The Influence of Baseline Parameters on Changes in International Prostate Symptom Score with Dutasteride, Tamsulosin, and Combination Therapy among Men with Symptomatic Benign Prostatic Hyperplasia and an Enlarged Prostate: 2-Year Data from the CombAT Study

Claus Roehrborn, Paul Siami, Jack Barkin, Ronaldo Damião, Edgardo Becher, Bernardino Miñana, Vicenzo Mirone, Ramiro Castro, Timothy Wilson, Francesco Montorsi

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Abstract

Background: Knowledge of baseline factors that influence outcomes for men with benign prostatic hyperplasia (BPH) receiving medical therapy may help to improve outcomes and cost effectiveness. Objectives: To examine the influence of baseline parameters on changes in International Prostate Symptom Score (IPSS) and maximum urinary flow rate (Qmax) in men with BPH receiving dutasteride, tamsulosin, or a combination of the two using 2-yr Combination of Avodart and Tamsulosin (CombAT) study data. Design, setting, and participants: CombAT is an ongoing, 4-yr, multicentre, randomised, double-blind study in 4844 men aged ≥50 yr with clinical diagnosis of BPH, IPSS ≥12, prostate volume ≥30 cm3, prostate-specific antigen (PSA) 1.5-10 ng/ml, and Qmax >5 and ≤15 ml/s with minimum voided volume ≥125 ml. Intervention: Daily tamsulosin 0.4 mg, dutasteride 0.5 mg, or the combination. Measurements: Post hoc analyses of mean IPSS and Qmax changes from baseline by treatment group and by baseline prostate volume, PSA, age, body mass index (BMI), IPSS, IPSS quality of life (QoL) score, BPH Impact Index score, Qmax, and previous BPH medical therapy. Results and limitations: Combination therapy was more effective than either monotherapy after 24 mo in improving IPSS in all baseline subgroups, with benefit onset varying by baseline prostate volume. Combination therapy was also more effective in improving Qmax versus tamsulosin in all subgroups and versus dutasteride in 10 of 18 subgroups. At 24 mo, dutasteride monotherapy resulted in significantly greater IPSS improvements versus tamsulosin in men with lower age, worse symptoms, worse QoL, less bother, higher BMI, greater Qmax, higher prostate volume, and higher PSA at baseline. Post hoc analyses, the lack of placebo control, and the exclusion of men with unsuccessful medical BPH treatment are study limitations. Conclusions: Combination therapy with tamsulosin and dutasteride affords the greatest and the most rapid symptomatic benefit among men with higher baseline prostate volume and is effective regardless of previous BPH medical therapy. Dutasteride monotherapy is more effective than tamsulosin in men with higher baseline prostate volume or PSA and worse symptoms.

Original languageEnglish (US)
Pages (from-to)461-471
Number of pages11
JournalEuropean Urology
Volume55
Issue number2
DOIs
StatePublished - Feb 2009

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tamsulosin
Prostatic Hyperplasia
Prostate
Prostate-Specific Antigen
Therapeutics
Dutasteride
Body Mass Index

Keywords

  • Benign prostatic hyperplasia
  • Combination therapy
  • Dutasteride
  • IPSS
  • Lower urinary tract symptoms
  • Q
  • Tamsulosin

ASJC Scopus subject areas

  • Urology

Cite this

The Influence of Baseline Parameters on Changes in International Prostate Symptom Score with Dutasteride, Tamsulosin, and Combination Therapy among Men with Symptomatic Benign Prostatic Hyperplasia and an Enlarged Prostate : 2-Year Data from the CombAT Study. / Roehrborn, Claus; Siami, Paul; Barkin, Jack; Damião, Ronaldo; Becher, Edgardo; Miñana, Bernardino; Mirone, Vicenzo; Castro, Ramiro; Wilson, Timothy; Montorsi, Francesco.

In: European Urology, Vol. 55, No. 2, 02.2009, p. 461-471.

