The Real-Life Safety and Efficacy of vardenafil (REALISE) study: results in men from Europe and overseas with erectile dysfunction and cardiovascular or metabolic conditions

J Sex Med. 2010 Sep;7(9):3161-9. doi: 10.1111/j.1743-6109.2010.01921.x.

Abstract

Introduction: The Real-Life Safety and Efficacy of vardenafil study is an international, open-label, prospective, noncomparative, noninterventional study in men with erectile dysfunction (ED).

Aim: To determine the safety and efficacy of vardenafil in a large international pool of men with ED (aged ≥ 18 years) and associated underlying conditions (N=73,946), in a real-life setting.

Methods: Patients attended an initial physician visit and one to two follow-up visits. Data were acquired by physician interviews and patient diaries and recorded in case report forms (CRFs). Data were pooled from 47 countries in Europe, Asia-Pacific, Latin America, and the rest of the world (excluding the United States and Japan for methodological reasons). Results were stratified by baseline ED severity, body mass index (BMI), and the presence of hypertension, diabetes, lipid metabolism disorder, or cardiovascular disease (CVD).

Main outcome measures: CRFs and patient questionnaires containing questions on overall improvement of erection, satisfaction with efficacy, and desire to continue vardenafil use.

Results: Many participants had hypertension (32.0%), diabetes (22.1%), lipid metabolism disorder (14.6%), or CVD (42.2%). High percentages of patients reported improvements in erectile function, irrespective of baseline ED severity (mild, 97.0%; moderate, 96.2%; severe, 85.5%), BMI (<25, 94.1%; ≥ 25 and <30, 94.6%; ≥ 30, 92.9%), or the presence of hypertension (93.6%), diabetes (92.6%), lipid metabolism disorder (94.7%), or CVD (93.3%). Over 90% of patients, including those with underlying conditions, reported being "satisfied" or "very satisfied" with vardenafil efficacy, and stated their intention to continue vardenafil use after the end of the study period. The incidence of adverse events was low, and 97.0% of patients were either "satisfied" or "very satisfied" with vardenafil tolerability.

Conclusions: These data from a worldwide population of men with ED and associated underlying conditions show that vardenafil is effective and well-tolerated for the treatment of ED in a real-life setting, supporting its use as a first-line ED therapy.

MeSH terms

  • Cardiovascular Diseases / epidemiology
  • Diabetes Mellitus / epidemiology
  • Erectile Dysfunction / drug therapy*
  • Erectile Dysfunction / epidemiology
  • Humans
  • Hypertension / epidemiology
  • Imidazoles / therapeutic use*
  • Lipid Metabolism Disorders / epidemiology
  • Male
  • Middle Aged
  • Patient Satisfaction
  • Phosphodiesterase 5 Inhibitors / therapeutic use*
  • Piperazines / therapeutic use*
  • Product Surveillance, Postmarketing
  • Prospective Studies
  • Severity of Illness Index
  • Sulfones / therapeutic use
  • Triazines / therapeutic use
  • Vardenafil Dihydrochloride

Substances

  • Imidazoles
  • Phosphodiesterase 5 Inhibitors
  • Piperazines
  • Sulfones
  • Triazines
  • Vardenafil Dihydrochloride