A randomised, double-blind study comparing the efficacy and tolerability of controlled-release doxazosin and tamsulosin in the treatment of benign prostatic hyperplasia in Brazil

Abstract

SUMMARYBrazilian patients with benign prostatic hyperplasia were randomised in a 12-week, double-blind, double-dummy study to receive doxazosin gastrointestinal therapeutic system (GITS) 4 mg q.i. I N T R O D U C T I O NBenign prostatic hyperplasia (BPH) is a non-malignant enlargement of the prostate that can cause bladder obstruction leading to lower urinary tract symptoms (LUTS) as the increased prostatic mass compresses the urethra and inhibits urinary flow (1). The incidence of BPH increases proportionately with advancing age, with more than 70% of men older than 70 years having histologic evidence of BPH (2).Selective a 1 -adrenoceptor antagonists are considered the first line of standard pharmacologic treatment for patients with BPH (3). These agents reduce urethral pressure (3) and inhibit smooth muscle tone in the prostate and lower urinary tract (4) by interrupting the motor sympathetic adrenergic nerve supply to the prostate, reducing the pressure, and improving the LUTS and urinary function in patients with BPH (5).Although all of the currently available a 1 -adrenoceptor antagonists have demonstrated efficacy in the treatment of BPH, each is unique in its affinity for various receptor subtypes (a 1A , a 1B and a 1D ) (3) and, thus, the potential for both beneficial and adverse events (AEs). Doxazosin and tamsulosin, both a 1 -adrenoceptor antagonists, have been shown to provide the relief of symptomatic BPH with once-daily dosing. The efficacy of doxazosin, a long-acting, selective a 1 -adrenoceptor antagonist, has been demonstrated by improvements in urinary flow rate and symptomatic measures (e.g. nocturia, hesitancy, urgency and weak stream) (6,7). Recently, a controlled-release formulation, doxazosin gastrointestinal therapeutic system (GITS), has been shown to enhance the pharmacokinetic profile and drug delivery rate, minimising the fluctuations and extending the time to peak serum concentration compared with the doxazosin standard formulation (8). Doxazosin GITS eliminates the need for

Comparative rapid onset of efficacy between doxazosin gastrointestinal therapeutic system and tamsulosin in patients with lower urinary tract symptoms from benign prostatic hyperplasia: a multicentre, prospective, randomised study

“…Our study showed that early onset (1 week and 4 weeks) efficacy of doxazosin‐GITS is superior to that of tamsulosin. This result is consistent with a previous report demonstrating that improvement in LUTS was significantly greater at 4 weeks for doxazosin‐GITS than it was for tamsulosin (17). Similarly, a significant difference in IPSS obstructive subscore between the two drugs after the first 4 weeks of treatment was noted, in a 20‐week, randomised, crossover study (18).…”

“…Similarly, a significant difference in IPSS obstructive subscore between the two drugs after the first 4 weeks of treatment was noted, in a 20-week, randomised, crossover study (18). We believe that the superior effect of doxazosin-GITS over tamsulosin with regard to total IPSS may be explained by the non-subtypespecific antagonism of a1-adrenoreceptors (ARs) by doxazosin-GITS or by its proapoptotic effects on the a1-(ARs) of prostatic smooth muscle, as suggested by other reports (15,(17)(18)(19).…”

Impact of Medical Treatments for Male Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia on Ejaculatory Function: A Systematic Review and Meta-Analysis

“…A single study compared Tamsulosin and Doxazosin [24], demonstrating similar rates of EjD for the 2 drugs (4.8% vs. 2.4%, respectively; OR 0.49; CI: 0.09–2.77; P = 0.42). Conversely, data for about 1,400 patients from 4 RCTs evaluated are available for comparison of Silodosin and Tamsulosin.…”

“…The remaining 91 papers were evaluated in full text form. Once excluded duplicate publication (n = 65), review paper (n = 2), open‐label extension studies (n = 4), cross‐over studies (n = 1), studies with duration <12 weeks (n = 2), retrospective studies (n = 4), we obtained 13 RCTs [12–24], including more than 33 000 patients. Moreover 9 further RCTs were identified from the Cochrane search [10,25–32].…”

Current role of α‐blockers in the treatment of benign prostatic hyperplasia

“…Improvement in symptoms was significantly greater ( P < 0.001) at 4 weeks in patients receiving doxazosin GITS compared with those receiving tamsulosin. Additionally, the proportion of patients reporting little or no difficulty in ejaculation was greater in patients treated with doxazosin GITS than patients treated with tamsulosin ( P = 0.019) [27].…”