Research output: Contribution to journalArticle

Roehrborn, Claus ; Siami, Paul ; Barkin, Jack ; Damião, Ronaldo ; Becher, Edgardo ; Miñana, Bernardino ; Mirone, Vicenzo ; Castro, Ramiro ; Wilson, Timothy ; Montorsi, Francesco. / The Influence of Baseline Parameters on Changes in International Prostate Symptom Score with Dutasteride, Tamsulosin, and Combination Therapy among Men with Symptomatic Benign Prostatic Hyperplasia and an Enlarged Prostate : 2-Year Data from the CombAT Study. In: European Urology. 2009 ; Vol. 55, No. 2. pp. 461-471.
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abstract = "Background: Knowledge of baseline factors that influence outcomes for men with benign prostatic hyperplasia (BPH) receiving medical therapy may help to improve outcomes and cost effectiveness. Objectives: To examine the influence of baseline parameters on changes in International Prostate Symptom Score (IPSS) and maximum urinary flow rate (Qmax) in men with BPH receiving dutasteride, tamsulosin, or a combination of the two using 2-yr Combination of Avodart and Tamsulosin (CombAT) study data. Design, setting, and participants: CombAT is an ongoing, 4-yr, multicentre, randomised, double-blind study in 4844 men aged ≥50 yr with clinical diagnosis of BPH, IPSS ≥12, prostate volume ≥30 cm3, prostate-specific antigen (PSA) 1.5-10 ng/ml, and Qmax >5 and ≤15 ml/s with minimum voided volume ≥125 ml. Intervention: Daily tamsulosin 0.4 mg, dutasteride 0.5 mg, or the combination. Measurements: Post hoc analyses of mean IPSS and Qmax changes from baseline by treatment group and by baseline prostate volume, PSA, age, body mass index (BMI), IPSS, IPSS quality of life (QoL) score, BPH Impact Index score, Qmax, and previous BPH medical therapy. Results and limitations: Combination therapy was more effective than either monotherapy after 24 mo in improving IPSS in all baseline subgroups, with benefit onset varying by baseline prostate volume. Combination therapy was also more effective in improving Qmax versus tamsulosin in all subgroups and versus dutasteride in 10 of 18 subgroups. At 24 mo, dutasteride monotherapy resulted in significantly greater IPSS improvements versus tamsulosin in men with lower age, worse symptoms, worse QoL, less bother, higher BMI, greater Qmax, higher prostate volume, and higher PSA at baseline. Post hoc analyses, the lack of placebo control, and the exclusion of men with unsuccessful medical BPH treatment are study limitations. Conclusions: Combination therapy with tamsulosin and dutasteride affords the greatest and the most rapid symptomatic benefit among men with higher baseline prostate volume and is effective regardless of previous BPH medical therapy. Dutasteride monotherapy is more effective than tamsulosin in men with higher baseline prostate volume or PSA and worse symptoms.",
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T1 - The Influence of Baseline Parameters on Changes in International Prostate Symptom Score with Dutasteride, Tamsulosin, and Combination Therapy among Men with Symptomatic Benign Prostatic Hyperplasia and an Enlarged Prostate

