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

 Mun Su Chung  ;  Byung Il Yoon  ;  Seung Hwan Lee 
 YONSEI MEDICAL JOURNAL, Vol.58(4) : 800-806, 2017 
Journal Title
Issue Date
Adrenergic alpha-Antagonists/adverse effects ; Adrenergic alpha-Antagonists/pharmacology ; Adrenergic alpha-Antagonists/therapeutic use ; Aged ; Blood Pressure/drug effects ; Demography ; Humans ; Hypertension/complications* ; Hypertension/drug therapy* ; Male ; Middle Aged ; Naphthalenes/adverse effects* ; Naphthalenes/pharmacology ; Naphthalenes/therapeutic use* ; Patient Compliance ; Patient Satisfaction ; Piperazines/adverse effects* ; Piperazines/pharmacology ; Piperazines/therapeutic use* ; Prospective Studies ; Prostatic Hyperplasia/complications* ; Prostatic Hyperplasia/drug therapy* ; Quality of Life ; Surveys and Questionnaires ; Treatment Outcome
BPH ; hypertension ; naftopidil ; α-adrenoceptor antagonists
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.
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1. College of Medicine (의과대학) > Dept. of Urology (비뇨의학교실) > 1. Journal Papers
Yonsei Authors
Lee, Seung Hwan(이승환) ORCID logo https://orcid.org/0000-0001-7358-8544
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