Norvasc

[Amlodipine]

Another study (PRAISE-2) randomized patients with NYHA class III (80%) or IV (20%) heart failure without clinical symptoms or objective evidence of underlying ischemic disease, on stable doses of ACE inhibitor (99%), digitalis (99%) and diuretics (99%), to placebo (n= 827) or NORVASC (n= 827) and followed them for a mean of 33 months. There was no statistically significant difference between NORVASC and placebo in the primary endpoint of all cause mortality (95% confidence limits from 8% reduction to 29% increase on NORVASC). With NORVASC there were more reports of pulmonary edema.

Electrophysiologic Effects

NORVASC does not change sinoatrial nodal function or atrioventricular conduction in intact animals or man. In patients with chronic stable angina, intravenous administration of 10 mg did not significantly alter A-H and H-V conduction and sinus node recovery time after pacing. Similar results were obtained in patients receiving NORVASC and concomitant beta blockers. In clinical studies in which NORVASC was administered in combination with beta-blockers to patients with either hypertension or angina, no adverse effects on electrocardiographic parameters were observed. In clinical trials with angina patients alone, NORVASC therapy did not alter electrocardiographic intervals or produce higher degrees of AV blocks.

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Effects in Hypertension

Adult Patients

The antihypertensive efficacy of NORVASC has been demonstrated in a total of 15 double-blind, placebo-controlled, randomized studies involving 800 patients on NORVASC and 538 on placebo. Once daily administration produced statistically significant placebo-corrected reductions in supine and standing blood pressures at 24 hours postdose, averaging about 12/ 6 mmHg in the standing position and 13/ 7 mmHg in the supine position in patients with mild to moderate hypertension. Maintenance of the blood pressure effect over the 24-hour dosing interval was observed, with little difference in peak and trough effect.

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