Comparison of the response to treatment between Asian and Caucasian men with benign prostatic hyperplasia: Long‐term results from the combination of dutasteride and tamsulosin study

Abstract

Abbreviations & Acronyms 5AR = 5a-reductase 5ARI = 5a-reductase inhibitor AE = adverse events AUR = acute urinary retention BII = BPH impact index BMI = body mass index BPH = benign prostatic hyperplasia CombAT = Combination of Avodart and Tamsulosin IPSS = International Prostate Symptom Score LUTS = lower urinary tract symptoms PSA = prostate-specific antigen PV = prostate volume Qmax = maximum urinary flow rate QoL = quality of life SAE = serious adverse events Abstract: The Combination of Avodart and Tamsulosin study was a 4-year, randomized , double-blind study of the efficacy and safety of dutasteride and tamsulosin, alone or in combination, in men with moderate-to-severe benign prostatic hyperplasia. In this post-hoc investigation, we analyzed primary and secondary end-points from the Combination of Avodart and Tamsulosin study in Asian (n = 325) and Caucasian men (n = 4259). The incidence of acute urinary retention or benign prostatic hyperplasiarelated surgery did not differ significantly between treatment groups in the Asian subpopulation. In Caucasian men, the incidence of acute urinary retention/benign prostatic hyperplasia-related surgery was significantly lower in the combination therapy group compared with the tamsulosin monotherapy group (P < 0.001), but not compared with dutasteride monotherapy. Combination therapy significantly increased the time to benign prostatic hyperplasia clinical progression and resulted in improved International Prostate Symptom Score, maximum urinary flow rate, quality of life, and reduced prostate volume in Asian and Caucasian men who received combination therapy compared with tamsulosin monotherapy. Combination therapy also significantly improved (P < 0.05) time to benign prostatic hyperplasia clinical progression, International Prostate Symptom Score, maximum urinary flow rate and quality of life versus dutasteride in the Caucasian subpopulation. The adverse-event profile was comparable between subpopulations. In conclusion, Asian and Caucasian men respond similarly to these treatments, despite apparent racial differences in 5a-reductase activity.

Comparison of the clinical effect of dutasteride therapy for benign prostatic hyperplasia when initiated at different time points: A multicentre, observational, retrospective chart review study

“…Randomised controlled trials have shown that treatment with dutasteride reduces AUR and BPH‐related surgery in patients with BPH at risk of disease progression, and database studies indicate that earlier initiation of dutasteride prevents disease progression to a greater extent than later initiation . However, the appropriate timing of dutasteride initiation in Japanese patients with BPH has not yet been determined.…”

Clinical guidelines for male lower urinary tract symptoms and benign prostatic hyperplasia

“…Combined therapy of α1‐blockers and 5α‐reductase inhibitors is recommended for BPH with prostate volume >30 mL (level 1; grade A) . Superiority of combined therapy to monotherapy of 5α‐reductase inhibitors might be uncertain for BPH with prostates >60 mL …”

Fixed-dose combination therapy with dutasteride and tamsulosin in the management of benign prostatic hyperplasia

“…Another subanalysis of CombAT data revealed sustained superior therapeutic effect of combination treatment over tamsulosin monotherapy in improving LUTS, regardless of patients’ ethnic background. Even though racial differences in 5-AR activity, prostate volume, PSA levels and LUTS severity have been proved, no difference was found between Asian and White men in terms of clinical response to treatment [Chung et al . 2012].…”