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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

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Abstract

Purpose

To assess the impact of dutasteride compared with placebo on nocturia in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia, using pooled data from dutasteride phase III studies.

Methods

Nocturia was assessed using Question 7 of the International Prostate Symptom Score questionnaire. Efficacy measures included: mean change in nocturia at 24 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 baseline score ≥2.

Results

In total, 4,321 patients with a mean age of 66 years were evaluated. From month 12 onwards, mean nocturia improvements were significantly superior with dutasteride than with placebo (p ≤ 0.05). Reduction in nocturia was significantly better with dutasteride than with placebo across all baseline subgroups tested (p ≤ 0.05). Also at month 24, dutasteride therapy resulted in a greater proportion of subjects with nocturia improvement compared with placebo (p ≤ 0.05), with the largest treatment group differences in subjects with a baseline nocturia score of 2 or 3. Among patients with significant nocturia at baseline (score ≥2), significantly more subjects with dutasteride versus placebo had a score <2 at month 24 (26 vs. 19 %, p < 0.001).

Conclusions

After 24 months of treatment, dutasteride treatment provided significantly greater improvements in nocturia, and less worsening, compared with placebo, primarily in subjects with two or three nocturia episodes per night. Studies specifically designed to assess nocturia are required to prospectively confirm these findings.

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Acknowledgments

Medical writing support was provided by Tony Reardon of Spirit Medical Communications Ltd, funded by GlaxoSmithKline. The three studies on which these analyses were based were 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 original dutasteride phase III studies were approved by the appropriate ethics committees and performed in accordance with the ethical standards defined by the 1964 Declaration of Helsinki and later amendments. All participants provided written informed consent prior to inclusion in the studies.

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Authors and Affiliations

  1. Department of Urology, Hannover Medical School, OE 6240, Carl-Neuberg-Str. 1, 30625, Hannover, Germany

    Matthias Oelke

  2. Department of Urology, University of Texas Southwestern Medical Center, Dallas, TX, USA

    Claus G. Roehrborn

  3. Division of Urology, University of Campinas School of Medicine, Campinas, Sao Paulo, Brazil

    Carlos D’Ancona

  4. GlaxoSmithKline, Research Triangle Park, NC, USA

    Timothy H. Wilson & Michael Manyak

  5. GlaxoSmithKline, King of Prussia, PA, USA

    Ramiro Castro

Authors
  1. Matthias Oelke
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  2. Claus G. Roehrborn
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  3. Carlos D’Ancona
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  4. Timothy H. Wilson
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  5. Ramiro Castro
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  6. Michael Manyak
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Corresponding author

Correspondence to Matthias Oelke.

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Oelke, M., Roehrborn, C.G., D’Ancona, C. et al. 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. World J Urol 32, 1141–1147 (2014). https://doi.org/10.1007/s00345-014-1316-3

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  • DOI: https://doi.org/10.1007/s00345-014-1316-3

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