IngentaConnect Tolerability of Nisoldipine Coat-Core in Hypertension

Abstract:

Nisoldipine, a dihydropyridine second generation calcium antagonist, is an effective antihypertensive agent when administered alone or as combination therapy. Nisoldipine coat-core (CC) is a recently developed extended-release formulation that provides sustained 24-hour blood pressure control after once-daily administration. This review outlines the tolerability profile of nisoldipine CC in hypertensive patients. Tolerability data were drawn from a pooled analysis of five short-term (<12 weeks), randomised, placebo-controlled double-blind studies of nisoldipine CC (10 to 60mg) in outpatients with mild to moderate essential hypertension. Data were also obtained from individual controlled trials comparing nisoldipine CC with amlodipine, felodipine, atenolol, enalapril, hydrochlorothiazide, lisinopril and verapamil SR. In the pooled data analysis, headache (30%) and peripheral oedema (22.6%) were the most common adverse events. Most adverse events were of mild intensity and transient in nature. Similar results were found during long-term treatment. In elderly patients, nisoldipine had a similar tolerability profile to enalapril. Nisoldipine at the maximum recommended dosage (60 mg/day) was also well tolerated in Black patients with severe hypertension. Clinical experience with nisoldipine CC indicates that it has a neutral metabolic profile; thus, it appears to be suitable for the treatment of hypertension in patients with concomitant diabetes or renal disease. Nisoldipine CC has shown no evidence of negative inotropic effects in patients with mild to moderate left ventricular dysfunction and no overt heart failure. There is no evidence of reflex tachycardia or postural hypotension during nisoldipine CC therapy.

In conclusion, nisoldipine CC appears to be a well-tolerated antihypertensive agent suitable for the treatment of patients with arterial hypertension, including those with concomitant diabetes or renal disease. Moreover, it is well tolerated in the elderly and in patients with symptomatic ischaemic heart disease.

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