Nisoldipine CC:Clinical Experience in Hypertension

Abstract

Nisoldipine coat core (CC) is a long-acting formulation of the dihydropyridine calcium channel blocker nisoldipine, suitable for once-daily administration in the treatment of patients with hypertension. Data are reported from three randomized, controlled trials. In two of these, nisoldipine CC was shown to be equivalent in efficacy and tolerability to atenolol in patients with mild to moderate hypertension and to enalapril in elderly patients with hypertension. In a third study using ambulatory blood pressure monitoring in black patients with severe hypertension, nisoldipine CC maintained blood pressure control over the 24-hour dosing period. In addition, regression of left ventricular (LV) mass and improvement in LV function were observed at the end of the 4-month treatment period. Further data are presented from a pharmacokinetic pharmacodynamic modelling study investigating the potential effects of dose-dumping of nisoldipine from the controlled-release formulation, which may occur when the drug is taken with food. This study illustrates the superior control of plasma nisoldipine concentrations and blood pressure provided by the CC compared with an immediate-release formulation, and indicates that an interaction between nisoldipine CC and food is unlikely to cause adverse events. The results of these trials provide further support for the use of nisoldipine CC as an effective agent for the treatment of patients with hypertension, providing consistent antihypertensive efficacy and good tolerability with once-daily administration.