 |
| About Bioline | All Journals | Testimonials | Membership | News |
|
||||||
|
||||||
Indian Journal of Pharmacology, Vol. 36, No. 5, October, 2004, pp. 317 Research Letter Efficacy and tolerability of sildenafil in Indian males with erectile dysfunction: A double-blind, randomized, placebo-controlled, crossover study Bawa AS, Sharma DR, Singh R, Singh P Department of Surgery, Government Medical College Hospital, Chandigarh Code Number: ph04107 Sir, A randomized, double-blind, placebo-controlled, crossover study was conducted over one year to assess whether sildenafil (50 mg) is effective in Indian males. Fifty-nine patients in the age group 18 to 60 years with erectile dysfunction (ED) for more than 6 months completed the study. The sexual partners were also questioned during and after the study period. The subjects underwent either sildenafil or placebo therapy for 3 weeks, after which they were switched over to the other group (i.e. the sildenafil group switched over to placebo, and vice versa). Efficacy assessments were made using the International Index of Erectile Function. Adverse events included any clinical, biochemical or hematological parameters, which were recorded 4 times over the study period. Statistical analysis was done using the Student′s ′t′ test. P<0.05 was considered significant. Mean age of the patients was 32.8 years (18 to 60 years) and the mean duration of ED was 25.3 months (6-120 months) prior to enrolment in the study. A highly significant improvement in the ability to achieve and sustain an erection was demonstrated (P<0.001). Intercourse satisfaction and improvement in sexual desire did not show significant improvements. 81.3% of patients reported that treatment over three weeks had improved their erections, compared with 28.8% who reported improved erections with placebo [Table - 1]. Adverse events were reported in 4 (6.77%) patients receiving sildenafil as compared to 3.38% of patients on placebo, and were mild to moderate and transient in nature. The adverse effects seen were headache (30.2%), flushing (43.5%), dyspepsia (18.8%) and dizziness (7.5%). None of the patients discontinued treatment because of adverse effects. Erectile dysfunction is a common sexual disorder with a prevalence of more than 30% in men aged 40 to 70 years.[1] In the current study, sildenafil administered in a dose of 50 mg improved ED. Satisfactory erectile function was achieved and this result corresponds to other studies.[2] The most serious adverse effects noted are myocardial infarction and unstable angina, the incidence of which was 3% each in patients with underlying ischemic heart disease,[3] and less than 1% if no cardiac disease was present. None of our patients had cardiac events because strict exclusion criteria were followed. REFERENCES
Copyright 2004 - Indian Journal of Pharmacology The following images related to this document are available:Photo images[ph04107t1.jpg] |
| |||||||||
![[Table - 1]](/showimage?ph/photo/ph04107t1.jpg){kind=link}