Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia: 2-year data from the CombAT trial

Jack Barkin, Claus Roehrborn, Paul Siami, Olivier Haillot, Betsy Morrill, Libby Black, Francesco Montorsi

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33 Citations (Scopus)

Abstract

OBJECTIVE To investigate the effect of dutasteride and tamsulosin as combined therapy compared with each monotherapy for improving patient-reported health outcomes in men with moderate-to-severe urinary symptoms and prostate enlargement, reporting the pre-planned 2-year analyses from the CombAT trial. PATIENTS AND METHODS The CombAT study is an ongoing, international, double-blind, randomized, parallel-group trial. Men aged ≥50 years with a clinical diagnosis of benign prostatic hyperplasia (BPH), an International Prostate Symptom Score (IPSS) of ≥12 units, a prostate volume of ≥30 mL, a total serum prostate-specific antigen level of 1.5-10 ng/mL and a peak urinary flow of >5 and ≤15 mL/s, with a minimum voided volume of ≥125 mL, were randomized to receive 0.5 mg dutasteride, 0.4 mg tamsulosin or the combination once daily for 4 years. Symptoms were assessed every 3 months. The primary endpoint at 2 years was the change in IPSS from baseline. Secondary endpoints included various measures of health outcomes, which included the BPH Impact Index (BII), IPSS Question 8 (Q8), and the Patient Perception of Study Medication (PPSM) questionnaire. RESULTS Combined therapy resulted in significantly greater improvements in BII and IPSS Q8 from baseline than did dutasteride from 3 months and compared with tamsulosin from 9 months (BII) or 12 months (IPSS Q8). Assessments using the PPSM questionnaire showed that a significantly higher proportion of patients were satisfied with and would request dutasteride and tamsulosin combined therapy than with each monotherapy at 24 months. CONCLUSIONS Dutasteride and tamsulosin combined therapy provides significantly greater improvements in patient-reported quality of life and treatment satisfaction than both monotherapies at 2 years, following the trends for clinical improvements in symptom scores and peak urinary flow rates, in men with moderate-to-severe BPH symptoms.

Original languageEnglish (US)
Pages (from-to)919-926
Number of pages8
JournalBJU International
Volume103
Issue number7
DOIs
StatePublished - Apr 2009

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tamsulosin
Prostatic Hyperplasia
Prostate
Quality of Life
Therapeutics
Health
Prostate-Specific Antigen
Dutasteride

Keywords

  • BPH
  • Combined therapy
  • Dutasteride
  • Impact index
  • Tamsulosin

ASJC Scopus subject areas

  • Urology

Cite this

Effect of dutasteride, tamsulosin and the combination on patient-reported quality of life and treatment satisfaction in men with moderate-to-severe benign prostatic hyperplasia : 2-year data from the CombAT trial. / Barkin, Jack; Roehrborn, Claus; Siami, Paul; Haillot, Olivier; Morrill, Betsy; Black, Libby; Montorsi, Francesco.

In: BJU International, Vol. 103, No. 7, 04.2009, p. 919-926.

Research output: Contribution to journalArticle

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abstract = "OBJECTIVE To investigate the effect of dutasteride and tamsulosin as combined therapy compared with each monotherapy for improving patient-reported health outcomes in men with moderate-to-severe urinary symptoms and prostate enlargement, reporting the pre-planned 2-year analyses from the CombAT trial. PATIENTS AND METHODS The CombAT study is an ongoing, international, double-blind, randomized, parallel-group trial. Men aged ≥50 years with a clinical diagnosis of benign prostatic hyperplasia (BPH), an International Prostate Symptom Score (IPSS) of ≥12 units, a prostate volume of ≥30 mL, a total serum prostate-specific antigen level of 1.5-10 ng/mL and a peak urinary flow of >5 and ≤15 mL/s, with a minimum voided volume of ≥125 mL, were randomized to receive 0.5 mg dutasteride, 0.4 mg tamsulosin or the combination once daily for 4 years. Symptoms were assessed every 3 months. The primary endpoint at 2 years was the change in IPSS from baseline. Secondary endpoints included various measures of health outcomes, which included the BPH Impact Index (BII), IPSS Question 8 (Q8), and the Patient Perception of Study Medication (PPSM) questionnaire. RESULTS Combined therapy resulted in significantly greater improvements in BII and IPSS Q8 from baseline than did dutasteride from 3 months and compared with tamsulosin from 9 months (BII) or 12 months (IPSS Q8). Assessments using the PPSM questionnaire showed that a significantly higher proportion of patients were satisfied with and would request dutasteride and tamsulosin combined therapy than with each monotherapy at 24 months. CONCLUSIONS Dutasteride and tamsulosin combined therapy provides significantly greater improvements in patient-reported quality of life and treatment satisfaction than both monotherapies at 2 years, following the trends for clinical improvements in symptom scores and peak urinary flow rates, in men with moderate-to-severe BPH symptoms.",
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AU - Montorsi, Francesco

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