Efficacy and Safety of Amlodipine Camsylate(Amodipin(TM)) for Treatment of Essential Hypertension

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.