The effects of dutasteride, tamsulosin and combination therapy on lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the CombAT study

Claus Roehrborn, Paul Siami, Jack Barkin, Ronaldo Damião, Kim Major-Walker, Betsy Morrill, Francesco Montorsi

Research output: Contribution to journalArticle

221 Citations (Scopus)

Abstract

Purpose: We investigated whether combination therapy with dutasteride and tamsulosin is more effective than either monotherapy alone for improving symptoms and long-term outcomes in men with moderate to severe lower urinary tract symptoms and prostatic enlargement (30 cc or greater). We report preplanned 2-year analyses. Materials and Methods: The CombAT study is an ongoing, multicenter, randomized, double-blind, parallel group study. Men 50 years or older with a clinical diagnosis of benign prostatic hyperplasia, International Prostate Symptom Score 12 points or greater, prostate volume 30 cc or greater, total serum prostate specific antigen 1.5 ng/ml or greater to 10 ng/ml or less and peak urinary flow greater than 5 to 15 ml per second or less with a minimum voided volume of 125 ml or greater were randomized to 0.5 mg dutasteride, 0.4 mg tamsulosin or the combination once daily for 4 years. Symptoms were assessed every 3 months and peak urinary flow was assessed every 6 months. The primary end point at 2 years was the change in International Prostate Symptom Score from baseline. Results: Combination therapy resulted in significantly greater improvements in symptoms vs dutasteride from month 3 and tamsulosin from month 9, and in benign prostatic hyperplasia related health status from months 3 and 12, respectively. There was a significantly greater improvement from baseline in peak urinary flow for combination therapy vs dutasteride and tamsulosin monotherapies from month 6. There was a significant increase in drug related adverse events with combination therapy vs monotherapies, although most did not result in the cessation of therapy. Conclusions: In men with moderate to severe lower urinary tract symptoms and prostate enlargement (30 cc or greater) combination therapy provides a significantly greater degree of benefit than tamsulosin or dutasteride monotherapy.

Original languageEnglish (US)
Pages (from-to)616-621
Number of pages6
JournalJournal of Urology
Volume179
Issue number2
DOIs
StatePublished - Feb 2008

Fingerprint

tamsulosin
Lower Urinary Tract Symptoms
Prostatic Hyperplasia
Prostate
Therapeutics
Prostate-Specific Antigen
Drug-Related Side Effects and Adverse Reactions
Health Status
Dutasteride

Keywords

  • Drug therapy, combination
  • Dutasteride
  • Prostate
  • Prostatic hyperplasia
  • Tamsulosin

ASJC Scopus subject areas

  • Urology
  • Medicine(all)

Cite this

The effects of dutasteride, tamsulosin and combination therapy on lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement : 2-year results from the CombAT study. / Roehrborn, Claus; Siami, Paul; Barkin, Jack; Damião, Ronaldo; Major-Walker, Kim; Morrill, Betsy; Montorsi, Francesco.

In: Journal of Urology, Vol. 179, No. 2, 02.2008, p. 616-621.

Research output: Contribution to journalArticle

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abstract = "Purpose: We investigated whether combination therapy with dutasteride and tamsulosin is more effective than either monotherapy alone for improving symptoms and long-term outcomes in men with moderate to severe lower urinary tract symptoms and prostatic enlargement (30 cc or greater). We report preplanned 2-year analyses. Materials and Methods: The CombAT study is an ongoing, multicenter, randomized, double-blind, parallel group study. Men 50 years or older with a clinical diagnosis of benign prostatic hyperplasia, International Prostate Symptom Score 12 points or greater, prostate volume 30 cc or greater, total serum prostate specific antigen 1.5 ng/ml or greater to 10 ng/ml or less and peak urinary flow greater than 5 to 15 ml per second or less with a minimum voided volume of 125 ml or greater were randomized to 0.5 mg dutasteride, 0.4 mg tamsulosin or the combination once daily for 4 years. Symptoms were assessed every 3 months and peak urinary flow was assessed every 6 months. The primary end point at 2 years was the change in International Prostate Symptom Score from baseline. Results: Combination therapy resulted in significantly greater improvements in symptoms vs dutasteride from month 3 and tamsulosin from month 9, and in benign prostatic hyperplasia related health status from months 3 and 12, respectively. There was a significantly greater improvement from baseline in peak urinary flow for combination therapy vs dutasteride and tamsulosin monotherapies from month 6. There was a significant increase in drug related adverse events with combination therapy vs monotherapies, although most did not result in the cessation of therapy. Conclusions: In men with moderate to severe lower urinary tract symptoms and prostate enlargement (30 cc or greater) combination therapy provides a significantly greater degree of benefit than tamsulosin or dutasteride monotherapy.",
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