Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 4-year data from the CombAT study

Francesco Montorsi (1) , Thomas Henkel (2) , Arno Geboers (3) , Vincenzo Mirone (4) , Peio Arrosagaray (5) , Betsy Morrill (6) , Libby Black (6)

1 Divisione di Urologia
2 Consultant Urologist
3 Slingeland Hospital
4 University of Naples Federico II = Università degli studi di Napoli Federico II
5 Hospital de Mendaro
6 GlaxoSmithKline

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) due to 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 AUR 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.

Mots clés: Medicine

Francesco Montorsi, Thomas Henkel, Arno Geboers, Vincenzo Mirone, Peio Arrosagaray, et al.. Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 4-year data from the CombAT study. International Journal of Clinical Practice, 2010, 64 (8), pp.1042. ⟨10.1111/j.1742-1241.2010.02428.x⟩. ⟨hal-00552660⟩