Vardenafil improves erectile function in men with erectile dysfunction and associated underlying conditions, irrespective of the use of concomitant medications.
BACKGROUND
Men with erectile dysfunction (ED) are also likely to have associated underlying conditions.


OBJECTIVE
This retrospective analysis evaluated the efficacy and safety of vardenafil in men with ED and underlying conditions, including those taking concomitant medications.


METHODS
A total of 13 randomized, double-blind, placebo-controlled clinical studies were included. Vardenafil was administered at a starting dose of 10 mg, adjustable to 5 or 20 mg after 4 weeks. Efficacy analyses were performed on the intent-to-treat (ITT) population, using a last observation carried forward approach. Efficacy was assessed for subgroups of patients with diabetes, hypertension, dyslipidemia, or metabolic syndrome (as defined by International Diabetes Federation criteria). Incidence rates of treatment-emergent adverse events were analyzed overall and by subgroup for patients in the safety population.


METHODS
Primary efficacy measures were the erectile function domain of the International Index of Erectile Function (IIEF-EF), and Sexual Encounter Profile questions 2 and 3 (SEP2, SEP3).


RESULTS
In total, 4,326 patients were randomized to treatment; the ITT population included 4,143 patients, with 4,266 patients valid for safety. At 12 weeks, vardenafil therapy was associated with statistically significant improvements from baseline in IIEF-EF scores, and SEP2 and SEP3 success rates, including patients with ED and diabetes, hypertension, dyslipidemia, or metabolic syndrome. These improvements were irrespective of level of glycemic control, or use of concomitant medications for the treatment of diabetes, hypertension, or dyslipidemia. Across all subgroups, the number and type of treatment-emergent adverse events were consistent with results from previous studies of phosphodiesterase type 5 inhibitors in men with ED and underlying conditions.


CONCLUSIONS
Vardenafil demonstrated favorable efficacy and tolerability in this large pool of patients with ED and underlying conditions. Importantly, the use of concomitant medications was not associated with any noteworthy changes in the efficacy or safety profile of vardenafil.
Eardley
Ian
I
Pyrah Department of Urology, St. James's University Hospital, Leeds, UK. ian.eardley@btinternet.com
Lee
Jay C
JC
Shabsigh
Ridwan
R
Dean
John
J
Maggi
Mario
M
Neuser
Dieter
D
Norenberg
Christiane
C
D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D018783:Impotence, Vasculogenic / Q000188:drug therapy* / Q000209:etiology*; D008297:Male; D008875:Middle Aged; D010410:Penile Erection / Q000187:drug effects; D058986:Phosphodiesterase 5 Inhibitors; D010726:Phosphodiesterase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D013450:Sulfones / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D014227:Triazines / Q000009:adverse effects / Q000627:therapeutic use; D000069058:Vardenafil Dihydrochloride
D007093:Imidazoles; D058986:Phosphodiesterase 5 Inhibitors; D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D013450:Sulfones; D014227:Triazines; D000069058:Vardenafil Dihydrochloride