A Randomized Clinical Study to Compare the Efficacy and Safety of Naftopidil Versus Tamsulosin in Symptomatic Benign Prostatic Hyperplasia

Abstract

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.cItAtION: UroToday Int J. 2013 April;6(2):art 17. http://dx.

A comparison of the efficacy of naftopidil and tamsulosin hydrochloride in medical treatment of benign prostatic enlargement

“…In our study, naftopidil showed significant improvement in irritative components of IPSS mainly Frequency and Nocturia at 15 and 30 days of treatment which was supported by a recent comparative study conducted by Iqbal et al . [ 19 ] Tamsulosin showed better response in obstructive symptoms such as poor stream, intermittency and straining at 15 and 30 days of treatment which is similar to a comparative study reported by Ukimura et al . [ 18 ] and Nishino and Deguchi[ 16 ] in Japan.…”

“…[ 18 ] and Iqbal et al . [ 19 ] Alpha-1D receptors have been found to be involved in the storage of urine in the bladder as was suggested by Chen et al ., the bladder capacity and urine volume per urination were significantly higher in alpha-1D knock-out mice than wild mice. [ 21 ] Thus, this report suggests that with relatively greater affinity to alpha-1D receptors, naftopidil can affect the storage function.…”

Outcomes and complications of naftopidil versus tamsulosin for elderly men with lower urinary tract symptoms secondary to benign prostatic hyperplasia: A systematic review and meta‐analysis

“…From the remaining 72 articles, 61 articles were excluded after the full text was assessed. Finally, 11 RCTs (Gotoh et al., 2005; Griwan et al., 2014; Hanyu et al., 2010; Ju et al., 2002; Kwon et al., 2018; Li et al., 2007; Masumori et al., 2009; Perumal et al., 2015; Singh et al., 2013; Ukimura et al., 2008; Yokoyama et al., 2011) were included to evaluate the efficacy and safety of naf versus tam in men with LUTS/BPH. A flow diagram is shown in Figure 1, which demonstrates the study selection process.…”

“…Ukimura et al (Ukimura et al., 2008) reported naf benefitted more in early improvement of urinary frequency and nocturia at 2 weeks than tam. Singh et al (Singh et al., 2013) also found that naf could improve the total IPSS, IPSS storage score, PVR and QoL earlier than tam. The reason for the early response may be based on the effect of naf on alpha1‐D receptors in the central neural system, spinal cord and bladder (Schwinn & Roehrborn, 2008).…”