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      Comparative evaluation of naftopidil and tamsulosin in the treatment of patients with lower urinary tract symptoms with benign prostatic hyperplasia

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          Abstract

          Introduction:

          Naftopidil, approved initially in Japan, is an α1d-adrenergic receptor antagonist (α1-blocker) used to treat lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). It is different from tamsulosin hydrochloride and silodosin, in that it has a higher affinity for the α1D-adrenergic receptor subtype than for the α1A subtype and has a superior efficacy to a placebo and comparable efficacy to other α1-blockers such as tamsulosin. The incidences of ejaculatory disorders and intraoperative floppy iris syndrome induced by naftopidil may also be lower than that for tamsulosin and silodosin, which have a high affinity for the α1A-adrenergic receptor subtype. However, it remains unknown if the efficacy and safety of naftopidil in Japanese men is applicable to Indian men having LUTS/BPH.

          Material and Methods:

          Two groups of 60 patients each, having LUTS due to BPH, were treated with tamsulosin 0.4 mg and Naftopidil 75 mg for three months. Ultrasonography (for prostate size, post-void residual volume), uroflowmetry, and the International Prostate Symptom Score (IPSS) and Quality of Life (QOL) score were recorded at the beginning of the study, and then at one and three months.

          Results:

          The prostate size, post-void residual volume, all the uroflowmetry variables, and the IPSS QOL scores showed a statistically significant improvement ( P < 0.001) in both the groups. The improvement in the average flow rate and the QOL index was better in the naftopidil group on the intergroup comparison and was statistically significant ( P < 0.001).

          Conclusion:

          Although the QOL life index was significantly better in the naftopidil group, overall both naftopidil and tamsulosin were found to be equally effective in the treatment of LUTS due to BPH.

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          Most cited references15

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          The prevalence of lower urinary tract symptoms (LUTS) in the USA, the UK and Sweden: results from the Epidemiology of LUTS (EpiLUTS) study.

          To estimate and compare the prevalence and associated bother of lower urinary tract symptoms (LUTS) in the general populations of the USA, UK and Sweden using current International Continence Society (ICS) definitions, as no previous population-based studies evaluating the prevalence of LUTS in the USA, using the 2002 ICS definitions, have been conducted. This cross-sectional, population-representative survey was conducted via the Internet in the USA, the UK and Sweden. Members of Internet-based panels were randomly selected to receive an e-mailed invitation to participate. If interested, respondents selected a link to an informed consent page, followed by the survey. Participants were asked to rate how often they experienced individual LUTS during the previous 4 weeks, on a five-point Likert scale, and, if experienced, how much the symptom bothered them. Descriptive statistics were used to summarize and present the data. Responses rates for the USA, the UK and Sweden were 59.6%, 60.6% and 52.3%, respectively, with a final sample of 30,000 (USA 20,000; UK 7500; Sweden 2500). The mean age (range) of the participants was 56.6 (40-99) years; the mean percentages for race were 82.9% white, 6.7% black, 6.0% Hispanic and 4.4% Asian/other. The prevalence of LUTS was defined by two symptom frequency thresholds, i.e. at least 'sometimes' and at least 'often' for all LUTS except incontinence, where frequency thresholds were at least 'a few times per month' and at least 'a few times per week'. The prevalence of at least one LUTS at least 'sometimes' was 72.3% for men and 76.3% for women, and 47.9% and 52.5% for at least 'often' for men and women, respectively. For most LUTS, at least half of the participants were bothered 'somewhat' or more using a frequency threshold of at least 'sometimes'. For a threshold of at least 'often', 'somewhat' or more bother was reported by > or =70% of participants except for terminal dribble in men and split stream in women. In this large population study of three countries, LUTS are highly prevalent among men and women aged >40 years. In general, LUTS experienced 'often' or more are bothersome to most people.
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            Comparison of two alpha1-adrenoceptor antagonists, naftopidil and tamsulosin hydrochloride, in the treatment of lower urinary tract symptoms with benign prostatic hyperplasia: a randomized crossover study.

