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1. A combination of an α-blocker (tamsulosin) and 5α reductase inhibitor (dutaseride) was shown to be superior to monotherapy for improvement in lower urinary tract symptoms for those with moderate to severe benign prostatic hyperplasia (BPH).
2. Improvement in average quality of life score was greater with combination therapy group than either single drug study group at 48 months.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Male patients with lower urinary tract symptoms (LUTS) who are at risk of progression of benign prostatic hyperplasia (BPH) are often treated with a 5α reductase inhibitor (5ARI), an α-blocker, or combination therapy (CT). This study measured both LUTS and quality of life (QoL) as it relates to said symptoms in patients taking one of these regimens over a 48 month period. In regard to baseline patient characteristics, those with prostate volume (PV) ≥30 mL and PSA >1.5 ng/mL were shown to have improvement in flow, symptom score, and QoL at one, two, and four years for those who received CT over either monotherapy. CT was similarly shown superior in preventing progression of acute urinary symptoms, reducing the need for prostate surgery, and significant superiority in QoL measurements at 48 months. To note, CT appears to have the greatest treatment effect across all categories in the first 18 months, and showed no significant benefit over dutaseride alone when PV >60 mL or PSA >4.0 ng/mL. When all subgroup analysis is considered, the authors believe combination therapy > dutaseride > tamsulosin for treatment of BPH symptoms independent of PV, PSA and IPSS baseline characteristics.
Click to read this article in the British Journal of Urology
Relevant Reading: Dutasteride for the treatment of benign prostatic hyperplasia
In-Depth [randomized controlled trial]: This multinational, multicenter, randomized, double-blind, parallel-group trial looked at 4,844 men ≥50 years of age with a clinical diagnosis of BPH, international prostate symptom score (IPSS) ≥12 points, PV ≥30 mL by trans-rectal ultrasound (TRUS), total serum PSA level ≥1.5 ng/mL, and Qmax >5 mL/s and ≤15 mL/s with a minimum voided volume ≥125 mL. Subjects were randomized to receive a single daily dose, taken orally, of dutasteride 0.5 mg and tamsulosin 0.4 mg; dutasteride 0.5 mg and tamsulosin-matched placebo; or tamsulosin 0.4 mg and dutasteride-matched placebo. Study participants underwent measurement of lower urinary tract function and quality of life metrics every three to six months, and prostate volume annually, over a four year period. Analysis was performed post-hoc, and data for a multitude of subgroups was reported.
By Adam Schatz and Chaz Carrier
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