Efficacy, safety and tolerability of sildenafil in Brazilian hypertensive patients on multiple antihypertensive drugs

Efficacy, safety and tolerability of sildenafil in Brazilian hypertensive patients on multiple antihypertensive drugs

Author Albuquerque, Denilson C. Google Scholar
Miziara, Lineu J. Google Scholar
Saraiva, Jose F. K. Google Scholar
Rodrigues, Ulisses S. Google Scholar
Ribeiro, Artur B. Autor UNIFESP Google Scholar
Wajngarten, Mauricio Google Scholar
Institution State University of Rio de Janeiro Department of Cardiology
Federal University of Uberlandia Department of Cardiology
Pontifical Catholic University Department of Cardiology
Salgado Filho Hospital Department of General Practice
Universidade Federal de São Paulo (UNIFESP)
Institute of Heart CardioGeriatry Service
Abstract OBJECTIVE: To evaluate the efficacy, safety and tolerability of sildenafil among Brazilian patients with hypertension treated with combinations of anti-hypertensive drugs. MATERIALS AND METHODS: One hundred twenty hypertensive men aged 30 to 81 years old under treatment with 2 or more anti-hypertensive drugs and with erectile dysfunction (ED) lasting for at least 6 months were enrolled at 7 research centers in Brazil. Patients were randomized to receive treatment with either sildenafil or placebo taken 1 hour before sexual intercourse (initial dose of 50 mg, adjusted to 25 mg or 100 mg according to efficacy and toxicity). During the following 8 weeks, patients were evaluated regarding vital signs, adverse events, therapeutic efficacy, satisfaction with treatment and use of concurrent medications. RESULTS: The primary evaluation of efficacy, which was based on responses to questions 3 and 4 of the International Index of Erectile Function, showed significant differences regarding treatment with sildenafil (p = 0.0002 and p < 0.0001, respectively). In the assessment of global efficacy, 87% of the patients treated with sildenafil reported improved erections, as compared with 37% of patients given placebos (p < 0.0001). The other secondary evaluations supported the results favoring sildenafil. The most frequent adverse events among patients treated with sildenafil were headaches (11.4%), vasodilation (11.4%) and dyspepsia (6.5%). There were no significant changes in blood pressure measurements in both groups. CONCLUSION: Sildenafil is efficacious and safe for the treatment of hypertensive patients with ED who receive concurrent combinations of anti-hypertensive drugs.
Keywords erectile dysfunction
sildenafil
hypertension
anti-hypertensive
drugs
Language English
Date 2005-08-01
Published in International braz j urol. Sociedade Brasileira de Urologia, v. 31, n. 4, p. 342-355, 2005.
ISSN 1677-5538 (Sherpa/Romeo)
Publisher Sociedade Brasileira de Urologia
Extent 342-355
Origin http://dx.doi.org/10.1590/S1677-55382005000400008
Access rights Open access Open Access
Type Article
SciELO ID S1677-55382005000400008 (statistics in SciELO)
URI http://repositorio.unifesp.br/handle/11600/2593

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