PURPOSE: We investigated whether combination therapy with dutasteride and tamsulosin is more effective than either monotherapy alone for improving symptoms and long-term outcomes in men with moderate to severe lower urinary tract symptoms and prostatic enlargement (30 cc or greater). We report preplanned 2-year analyses. MATERIALS AND METHODS: The CombAT study is an ongoing, multicenter, randomized, double-blind, parallel group study. Men 50 years or older with a clinical diagnosis of benign prostatic hyperplasia, International Prostate Symptom Score 12 points or greater, prostate volume 30 cc or greater, total serum prostate specific antigen 1.5 ng/ml or greater to 10 ng/ml or less and peak urinary flow greater than 5 to 15 ml per second or less with a minimum voided volume of 125 ml or greater were randomized to 0.5 mg dutasteride, 0.4 mg tamsulosin or the combination once daily for 4 years. Symptoms were assessed every 3 months and peak urinary flow was assessed every 6 months. The primary end point at 2 years was the change in International Prostate Symptom Score from baseline. RESULTS: Combination therapy resulted in significantly greater improvements in symptoms vs dutasteride from month 3 and tamsulosin from month 9, and in benign prostatic hyperplasia related health status from months 3 and 12, respectively. There was a significantly greater improvement from baseline in peak urinary flow for combination therapy vs dutasteride and tamsulosin monotherapies from month 6. There was a significant increase in drug related adverse events with combination therapy vs monotherapies, although most did not result in the cessation of therapy. CONCLUSIONS: In men with moderate to severe lower urinary tract symptoms and prostate enlargement (30 cc or greater) combination therapy provides a significantly greater degree of benefit than tamsulosin or dutasteride monotherapy.
RCT Entities:
PURPOSE: We investigated whether combination therapy with dutasteride and tamsulosin is more effective than either monotherapy alone for improving symptoms and long-term outcomes in men with moderate to severe lower urinary tract symptoms and prostatic enlargement (30 cc or greater). We report preplanned 2-year analyses. MATERIALS AND METHODS: The CombAT study is an ongoing, multicenter, randomized, double-blind, parallel group study. Men 50 years or older with a clinical diagnosis of benign prostatic hyperplasia, International Prostate Symptom Score 12 points or greater, prostate volume 30 cc or greater, total serum prostate specific antigen 1.5 ng/ml or greater to 10 ng/ml or less and peak urinary flow greater than 5 to 15 ml per second or less with a minimum voided volume of 125 ml or greater were randomized to 0.5 mg dutasteride, 0.4 mg tamsulosin or the combination once daily for 4 years. Symptoms were assessed every 3 months and peak urinary flow was assessed every 6 months. The primary end point at 2 years was the change in International Prostate Symptom Score from baseline. RESULTS: Combination therapy resulted in significantly greater improvements in symptoms vs dutasteride from month 3 and tamsulosin from month 9, and in benign prostatic hyperplasia related health status from months 3 and 12, respectively. There was a significantly greater improvement from baseline in peak urinary flow for combination therapy vs dutasteride and tamsulosin monotherapies from month 6. There was a significant increase in drug related adverse events with combination therapy vs monotherapies, although most did not result in the cessation of therapy. CONCLUSIONS: In men with moderate to severe lower urinary tract symptoms and prostate enlargement (30 cc or greater) combination therapy provides a significantly greater degree of benefit than tamsulosin or dutasteride monotherapy.
Authors: Alexandre Fornari; Ernani Luis Rhoden; Cláudio G Zettler; Eduardo P Ribeiro; Claudia R Rhoden Journal: Int Urol Nephrol Date: 2010-06-08 Impact factor: 2.370
Authors: J Curtis Nickel; Carlos E Méndez-Probst; Thomas F Whelan; Ryan F Paterson; Hassan Razvi Journal: Can Urol Assoc J Date: 2010-10 Impact factor: 1.862
Authors: Abdulmaged M Traish; Roberto Cosimo Melcangi; Marco Bortolato; Luis M Garcia-Segura; Michael Zitzmann Journal: Rev Endocr Metab Disord Date: 2015-09 Impact factor: 6.514
Authors: Michael K Brawer; Danil V Makarov; Alan W Partin; Claus G Roehrborn; J Curtis Nickel; Shing-Hwa Lu; Naoki Yoshimura; Michael B Chancellor; Dean G Assimos Journal: Rev Urol Date: 2008