|
KMID : 0648320030090010011
|
|
Journal of The Korean Society of Hypertension
2003 Volume.9 No. 1 p.11 ~ p.26
|
|
|
Efficacy and safety of NZ-105(Efonidipine hydrochloride) in patients with essential hypertension; The phase III multicenter open trial
|
|
Bae Jong-Hoa
Lee Seon-Yeong
Kim Seong-Won
Kim Young-Sik
Yang Yun-Jun
Sun Woo-Sung
Kang Heung-Sun
Choue Chung-Whee
Sohn Il-Suk
Kang Jae-Heon
|
|
|
Abstract
|
|
|
Background: Calcium antagonists have assumed a major role in the treatment of hypertensive patients and are
now among the most frequently prescribed drugs for the treatment of cardiovascular diseases. A novel calcium
antagonist, efonidipine hydrochloride (NZ-105, Finte Tab®) is a 1, 4- dihydroxy-pyridine derivative with property
of blocking both L-and T-type calcium channels from Japan. We compared the efficacy and safety of NZ-105 with
those of Nicardipine.
Methods: A multicenter open trial was performed in the three medical centers. Eighty six patients with essential
hypertension were randomly assigned to NZ-105 or Nicardipine treatment. Of the 86 patients, only 70 were treated
to the end of study. We performed intention-to-treat (ITT) analysis for 86 subjects enrolled and per-protocol (PP)
analysis for 62 patients ended the scheduled study of 12 weeks completely. NZ-105 20mg and Nicardipine HCl
40mg were starting doses and doubled at 4th week to the patients with uncontrolled blood pressure.
Results: After 12 weeks of treatment, both NZ-105 and Nicardipine produced a similar, significant degree of
reductions in both systolic blood pressure (SBP)(NZ-105, 14.0±15.8 mmHg; Nicardipine, 15.6±14.7 mmHg) and
diastolic blood pressure (DBP)(8.2±10.8 mmHg; 7.0±8.4 mmHg) (ITT analysis, P>0.05, NZ-105 vs Nicardipine).
And a similar degree of reductions in both SBP (NZ-105, 15.3±16.2 mmHg; Nicardipine, 17.0±14.9 mmHg) and
DBP (9.3±11.5 mmHg; 7.8±8.3 mmHg) were also noted in PP analysis (P>0.05, NZ-105 vs Nicardipine). No
fatal major adverse events were occurred in this study. And the incidence of adverse effects, including headache
and facial flushing noted by patients, were not different in both treatment groups (NZ-105, 31.1%; Nicardipine
34.1%). No significant changes of body weight, resting heart rate and electrocardiographic findings were observed.
Conclusions: Both NZ-105 and Nicardipine reduced blood pressure significantly without any fatal adverse events.
This study suggests that efonidipine hydrochloride is an effective and safe drug in the treatment of hypertension.
|
|
|
KEYWORD
|
|
|
Hypertension, Calcium antagonist, Efonidipine, Nicardipine
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|