Efficacy of Low-dose Tamsulosin on Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia : a Nonblind Multicentre Korean Study

Overview

Journal Clin Drug Investig

Date 2007 May 23

PMID 17516689

Citations 14

Authors

Choal Hee Park

Hyuk Soo Chang

Bong Ryul Oh

Hyung Jee Kim

Chong Koo Sul

Sung Kwang Chung

Se Il Jung

Affiliations

Soon will be listed here.

Abstract

Objective: To evaluate the efficacy and tolerability of tamsulosin 0.2mg once daily in Korean patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH), who were treated for up to 1 year.

Materials And Methods: Of the 211 patients from six urology outpatient centres who participated in this investigation, 146 patients were evaluable. Tamsulosin 0.2 mg/day was administered orally in a nonblind design for a 1-year period. The primary efficacy parameters were improvement in the total, obstructive and irritative International Prostate Symptom Score (IPSS), measured at baseline and at weeks 12, 24, 36 and 52, and in the maximal urinary flow rate (Qmax) measured at baseline and at weeks 24 and 52. The secondary efficacy parameters were a decrease of >/=30% in IPSS, and an increase in Qmax of >/=30% from baseline. Changes in parameters between baseline and 52 weeks were assessed using Student's paired t-test.

Results: Statistically significant, gradual improvements in all efficacy parameters were observed over the 1-year period. Tamsulosin 0.2 mg/day resulted in a mean reduction of 41.1% in total IPSS (p < 0.001) and a mean increase of 4.56 mL/sec in Qmax at 52 weeks (p < 0.001). Tamsulosin was well tolerated; adverse events occurred in 6.2% of patients and there were no withdrawals as a result of adverse events. There were no significant changes in blood pressure or pulse rate during the study.

Conclusions: One-year treatment with tamsulosin 0.2 mg/day in Korean patients with suspected BPH was well tolerated and effective in improving LUTS and urinary flow. The effect on symptoms was apparent after 12 weeks of treatment, and symptom improvement was observed for up to 1 year.

Citing Articles

Tamsulosin 0.8 mg daily dose in management of BPH patients with failed tamsulosin 0.4 mg monotherapy and unfit for surgical intervention.

Dogha M, Shaker H, Abdelazeez A, Abd-El Latif A, ElAdawy M World J Urol. 2024; 42(1):365.

PMID: 38822877 PMC: 11144140. DOI: 10.1007/s00345-024-05050-w.

Evaluation of intermittent tamsulosin in treating symptomatic patients with benign prostatic hyperplasia.

Soliman M, Al-Ghadeer M, Al-Shabaan H, Al-Hamrani A, AlGhadeer H Urol Ann. 2023; 15(1):43-47.

PMID: 37006221 PMC: 10062509. DOI: 10.4103/ua.ua_143_21.

Evaluation of the pharmacokinetics and food effects of a novel formulation tamsulosin 0.4 mg capsule compared with a 0.2 mg capsule in healthy male volunteers.

Ban M, Kim Y, Kim B, Jung J, Kim Y, Oh J Transl Clin Pharmacol. 2021; 28(4):181-188.

PMID: 33425801 PMC: 7781808. DOI: 10.12793/tcp.2020.28.e17.

Invasome: A Novel Nanocarrier for Transdermal Drug Delivery.

Babaie S, Del Bakhshayesh A, Ha J, Hamishehkar H, Kim K Nanomaterials (Basel). 2020; 10(2).

PMID: 32079276 PMC: 7075144. DOI: 10.3390/nano10020341.

A Prospective, Multicenter, Open-Label Study of Dose Escalation Therapy in Male Patients With Nocturia Refractory to 0.2-mg Tamsulosin Monotherapy.

Yu H, Lee J, Yu J, Cho M, Cho S Int Neurourol J. 2020; 23(4):294-301.

PMID: 31905276 PMC: 6944788. DOI: 10.5213/inj.1938076.038.

References

Abrams P, Schulman C, VAAGE S . Tamsulosin, a selective alpha 1c-adrenoceptor antagonist: a randomized, controlled trial in patients with benign prostatic 'obstruction' (symptomatic BPH). The European Tamsulosin Study Group. Br J Urol. 1995; 76(3):325-36. DOI: 10.1111/j.1464-410x.1995.tb07709.x. View

Kaplan S, Goluboff E, Olsson C, Deverka P, Chmiel J . Effect of demographic factors, urinary peak flow rates, and Boyarsky symptom scores on patient treatment choice in benign prostatic hyperplasia. Urology. 1995; 45(3):398-405. DOI: 10.1016/S0090-4295(99)80007-7. View

Garraway W, Collins G, Lee R . High prevalence of benign prostatic hypertrophy in the community. Lancet. 1991; 338(8765):469-71. DOI: 10.1016/0140-6736(91)90543-x. View

