Summary
Objective: To investigate the effect of combination therapy with dutasteride plus tamsulosin compared with each monotherapy on patient‐reported health outcomes over 4 years in men with ...moderate‐to‐severe lower urinary tract symptoms (LUTS) because of benign prostatic hyperplasia (BPH).
Methods: CombAT was a 4‐year international, double‐blind, randomised, parallel‐group trial in men (n = 4844) with moderate‐to‐severe symptoms of BPH and at increased risk of disease progression age ≥ 50 years, International Prostate Symptom Score (IPSS) ≥ 12, prostate volume ≥ 30 cc, serum prostate‐specific antigen ≥ 1.5 ng/ml to ≤ 10 ng/ml and maximum urinary flow rate 5–15 ml/s with minimum voided volume ≥ 125 ml. Subjects were randomised to receive 0.5 mg dutasteride, 0.4 mg tamsulosin or the combination once daily for 4 years. The primary endpoint at 4 years was the time to event and proportion of subjects with acute urinary retention or undergoing BPH‐related prostate surgery. Secondary endpoints included the health‐outcomes measures, BPH Impact Index (BII), IPSS question 8 (IPSS Q8) and the Patient Perception of Study Medication (PPSM) questionnaire.
Results: At 4 years, combination therapy resulted in significantly superior improvements from baseline in BII and IPSS Q8 than either monotherapy; these benefits were observed from 3 months onwards compared with dutasteride and from 9 months (BII) or 12 months (IPSS Q8) onwards compared with tamsulosin. Also at 4 years, the PPSM questionnaire showed that a significantly higher proportion of patients was satisfied with, and would request treatment with, combination therapy compared with either monotherapy.
Conclusions: Combination therapy (dutasteride plus tamsulosin) provides significantly superior improvements in patient‐reported quality of life and treatment satisfaction than either monotherapy at 4 years in men with moderate‐to‐severe BPH symptoms.
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