Clinical Safety Profile of Sildenafil in Singaporean Men with Erectile Dysfunction: Pre-Marketing Experience (ASSESS-I Evaluation)
| Autor: | M. Y. C. Wong, C. W. S. Cheng, P. Moorthy, F. C. Ng, C. T. Y. Chee, P. H. C. Lim, S. S. Vasan |
|---|---|
| Rok vydání: | 2002 |
| Předmět: |
Adult
Male medicine.medical_specialty Sildenafil Philippines Vasodilator Agents Population 030204 cardiovascular system & hematology Placebo Biochemistry Piperazines Sildenafil Citrate Placebos 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Double-Blind Method Erectile Dysfunction Internal medicine Humans Medicine Sulfones education Adverse effect Marketing Singapore education.field_of_study business.industry Incidence (epidemiology) Biochemistry (medical) Malaysia Cell Biology General Medicine Middle Aged medicine.disease Erectile dysfunction Tolerability chemistry Purines 030220 oncology & carcinogenesis Anesthesia Clinical safety business |
| Zdroj: | Journal of International Medical Research. 30:137-143 |
| ISSN: | 1473-2300 0300-0605 |
| DOI: | 10.1177/147323000203000206 |
| Popis: | Safety and tolerability of sildenafil citrate was assessed in a population subset of 60 Singaporean men with erectile dysfunction taken from the Asian Sildenafil Efficacy and Safety Study (ASSESS-I), a double-blind, placebo-controlled, flexible-dose study. The men, from two centres, with ≥ 6 months' history of erectile dysfunction, were randomized to two treatment arms for 12 weeks. One group (30 patients) received sildenafil (initial dose 50 mg taken 1 h before sexual activity for the first 2 weeks, increased to 100 mg or decreased to 25 mg, according to efficacy and/or tolerability). The remaining 30 patients received a matching placebo. Incidence and type of adverse effects were evaluated at 2, 4, 8 and 12 weeks. Nine patients (30.0%) on sildenafil (33.1% in the full ASSESS-I study) and one patient (3.3%) on placebo (22.8% in the full ASSESS-I study) experienced treatment-related adverse events, the most frequent being headache in the sildenafil group (reported by five patients [16.7%]; 11.0% in the full ASSESS-I study). Flushing, visual disturbance, dizziness, insomnia, myalgia and back pain each occurred in one patient in the sildenafil group (3.3%); in the placebo group, one patient (3.3%) had headache. Importantly, the incidence of cardiovascular and respiratory system adverse events were relatively less than in the full ASSESS-I population (cardiovascular 3.3% in the present study versus 10.2% in the full ASSESS-I population; respiratory 3.3% versus 5.5%). All adverse events were transient and mild, and did not lead to treatment withdrawal. There was no effect on sitting blood pressure, heart rate or standard laboratory parameters; more importantly, there was no incidence of myocardial infarction, stroke or priapism. These results should reassure Singaporean patients and their physicians of the safety of sildenafil for erectile dysfunction. |
| Databáze: | OpenAIRE |
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