We established the efficacy and safety of sublingual apomorphine compared with oral sildenafil in comparable groups of patients with erectile dysfunction (ED). Materials and Methods: This prospective, randomized, crossover study included 77 heterosexual men with ED of various etiologies and severities. A total of 62 men were randomized but only 34 were evaluable for efficacy and tolerability. The study started with a run-in period of 2 to 4 weeks. The first 4 weeks of treatment were followed by a washout period of 4 weeks, after which patients changed to the alternate treatment for an additional 4-week period. The sequence of the 2 treatments was established by a randomization list in blocks in closed packets. The primary efficacy end point was the percent of attempts resulting in erection firm enough for intercourse. Additional variables were the percent of attempts resulting in intercourse and improvement in ED, as evaluated by the erectile function domain score of the International Index of Erectile Function questionnaire. Results: Sildenafil was significantly more effective than apomorphine in regard to the percent of attempts resulting in erection firm enough for intercourse (85% vs 44%, p <0.0001) and actually resulting in intercourse (81% vs 43%, p <0.0001) as well as erectile function evaluated by the erectile function domain score of the International Index of Erectile Function (p <0.001). The incidence of adverse events was not significantly different for the 2 drugs. Although the number of patients was small, this study had strong statistical power due to the striking difference in results. Conclusions: Sildenafil was significantly more effective than apomorphine for ED. No statistical difference in adverse events was noted.
Lingua originaleEnglish
pagine (da-a)2347-2349
Numero di pagine3
RivistaTHE JOURNAL OF UROLOGY
Volume172 (6)
Stato di pubblicazionePublished - 2004

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Apomorphine
Erectile Dysfunction
Heterosexuality
Random Allocation
Cross-Over Studies
Therapeutics
Safety
Incidence
Pharmaceutical Preparations
Sildenafil Citrate

All Science Journal Classification (ASJC) codes

  • Urology

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title = "PROSPECTIVE, RANDOMIZED, CROSSOVER COMPARISON OF SUBLINGUAL APOMORPHINE (3 mg) WITH ORAL SILDENAFIL (50 mg) FOR MALE ERECTILE DYSFUNCTION",
abstract = "Purpose: We established the efficacy and safety of sublingual apomorphine compared with oral sildenafil in comparable groups of patients with erectile dysfunction (ED). Materials and Methods: This prospective, randomized, crossover study included 77 heterosexual men with ED of various etiologies and severities. A total of 62 men were randomized but only 34 were evaluable for efficacy and tolerability. The study started with a run-in period of 2 to 4 weeks. The first 4 weeks of treatment were followed by a washout period of 4 weeks, after which patients changed to the alternate treatment for an additional 4-week period. The sequence of the 2 treatments was established by a randomization list in blocks in closed packets. The primary efficacy end point was the percent of attempts resulting in erection firm enough for intercourse. Additional variables were the percent of attempts resulting in intercourse and improvement in ED, as evaluated by the erectile function domain score of the International Index of Erectile Function questionnaire. Results: Sildenafil was significantly more effective than apomorphine in regard to the percent of attempts resulting in erection firm enough for intercourse (85{\%} vs 44{\%}, p <0.0001) and actually resulting in intercourse (81{\%} vs 43{\%}, p <0.0001) as well as erectile function evaluated by the erectile function domain score of the International Index of Erectile Function (p <0.001). The incidence of adverse events was not significantly different for the 2 drugs. Although the number of patients was small, this study had strong statistical power due to the striking difference in results. Conclusions: Sildenafil was significantly more effective than apomorphine for ED. No statistical difference in adverse events was noted.",
author = "{Curto, F; Pavone-Macaluso, M} and Carlo Pavone and Almasio, {Pier Luigi} and Vincenzo Serretta and Gaetano Anello",
year = "2004",
language = "English",
volume = "172 (6)",
pages = "2347--2349",
journal = "Journal of Urology",
issn = "0022-5347",
publisher = "Elsevier Inc.",

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TY - JOUR

T1 - PROSPECTIVE, RANDOMIZED, CROSSOVER COMPARISON OF SUBLINGUAL APOMORPHINE (3 mg) WITH ORAL SILDENAFIL (50 mg) FOR MALE ERECTILE DYSFUNCTION

AU - Curto, F; Pavone-Macaluso, M

AU - Pavone, Carlo

AU - Almasio, Pier Luigi

AU - Serretta, Vincenzo

AU - Anello, Gaetano

PY - 2004

Y1 - 2004

N2 - Purpose: We established the efficacy and safety of sublingual apomorphine compared with oral sildenafil in comparable groups of patients with erectile dysfunction (ED). Materials and Methods: This prospective, randomized, crossover study included 77 heterosexual men with ED of various etiologies and severities. A total of 62 men were randomized but only 34 were evaluable for efficacy and tolerability. The study started with a run-in period of 2 to 4 weeks. The first 4 weeks of treatment were followed by a washout period of 4 weeks, after which patients changed to the alternate treatment for an additional 4-week period. The sequence of the 2 treatments was established by a randomization list in blocks in closed packets. The primary efficacy end point was the percent of attempts resulting in erection firm enough for intercourse. Additional variables were the percent of attempts resulting in intercourse and improvement in ED, as evaluated by the erectile function domain score of the International Index of Erectile Function questionnaire. Results: Sildenafil was significantly more effective than apomorphine in regard to the percent of attempts resulting in erection firm enough for intercourse (85% vs 44%, p <0.0001) and actually resulting in intercourse (81% vs 43%, p <0.0001) as well as erectile function evaluated by the erectile function domain score of the International Index of Erectile Function (p <0.001). The incidence of adverse events was not significantly different for the 2 drugs. Although the number of patients was small, this study had strong statistical power due to the striking difference in results. Conclusions: Sildenafil was significantly more effective than apomorphine for ED. No statistical difference in adverse events was noted.

AB - Purpose: We established the efficacy and safety of sublingual apomorphine compared with oral sildenafil in comparable groups of patients with erectile dysfunction (ED). Materials and Methods: This prospective, randomized, crossover study included 77 heterosexual men with ED of various etiologies and severities. A total of 62 men were randomized but only 34 were evaluable for efficacy and tolerability. The study started with a run-in period of 2 to 4 weeks. The first 4 weeks of treatment were followed by a washout period of 4 weeks, after which patients changed to the alternate treatment for an additional 4-week period. The sequence of the 2 treatments was established by a randomization list in blocks in closed packets. The primary efficacy end point was the percent of attempts resulting in erection firm enough for intercourse. Additional variables were the percent of attempts resulting in intercourse and improvement in ED, as evaluated by the erectile function domain score of the International Index of Erectile Function questionnaire. Results: Sildenafil was significantly more effective than apomorphine in regard to the percent of attempts resulting in erection firm enough for intercourse (85% vs 44%, p <0.0001) and actually resulting in intercourse (81% vs 43%, p <0.0001) as well as erectile function evaluated by the erectile function domain score of the International Index of Erectile Function (p <0.001). The incidence of adverse events was not significantly different for the 2 drugs. Although the number of patients was small, this study had strong statistical power due to the striking difference in results. Conclusions: Sildenafil was significantly more effective than apomorphine for ED. No statistical difference in adverse events was noted.

UR - http://hdl.handle.net/10447/31957

M3 - Article

VL - 172 (6)

SP - 2347

EP - 2349

JO - Journal of Urology

JF - Journal of Urology

SN - 0022-5347

ER -