title: The effects of combination therapy with dutasteride plus tamsulosin on clinical outcomes in men with symptomatic BPH: 4-year post hoc analysis of European men in the CombAT study.
abstract: CombAT (Combination of Avodart and Tamsulosin) was a randomised, double-blind study in men (n=4844) aged ≥ 50 years with a clinical diagnosis of 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 lower urinary tract symptoms because of BPH and prostatic enlargement. The results in the European subgroup are generally consistent with those in the overall study population.
authors.affiliation: Université F Rabelais, CHRU, Tours, France. haillot@med.univ-tours.fr
authors.forename: O
authors.initials: O
authors.lastname: Haillot
authors.forename: A
authors.initials: A
authors.lastname: Fraga
authors.forename: P
authors.initials: P
authors.lastname: Maciukiewicz
authors.forename: D
authors.initials: D
authors.lastname: Pushkar
authors.forename: T
authors.initials: T
authors.lastname: Tammela
authors.forename: K
authors.initials: K
authors.lastname: Höfner
authors.forename: V
authors.initials: V
authors.lastname: Chantada
authors.forename: P
authors.initials: P
authors.lastname: Gagnier
authors.forename: B
authors.initials: B
authors.lastname: Morrill
mesh_terms: D058891:5-alpha Reductase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D058668:Adrenergic alpha-1 Receptor Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D000368:Aged; D001378:Azasteroids / Q000009:adverse effects / Q000627:therapeutic use*; D018450:Disease Progression; D004359:Drug Therapy, Combination; D000068538:Dutasteride; D006801:Humans; D008297:Male; D008875:Middle Aged; D011470:Prostatic Hyperplasia / Q000150:complications / Q000188:drug therapy* / Q000601:surgery; D012720:Severity of Illness Index; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D000077409:Tamsulosin; D016896:Treatment Outcome; D016055:Urinary Retention / Q000209:etiology
chemical_list: D058891:5-alpha Reductase Inhibitors; D058668:Adrenergic alpha-1 Receptor Antagonists; D001378:Azasteroids; D013449:Sulfonamides; D000077409:Tamsulosin; D000068538:Dutasteride