Effect of vardenafil on blood pressure profile of patients with erectile dysfunction concomitantly treated with doxazosin gastrointestinal therapeutic system for benign prostatic hyperplasia.
OBJECTIVE
We investigated the effect of the combination of the doxazosin gastrointestinal therapeutic system and 10 mg vardenafil on the hemodynamic status of patients with benign prostatic hyperplasia and erectile dysfunction.


METHODS
This was a double-blinded, randomized, placebo controlled crossover trial. Patients with benign prostatic hyperplasia and erectile dysfunction treated with the doxazosin gastrointestinal therapeutic system on a regular basis, with no other antihypertensive events, were recruited. Subjects took 10 mg vardenafil or placebo in a randomized crossover fashion with a washout period of at least 7 days between each treatment. The supine and standing blood pressure of the subjects was recorded from 1 hour before to 6 hours after the administration of vardenafil or placebo. The primary outcome of the study was the maximal change in standing systolic blood pressure of the subjects from 1 half hour before to 6 hours after the administration of drugs.


RESULTS
A total of 37 patients, 25 (67.6%) and 12 (32.4%) on the doxazosin gastrointestinal therapeutic system at 4 mg and 8 mg, respectively, completed the trial. The combination drug therapy resulted in a maximal decrease in standing systolic blood pressure of 6.18 mm Hg (95% CI -12.02, -0.33; p = 0.039). Only 1 patient had an asymptomatic standing systolic blood pressure of less than 85 mm Hg. Otherwise no symptomatic hypotension or clinically significant adverse cardiovascular event was observed during the study.


CONCLUSIONS
In patients on the doxazosin gastrointestinal therapeutic system for benign prostatic hyperplasia a single 10 mg dose of vardenafil had no symptomatic hemodynamic effects.
Ng
Chi-Fai
CF
Division of Urology, Department of Surgery, The Chinese University of Hong Kong, Hong Kong SAR, China. ngcf@surgery.cuhk.edu.hk
Wong
Annie
A
Cheng
Chi-Wai
CW
Chan
Eddie Shu-Yin
ES
Wong
Hon-Ming
HM
Hou
See-Ming
SM
D000317:Adrenergic alpha-Antagonists / Q000627:therapeutic use*; D000368:Aged; D000704:Analysis of Variance; D001794:Blood Pressure / Q000187:drug effects*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D017292:Doxazosin / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D007172:Erectile Dysfunction / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010726:Phosphodiesterase Inhibitors / Q000627:therapeutic use*; D010879:Piperazines / Q000627:therapeutic use*; D010919:Placebos; D011470:Prostatic Hyperplasia / Q000150:complications / Q000188:drug therapy*; D013450:Sulfones / Q000627:therapeutic use; D016896:Treatment Outcome; D014227:Triazines / Q000627:therapeutic use; D000069058:Vardenafil Dihydrochloride
D000317:Adrenergic alpha-Antagonists; D007093:Imidazoles; D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D010919:Placebos; D013450:Sulfones; D014227:Triazines; D000069058:Vardenafil Dihydrochloride; D017292:Doxazosin