Clinical outcomes after combined therapy with dutasteride plus tamsulosin or either monotherapy in men with benign prostatic hyperplasia (BPH) by baseline characteristics: 4‐year results from the randomized, double‐blind Combination of Avodart and Tamsulosin (CombAT) trial

Abstract

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...

Decline of seminal parameters in middle-aged males is associated with lower urinary tract symptoms, prostate enlargement and bladder outlet obstruction

“…The most sophisticated problem was to compose an optimal and operative protocol for the study to assess all parameters related to reproductive quality and lower urinary tract symptoms in males > 45 years. However, we tried to use well-known and current LUTS parameters and optimal cut-off levels from clinical practice, described in the guidelines of lower urinary tract symptoms (9) and in previous large-scale studies (14,15).…”

“…According to lower urinary tract symptoms, the subjects were divided into four groups -without LUTS score (IPSS 0) and with mild (I--PSS score 1-7), moderate (I-PSS score [8][9][10][11][12][13][14][15][16][17][18][19], and severe (I-PSS score 20-35) symptom scores (9). The separation of subjects according to total prostate volume was made using the cut-off levels of previous large-scale, long-term medical studies (14,15) and the risk for BPH progression (TPV < 30 and ≥ 30 mL, respectively) (16).…”

“…The separation of subjects according to total prostate volume was made using the cut-off levels of previous large-scale, long-term medical studies (14,15) and the risk for BPH progression (TPV < 30 and ≥ 30 mL, respectively) (16).…”

α1‐blocker tamsulosin as initial treatment for patients with benign prostatic hyperplasia: 5‐year outcome analysis of a prospective multicenter study

“…The Combination of Avodart and Tamsulosin study showed that the long-term outcome of a1-blockers was not always promising, [9][10][11] especially for patients with a large PV and high PSA level. We also showed that patients who had a large PV at baseline, as well as severe IPSS at 12 weeks after treatment, were more likely to have treatment failure during a 4-year follow-up period.…”

Profile of Prostatectomy Cases

“…In the statistical analysis; AUR was found to be correlated with a large prostate volume (Vp), high PSA, and combination of prostatic inflammation with benign prostatic hyperplasia in the prostatectomy pathology report (p<0.05). According to the International Index of Erectile Function (IIEF-5) questionnaire, only 15.6% of the cases had no erectile disfunction (ED) (score [22][23][24][25] preoperatively. Age had a negative correlation with IIEF-5 scores (p<0.05).…”