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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.

IPSS health-related quality of life [HRQL], PV, PSA, IPSS, peak urinary flow rate [Q max ] and body-mass index [BMI]) on the incidence of AUR or BPH-related surgery, clinical progression of BPH, and symptoms were performed. RESULTS• There were 4844 men in the intent-totreat population. Overall baseline characteristics were similar across all patient groups.• Regardless of baseline subgroup, the incidence of AUR or BPH-related surgery was higher in men treated with tamsulosin than in those treated with dutasteride or combined therapy.• Combined therapy was statistically better than tamsulosin in reducing the risk of AUR or BPH-related surgery in subgroups of baseline PV > 42.0 mL, in all subgroups of baseline PSA level, and all other baseline subgroups ( P ≤ 0.001).• Across treatment groups, the incidence of clinical progression was highest in men with a baseline IPSS of < 20 or IPSS HRQL score of < 4. The incidence of clinical progression was also higher in men receiving tamsulosin than dutasteride or combined therapy in all baseline subgroups, except for men with a baseline PV of < 40 mL. Combined therapy reduced the relative risk (RR) of clinical progression compared with tamsulosin across all baseline subgroups and compared with dutasteride across most baseline subgroups. Study Type -Therapy (RCT) Level of Evidence 1b OBJECTIVE• To investigate the influence of baseline variables on the 4-year incidence of acute urinary retention (AUR), benign prostatic hyperplasia (BPH)-related surgery and overall clinical progression in men treated with tamsulosin, dutasteride, or a combination of both. PATIENTS AND METHODS• The 4-year Combination of Avodart® and Tamsulosin (CombAT) study was a multicenter, randomized, double-blind, parallel-group study of clinical outcomes in men aged ≥ 50 years with symptomatic (International Prostate Symptom Score [IPSS] ≥ 12) BPH, with prostate-specific antigen (PSA) levels of ≥ 1.5 ng/mL and ≤ 10 ng/mL, and a prostate volume (PV) of ≥ 30 mL.• Eligible patients received tamsulosin 0.4 mg, dutasteride 0.5 mg, or a combination of both.• The primary endpoint was time to first AUR or BPH-related surgery. Secondary endpoints included clinical progression of BPH and symptoms. Posthoc analyses of the influence of baseline variables (including age, BJUI B J U I N T E R N A T I O N A LWhat's known on the subject? and What does the study add? Treatment of benign prostatic hyperplasia (BPH) centres on two drug classes, 5 α -reductase inhibitors and α -blockers. The 4-year Combination of Avodart® and Tamsulosin (CombAT) study investigated whether the combination of dutasteride and tamsulosin was more effective than either monotherapy in reducing the relative risk of AUR, BPH-related surgery, and BPH clinical progression in men with moderate-to-severe LUTS who were at increased risk of disease progression. Data from the 2-and 4-year, pre-planned primary and secondary endpoint analyses for the CombAT study have been reported previously.This study reports the outcomes of post hoc analyses of the influe...

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OBJECTIVE To examine, in a 2‐year, non‐comparative, open‐label extension study, the safety, tolerability and efficacy of darifenacin controlled‐release (CR) 7.5/15 mg once daily in patients with overactive bladder (OAB) who completed two 12‐week randomized, double‐blind, placebo‐controlled ‘feeder’ studies. PATIENTS AND METHODS Patients entering the extension received darifenacin 7.5 mg once daily for 2 weeks, after which a voluntary increase in dose to 15 mg was permitted. Thereafter, patients could adjust the dose (either 7.5 or 15 mg). Safety and tolerability were assessed from adverse events (AEs) and discontinuations. Efficacy was determined using various endpoints. RESULTS In all, 716 patients entered the extension (mean age 57.3 years; 85.1% women) and 475 (66.3%) completed it (1089.9 patient‐years of exposure). Darifenacin was well tolerated with no significant safety concerns. The most commonly reported AEs were dry mouth and constipation (all‐causality rates 23.3% and 20.9%, respectively), leading to discontinuation in 1.3% and 2.4% of patients, respectively. Constipation infrequently required intervention, and analysis of bowel‐habit questionnaires revealed that the reporting of constipation was related to minor changes in bowel habit rather than true constipation. The efficacy of darifenacin was maintained, including significant improvements in the number of incontinence episodes/week (median change −84.4% at 2 years, P < 0.001 vs feeder‐study baseline). After 2 years, >40% of patients achieved a ≥90% reduction in incontinence episodes/week. CONCLUSION In the first published 2‐year, open‐label study of a CR antimuscarinic agent, darifenacin 7.5/15 mg once daily had a favourable safety, tolerability and efficacy profile during the long‐term treatment of OAB. As such, darifenacin represents a valuable therapeutic option for OAB.