PubMed · 11054942
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2000. PIs may cause sexual dysfunction.. https://doi.org/10.1089/108729100750018344
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BACKGROUND: Our purpose was to assess the efficacy and safety of sildenafil as a treatment for erectile dysfunction in hypertensive patients, and to investigate those factors associated with a treatment failure. PATIENTS AND METHOD: Open, prospective study including 114 patients suffering from erectile dysfunction plus arterial hypertension who were evaluated by anamnesis, physical examination, blood tests including glycemia and lipidic and hormonal profiles, penile colour Doppler ultrasonography after intracavernosal prostaglandin E1 (PGE1) injection, and the Sexual Health Inventory for Men (SHIM). Efficacy of sildenafil was assessed by administering again the SHIM and by means of a global assessment questionnaire. Side effects were also recorded. Factors influencing treatment outcome were evaluated by univariate and multivariate statistical analysis. RESULTS: Overall, sildenafil was effective in 59.2% of 103 eligible patients. Efficacy in patients with psychogenic erectile dysfunction was 75%, whereas in those with an organic etiology, the efficacy was 50.7%. Age, diabetes mellitus, nocturnal penile tumescence, response to intracavernosal PGE1 injection and erectile dysfunction severity (defined by the SHIM basal score) significantly influenced treatment response (p < 0.05) after an univariate analysis. The multivariate analysis, however, selected only diabetes mellitus and severity of erectile dysfunction as the prognostic factors. No severe side effects were noticed. CONCLUSIONS: Sildenafil is a rather effective and well-tolerated treatment for erectile dysfunction in hypertensive patients. Baseline severity of erectile dysfunction and diabetes mellitus represent the prognostic factors most significantly associated with treatment outcome.
BACKGROUND: Evaluation of company clinical trial reports could provide information for meta-analysis at the commercial introduction of a new technology. METHODS: Clinical trial reports of sildenafil for erectile dysfunction from September 1997 were used for meta-analysis of randomised trials (at least four weeks duration) and using fixed or dose optimisation regimens. The main outcome sought was an erection, sufficiently rigid for penetration, followed by successful intercourse, and conducted at home. RESULTS: Ten randomised controlled trials fulfilled the inclusion criteria (2123 men given sildenafil and 1131 placebo). NNT or NNH were calculated for important efficacy, adverse event and discontinuation outcomes. Dose optimisation led to at least 60% of attempts at sexual intercourse being successful in 49% of men, compared with 11% with placebo; the NNT was 2.7 (95% confidence interval 2.3 to 3.3). For global improvement in erections the NNT was 1.7 (1.6 to 1.9). Treatment-related adverse events occurred in 30% of men on dose optimised sildenafil compared with 11% on placebo; the NNH was 5.4 (4.3 to 7.3). All cause discontinuations were less frequent with sildenafil (10%) than with placebo (20%). Sildenafil dose optimisation gave efficacy equivalent to the highest fixed doses, and adverse events equivalent to the lowest fixed doses. CONCLUSION: This review of clinical trial reports available at the time of licensing agreed with later reviews that had many more trials and patients. Making reports submitted for marketing approval available publicly would provide better information when it was most needed, and would improve evidence-based introduction of new technologies.
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