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KMID : 0378019960390010050
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New Medical Journal
1996 Volume.39 No. 1 p.50 ~ p.56
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A Clinical Study on the Anti-Hypertensive Effect of Sustained-Release Nifedipine(Nifelan^(®)) in Moderate Hypertensive Patients
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Abstract
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Sustained-release(SR) nifedipine(Nifelan?, developed by Elan) is a new nifedipine formulation suitable for once a day administration. To investigate the efficacy and tolerability of nifedipine SR, we performed a clinical study in 20 hypertensive patients. After 2-week wash-out period, a single daily dose of 25-50 mg nifedipine SR was administered. If diastolic blood pressure decreased less than 10 mmHg from the baseline value or did not reach 90 mmHg or less, the dose of nifedipine SR was increased by 25 mg every 2 seeks. Blood pressure and heart rate were measured every 2 weeks. The laboratory tests were performed at baseline and the end of 8th week.
Baseline systolic and diastolic blood pressure were 148.1 ±20.2 and 99.5±5.8 mmHg, respectively. There were statistically significant reductions of systolic blood pressure and diastolic blood pressure 2 weeks after treatment which were maintained up to 8 weeks after treatment (P<0.05). The proportion of responders defined by diastolic blood pressure less than 90 mmHg or decline more than 10 mmHg was 90%.
There were no significant changes in heart rate and laboratory tests over the treatment period. Facial flushing and headache were noted in 6 cases(33%) and 5 cases(25%), respectively. In one case, we reduced the dose of nifedipine SR due to severe facial flushing.
In conclusion, anti-hypertensive therapy with nifedipine SR was effective in patients with mild to moderate hypertension and facial flushing and headache were the main adverse effects.
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