Summary
The antihypertensive efficacy of sustained-release nicardipine compared to placebo as third-line therapy has been assessed by ambulatory blood pressure monitoring in severly hypertensive patients with clinically unsatisfactory blood pressure control on 50 mg hydrochlorothiazide o.d. and 75 mg captopril b.d. Forty-two patients, 31 m and 11 f, with supine diastolic blood pressure 95–115 mm Hg after a 4 week run-in period on open hydrochlorothiazide and captopril, were randomly allocated to sustained-release nicardipine 45–60 mg/d or placebo.
At a visit to the clinic blood pressure and heart rate were measured 12 h after the evening dose by a trained observer unaware of the treatment. Twenty-four hour ambulatory monitoring was performed at the end of baseline and after 8 weeks of blinded medication.
There was no significant change in BD at the visit or on ambulatory monitoring in the placebo treated patients. In contrast, nicardipine produced a significant reduction in both blood pressures without affecting heart rate. Nicardipine also decreased the mean 24-h blood pressure by 14/10 mm Hg in patients whose clinical hypertension had been confirmed by ambulatory blood pressure monitoring but by only 3/2 mm Hg in ambulant patients who were normotensive on two-drug therapy.
One patient experienced an episode of severe symptomatic hypotension while on nicardipine. Otherwise, the numbers and percentages of patients from each group reporting adverse experiences were similar.
It is concluded that nicardipine appears to be an effective antihypertensive agent when used as third line therapy with diuretics and angiotensin converting enzyme inhibitors in patients with severe hypertension. In addition, since 40% of such patients already on two drug therapy were found to have a normal ambulatory blood pressure, the results reinforce the value of ambulatory monitoring in distinguishing hypertensives in whom more aggressive treatment may not by justified.
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Lacourcière, Y., Poirier, L., Lévesque, C. et al. Ambulatory blood pressure monitoring for the assessment of nicardipine as a third drug in severe essential hypertension. Eur J Clin Pharmacol 42, 131–136 (1992). https://doi.org/10.1007/BF00278471
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DOI: https://doi.org/10.1007/BF00278471