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Double-blind crossover study of once daily nifedipine coat core in essential hypertension
C G Missouris1, F P Cappuccio, N D Markandu
1Department of Medicine, St. George's Hospital Medical School, London, UK.
Insights
This study found that the new nifedipine coat core formulation effectively lowers blood pressure (BP) in patients with essential hypertension. A 60 mg dose showed greater BP reduction than 30 mg, though effects diminished by 24 hours.
Area of Science:
- Cardiology
- Pharmacology
- Hypertension Research
Background:
- Essential hypertension remains a significant global health concern.
- Nifedipine is a widely used calcium channel blocker for managing hypertension.
- Evaluating new drug formulations is crucial for optimizing therapeutic outcomes.
Purpose of the Study:
- To assess the efficacy and safety of a novel nifedipine coat core formulation in patients with essential hypertension.
- To compare the blood pressure (BP) lowering effects of two different once-daily doses (30 mg and 60 mg) of the new formulation.
- To investigate the relationship between plasma nifedipine levels and BP response over a 24-hour period.
Main Methods:
- A double-blind, randomized crossover study involving 19 patients with essential hypertension.
- Patients received either 30 mg or 60 mg of nifedipine coat core once daily for three weeks.
- Blood pressure and plasma nifedipine levels were measured at multiple time points post-dosing (24 hours, 2, 4, and 6 hours).
Main Results:
- Both 30 mg and 60 mg doses of the nifedipine coat core formulation demonstrated BP lowering effects.
- The 60 mg dose achieved a significantly greater BP reduction compared to the 30 mg dose.
- Higher plasma nifedipine levels were significantly associated with a greater BP lowering effect, with levels decreasing by 24 hours post-dose.
Conclusions:
- Nifedipine coat core formulation is effective for managing essential hypertension.
- The 60 mg dose offers superior BP control compared to the 30 mg dose.
- While effective, the peak BP lowering effect of this formulation is not sustained for the full 24-hour dosing interval.
Abstract:
Nineteen patients with essential hypertension on regular treatment with nifedipine tablets 20 mg twice daily and whose DBP was < 95 mmHg on at least two occasions two weeks apart were entered in a double-blind randomised crossover study of three weeks treatment with nifedipine coat core (new formulation) either as 30 mg one daily or as 60 mg once daily dose. BP and plasma nifedipine levels were measured at 24, two, four and six hours after dosing. The pattern of BP response to both doses was similar over the 24h period. However, a greater BP lowering effect was achieved with 60 mg compared with 30 mg. The BP lowering effect of both doses was less at 24h after the last dose compared with peak effect. Plasma nifedipine levels were significantly associated with the BP lowering effect in the group as a whole (i.e. the higher the nifedipine levels, the lower the BP) and were significantly less at 24 hours compared with peak. Nifedipine in the coat core formulation is effective in lowering BP in patients with essential hypertension. The 60 mg dose is more effective than the 30 mg dose and induces higher nifedipine levels which are associated with greater BP lowering effect. However, the maximum BP lowering effect is not maintained up to 24 hours.