T2 - 2-Year Data from the CombAT Study

AU - Roehrborn, Claus

AU - Siami, Paul

AU - Barkin, Jack

AU - Damião, Ronaldo

AU - Becher, Edgardo

AU - Miñana, Bernardino

AU - Mirone, Vicenzo

AU - Castro, Ramiro

AU - Wilson, Timothy

AU - Montorsi, Francesco

PY - 2009/2

Y1 - 2009/2

N2 - Background: Knowledge of baseline factors that influence outcomes for men with benign prostatic hyperplasia (BPH) receiving medical therapy may help to improve outcomes and cost effectiveness. Objectives: To examine the influence of baseline parameters on changes in International Prostate Symptom Score (IPSS) and maximum urinary flow rate (Qmax) in men with BPH receiving dutasteride, tamsulosin, or a combination of the two using 2-yr Combination of Avodart and Tamsulosin (CombAT) study data. Design, setting, and participants: CombAT is an ongoing, 4-yr, multicentre, randomised, double-blind study in 4844 men aged ≥50 yr with clinical diagnosis of BPH, IPSS ≥12, prostate volume ≥30 cm3, prostate-specific antigen (PSA) 1.5-10 ng/ml, and Qmax >5 and ≤15 ml/s with minimum voided volume ≥125 ml. Intervention: Daily tamsulosin 0.4 mg, dutasteride 0.5 mg, or the combination. Measurements: Post hoc analyses of mean IPSS and Qmax changes from baseline by treatment group and by baseline prostate volume, PSA, age, body mass index (BMI), IPSS, IPSS quality of life (QoL) score, BPH Impact Index score, Qmax, and previous BPH medical therapy. Results and limitations: Combination therapy was more effective than either monotherapy after 24 mo in improving IPSS in all baseline subgroups, with benefit onset varying by baseline prostate volume. Combination therapy was also more effective in improving Qmax versus tamsulosin in all subgroups and versus dutasteride in 10 of 18 subgroups. At 24 mo, dutasteride monotherapy resulted in significantly greater IPSS improvements versus tamsulosin in men with lower age, worse symptoms, worse QoL, less bother, higher BMI, greater Qmax, higher prostate volume, and higher PSA at baseline. Post hoc analyses, the lack of placebo control, and the exclusion of men with unsuccessful medical BPH treatment are study limitations. Conclusions: Combination therapy with tamsulosin and dutasteride affords the greatest and the most rapid symptomatic benefit among men with higher baseline prostate volume and is effective regardless of previous BPH medical therapy. Dutasteride monotherapy is more effective than tamsulosin in men with higher baseline prostate volume or PSA and worse symptoms.

AB - Background: Knowledge of baseline factors that influence outcomes for men with benign prostatic hyperplasia (BPH) receiving medical therapy may help to improve outcomes and cost effectiveness. Objectives: To examine the influence of baseline parameters on changes in International Prostate Symptom Score (IPSS) and maximum urinary flow rate (Qmax) in men with BPH receiving dutasteride, tamsulosin, or a combination of the two using 2-yr Combination of Avodart and Tamsulosin (CombAT) study data. Design, setting, and participants: CombAT is an ongoing, 4-yr, multicentre, randomised, double-blind study in 4844 men aged ≥50 yr with clinical diagnosis of BPH, IPSS ≥12, prostate volume ≥30 cm3, prostate-specific antigen (PSA) 1.5-10 ng/ml, and Qmax >5 and ≤15 ml/s with minimum voided volume ≥125 ml. Intervention: Daily tamsulosin 0.4 mg, dutasteride 0.5 mg, or the combination. Measurements: Post hoc analyses of mean IPSS and Qmax changes from baseline by treatment group and by baseline prostate volume, PSA, age, body mass index (BMI), IPSS, IPSS quality of life (QoL) score, BPH Impact Index score, Qmax, and previous BPH medical therapy. Results and limitations: Combination therapy was more effective than either monotherapy after 24 mo in improving IPSS in all baseline subgroups, with benefit onset varying by baseline prostate volume. Combination therapy was also more effective in improving Qmax versus tamsulosin in all subgroups and versus dutasteride in 10 of 18 subgroups. At 24 mo, dutasteride monotherapy resulted in significantly greater IPSS improvements versus tamsulosin in men with lower age, worse symptoms, worse QoL, less bother, higher BMI, greater Qmax, higher prostate volume, and higher PSA at baseline. Post hoc analyses, the lack of placebo control, and the exclusion of men with unsuccessful medical BPH treatment are study limitations. Conclusions: Combination therapy with tamsulosin and dutasteride affords the greatest and the most rapid symptomatic benefit among men with higher baseline prostate volume and is effective regardless of previous BPH medical therapy. Dutasteride monotherapy is more effective than tamsulosin in men with higher baseline prostate volume or PSA and worse symptoms.

KW - Benign prostatic hyperplasia

KW - Combination therapy

KW - Dutasteride

KW - IPSS

KW - Lower urinary tract symptoms

KW - Q

KW - Tamsulosin

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