Naftopidil monotherapy vs naftopidil and an anticholinergic agent combined therapy for storage symptoms associated with benign prostatic hyperplasia: A prospective randomized controlled study

Abstract

Aim:The aim of this study was to compare the efficacy and safety of α 1 -adrenoceptor (α 1 -AR) antagonist monotherapy with combination therapy using α 1 -AR antagonist and anticholinergic agent for benign prostatic hyperplasia (BPH) with storage symptoms as the chief complaint. Methods: In this prospective comparative study, either 25-75 mg/day of naftopidil monotherapy (monotherapy group) or combination therapy using 25-75 mg/day of naftopidil and an anticholinergic agent (10-20 mg/day of propiverine hydrochloride or 2-6 mg/day of oxybutynin hydrochloride; cotherapy group) were administered for 12 weeks to 101 BPH patients with storage symptoms. Results: International prostate symptom score (IPSS) and quality of life (QOL) index improved significantly in both groups, with no marked differences between groups. Maximum flow rate (Q max ) and residual urine volume (RUV) tended to improve in both groups, again with no marked differences between groups. However, median post-therapeutic RUV was significantly worse for the cotherapy group (45.0 mL) than for the monotherapy group (13.5 mL; P = 0.0210). Ratio of patients with increased RUV was also significantly worse for cotherapy (22.9%) than for monotherapy (5.0%; P = 0.038). Conclusions: Although the anticholinergic dosage was low, the present results suggest that naftopidil monotherapy was as useful as combination therapy of naftopidil and an anticholinergic agent. Therefore, naftopidil is a useful agent as the first choice in BPH patients with storage symptoms.

Clinical guideline for male lower urinary tract symptoms

“…[107][108][109] A Japanese study also found that combination therapy improved storage symptoms, especially urgency, in BPH. 110 In a 12-week trial of combination therapy in men with LUTS, the benefits were significantly greater in the combination therapy group, with only a mild increase in residual urine volumes, and a 1% incidence of urinary retention, with no difference between groups. 111 It should be noted , however, that most of these studies were conducted with Caucasian men with strict exclusion criteria, specialists' supervision, and relatively short-term observational period.…”

Naftopidil for the treatment of benign prostate hyperplasia: a systematic review

“…In this context, Maruyama and colleagues 24 (Table 1) compared the efficacy and safety of naftopidil monotherapy to its combination with anticholinergic agents. In this 12 week RCT, 101 BPH/LUTS patients were randomly divided in two groups treated with either naftopidil monotherapy (25-75 mg/day, n ¼ 53) or naftopidil plus an anticholinergic agent (propiverine hydrochloride 10-20 mg/day or oxybutynin hydrochloride 2-6 mg/day, n ¼ 48).…”

“…Two studies compared low (25 mg/day) versus high (75 mg/day) dose naftopidil 22 , and 25 mg naftopidil thrice-a-day versus 75 mg/day 23 . Further studies compared naftopidil monotherapy to naftopidil plus either of two antimuscarinic agents, oxybutynin or propiverine 24,25 . Finally, eleven trials 12,14,17-25 used a parallel treatment design and three trials 13,15,16 used a crossover design (Table 1).…”

Naftopidil for the treatment of urinary symptoms in patients with benign prostatic hyperplasia

“…Recently, solid evidence to support the efficacy and safety of combination of α1-blockers and anticholinergic agents for male LUTS associated OAB has been reported 42–45. Maruyama et al compared the efficacy and safety of naftopidil monotherapy with combination therapy using naftopidil and anticholinergic agents for patients having LUTS/BPH with storage symptoms 46. Either monotherapy with 25–75 mg of naftopidil (n = 45) or combination therapy using 25–75 mg of naftopidil and an anticholinergic agent (10–20 mg of propiverine hydrochloride or 2–6 mg of oxybutynin hydrochloride, n = 41) was randomly given to 101 patients with LUTS/BPH with IPSS ≥ 8, QOL index ≥ 3, a score for day frequency ≥ 3, and a score for nocturia ≥ 2 for 12 weeks.…”