The real-life safety and efficacy of vardenafil: an international post-marketing surveillance study--results from 29 358 German patients

J Int Med Res. May-Jun 2005;33(3):337-48. doi: 10.1177/147323000503300309.


We assessed the safety, efficacy and patient acceptability of vardenafil (Levitra, Bayer HealthCare, Leverkusen, Germany) under real-life conditions in patients with erectile dysfunction (ED) in a multinational post-marketing surveillance study. An initial and up to two follow-up visits were documented for 29 358 German ED patients receiving vardenafil. Patients were interviewed about overall treatment success, and individual sexual attempts were evaluated in a patient questionnaire. Overall erectile improvement was reported by 93.9% of physicians, and similar improvement rates were reported for both 10 mg and 20 mg vardenafil dosages. Most patients experienced improved erections after the first (73.6%) or second (88.5%) tablet. Sexual attempts were successful with respect to partner penetration in 94.9% of patients and with respect to maintenance of erection during intercourse in 87.7% of patients. Adverse drug reactions were very rare (1.3% of patients). Vardenafil was highly effective, reliable and well tolerated in ED patients treated under real-life conditions.

MeSH terms

  • Aged
  • Erectile Dysfunction / drug therapy*
  • Germany
  • Humans
  • Imidazoles / adverse effects
  • Imidazoles / pharmacology*
  • International Cooperation
  • Male
  • Middle Aged
  • Penile Erection
  • Phosphodiesterase Inhibitors / adverse effects
  • Phosphodiesterase Inhibitors / pharmacology
  • Piperazines / adverse effects
  • Piperazines / pharmacology*
  • Prospective Studies
  • Safety
  • Sulfones / adverse effects
  • Sulfones / pharmacology
  • Surveys and Questionnaires
  • Time Factors
  • Treatment Outcome
  • Triazines / adverse effects
  • Triazines / pharmacology
  • Vardenafil Dihydrochloride


  • Imidazoles
  • Phosphodiesterase Inhibitors
  • Piperazines
  • Sulfones
  • Triazines
  • Vardenafil Dihydrochloride