Efficacy of once-A-day terazosin in benign prostatic hyperplasia: A randomized, double-blind placebo-controlled clinical trial

Abstract

This randomized, placebo-controlled, double-blind study was performed to evaluate the efficacy and safety of once-a-day terazosin (10 mg/day) in ambulatory patients (n = 57) with benign prostatic hyperplasia (BPH). After a 4-week placebo lead-in and a 24-week treatment period with terazosin (both single-blind), 30 patients who responded to terazosin were randomly assigned to either the terazosin or placebo treatment group for 12 weeks.During the single-blind treatment period, the peak urine flow rate increased 54% from a baseline average of 7.76 ml/sec to 11.92 mYsec after terazosin; the mean flow rate increased 55% from a baseline of 4.90 ml/sec to 7.59 ml/sec; and the residual volume decreased 56% from 93.1 ml to 40.7 ml. The mean obstructive symptom score, irritative symptom score and physician's global assessment score improved by 68%. 34% and 27%, respectively. All these changes were significant (P < 0.05) when compared to baseline values.During the double-blind period, the improvement in all the variables was sustained in the terazosin group but not in the placebo group. Peak and mean urinary flow rates, and physician's global assessment showed significant ( P 5 0.05) differences at the end of the double-blind period. Adverse events occurred only during the single-blind period. The most frequent were headache (n = 6), asthenia (n = 3), and hypotension (n = 3).In summary, terazosin administered once-a-day improved the obstructive and irritative symptoms of BPH, urine flow rates and residual volume. Terazosin was well tolerated.

Rationale for the Inclusion of Alpha-Adrenergic Blockade in Benign Prostatic Hyperplasia Treatment Guidelines

“…Failure rates do not equal retreatment rates. In fact, patients might fail a treat ment due to lack of efficacy (-failure), but still not seek Roehrborn EurUrol 1996;29(suppl 1 ): [40][41][42][43][44][45][46][47][48] very similar to the compliance rate of patients with watch ful waiting, thermotherapy, balloon dilation, and prostate stents.…”

“…These trials must be prospective in nature, randomized to either drug or placebo (or sham in the case of device treat ments), and double-blind (or single-blind in the case of devices) [24], It is believed that some of the lower urinary tract symp toms caused by BPH are due to obstruction caused by the tone of the smooth muscle in the prostatic adenoma, the prostatic capsule, and the bladder neck [27], The tone of the smooth muscle is regulated by neurotransmitters of the adrenergic nervous system via ai-receptors located in these structures [28,29], a-Receptor blockade as a thera peutic concept in the treatment of prostatism was first explored by Caine in 1976, who used a short-acting, non specific a-receptor blocker, namely phenoxybenzamine [30], Today, long-acting, ai-receptor-specific blockers are being used for this purpose. Effectiveness has been dem onstrated in randomized, placebo-controlled, double blind clinical trials for alfuzosin [31], doxazosin [32][33][34][35], and terazosin [36][37][38][39][40][41], Effectiveness of treatment for BPE1 can be measured in a variety of ways. Traditionally, physicians have used residual urine and flow rate measurements as so-called objective outcome assessment tools, while symptom as sessment was considered a subjective assessment.…”

Does Anamnestic Symptom Evaluation or Clinical Examination Give Enough Information to Evaluate the Severity of Obstruction in Benign Prostatic Hyperplasia?

“…This has resulted in a great number of alternatives for the treatment of bladder outflow obstruction and the symptoms caused by it. TURP (l), open prostatectomy, balloon dilatation (14,26), stents (10,28), pharmacotherapy (15,17,24), bladder neck incision (1 l), lasers (12) and microwave thermotherapy (13) are some of the methods we have to evaluate and choose between. Many of these methods give excellent or fair symptomatic relief and clinical improvement of peak flow and some, such as TURP and open prostatectomy, have proved to be effective in relieving the infravesical obstruction (2,29).…”

Ionic Liquid Crystals Modifier for Selective Determination of Terazosin Antihypertensive Drug in Presence of Common Interference Compounds

“…Terazosin hydrochloride (TZ), 2-[4-(2-tetrahydrofuranyl) carbonyl]-1-piperazinyl-6,7-di-methoxy-4-quinazolinamine monohydro-chloride dehydrate, an alpha-1-selective adrenoceptor blocking agent, is a quinazoline derivative which is used to treat hypertension (high blood pressure) [1,2] and for the treatment of symptoms of an enlarged prostate [3,4]. Several methods for determination of this drug have been reported in the literature, including high performance liquid chromatography [5][6][7][8][9][10][11][12][13][14][15][16], capillary zone electrophoresis [17], spectrofluorimetry [18,19], X-ray fluorescence spectrometry based on the formation of ion-pair associates with zinc thiocyanate [20] and voltammetric methods [19,20].…”