Korean Circ J.
2005 Mar;35(3):247-252. 10.4070/kcj.2005.35.3.247.
Efficacy and Safety of Amlodipine Camsylate(Amodipin(TM)) for Treatment of Essential Hypertension
- Affiliations
-
- 1Division of Cardiology, Gil Medical Center, Gachon Medical School, Incheon, Korea. ekshin@ghil.com
- 2Division of Cardiology, Yeoeuido St. Mary's Hospital, College of Medicine, The Catholic University, Seoul, Korea.
- 3Division of Cardiology, Korea University College of Medicine, Guro Hospital, Seoul, Korea.
- 4Division of Cardiology, Nation Health Insurance Corporation Ilsan Hospital, Ilsan, Korea.
- 5Division of Cardiology, College of Medicine, University of Sungkyunkwan, Seoul, Korea.
- 6Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
- 7Division of Cardiology, College of Medicine, Soonchunhyang University, Seoul, Korea.
- KMID: 2093926
- DOI: http://doi.org/10.4070/kcj.2005.35.3.247
Abstract
- BACKGROUND AND OBJECTIVES
Amlodipine camsylate (Amodipin(TM)), a newly developed amlodipine formulation, has similar physical properties and pharmacokinetic equivalency to that of the conventional formulation (amlodipine besylate, Norvasc(R)).
SUBJECTS AND METHODS
This prospective, randomized, double-blind, parallel designed, multicenter study was conducted at a total of 7 sites. 95 patients with mild to moderate essential hypertension were enrolled. Following the 2 week administration of a placebo, the patients received 5 mg of amlodipine once a day for a total of 8 weeks. If either the blood pressure was > or =140/90 mmHg or the sitting diastolic blood pressure had not decreased by > or =10 mmHg from those at the baseline after 4 weeks of treatment, the dose of amlodipine was increased to 10 mg. The blood pressure was measured twice every 4 weeks and mean value recorded.
RESULTS
The diastolic and systolic blood pressures were significantly decreased with both amlodipine camsylate (baseline DBP: 97.4+/-5.8 mmHg, 8th week DBP: 84.1+/-8.8 mmHg, mean differences: -13.3+/-7.4) and amlodipine besylate (baseline DBP: 95.9+/-5.9 mmHg, 8th week DBP: 83.2+/-9.2 mmHg, mean differences: -12.4+/-8.3). The incidence of drug related adverse events was similar in both groups.
CONCLUSION
This study suggests that once-a-day monotherapy of amlodipine camsylate is effective for the control of blood pressure in patients with essential hypertension, without significant adverse events.
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