The effects of combination therapy with dutasteride plus tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year post hoc analysis of European men in the CombAT study

Olivier Haillot (1) , Avelino Fraga (1) , Piotr Maciukiewicz (1) , Dmitry Pushkar (1) , Teuvo Tammela (1) , Klaus Hofner (1) , Venancio Chantada (1) , Paul Gagnier (1) , Betsy B Morrill (1)

1 Urologie

CombAT was a randomised, double-blind study in men (n=4844) aged 50 years with a clinical diagnosis of benign prostatic hyperplasia (BPH). Patients were randomised to daily tamsulosin 0.4 mg, dutasteride 0.5 mg or both for 4 years. The primary endpoint was time to acute urinary retention (AUR) or BPH-related surgery. Secondary endpoints included BPH clinical progression, symptoms and maximum urinary flow rate. A post-hoc analysis of data from the European subgroup was conducted. A total of 2925 men were randomised to treatment in Europe as part of CombAT (tamsulosin, n=972; dutasteride, n=970; combination, n=983). Combination therapy significantly reduced the relative risk of AUR or BPH-related surgery compared with either monotherapy at 4 years, and also significantly reduced the risk of BPH clinical progression. Combination therapy also provided significantly greater symptom improvement than either monotherapy at 4 years. Safety and tolerability of dutasteride plus tamsulosin was consistent with previous experience of this combination and with the monotherapies. These data provide further evidence to support the use of long-term combination therapy (dutasteride plus tamsulosin) in men with moderate-to-severe LUTS due to BPH and prostatic enlargement. The results in the European subgroup are generally consistent with those in the overall study population.

Mots clés: benign prostatic hyperplasia; combination therapy; CombAT; dutasteride; tamsulosin

Olivier Haillot, Avelino Fraga, Piotr Maciukiewicz, Dmitry Pushkar, Teuvo Tammela, et al.. The effects of combination therapy with dutasteride plus tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year post hoc analysis of European men in the CombAT study. Prostate Cancer and Prostatic Diseases, 2011, ⟨10.1038/pcan.2011.13⟩. ⟨hal-00633598⟩