Authors: Matthias Oelke Claus G Roehrborn Carlos D’Ancona Timothy H Wilson Ramiro Castro Michael Manyak
Publish Date: 2014/06/06
Volume: 32, Issue: 5, Pages: 1141-1147
Abstract
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 ≥2In total 4321 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 ≤ 005 Reduction in nocturia was significantly better with dutasteride than with placebo across all baseline subgroups tested p ≤ 005 Also at month 24 dutasteride therapy resulted in a greater proportion of subjects with nocturia improvement compared with placebo p ≤ 005 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 0001After 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 findingsMatthias 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 GlaxoSmithKlineThe 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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