NOVEL DELIVERY SYSTEM FOR VERAPAMIL DESIGNED TO ACHIEVE MAXIMAL BLOOD-PRESSURE CONTROL DURING THE EARLY-MORNING

Because the risk of cardiovascular events appears to be greatest in th e early morning, this period is a time during which adequate blood pre ssure (BP) control appears to be mast desirable, In this study, a cont rolled-onset extended-release system (COER-24) that delivers verapamil in a manner designed to achieve maximal levels of drug during the ear ly morning surge in BP was compared with placebo. Ninety-five patients with mild to moderate hypertension were studied, of this group, 49 pa tients (mean age 57.6 +/- 1.4 years; 35 men and 14 women) were randomi zed to take verapamil COER-24, 240 mg at 10 PM, and 46 subjects (mean age 55.8 +/- 1,5 years: 29 men and 17 women) were randomized to take p lacebo, Ambulatory BP monitoring was performed after a 4-week initial placebo period and was repeated after 4 weeks of treatment with verapa mil or placebo, Verapamil COER-24 resulted in significant (p < 0.001) decreases in mean whole-day systolic and diastolic BP (-8,2/-6,3 mm Hg ; baseline 152/93.0 man Hg) when compared with placebo (+0,3/-0,9 mm H g; baseline 150.3/93.2 mm Hg), From 6 AM to noon, verapamil COER-24 re sulted in a change in systolic and diastolic BP of -11,6/-9,0 mm Hg, w hich was significantly (p < 0.001) greater than the change that occurr ed with placebo (-0,5/-1.0 mm Hg) during the same period, In the last 4 hours of the dosing interval (6 PM to 10 PM), verapamil COER-24 caus ed significantly greater (p < 0,001) decreases in BP (-7,4/-4,8 mm Hg) than did placebo (+2,7/+1.0 mm Hg), These data demonstrate that the C OER-24 system, when administered in the late evening, achieves maximal BP reduction during the early morning hours, Moreover, BP reductions were sustained throughout the 24-hour period.