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Sildenafil: efficacy and safety in daily clinical experience

Palumbo F, Bettocchi C, Selvaggi FP, Pryor JP, Ralph DJ

European urology, 2001

Abstract

OBJECTIVES: Sildenafil citrate (Viagra) is a potent selective inhibitor of phosphodiesterase type 5 proposed for the oral treatment of erectile dysfunction (ED). The aim of this study was to evaluate its efficacy and safety when used in daily practice in patients with ED of various aetiology.

PATIENTS AND METHODS: From September 1998 to April 1999, 380 patients chose sildenafil as treatment for their ED. One hundred and forty-five (38%) of them suffered from psychogenic ED, 125 (33%) organic and 110 (29%) of mixed aetiology. The grade of erection achieved and the occurrence of satisfactory sexual intercourse assessed the efficacy. Safety and tolerance were evaluated recording any side effect or adverse event.

RESULTS: The overall efficacy of Viagra was 77%, with a response of 100% among the group of hormonal patients, 88% for psychogenic, 72% for mixed, 69% for diabetes, 65% for vascular and 60% for neurological symptoms. A few and mild to moderate side effects were recorded.

CONCLUSION: These results indicate that the use of sildenafil citrate is an effective and well-tolerated therapy for men with ED of various aetiology with an overall success rate of 77%.

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Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.

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