            To compare the efficacy of two alpha(1)-adrenoceptor antagonists, alpha(1A)-adrenoceptor-selective tamsulosin hydrochloride and alpha(1D)-adrenoceptor-selective naftopidil, in the treatment of lower urinary tract symptoms (LUTS) with benign prostatic hyperplasia (BPH). Thirty-four patients (mean age 72.4 years, sd 4.3, range 66-79) with LUTS (International Prostate Symptom Score, IPSS >8) secondary to BPH were enrolled in a randomized crossover study. Seventeen patients were initially prescribed naftopidil 50 mg for 4 weeks, followed by tamsulosin 0.2 mg for 4 weeks (group A); another 17 were initially prescribed tamsulosin 0.2 mg, followed by naftopidil 50 mg (group B). Patients changed to the alternative treatment after a 1-week washout period. Efficacy criteria were improvement in LUTS (IPSS), quality of life (QoL), uroflowmetry, and pressure-flow study (PFS) values based on the treatment with each agent. At baseline there were no significant differences between the groups in IPSS, QoL, uroflowmetry values or PFS values, except for the volume at maximum desire to void. After treatment with each agent, the IPSS and QoL were significantly improved and the reduction in bladder outlet obstruction confirmed by PFS. Naftopidil was significantly more effective than tamsulosin in relieving nocturia. The increases from baseline (before treatment) to the endpoint (after treatment with each agent) in the volume at first desire and maximum desire to void were significantly higher with naftopidil than with tamsulosin. Involuntary contractions disappeared in two patients with relief of nocturia with naftopidil, but not with tamsulosin. The decrease in other symptoms of the IPSS, QoL, increase in uroflowmetry values and changes in other PFS values were similar for both agents. The two agents provided similar efficacy in the treatment of LUTS with BPH. However, naftopidil was better than tamsulosin for nocturia. The disappearance of involuntary contraction and the greater increase in first-desire volume with naftopidil may be associated with the relief of nocturia. The alpha(1D)-adrenoceptor antagonist is effective in alleviating both voiding and storage symptoms. The alpha(1D)-adrenoceptor antagonist may be more effective than the alpha(1A)-adrenoceptor antagonist in LUTS with BPH.
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              Naftopidil, a novel alpha1-adrenoceptor antagonist, displays selective inhibition of canine prostatic pressure and high affinity binding to cloned human alpha1-adrenoceptors.

              The pharmacological profiles of the alpha1-adrenoceptor antagonists naftopidil, tamsulosin and prazosin were studied in an anesthetized dog model that allowed the simultaneous assessment of their antagonist potency against phenylephrine-mediated increases in prostatic pressure and mean blood pressure. The intravenous administration of each of these compounds dose-dependently inhibited phenylephrine-induced increases in prostatic pressure and mean blood pressure. To further assess the ability of the three compounds to inhibit phenylephrine-induced responses, the doses required to produce a 50% inhibition of the phenylephrine-induced increases in prostatic and mean blood pressure and the selectivity index obtained from the ratio of those two doses were determined for each test compound. Forty minutes after the intravenous administration of naftopidil, the selectivity index was 3.76, and those of tamsulosin and prazosin were 1.23 and 0.61, respectively. These findings demonstrated that naftopidil selectively inhibited the phenylephrine-induced increase in prostatic pressure compared with mean blood pressure in the anesthetized dog model. The selectivity of naftopidil for prostatic pressure was the most potent among the test compounds. In addition, using cloned human alpha1-adrenoceptor subtypes, naftopidil was selective for the alpha1d-adrenoceptor with approximately 3- and 17-fold higher affinity than for the alpha1a- and alpha1b-adrenoceptor subtypes, respectively. The selectivity of naftopidil for prostatic pressure may be attributable to its high binding affinity for alpha1a- and alpha1d-adrenoceptor subtypes.
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                Author and article information

                Journal
                Urol Ann
                Urol Ann
                UA
                Urology Annals
                Medknow Publications & Media Pvt Ltd (India )
                0974-7796
                0974-7834
                Jul-Sep 2014
                : 6
                : 3
                : 181-186
                Affiliations
                [1]Department of General Surgery, Pt. B.D. Sharma Postgraduate Institute of Medical Sciences, Rohtak, Harayana, India
                [1 ]Department of Urology, Pt. B.D. Sharma Postgraduate Institute of Medical Sciences, Rohtak, Harayana, India
                Author notes
                Address for correspondence: Dr. Mahavir Singh Griwan, 4/6J Medical Campus, Pt. B.D. Sharma Postgraduate Institute of Medical Sciences, Rohtak, Haryana, India. E-mail: mahavir.griwan@ 123456gmail.com
                Article
                UA-6-181
                10.4103/0974-7796.134254
                4127851
                25125888
                e10207a8-11f2-4e6d-8ee7-e81e1b28c2c7
                Copyright: © Urology Annals

                This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 08 February 2013
                : 31 July 2013
                Categories
                Original Article

                Urology
                benign prostatic hyperplasia,luts,naftopidil,tamsulosin
                Urology
                benign prostatic hyperplasia, luts, naftopidil, tamsulosin

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