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Dutasteride/tamsulosin: in benign prostatic hyperplasia.

Gillian M Keating¹

¹Adis, Auckland, New Zealand.

|May 4, 2012

Summary

Combination therapy with dutasteride and tamsulosin significantly improves lower urinary tract symptoms (LUTS) and quality of life in men with benign prostatic hyperplasia (BPH). This fixed-dose combination offers superior efficacy compared to monotherapy.

Area of Science:

Urology
Pharmacology

Background:

Benign prostatic hyperplasia (BPH) is a common condition in aging men.
Symptomatic BPH significantly impacts quality of life and can lead to complications.
Available treatments include 5α-reductase inhibitors and α(1)-adrenergic receptor antagonists.

Purpose of the Study:

To evaluate the efficacy and safety of a fixed-dose combination of dutasteride and tamsulosin.
To compare the combination therapy against monotherapy with dutasteride or tamsulosin.
To assess the impact on lower urinary tract symptoms (LUTS) and disease progression in men with BPH.

Main Methods:

Randomized, double-blind, multinational CombAT trial.
Participants with symptomatic BPH, moderate to severe LUTS, and increased risk of progression were included.

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Evaluated outcomes included International Prostate Symptom Score (IPSS), time to acute urinary retention or BPH-related surgery, quality of life, and treatment satisfaction.

Main Results:

Dutasteride plus tamsulosin demonstrated significantly greater improvement in total IPSS compared to either monotherapy at 2 and 4 years.
The combination therapy significantly reduced the time to acute urinary retention or BPH-related surgery compared to tamsulosin alone.
Health-related quality of life and treatment satisfaction were significantly higher with the combination therapy.

Conclusions:

Fixed-dose combination of dutasteride and tamsulosin is more effective than monotherapy for managing symptomatic BPH.
The combination therapy offers significant benefits in symptom relief, disease progression, and patient-reported outcomes.
Combination therapy was generally well-tolerated in the study population.