A comparative study of fixed dose of Tamsulosin with finasteride vs Tamsulosin with dutasteride in the management of benign prostatic hyperplasia

OBJECTIVE: The aim of this study was to compare the efficacy, safety and tolerability of Dutasteride vs Finasteride in a fixed dose combination, with a uro-selective a-blocker Tamsulosin, in the management of symptomatic BPH associated with LUTS. MATERIALS AND METHODS: 105 males between 40-80 years, clinically diagnosed as Benign prostatic hyperplasia (BPH) having a baseline evaluation of their IPSS, UFR, PSA, LFT, KFT, sex health, ultrasound of prostate and PVUV, were randomized to receive a fixed dose combination therapy of Tamsulosin (0.4 mg) with Finasteride (5 mg), vs Tamsulosin (0.4 mg) with Dutasteride (0.5 mg), daily for six consecutive months. Follow-up at the end of the 2nd, 4th, 8th, 12th and 24th week was done with IPSS, UFR, PSA, ultrasound of Prostate, PVUV and sex health. RESULTS: There were five dropouts, three from the Finasteride arm and two from Dutasteride arm, leaving a total of 100 patients for the final evaluation. Patients in both the groups showed improvement in their symptoms score and urine flow rate from the baseline, but those with the Dutasteride combination not only showed much better improvement in their symptoms score and urine flow, but were also relieved of their obstructive symptoms earlier (10-14 days) than seen in the Finasteride group (24-35 days). None of the patients had acute retention of urine (AUR) during the trial. The post void urine volume was decreased more in the Dutasteride group, than in patients with Finasteride. Sexual dysfunction incidence was same in both the groups. Approximately 50% reduction in the PSA level was seen in both the groups, while LFT did not show significant difference from the baseline, in either group. Both the drugs were well tolerated, with the patient's good compliance and with no drop-out due to adverse effects. CONCLUSION: A combination of a-adrenergic blocker and 5-ARI is the best therapeutic option for medical management of BPH as it is safe, effective and well tolerated. A combination of Tamsulosin with Dutasteride results in early symptomatic relief and low PVUV, than seen with the Tamsulosin with Finasteride combination.