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World Journal of Urology

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01-10-2014 | Topic Paper

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

Authors: Matthias Oelke, Claus G. Roehrborn, Carlos D’Ancona, Timothy H. Wilson, Ramiro Castro, Michael Manyak

Published in: World Journal of Urology | Issue 5/2014

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.

Schulman CC, Asplund R, Desgrandchamps F, Jonas U (2005) The impact of nocturia on health status and quality of life in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH). Eur Urol Suppl 4:1–8

van Dijk MM, Wijksra H, Debruyne FM, de La Rosette JJ, Michel MC (2009) The role of nocturia in the quality of life of men with lower urinary tract symptoms. BJU Int 105:1141–1146CrossRef

Abrams P, Cardozo L, Fall M et al (2002) The standardization of terminology in lower urinary tract function: report from the standardization sub-committee of the International Continence Society. Neurourol Urodyn 21:167–178PubMedCrossRef

Coyne KS, Zhou Z, Bhattacharyya SK, Thompson CL, Dhawan R, Versi E (2003) The prevalence of nocturia and its effect on health-related quality of life and sleep in a community sample in the USA. BJU Int 92:948–954PubMedCrossRef

Tikkinen KA, Johnson TM 2nd, Tammela TL et al (2010) Nocturia frequency, bother, and quality of life: how often is too often? A population-based study in Finland. Eur Urol 57:488–496PubMedCrossRef

Kupelian V, Fitzgerald MP, Kaplan SA, Norgaard JP, Chiu GR, Rosen RC (2011) Association of nocturia and mortality: results from the Third National Health and Nutrition Examination Survey. J Urol 185:7–571CrossRef

Galizia G, Langellotto A, Cacciatore F et al (2012) Association between nocturia and fall-related long-term mortality in the elderly. J Am Med Dir Assoc 13:640–644PubMedCrossRef

Oelke M, Bachman A, Descazeaud A et al (2013) EAU guidelines on the treatment and follow-up of non-neurogenic male lower urinary tract symptoms including benign prostatic obstruction. Eur Urol 64:118–140PubMedCrossRef

Roehrborn CG, Siami P, Barkin J et al (2010) The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study. Eur Urol 57:123–131PubMedCrossRef

10.

Siami P, Roehrborn CG, Barkin J et al (2007) Combination therapy with dutasteride and tamsulosin in men with moderate-to-severe benign prostatic hyperplasia and prostate enlargement: the CombAT (Combination of Avodart and Tamsulosin) trial rationale and study design. Contemp Clin Trials 28:770–779PubMedCrossRef

11.

Johnson TM 2nd, Jones K, Williford WO, Kutner MH, Issa MM, Lepor H (2003) Changes in nocturia from medical treatment of benign prostatic hyperplasia: secondary analysis of the Department of Veterans Affairs Co-operative Study Trial. J Urol 170:145–148PubMedCrossRef

12.

Johnson TM 2nd, Burrows PK, Kusek JW et al (2007) The effect of doxazosin, finasteride and combination therapy on nocturia in men with benign prostatic hyperplasia. J Urol 178:2045–2051PubMedCrossRef

13.

Oelke M, Roehrborn CG, D’Ancona C, Wilson TH, Castro R, Manyak M (2014) Impact of dutasteride on nocturia in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH): a pooled analysis of three phase III studies. doi:10.1007/s00345-014-1316-3

14.

Eisenhardt A, Schneider T, Cruz F, Oelke M (2014) Consistent and significant improvement of nighttime voiding frequency (nocturia) with silodosin in men with LUTS suggestive of BPH: pooled analysis of three randomized, placebo-controlled, double-blind phase III studies. World J Urol. doi:10.1007/s00345-013-122-7 PubMed

15.

Djavan B, Milani S, Davies J, Bolodeoku J (2005) The impact of tamsulosin oral controlled absorption system (OCAS) on nocturia and the quality of sleep: preliminary results of a pilot study. Eur Urol Suppl 4:61–68CrossRef

Title: Nocturia improvement in the combination of Avodart® and tamsulosin (CombAT) study
Authors: Matthias Oelke
Claus G. Roehrborn
Carlos D’Ancona
Timothy H. Wilson
Ramiro Castro
Michael Manyak
Publication date: 01-10-2014
Publisher: Springer Berlin Heidelberg
Published in: World Journal of Urology / Issue 5/2014
Print ISSN: 0724-4983
Electronic ISSN: 1433-8726
DOI: https://doi.org/10.1007/s00345-014-1296-3

At a glance: The STEP trials

Springer Medicine

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

Abstract

Purpose

Methods

Results

Conclusions

At a glance: The STEP trials

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusions

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