A Randomized, Placebo-Controlled Multicenter Study of the Efficacy and Safety of Terazosin in the Treatment of Benign Prostatic Hyperplasia

Lepor, Herbert; Auerbach, Stephen M.; Puras-Baez, Anthony; Narayan, Perinchery; Soloway, Mark S.; Lowe, Franklin C.; Moon, Timothy D.; Leifer, Gary; Madsen, Paul O.

doi:10.1016/s0022-5347(17)36941-0

Cited by 291 publications

(129 citation statements)

References 29 publications

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“…In Japan, terazosin and tamsulosin are widely used for the treatment of BPH. Although an incremental dose regimen of terazosin (2± 10 mg once daily at bedtime) [10] is recommended in Western countries, 1±2 mg daily is advised in Japan. The dose of terazosin required to maintain effective blood levels in Japanese people is about one-third of that required in Caucasians and the dose suitable for treating BPH seems to be lower in Japan than that in Western countries [18].…”

Section: Discussionmentioning

confidence: 99%

A comparative study of terazosin and tamsulosin for symptomatic benign prostatic hyperplasia in Japanese patients

et al. 2000

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Objective To compare the ef®cacy and safety of an incremental-dose regimen of terazosin (1±2 mg daily) and a ®xed-dose regimen of tamsulosin (0.2 mg daily), on Japanese patients with symptomatic benign prostatic hyperplasia (BPH). Patients and methods This multicentre, single-blind, randomized trial compared terazosin and tamsulosin over 4 weeks, in 61 patients with symptomatic BPH randomly assigned to terazosin (n=31) or tamsulosin (n=30). Terazosin 0.5 mg twice daily was administered for 2 weeks, followed by 1 mg twice daily for 2 weeks. Tamsulosin (0.2 mg) was administered once daily for 4 weeks. Symptoms were evaluated using the International Prostate Symptom Score (IPSS), and quality of life (QOL) was assessed subjectively before treatment, and again after 2 and 4 weeks of treatment.Objective measurements taken before and after the treatment period were the maximum (Q max ) and average (Q ave ) urinary¯ow rates, and the percentage residual urine volume. Improvement was de®ned as a 25% decrease from baseline in IPSS, >1 point increase in QOL score, and >2.5 mL/s increase in Q max . Adverse reactions potentially related to the study drugs were recorded throughout the treatment period. Results Both terazosin and tamsulosin produced statistically signi®cant improvements in subjective and objective variables. Neither treatment affected systolic or diastolic blood pressure or pulse rate. Adverse reactions were noted in four patients (three in the terazosin group and one in the tamsulosin group). However, there was no statistically signi®cant difference in the incidence of adverse effects between the groups. Conclusions Despite the limitations of small sample size and relatively short treatment periods, terazosin and tamsulosin were equally effective in the treatment of symptomatic BPH in Japanese patients, using relatively lower doses than those used in Western countries.

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Section: Discussionmentioning

confidence: 99%

A comparative study of terazosin and tamsulosin for symptomatic benign prostatic hyperplasia in Japanese patients

et al. 2000

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“…Blocking the a 1 -adrenergic receptors in the prostate results in relaxation of the smooth muscle, decreasing the dynamic component, and contributing to improvements in the symptoms of BPH. 4 A great deal of experience has been obtained with the use of selective a 1 -adrenoceptor antagonists, such as doxazosin, in hypertension, and are recommended as ®rst-line treatment for essential hypertension by the World Health Organization/The International Society of Hypertension 5 and the Joint National Committee on the Detection, Evaluation and Treatment of Hypertension. 6 Various studies have shown that a 1 -adrenoceptor antagonists can alleviate the symptoms of BPH, 4,7±9 and the use of these agents for the treatment of BPH has been endorsed in international guidelines.…”

Section: Introductionmentioning

confidence: 99%

Morning vs evening dosing with doxazosin in benign prostatic hyperplasia: efficacy and safety

Kirby

Chapple

Sethia

et al. 1998

Prostate Cancer Prostatic Dis

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Three hundred and ®fty-three patients with symptomatic benign prostatic hyperplasia were randomized to doxazosin or placebo, with morning or evening dosing, to compare the effect of dosing time on the ef®cacy and safety of doxazosin treatment. After 24 weeks of treatment, the mean International Prostate Symptom Score had decreased by 6.8 units in the doxazosin group compared with 4.5 units in the placebo group (P 0.003). Improvements in Q max of 2.03 mlas and 0.30 mlas were seen for the doxazosin and the placebo groups, respectively (P`0.001). No differences in ef®cacy or safety between the morningand evening-dosed subgroups were observed. Doxazosin was signi®cantly more effective than placebo at improving symptoms of BPH and urinary¯ow rates at endpoint, and was well tolerated. The time of dosing did not appear to in¯uence the ef®cacy or safety of doxazosin, suggesting that there is no need to restrict administration of doxazosin to the evening in BPH patients.

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“…Traditionally, BPH patients have been treated by transurethral resection of the prostate or by open prostatectomy. However, several al-adrenoceptor antagonists have been found to be useful for treating difficulty in urination, and are now in clinical use (Abrams et al, 1982;Kawabe et al, 1990;Lepor et al, 1992). Yet different antagonists have different effects on BPH, suggesting the existence of subtypes of the oel-adrenoceptor.…”

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confidence: 99%

Quantification and distribution of α1‐adrenoceptor subtype mRNAs in human prostate: comparison of benign hypertrophied tissue and non‐hypertrophied tissue

Nasu

Moriyama

Kawabe

et al. 1996

British J Pharmacology

160

127

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1 There are at least three cxl-adrenoceptor subtypes, cxla, alb and ald, in human tissues. Using an RNase protection assay, we have now determined the amount of each subtype mRNA in human prostatic tissue, for both benign prostatic hypertrophy (BPH) and non-BPH. In all tissue samples examined, the predominant subtype mRNA was ala. The total abundance of al-adrenoceptor mRNA in BPH samples was over six times that in non-BPH samples. This increase was mostly accounted for by ala, which was almost nine times as abundant in BPH samples as in non-BPH samples. The abundance of alb was almost the same between BPH and non-BPH samples, and the abundance of ald in BPH samples was about three times that in non-BPH samples. The ratio of the numbers of the subtype mRNAs, ala: alb: ald, was 85:1:14 in BPH samples and 63 :6:31 in non-BPH samples. 2 In situ hybridization studies showed no significant differences in the tissue localization of Lxladrenoceptor subtype mRNAs between BPH and non-BPH samples. atla and acld were clearly detected in the interstitium of the prostate, where axla was stained more intensely than Lxld, and the positive sites were primarily smooth muscle cells. In contrast, alb staining was very faint. 3 This increase in mRNA abundance may be directly related to the contraction of prostatic tissue that leads to obstruction of the urinary tract in BPH patients. Specifically, our data suggest that increased expression of the Lxla subtype may be primarily responsible for the contraction of the prostate.

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A Randomized, Placebo-Controlled Multicenter Study of the Efficacy and Safety of Terazosin in the Treatment of Benign Prostatic Hyperplasia

Cited by 291 publications

References 29 publications

A comparative study of terazosin and tamsulosin for symptomatic benign prostatic hyperplasia in Japanese patients

A comparative study of terazosin and tamsulosin for symptomatic benign prostatic hyperplasia in Japanese patients

Morning vs evening dosing with doxazosin in benign prostatic hyperplasia: efficacy and safety

Quantification and distribution of α1‐adrenoceptor subtype mRNAs in human prostate: comparison of benign hypertrophied tissue and non‐hypertrophied tissue

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