Yonsei Med J.  2017 Jul;58(4):800-806. 10.3349/ymj.2017.58.4.800.

Clinical Efficacy and Safety of Naftopidil Treatment for Patients with Benign Prostatic Hyperplasia and Hypertension: A Prospective, Open-Label Study

• Chung MS
• Yoon BI
• Lee SH

• KMID: 2419087
• DOI: http://doi.org/10.3349/ymj.2017.58.4.800

Abstract

PURPOSE
To investigate the efficacy and safety of naftopidil for benign prostatic hyperplasia (BPH) patients, mainly focusing on changes in blood pressure (BP).
MATERIALS AND METHODS
Of a total of 118 patients, 90 normotensive (NT) and 28 hypertensive (HT) patients were randomly assigned to be treated with naftopidil 50 mg or 75 mg for 12 weeks, once-daily. Safety and efficacy were assessed by analyzing changes from baseline in systolic/diastolic BP and total International Prostate Symptom Score (IPSS) at 4 and 12 weeks. Adverse events (AEs), obstructive/irritative subscores, quality of life (QoL) score, maximum urinary flow rate (Qmax), and benefit, satisfaction with treatment, and willingness to continue treatment (BSW) questionnaire were also analyzed.
RESULTS
Naftopidil treatment decreased mean systolic BP by 18.7 mm Hg for the HT 50 mg group (p<0.001) and by 18.3 mm Hg for the HT 75 mg group (p<0.001) and mean diastolic BP by 17.5 mm Hg for the HT 50 mg group (p<0.001) and by 14.7 mm Hg for the HT 75 mg group (p=0.022). In the NT groups (both naftopidil 50 mg and 75 mg), naftopidil elicited no significant changes in BP from baseline values. After 12 weeks, naftopidil 50 and 75 mg groups showed significant improvements in IPSS scores (total, obstructive/irritative subscores, QoL score) and Qmax from baseline. AEs were reported in 7.8% (50 mg group) and 2.9% (75 mg group) of patients. In both the 50 mg and 75 mg groups, >86% of all patients agreed to continue their current medications.
CONCLUSION
Our results suggest that naftopidil treatment in BPH patients with hypertension allows for optimal management of BP within the normal range.

Keyword

α-adrenoceptor antagonists; BPH; hypertension; naftopidil

MeSH Terms

Adrenergic alpha-Antagonists/adverse effects/pharmacology/therapeutic use
Aged
Blood Pressure/drug effects
Demography
Humans
Hypertension/*complications/*drug therapy
Male
Middle Aged
Naphthalenes/*adverse effects/pharmacology/*therapeutic use
Patient Compliance
Patient Satisfaction
Piperazines/*adverse effects/pharmacology/*therapeutic use
Prospective Studies
Prostatic Hyperplasia/*complications/*drug therapy
Quality of Life
Surveys and Questionnaires
Treatment Outcome
Adrenergic alpha-Antagonists
Naphthalenes
Piperazines

Figure

• 

  Fig. 1 Patient disposition. A total of 120 patients were screened and 118 were enrolled in this study. Ninety normotensive (NT) patients and 28 hypertensive (HT) patients were randomly assigned into the naftopidil 50 mg or naftopidil 75 mg group for 12-week, once-daily treatment. In the NT group, 83 patients completed the study. The main reason for study discontinuation was AEs (6 patients, 6.6%). In the HT group, 27 patients completed the study, and one discontinued because of loss during follow-up. AE, adverse event.

• 

  Fig. 2 Comparison of the mean changes in BP from baseline value according to group. BP, blood pressure.

• 

  Fig. 3 Change in efficacy parameters from baseline to each visit in the ITT population. IPSS, international prostate symptom score; SD, standard deviation; QoL, quality of life; Qmax, maximum urinary flow rate; ITT, intention to treat.

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