The Real-Life Safety and Efficacy of Vardenafil (REALISE) study – results from the Latin-American region

Jasperson, J⁽¹⁾; Da Ros, CT⁽²⁾; Gromatzky, C⁽³⁾; Salas, M⁽⁴⁾; Amenabar Soto, CA⁽⁵⁾; Iraheta Martí, H⁽⁶⁾; Oquelí Torres, C⁽⁷⁾; Espino Corea, O⁽⁸⁾; Grunhaus, A⁽⁹⁾; Fletcher, E⁽¹⁰⁾; Grullon, E⁽¹¹⁾; Landen, H⁽¹²⁾

⁽¹⁾Hospital General de México, Mexico City ⁽²⁾Department of Urology, Santa Casa de Porto Alegre ⁽³⁾Department of Urology, Universidade de São Paulo ⁽⁴⁾ Hospital Depreca, Santiago ⁽⁵⁾Universitario Esperanza, Guatemala City ⁽⁶⁾Hospital de La Mujer, San Salvador ⁽⁷⁾Hospital y Clinicas Viera, Tegucigalpa ⁽⁸⁾Clínica de Impotencia Sexual ⁽⁹⁾Hospital Cima, San José ⁽¹⁰⁾Centro Médico Especializado, San Fernando ⁽¹¹⁾Clínica Unión Médica ⁽¹²⁾Bayer HealthCare

Objectives: To determine the safety, efficacy and patient acceptance of vardenafil 5, 10 and 20 mg in real-life use.

Material and Methods: A prospective, international post-marketing surveillance study was conducted to evaluate the use of vardenafil for erectile dysfunction (ED) in routine clinical practice. Patients prescribed vardenafil were followed-up for a period of 2 months. Safety and efficacy were assessed under daily life conditions with data acquired by interviews. We report an evaluation of pooled data collected in 21 countries in the Latin-American region.

Results: Data were analyzed from 10,837 men with ED with a mean age of 54.2 (SD 10.8) years. Vardenafil 10 mg was the most frequently used dose (91.2%) at start of therapy. Dose changes during the course of the study occurred rarely (91.9% without dose changes). In 94.5% of patients the erections had improved under vardenafil. Many patients had ED-related concomitant disease, in particular type 2 diabetes (24.9%), hypertension (30.2%) or lipid metabolic disorders (BPH, 13.0%). Improvement of ED was comparable across most subgroups. Improvement was seen after the first tablet in 69.1% of patients responding to therapy, this was 84.7% (cumulative) after the first or second tablet. Among 4370 patients pretreated for ED, 3505 (80.2%) preferred vardenafil over their previous treatment. Vardenafil was generally well tolerated. Overall tolerability was rated very satisfying/satisfying by 94.9% of patients, whereas 2.6% were unsatisfied. Adverse drug reactions (ADRs) were experienced by 881 patients (8.1%). Symptoms such as headache (4.3%), erythema (1.6%) and nasal congestion (0.8%), all associated with the mode of action of phosphodiesterase-type 5 inhibitors, were predominant.

Conclusions: Vardenafil showed very good safety and efficacy in this non-interventional study in 10,837 patients. The results from this large pool of data were consistent with findings from other open-label studies of vardenafil.