1785 COMBINATION THERAPY WITH DUTASTERIDE AND TAMSULOSIN PROVIDED GREATER IMPROVEMENTS THAN EITHER MONOTHERAPY REGARDLESS OF PRIOR BENIGN PROSTATIC HYPERPLASIA OR LOWER URINARY TRACT TREATMENT STATUS

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Medical and Hormonal Therapy1 Apr 20101785 COMBINATION THERAPY WITH DUTASTERIDE AND TAMSULOSIN PROVIDED GREATER IMPROVEMENTS THAN EITHER MONOTHERAPY REGARDLESS OF PRIOR BENIGN PROSTATIC HYPERPLASIA OR LOWER URINARY TRACT TREATMENT STATUS Paul Siami, Ronaldo Damião, Francesco Montorsi, Timothy H. Wilson, Kim Major-Walker, and R. Paul Gagnier Paul SiamiPaul Siami Evansville, IN , Ronaldo DamiãoRonaldo Damião Rio de Janeiro, Brazil , Francesco MontorsiFrancesco Montorsi Milan, Italy , Timothy H. WilsonTimothy H. Wilson Research Triangle Park, NC , Kim Major-WalkerKim Major-Walker Research Triangle Park, NC , and R. Paul GagnierR. Paul Gagnier Research Triangle Park, NC View All Author Informationhttps://doi.org/10.1016/j.juro.2010.02.1696AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES To assess the efficacy and safety of dutasteride/tamsulosin combination vs. each monotherapy for improving symptoms and clinical outcomes in men with or without previous treatment (α-blockers and/or 5α-reductase inhibitors) for benign prostatic hyperplasia (BPH) or lower urinary tract symptoms from the Combination of Avodart and Tamsulosin (CombAT) BPH study. METHODS In this 4-year, double-blind study, 4844 men age ≥50 years with BPH (International Prostate Symptom Score [IPSS] ≥12, prostate volume [PV] ≥30 cc, serum PSA 1.5-10 ng/mL, Qmax 5-15 mL/s) were randomized to receive dutasteride 0.5 mg/day, tamsulosin 0.4 mg/day, or the combination. Here, we report results for acute urinary retention (AUR) or BPH-related surgery, BPH clinical progression, IPSS, Qmax, and PV by treatment group in previously treated and untreated men. RESULTS At baseline, 2511 men had received previous treatment with α-blockers (2444/2511; 97%) and/or 5α-reductase inhibitors (531/2511; 21%) and 2250 had not. Time to first AUR or BPH-related surgery was significantly lower for combination vs. tamsulosin in both previously treated and untreated subgroups (p<0.001 for both), but not significant for combination vs. dutasteride in either subgroup (p=0.23 previously treated, p=0.43 untreated). The relative risk reduction (RRR) of AUR/surgery for combination vs. tamsulosin in previously treated and untreated men was 64.8% (95% CI: 49.2, 75.6) and 67.0% (95% CI: 49.0, 78.7), respectively. The RRR of AUR/surgery was not significant for combination vs. dutasteride for either subgroup. The table includes results for safety/tolerability. CONCLUSIONS Regardless of past BPH treatment, combination therapy with dutasteride and tamsulosin vs. tamsulosin monotherapy over 4 years provided a significantly reduced relative risk of AUR and BPH-related surgery and BPH clinical progression. A significant RRR was also seen in BPH clinical progression with combination vs. dutasteride for both previously treated and untreated subgroups. Combination vs. tamsulosin led to significant improvements in IPSS, Qmax, and PV, regardless of past BPH treatment. Table 1. Efficacy and tolerability measures after 4 years of treatment with combination therapy or either monotherapy. Previously treated Previously untreated D+T D T D+T D T n=836 n=836 n=839 n=746 n=757 n=747 AUR or BPH-related surgery Crude incidence rate 4.7% 6.0% 12.6% 3.6% 4.5% 10.8% p value vs. combination — 0.23 <0.001 — 0.39 <0.001 BPH clinical progression‡ Crude incidence rate 13.0% 18.5% 23.1% 11.9% 16.9% 19.9% p value vs. combination — 0.002 <0.001 — 0.006 <0.001 Adjusted mean (SE) change from baseline IPSS -6.7 (0.23) -5.6⁎ (0.23) -3.8⁎ (0.23) -6.3 (0.23) -5.5† (0.23) -4.2⁎ (0.23) Qmax, mL/sec 2.3 (0.17) 1.9 (0.17) 0.7⁎ (0.17) 2.6 (0.20) 2.3 (0.20) 0.9⁎ (0.19) Prostate volume,% change -26.8 (0.89) -28.5 (0.87) 4.5⁎ (1.26) -28.3 (0.98) -28.0 (0.97) 4.1⁎ (1.39) Any adverse event,% 74 76 74 72 69 70 Serious adverse events,% 19 23 22 19 19 22 Drug-related adverse events,% 27 23 19⁎ 30 18⁎ 18⁎ Abbreviations: D+T, combination dutasteride/tamsulosin; D, dutasteride; T, tamsulosin; CI, confidence interval; SE, standard error. ⁎ p<0.001, † p=0.013 vs. D+T. ‡ Defined as one of the following: symptom deterioration by IPSS ≥4 points on two consecutive visits; BPH-related AUR; BPH-related urinary incontinence; recurrent BPH-related urinary tract infection or urosepsis; or BPH-related renal insufficiency. © 2010 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 183Issue 4SApril 2010Page: e692 Advertisement Copyright & Permissions© 2010 by American Urological Association Education and Research, Inc.Metrics Author Information Paul Siami Evansville, IN More articles by this author Ronaldo Damião Rio de Janeiro, Brazil More articles by this author Francesco Montorsi Milan, Italy More articles by this author Timothy H. Wilson Research Triangle Park, NC More articles by this author Kim Major-Walker Research Triangle Park, NC More articles by this author R. Paul Gagnier Research Triangle Park, NC More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...