Response to On-demand Vardenafil was Improved by its Daily Usage in Hypertensive Men

• Published in: Urology (Ridgewood, N.J.) Vol. 80; no. 4; pp. 858 - 864
• Main Authors: Javaroni, Valter, Queiroz Miguez, Marcio, Burla, Adriana, Oigman, Wille, Neves, Mario Fritsch
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.10.2012; Elsevier
• Subjects: Aged; Arterial hypertension. Arterial hypotension; Biological and medical sciences; Blood and lymphatic vessels; Blood Glucose - metabolism; Brachial Artery - drug effects; Brachial Artery - physiology; Cardiology. Vascular system; Carotid Intima-Media Thickness; Cholesterol, LDL - blood; Erectile Dysfunction - blood; Erectile Dysfunction - complications; Erectile Dysfunction - drug therapy; Humans; Hypertension - complications; Imidazoles - administration & dosage; Logistic Models; Male; Medical sciences; Middle Aged; Multivariate Analysis; Nephrology. Urinary tract diseases; Nitrates - pharmacology; Phosphodiesterase 5 Inhibitors - administration & dosage; Piperazines - administration & dosage; Sulfones - administration & dosage; Surveys and Questionnaires; Treatment Outcome; Triazines - administration & dosage; Urology; Vardenafil Dihydrochloride; Demand; Human; Hypertension; Nephrology; Vasodilator agent; 3',5'-Cyclic-GMP phosphodiesterase; Enzyme; Enzyme inhibitor; Cardiovascular disease; Male; Esterases; Vardenafil; Phosphoric diester hydrolases; Urology; Phosphodiesterase inhibitor; Phosphodiesterase 5 inhibitor; Daily; Hydrolases; Adult
• ISSN: 0090-4295; 1527-9995
• DOI: 10.1016/j.urology.2012.06.042

Objective To evaluate whether the response to on-demand vardenafil could be improved by its daily usage in hypertensive men with erectile dysfunction (ED) who previously did not answer to on-demand regime. Methods Our main efficacy criterion was per patient percentage of positive answers on the Sexual Encounter Profile question 3 (SEP3). Carotid intima-media thickness (IMT), flow-mediated dilation (FMD), and nitrate-mediated dilation on brachial artery were considered as vascular parameters. A total of 74 hypertensive men with ED aged 50 to 70 years with no major cardiovascular disease were selected from 284 patients initially referred. After vardenafil on-demand usage during 4 weeks, patients with more than 50% of positive answers on the SEP3, or 50% and more than 6 points on the International Index of Erectile Function-Erection Function Domain (IIEF-EF) basal score or positive answer to global evaluation question were considered “responders.” “Nonresponders” (n = 35) were randomized to daily vardenafil 10 mg or placebo during 5 weeks along with open 10 mg of vardenafil before intercourse. Results In the active group, 38.8% of patients became responders to vardenafil ( P < .05). Clinical response to continuous vardenafil correlated with sexual frequency ( r = .68, P < .01), Framingham risk score ( r = −.65, P < .01), carotid IMT ( r = −.61, P = .01) and low-density lipoprotein (LDL)-cholesterol ( r = −.64, P < .01). Conclusion Daily vardenafil during 5 weeks rescued response to on-demand regime among ED hypertensive men with no major cardiovascular disease. Further clinical trials and cost-effectiveness studies are necessary to confirm these findings.