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Sildenafil citrate (VIAGRA™) in the treatment of male Erectile Dysfunction: A 6-week, Flexible Dose Evaluation of Efficacy and Safety
Abstract
Background: Erectile dysfunction (ED) is a major health concern which in some communities has been estimated to affect about half of men aged 40 years and above. Due to the high social stigma and its co-morbid nature, ED still remains highly under-diagnosed and hence untreated. Equally important is the lack of effective oral therapy for even those that opted for orthodox medicine. Currently available therapies are cumbersome and they remove the spontaneity in sexual intercourse coupled with the fact they could be rather expensive and out of the reach of the ordinary patient. The sum total of this is that there is a large pool of patients that are languishing in their despair and are being denied, and their spouses, an important ingredient of marriage. The availability of Sildenafil citrate (VIAGRA™) has increased the treatment options available and is set to revolutionize the attitude of the medical community and the lay public to this disease entity.
Objective: The study was conducted to evaluate the efficacy and safety of sildenafil citrate in black men with erectile dysfunction of varied etiologies.
Method: 50 successive patients with ED were recruited into the study. The starting dose was 50mg and this could be increased to 100mg or decreased to 25mg depending on efficacy and toleration. The International Index of Erectile Function (IIEF), patient event log and the global assessment of efficacy were used to assess efficacy while adverse events were monitored by safety laboratory assessments and by the reported and observed events.
Results: 78% of the patients were always able to achieve erections or achieve it most of the times as compared to 10% who were able to do this at baseline (p<0.0001). There was also a statistically significant improvement in those who were able to maintain their erections after penetration at end of therapy as compared to the baseline, 76% versus 6% (p<0.0001). Using the global efficacy question, 94% of the patients reported that taking sildenafil citrate improved their erections. The commonest drug related adverse event was headache (10%), which was transient and did not interfere with the day to day activities of the patients.
Conclusion: This study shows that Sildenafil citrate is an effective oral treatment option for erectile dysfunction in black patients and was well tolerated.
Key Words: Sildenafil citrate; Erectile dysfunction; IIEF.
[Nig. Jnl Health & Biomedical Sciences Vol.1(1) 2002: 45-48]
Objective: The study was conducted to evaluate the efficacy and safety of sildenafil citrate in black men with erectile dysfunction of varied etiologies.
Method: 50 successive patients with ED were recruited into the study. The starting dose was 50mg and this could be increased to 100mg or decreased to 25mg depending on efficacy and toleration. The International Index of Erectile Function (IIEF), patient event log and the global assessment of efficacy were used to assess efficacy while adverse events were monitored by safety laboratory assessments and by the reported and observed events.
Results: 78% of the patients were always able to achieve erections or achieve it most of the times as compared to 10% who were able to do this at baseline (p<0.0001). There was also a statistically significant improvement in those who were able to maintain their erections after penetration at end of therapy as compared to the baseline, 76% versus 6% (p<0.0001). Using the global efficacy question, 94% of the patients reported that taking sildenafil citrate improved their erections. The commonest drug related adverse event was headache (10%), which was transient and did not interfere with the day to day activities of the patients.
Conclusion: This study shows that Sildenafil citrate is an effective oral treatment option for erectile dysfunction in black patients and was well tolerated.
Key Words: Sildenafil citrate; Erectile dysfunction; IIEF.
[Nig. Jnl Health & Biomedical Sciences Vol.1(1) 2002: 45-48]
