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A 4-year update on the safety of sildenafil citrate (Viagra).
Urology. 2002 Sep; 60(2 Suppl 2):67-90.U

Abstract

Clinical studies have demonstrated that sildenafil citrate (Viagra) is an effective and well-tolerated oral treatment for erectile dysfunction. Despite its established safety profile, concern about its cardiovascular safety persists among some physicians and the general public. This concern has stemmed primarily from sporadic reports of adverse events published in the literature and sensationalized by the media. However, the only absolute contraindication for sildenafil is concurrent use of nitrates. Because sildenafil has been on the market for 4 years and under clinical investigation for even longer, we can now evaluate its long-term safety in men who have been taking the drug for several years. We review this issue from 3 perspectives. First, we reassess the overall safety profile of sildenafil by reviewing the initial controlled clinical trials and open-label studies. We present new data from patients who have been exposed to sildenafil for up to 4.5 years. We also evaluate the results from independent postmarketing studies. Second, we review the cardiovascular-specific results from the clinical trials, long-term extension, and postmarketing studies. Lastly, we review the specific effects on the visual system based on findings from studies conducted during drug development and post marketing.

Authors+Show Affiliations

The Male Clinic, Keck School of Medicine at the University of Southern California School of Medicine, Beverly Hills, California, USA. hpn@insyght.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't
Review

Language

eng

PubMed ID

12414335

Citation

Padma-nathan, Harin, et al. "A 4-year Update On the Safety of Sildenafil Citrate (Viagra)." Urology, vol. 60, no. 2 Suppl 2, 2002, pp. 67-90.
Padma-nathan H, Eardley I, Kloner RA, et al. A 4-year update on the safety of sildenafil citrate (Viagra). Urology. 2002;60(2 Suppl 2):67-90.
Padma-nathan, H., Eardley, I., Kloner, R. A., Laties, A. M., & Montorsi, F. (2002). A 4-year update on the safety of sildenafil citrate (Viagra). Urology, 60(2 Suppl 2), 67-90.
Padma-nathan H, et al. A 4-year Update On the Safety of Sildenafil Citrate (Viagra). Urology. 2002;60(2 Suppl 2):67-90. PubMed PMID: 12414335.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A 4-year update on the safety of sildenafil citrate (Viagra). AU - Padma-nathan,Harin, AU - Eardley,Ian, AU - Kloner,Robert A, AU - Laties,Alan M, AU - Montorsi,Francesco, PY - 2002/11/5/pubmed PY - 2002/11/26/medline PY - 2002/11/5/entrez SP - 67 EP - 90 JF - Urology JO - Urology VL - 60 IS - 2 Suppl 2 N2 - Clinical studies have demonstrated that sildenafil citrate (Viagra) is an effective and well-tolerated oral treatment for erectile dysfunction. Despite its established safety profile, concern about its cardiovascular safety persists among some physicians and the general public. This concern has stemmed primarily from sporadic reports of adverse events published in the literature and sensationalized by the media. However, the only absolute contraindication for sildenafil is concurrent use of nitrates. Because sildenafil has been on the market for 4 years and under clinical investigation for even longer, we can now evaluate its long-term safety in men who have been taking the drug for several years. We review this issue from 3 perspectives. First, we reassess the overall safety profile of sildenafil by reviewing the initial controlled clinical trials and open-label studies. We present new data from patients who have been exposed to sildenafil for up to 4.5 years. We also evaluate the results from independent postmarketing studies. Second, we review the cardiovascular-specific results from the clinical trials, long-term extension, and postmarketing studies. Lastly, we review the specific effects on the visual system based on findings from studies conducted during drug development and post marketing. SN - 1527-9995 UR - https://www.unboundmedicine.com/medline/citation/12414335/A_4_year_update_on_the_safety_of_sildenafil_citrate__Viagra__ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0090429502017521 DB - PRIME DP - Unbound Medicine ER -