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.
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Acknowledgments
Medical writing support was provided by Tony Reardon of Spirit Medical Communications Ltd, funded by GlaxoSmithKline.
Conflict of interest
Matthias Oelke has been a speaker, advisor, and/or trial participant for Allergan, Apogepha, Astellas, Bayer, Ferring, GlaxoSmithKline, Lilly, Mundipharma, Pfizer and Recordati. Claus G. Roehrborn has been a speaker, advisor, and/or trial participant for GlaxoSmithKline. Carlos D’Ancona has been a speaker and trial participant for GlaxoSmithKline and Astellas. Timothy H. Wilson, Ramiro Castro, and Michael Manyak are employees of GlaxoSmithKline.
Ethical standard
The CombAT study was approved by the appropriate ethics committees and performed in accordance with the ethical standards laid down by the 1964 Declaration of Helsinki and later amendments. All participants provided written informed consent prior to inclusion in the study.
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Oelke, M., Roehrborn, C.G., D’Ancona, C. et al. Nocturia improvement in the combination of Avodart® and tamsulosin (CombAT) study. World J Urol 32, 1133–1140 (2014). https://doi.org/10.1007/s00345-014-1296-3
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DOI: https://doi.org/10.1007/s00345-014-1296-3