PTU - Polskie Towarzystwo Urologiczne
list of articles:

The real-life safety and efficacy of vardenafil: an international post-marketing surveillance study - results from 5373 polish patients
Article published in Urologia Polska 2006/59/4.

authors

Piotr Trypens 1, Andrzej Depko 2, Roland Dadej 3, Harald Landen 4
1 UroVes Przychodnia Urologiczna w Warszawie
2 Poradnia Seksuologiczna Specjalistycznej Przychodni Lekarskiej dla Pracowników Wojska SPZOZ w Warszawie
3 Katedra i Klinika Urologii Akademii Medycznej w Poznaniu
4 Bayer HealthCare, Leverkusen, Niemcy

keywords

erectile dysfunction, vardenafil, surveillance study

summary

Introduction and the aim of the study. Erectile dysfunction (ED) is usually a serious problem for patient and it may markedly impair his quality of life. The management of ED has dramatically changed since the introduction of orally administered phosphodiesterase 5 (PDE 5) inhibitors. The aim of this study was to evaluate the efficacy, tolerability and patient acceptability of vardenafil under day-to-day clinical practice conditions.
Material and methods. In this non-controlled, non-interventional post-marketing surveillance study, 5373 patients attended to initiating and at least one control physician visits over approximately two months. Information on treatment success, successful penetration (SEP-2), maintenance of erection (SEP-3), and satisfaction with erection was obtained via physician interview and a voluntarily completed patient questionnaire.
Results. The large majority of patients reported an overall improvement in ED (97.9%), with similar improvements rates for the 10 mg (97.9%) and 20 mg (97.8%) doses. Most patients achieved treatment success after the first (78.7%) or second tablet (93% cumulative). Sexual attempts were successful with respect to partner penetration in 96.8% of patients and with respect to maintenance of erection during intercourse in 88.3% of patients. Vardenafil was generally well tolerated. Adverse events were very rare (0.7%), predominantly headache, flushing and flue syndrome were reported.
Conclusion. Under "real life" conditions encountered in clinical practice, vardenafil was an effective, reliable and well-tolerated treatment for patients with ED.

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correspondence

Piotr Trypens
UroVes Przychodnia Urologiczna
00-572 Warszawa
ul. Wyzwolenia 13
tel. (022) 621 84 16
piotr.trypens@uroves.pl