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Nocturia improvement in the combination of Avodart® and tamsulosin (CombAT)

Study By M. Oelke, C.G. Roehrborn, C. D'Ancona, T.H. Wilson, R. Castro and M. Manyak.

World Journal of Urology, Volume 8, 2014. Article in Press

Editor's comments:
This study, which is a part of the CombAT study program,  is the first to show that a combination treatment consisting of dutasteride plus tamsulosin versus monotherapy alone produce better results in improving nocturia in men affected by BPH and LUTS. The study included  the evaluation of 4,722 men, with a mean age of 66 years. The results showed that the decrease in nocturia score with combination therapy was significantly (p ≤ 0.01) better than tamsulosin monotherapy across all baseline subgroups tested, except for men with previous 5ARI use. This is an important observation for adequately treating nocturia due to BPH.

Abstract
Purpose

The purpose of the study was to assess the impact of dutasteride plus tamsulosin combination therapy, compared with dutasteride or tamsulosin monotherapy, on nocturia in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) using data from the 4-year CombAT study.

Methods
Nocturia was assessed using Question 7 of the International Prostate Symptom Score questionnaire. Efficacy measures included as follows: mean change in nocturia at 3-month intervals up to 48 months; proportion of patients with improvement/worsening in nocturia; nocturnal voiding frequency at baseline and study end, overall and by baseline subgroups; and nocturnal voiding frequency <2 at study end in patients with a baseline score ≥2.

Results
In total, 4,722 patients with a mean age of 66 years were included. Mean nocturia improvements were significantly superior (p ≤ 0.01) with combination therapy than with either monotherapy (adjusted mean change from baseline in IPSS Question 7 score at month 48: combination therapy -0.5, dutasteride -0.4, tamsulosin -0.3). Reduction in nocturia score with combination therapy was significantly (p ≤ 0.01) better than tamsulosin monotherapy across all baseline subgroups tested, except for men with previous 5ARI use. Among those with a baseline IPSS Q7 score ≥2, more patients with combination therapy had a score <2 at month 48 (34 %) compared with dutasteride (30 %, p = 0.018) or tamsulosin (26 %, p < 0.0001).

Conclusions 
Combination therapy provided greater improvements and less worsening of nocturia compared with both dutasteride and tamsulosin monotherapies. These analyses are the first to show greater improvement with a 5ARI/α-blocker combination versus either agent alone for the management of nocturia in patients with LUTS/BPH. © 2014 Springer-Verlag Berlin Heidelberg.