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Lee, Kim, and Kim: 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
Original Article
Korean Journal of Urology

Korean Journal of Urology 2006; 47(9): 1001-1006.

Published online: 30 September 2006

DOI: 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

Shin Young Lee, Sae-Chul Kim, Hyun Woo Kim1

Department of Urology, Chung-Ang University College of Medicine, Seoul, Korea.

1Department of Urology, The Catholic University of Korea College of Medicine, Seoul, Korea.

Corresponding author (saeckim@unitel.co.kr)

Received 3 May 2006       Accepted 8 August 2006

Copyright © 2006 The Korean Urological Association

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.

Keywords: Doxazosin, Tamsulosin, Vardenafil, Blood pressure

Figures and Tables

Table 1
Clinical characteristics of the patients (n=90)
kju-47-1001-i001

Mean±standard deviation (range). *IPSS: International Prostate Symptom Score, †IIEF-5: 5-item version of the International Index of Erectile Function, ‡BP: blood pressure

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
kju-47-1001-i002

Mean±standard deviation (range)

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
kju-47-1001-i003
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
kju-47-1001-i004

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