Schulman C, Cortvriend J, Jonas U, Lock T, VAAGE S, Speakman M . Tamsulosin: 3-year long-term efficacy and safety in patients with lower urinary tract symptoms suggestive of benign prostatic obstruction: analysis of a European, multinational, multicenter, open-label study. European Tamsulosin Study Group. Eur Urol. 1999; 36(6):609-20. DOI: 10.1159/000020056. View

Foglar R, Shibata K, Horie K, Hirasawa A, Tsujimoto G . Use of recombinant alpha 1-adrenoceptors to characterize subtype selectivity of drugs for the treatment of prostatic hypertrophy. Eur J Pharmacol. 1995; 288(2):201-7. DOI: 10.1016/0922-4106(95)90195-7. View

Caine M, Perlberg S, Meretyk S . A placebo-controlled double-blind study of the effect of phenoxybenzamine in benign prostatic obstruction. Br J Urol. 1978; 50(7):551-4. DOI: 10.1111/j.1464-410x.1978.tb06210.x. View

Lepor H . Long-term evaluation of tamsulosin in benign prostatic hyperplasia: placebo-controlled, double-blind extension of phase III trial. Tamsulosin Investigator Group. Urology. 1998; 51(6):901-6. DOI: 10.1016/s0090-4295(98)00127-7. View

Lepor H, Tang R, Kobayashi S, Shapiro E, Forray C, Wetzel J . Localization of the alpha 1A-adrenoceptor in the human prostate. J Urol. 1995; 154(6):2096-9. View

Forray C, BARD J, Wetzel J, Chiu G, Shapiro E, Tang R . The alpha 1-adrenergic receptor that mediates smooth muscle contraction in human prostate has the pharmacological properties of the cloned human alpha 1c subtype. Mol Pharmacol. 1994; 45(4):703-8. View

10.

Hampel C, Dolber P, Smith M, Savic S, Th roff J, Thor K . Modulation of bladder alpha1-adrenergic receptor subtype expression by bladder outlet obstruction. J Urol. 2002; 167(3):1513-21. View

11.

Noble A, Chess-Williams R, Couldwell C, Furukawa K, Uchyiuma T, Korstanje C . The effects of tamsulosin, a high affinity antagonist at functional alpha 1A- and alpha 1D-adrenoceptor subtypes. Br J Pharmacol. 1997; 120(2):231-8. PMC: 1564378. DOI: 10.1038/sj.bjp.0700907. View

12.

Lepor H . Phase III multicenter placebo-controlled study of tamsulosin in benign prostatic hyperplasia. Tamsulosin Investigator Group. Urology. 1998; 51(6):892-900. DOI: 10.1016/s0090-4295(98)00126-5. View

13.

Schulman C, Cortvriend J, Jonas U, Lock T, VAAGE S, Speakman M . Tamsulosin, the first prostate-selective alpha 1A-adrenoceptor antagonist. Analysis of a multinational, multicentre, open-label study assessing the long-term efficacy and safety in patients with benign prostatic obstruction (symptomatic BPH)..... Eur Urol. 1996; 29(2):145-54. View

14.

McKiernan J, Lowe F . Side effects of terazosin in the treatment of symptomatic benign prostatic hyperplasia. South Med J. 1997; 90(5):509-13. DOI: 10.1097/00007611-199705000-00009. View

15.

Berry S, Coffey D, Walsh P, EWING L . The development of human benign prostatic hyperplasia with age. J Urol. 1984; 132(3):474-9. DOI: 10.1016/s0022-5347(17)49698-4. View

16.

Lowe F . Safety assessment of terazosin in the treatment of patients with symptomatic benign prostatic hyperplasia: a combined analysis. Urology. 1994; 44(1):46-51. DOI: 10.1016/s0090-4295(94)80008-1. View

17.

Lepor H, Williford W, Barry M, Brawer M, DIXON C, Gormley G . The efficacy of terazosin, finasteride, or both in benign prostatic hyperplasia. Veterans Affairs Cooperative Studies Benign Prostatic Hyperplasia Study Group. N Engl J Med. 1996; 335(8):533-9. DOI: 10.1056/NEJM199608223350801. View

18.

Chapple C, Wyndaele J, Nordling J, Boeminghaus F, Ypma A, Abrams P . Tamsulosin, the first prostate-selective alpha 1A-adrenoceptor antagonist. A meta-analysis of two randomized, placebo-controlled, multicentre studies in patients with benign prostatic obstruction (symptomatic BPH). European Tamsulosin Study Group. Eur Urol. 1996; 29(2):155-67. View

19.

de Mey C . alpha(1)-blockers for BPH: are there differences?. Eur Urol. 1999; 36 Suppl 3:52-63. DOI: 10.1159/000052349. View

20.

Andersson K, Lepor H, Wyllie M . Prostatic alpha 1-adrenoceptors and uroselectivity. Prostate. 1997; 30(3):202-15. DOI: 10.1002/(sici)1097-0045(19970215)30:3<202::aid-pros9>3.0.co;2-n. View