Original Articles Efficacy and Safety of Doxazosin (CARDURATM) in the Management of Benign Prostatic Hyperplasia

Abstract

Objective
To assess the efficacy and safety of the selective á -blocker doxazosin in black men with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia.
Patients and Methods
An open-label study involving consecutive patients with benign prostatic hyperplasia. They were asked to complete the International Prostate Symptom Score (IPSS), with its eighth question (bother score) and perform basic uroflowmetry. The study involved the use of doxazosin for the treatment of symptomatic benign prostatic hyperplasia in three phases. Phase 1 of washout period/enrolment, a two weekly interval titration phase and a maintenance phase for four weeks. The symptom score (IPSS), bother score and uroflowmetry were used to evaluate the severity of the condition and the efficacy of the drug.
Results
Twenty-four patients were enrolled into the study, only 18(75%) completed the eight-week study. The ages of the patients ranged between 46 years and 82 years with a mean of 66 years. (SD, 10.0). Fourteen patients were stabilized on 4mg doxazosin while the remaining 4 patients had 2mg. There was significant improvement of the symptoms, with a remarkable sharp decline after two weeks of medication in IPSS by 8 points from baseline. The improvement was sustained over the following six weeks period. The bother score (quality of life index) was similarly observed to decline from a mean of 4.7 at baseline to 1.3 at the end of the study. The clinical trial showed a significant increase in the urine flow rate with an improvement of 4mls/second from baseline and a 24.1% increase in voided volume. There was no adverse event recorded in all the patients to warrant discontinuation of the study.
Conclusion
Doxazosin is an effective and well tolerated drug in the treatment of symptomatic BPH in Nigerians.

Key Words: BPH, LUTS, Quality of life, IPSS, a1-blocker, Doxazosin.