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The Real-Life Safety and Efficacy of Vardenafil

An International Post-Marketing Surveillance Study of 2824 Patients from the Middle East

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Objective: To assess the safety, efficacy and patient acceptability of vardenafil treatment under real-life conditions in patients with erectile dysfunction (ED).

Methods: The present publication shows the results of a subgroup analysis of a multinational post-marketing surveillance study, including 2824 Middle East patients with ED whose attending physician chose vardenafil as the most appropriate therapy. Patients were assessed at an initial visit for demographic and baseline characteristics. At one or two follow-up visits, covering a period of approximately 2 months or eight vardenafil intakes, patients were interviewed about overall treatment success (general improvement of erection, number of tablets taken until improvement, patient’s satisfaction with overall efficacy and tolerability, comparison with last ED treatment). All adverse events were recorded and assessed for a possible relationship to treatment, and for severity.

Results: An overall improvement in erections was reported in 94.3% of patients. Most patients achieved treatment success after the first (67.0%) or second (83.6% cumulative) tablet. Diabetic patients had a similar improvement rate (92.2%) and 73.5% of patients who had undergone radical prostatectomy reported an overall improvement. The rate of adverse drug reactions (ADRs) was low (9.1% of patients). The most common ADRs were headache (5.8%), flushing (1.6%), nasal congestion (1.0%), dyspepsia (0.6%) and nausea (0.5%). In total, 88.9% of patients wanted to continue treatment with vardenafil.

Conclusion: Vardenafil was effective, reliable and well tolerated in patients with ED treated under real-life conditions.

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This study was sponsored by Bayer HealthCare AG, Germany. Drs Fouad and Landen are employees of Bayer Healthcare; the other authors have no conflicts of interest that are directly relevant to the contents of this study.

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Correspondence to H. Landen.

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Kamel, A., Khaouli, R., Sabha, M. et al. The Real-Life Safety and Efficacy of Vardenafil. Clin. Drug Investig. 27, 339–346 (2007).

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