An open-label, prospective interventional study of the tolerability and efficacy of 0.4 mg oral tamsulosin oral controlled absorption system in men with lower urinary tract symptoms associated with benign prostatic hyperplasia who are unsatisfied with treatment with 0.2 mg tamsulosin.

Abstract

PURPOSE:

The aim of this study was to investigate the efficacy and tolerability of switching from 0.2 mg tamsulosin to 0.4 mg tamsulosin oral controlled absorption system (OCAS) over a 12-week period in Taiwanese men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).

PATIENTS AND METHODS:

Taiwanese male patients who were dissatisfied with treatment with 0.2 mg tamsulosin were enrolled in this clinical study and switched to 0.4 mg tamsulosin OCAS. Efficacy was assessed over a 12-week period by an International Prostate Symptom Score (IPSS) questionnaire and analysis of urinary flow by uroflowmetry.

RESULTS:

A statistically significant improvement was observed in total IPSS scores from baseline (14.94±7.41, moderate) to 12 weeks (7.36±5.77, mild) in 81 patients who were switched from 0.2 to 0.4 mg tamsulosin OCAS (P<0.001). The IPSS subscores for storage, voiding, nocturia, and quality of life (QOL) were also significantly improved over the 12-week period. Uroflowmetry analysis demonstrated significantly increased maximum flow rate, average flow rate, and mean voided volume from baseline to the end of the 12-week period. The 0.4 mg tamsulosin OCAS dose was well tolerated, with only mild dizziness (five patients) and headache (two patients) as the most frequent adverse events. No clinically significant reduction was observed in blood pressure or vital signs.

CONCLUSION:

Treatment with 0.4 mg tamsulosin OCAS in Taiwanese men with LUTS associated with BPH who were dissatisfied with 0.2 mg tamsulosin significantly improved IPSS scores, urinary flow, and QOL and was well tolerated, suggesting that this should be the recommended dose offered to Taiwanese male patients.

• Authors: Pei-Shan Yang, Chien-Lun Chen, Chen-Pang Hou, Yu-Hsiang Lin, Ke-Hung Tsui
• Journal: Clinical interventions in aging (Clin Interv Aging) Vol. 13 Pg. 235-242 ( 2018) ISSN: 1178-1998 [Electronic] New Zealand
• PMID: 29445269 (Publication Type: Clinical Trial, Phase IV, Journal Article, Randomized Controlled Trial)

Chemical References

• Sulfonamides
• Urological Agents
• Tamsulosin

Topics

• Administration, Oral
• Aged
• Aged, 80 and over
• Drug Tolerance
• Humans
• Lower Urinary Tract Symptoms (drug therapy, etiology, physiopathology)
• Male
• Middle Aged
• Patient Satisfaction
• Prospective Studies
• Prostatic Hyperplasia (complications, diagnosis, physiopathology)
• Quality of Life
• Sulfonamides (administration & dosage)
• Tamsulosin
• Treatment Outcome
• Urination (drug effects)
• Urological Agents (administration & dosage)