MILAN—Dutasteride and tamsulosin combination therapy provides significantly greater improvements in patient-reported, symptom-specific quality of life compared with either medication at two years in men with moderate to severe BPH, new data show.


“Our trial is the first to demonstrate significant superiority of the combination of a 5-alpha reductase inhibitor (ARI) and alpha blocker over each monotherapy in improving patient-reported reported quality of life,” said Jack Barkin, MD, professor of surgery at the University of Toronto.

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He presented findings from the ongoing Combination of Avodart and Tamsulosin (CombAT) study at the European Association of Urology’s 23rd Congress here.


For the trial, 4,800 men were randomized to receive dutasteride 0.5 mg/day, tamsulosin 0.4 mg/day, or the combination orally for four years.


At the time of enrollment, patients were 50 years of age or older with clinically diagnosed BPH, International Prostate Symptom Score (IPSS) of 12 or higher, total prostate volume of 30 cc or higher, and serum PSA level of 1.5-10 ng/mL. A pre-planned two-year analysis documented significantly larger improvements in symptoms and flow rate with combination therapy than with either drug as solo therapy, researchers noted.


“Key goals for BPH treatment include not only improvement in symptom scores and objective measures but improvement in patient-reported quality of life and reduction in BPH bother,” Dr. Barkin said.


Secondary end points in the two-year analysis thus included the BPH Impact Index (BII) and question 8 (Q8) of the IPSS, which is a standard BPH-related health status/motivational scale.At two years, the adjusted mean difference in the improvement in BII score was -0.62 between the combination and tamsulosin group and -0.35 between the combination and dutasteride group.


A pattern of continuous improvement in BII was noted with combination therapy over the two years. Dutasteride patients experienced a sustained improvement over time, and tamsulosin patients tended to decline from month 15 after an initial improvement.


The mean baseline IPSS Q8 score was 3.8 in each treatment arm. At two years, the adjusted mean difference in improvement in IPSS Q8 score was -0.30 between the combination and tamsulosin arm and -0.23 between the combination and dutasteride arm.


Improvements in BII and IPSS Q8 score from baseline with combination therapy were significantly greater from the third month compared with dutasteride and from the ninth month for BII and one year for IPSS Q8 compared with tamsulosin.


The study also found a significant benefit of combination therapy over each monotherapy for treatment satisfaction, which was examined using the Patient Perception of Study Medication (PPSM) questionnaire.


The questionnaire was specifically developed for use and validation in CombAT to assess patient treatment satisfaction across a range of domains including control of urinary problems, strength of urinary stream, pain of urination, effect on usual activities, and overall satisfaction.


The findings show that, at two years, combination outperformed either drug as single-agent therapy in quality of life measures. “The impact of BPH on quality of life is a major driver for patients seeking treatment,” Dr. Barkin said. “What’s more, patient satisfaction with treatment and health outcomes can have a strong effect on compliance.”