Aim: To compare the clinical efficacy and tolerability of naftopidil versus tamsulosin in patients with LUTS due to BPH. Tamsulosin acts via α1A-receptor and naftopidil acts via α1D-receptor blocker. The latter is believed to be more efficacious with fewer side effects.
Settings and Design: A prospective, randomized, non-placebo clinical study.
Methods and Materials: 110 patients fulfilling our inclusion criteria were randomized (double-blinded) to receive naftopidil (50 mg) or tamsulosin (0.4 mg) once daily for 3 months after obtaining institutional ethical clearance and administering informed consent. The patients were followed for changes in International Prostate Symptom Score (IPSS), Sexual Function Inventory Score (SFIS), peak flow rate (PFR), average flow rate (AFR), post-void residue (PVR), episodes of acute urinary retention (AUR), and side effects, which were recorded and analyzed using appropriate statistical tools.
Statistical Analysis: Recorded data was analyzed using appropriate statistical tools including the unpaired Student t test, Tukey test, and the repeated measure ANOVA test.
Results: Naftopidil and tamsulosin both improved patient symptoms, uroflowmetry, and other parameters. Naftopidil appeared to have an earlier onset of action shown by significant change in values of IPSS (P = 0.003), PVR (0.041), storage subscore (SIPSS) (P = 0.011), and Qol (P = 0.017) at 2 weeks. A higher incidence of postural hypotension, headache, and drug failure were observed with tamsulosin (not statistically significant). SFIS was significantly lower in the tamsulosin group.
Conclusions: The management of symptomatic BPH, with either naftopidil or tamsulosin, appeared to be equally effective, safe, and well tolerated. Naftopidil appeared to have a faster onset of action with fewer side effects versus tamsulosin. All patients appeared to be equally compliant, and there was no treatment withdrawal due to observed side effects with either drug.
Iqbal Singh, Ankit Gupta, Vivek Agrawal, Mohit Joshi
Submitted January 2, 2013 - Accepted for Publication February 14, 2013
KEYWORDS: Tamsulosin, naftopidil, voiding dysfunction, LUTS
CITATION: UroToday Int J. 2013 April;6(2):art 17. http://dx.doi.org/10.3834/uij.1944-5784.2013.04.04