IPSIndian Journal of Pharmacology
Home  IPS  Feedback Subscribe Top cited articles Login 
Users Online : 2612 
Small font sizeDefault font sizeIncrease font size
Navigate Here
  Search
 
  Next article
  Previous article 
  Table of Contents
  
Resource Links
   Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
   Article in PDF (44 KB)
   Citation Manager
   Access Statistics
   Reader Comments
   Email Alert *
   Add to My List *
* Registration required (free)

 
In This Article
   References

 Article Access Statistics
    Viewed4675    
    Printed139    
    Emailed2    
    PDF Downloaded160    
    Comments [Add]    

Recommend this journal

 
RESEARCH LETTER
Year : 2004  |  Volume : 36  |  Issue : 5  |  Page : 317
 

Efficacy and tolerability of sildenafil in Indian males with erectile dysfunction: A double-blind, randomized, placebo-controlled, crossover study


Department of Surgery, Government Medical College Hospital, Chandigarh, India

Correspondence Address:
Department of Surgery, Government Medical College Hospital, Chandigarh, India
rajdeep2000@hotmail.com



How to cite this article:
Bawa A S, Sharma D R, Singh R, Singh P. Efficacy and tolerability of sildenafil in Indian males with erectile dysfunction: A double-blind, randomized, placebo-controlled, crossover study. Indian J Pharmacol 2004;36:317


How to cite this URL:
Bawa A S, Sharma D R, Singh R, Singh P. Efficacy and tolerability of sildenafil in Indian males with erectile dysfunction: A double-blind, randomized, placebo-controlled, crossover study. Indian J Pharmacol [serial online] 2004 [cited 2020 Jun 1];36:317. Available from: http://www.ijp-online.com/text.asp?2004/36/5/317/12655


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 Top

1.Feldman HA, Goldstein I, Hatzichristou DG, Krane RJ, McKinlay JB. Impotence and its medical and psychosocial correlates: results of the Massachusetts Male Aging Study. J Urol 1994;151:54-61.  Back to cited text no. 1  [PUBMED]  
2.Marks LS, Duda C, Dorey FJ, Macairan ML, Santos PB. Treatment of erectile dysfunction with sildenafil. Urology 1999;53:19-24.  Back to cited text no. 2  [PUBMED]  [FULLTEXT]
3.McMahon CG, Samali R, Johnson H. Efficacy, safety and patient acceptance of sildenafil citrate as treatment for erectile dysfunction. J Urol 2000;164:1192-6.  Back to cited text no. 3  [PUBMED]  [FULLTEXT]
Top
Print this article  Email this article

    

Site Map | Home | Contact Us | Feedback | Copyright and Disclaimer
Online since 20th July '04
Published by Wolters Kluwer - Medknow