Published online Sep 30, 2006.
https://doi.org/10.4111/kju.2006.47.9.1001
Drug Interaction Study of Vardenafil 20mg and Doxazosin 4mg or Tamsulosin 0.2mg in Patients with Benign Prostatic Hyperplasia and Erectile Dysfunction to Evaluate Changes in Blood Pressure
Abstract
Purpose
This study aimed at evaluating the expected additive blood pressure (BP) lowering effect of vardenafil when administered in the background of chronic α1-blocker therapy.
Materials and Methods
Patients (n=90) with symptomatic benign prostatic hypertrophy (BPH) and erectile dysfunction (ED) took vardenafil 20mg in the morning following repeated doxazosin gastrointestinal therapeutic system (GITS) 4mg (n=60) or tamsulosin 0.2mg (n=30) HS a day for 30 days. The standing and sitting BP at baseline, before taking the vardenafil and 30 minutes and 1 hour post vardenafil were measured 3 consecutive times. The data were analyzed by Student's t-test (paired), repeated measures of two-way ANOVA, chi-square tests and Pearson correlation analysis.
Results
Doxazosin produced a significant reduction in systolic/diastolic BP (-12.3/-6.7mmHg), but tamsulosin did not. In the doxazosin group, the average reductions in BP from baseline (-24.7/-15.8mmHg) were significantly higher than that for the tamsulosin group (-14.6/-7.5mmHg). However, the average BP change was not different in both group (-12.4/-9.1mmHg in the doxazosin group and -11.3/-6.4mmHg in the tamsulosin group) following a single dose of 20mg vardenafil. The higher the BP was at baseline, the more the reduction in BP was in both the doxazosin and tamsulosin groups. Two patients of tamsulosin showed a sitting systolic BP <85mmHg, but they didn't experience dizziness.
Conclusions
We recommend starting Vardenafil treatment in the background of chronic α1 blocker therapy, including tamsulosin, with a low dose and to increase the dose by monitoring the BP, particularly for the patients with hypertension.
Table 1
Clinical characteristics of the patients (n=90)
Table 2
Changes of blood pressure (BP) by a single dose of vardenafil 20mg from baseline following repeated doxazosin 4mg or tamsulosin 0.2mg therapy of 30 days
Table 3
The patients with a significant change of blood pressure by a single dose of vardenafil 20mg from baseline following repeated doxazosin 4mg or tamsulosin 0.2mg therapy for 30 days
Table 4
Blood pressure by a single dose of vardenafil 20mg from baseline following repeated doxazosin 4mg or tamsulosin 0.2mg therapy for 30 days in normotensive, prehypertensive and hypertensive patients
References
-
Cha JS, Park JK. Association between lower urinary tract symptoms and erectile dysfunction. Korean J Urol 2005;46:1023–1027.
-
-
de Mey C. Cardiovascular effects of alpha-blockers used for the treatment of symptomatic BPH: impact on safety and well-being. Eur Urol 1998;34 Suppl 2:18–28.
-
-
Mazzu A, Sundaresan P, Xia C. In: Bayer Pharmaceutical data file. 2003. An interaction study to evaluate changes in blood pressure and pulse rate following vardenafil compared to placebo treatment on the background of the alpha-blockers, tamsulosin and terazosin, in separate cohorts of patients with benign prostatic hyperplasia.
-
-
Spera P, Dabiri G, Ilson B, Montague T, Patel B, Diringer K. In: Bayer Pharmaceutical data file. 2003. A radnomized, double-blind, placebo-controlled, two-part, three period crossover drug interaction study of vardenafil (10mg and 20mg) and tamsulosin (0.4mg) in healthy males aged 45 to 75 to evaluate changes in blood pressure.
-
-
Cases A. Doxazosin in a gastrointestinal therapeutic system formulation. Drugs Today (Barc) 2000;36:679–688.
-
-
Kloner RA, Mohan P, Segerson T, Thibonnier M, Norenberg C, Padma-Nathan H. Cardiovascular safety of vardenafil in patients receiving antihypertensive medication: a post-hoc analysis of five placebo-controlled clinical trials. J Am Coll Cardiol 2003;41:276A.
-