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Efficacy and safety of sildenafil citrate (Viagra®) for the treatment of erectile dysfunction in men in Egypt and South Africa

Abstract

The efficacy of sildenafil citrate (Viagra®), an oral agent for the treatment of erectile dysfunction (ED), has been demonstrated in global studies. This 12-week randomized, double-blind, placebo-controlled, parallel-group, flexible-dose study assessed the efficacy and safety of sildenafil to treat ED in men in Egypt and South Africa. Men with ED of varied etiology were randomized to receive sildenafil 50 mg (n=128) or placebo (n=126); doses could be adjusted to 100 or 25 mg. Questions from the International Index of Erectile Function (IIEF) assessing the ability to achieve (Q3) and maintain (Q4) erections demonstrated a significant improvement with sildenafil compared with placebo (P<0.0001). Improved erections were reported by 74% of patients receiving sildenafil and 27% of those receiving placebo (P<0.0001). Headache, dyspepsia, and flushing were the most common adverse events in sildenafil-treated patients. These results are consistent with clinical trials in other countries. We conclude that sildenafil is an efficacious and well-tolerated treatment for men with ED in Egypt and South Africa.

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Acknowledgements

This study was supported by a research grant from Pfizer Inc. Participants in the African Sildenafil Study Group included MAM Abdel Aal, MD; Said Abdel Azim, MD; Wael Abu Fad, MD; Luigi Aldera, MD; MS Bornman, MD; Gary Burgess, MD; Magdy A El Akkad, MD; Adel H El-Behairy, MD; M Hatem El-Bialy, MD; Moustafa El-Demiry, MD; Eman H El-Morsi, MD; Mohammad El-Gallad, MD; Ahmed M El-Taher, MD; MAH Habib, MD; AAL Hegazy, MD; Goolam M Hoosen, MD; Ismail M Khalaf, MD; Mohammad Koth, MD; Bernard Levinson, MD; Ivan P Levinson, MD; Irving Lissoos, MD; Kamal ZM Shaeer, MD; Bahgat A Metawea, MD; Sherif Mourad, MD; Johannes H Naude, MD; MAK Omar, MD; Simon Reif, MD; Mac Robertson, MD; A Carel Schmidt, MD; David O Smart, MD.

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Levinson, I., Khalaf, I., Shaeer, K. et al. Efficacy and safety of sildenafil citrate (Viagra®) for the treatment of erectile dysfunction in men in Egypt and South Africa. Int J Impot Res 15 (Suppl 1), S25–S29 (2003). https://doi.org/10.1038/sj.ijir.3900970

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