FDA approves Cardizem LA for treatment of angina
TORONTO, CANADA, April 5, 2004 -- Biovail Corporation announced that the FDA has approved Cardizem LA, for the treatment of chronic stable angina. Cardizem LA can be given orally once daily, either in the evening or in the morning.
Cardizem LA is already approved for the treatment of high blood
pressure or hypertension and is a long acting extended-release
formulation of diltiazem HCl. Cardizem LA provides 24-hour blood
pressure control with a single daily dose. CardizemLA may blunt a
rise in blood pressure in the early morning which is when risk of
an ischemia-associated cardiovascular event is highest.
Angina is often controlled by drugs. The choice of drug is usually
dependent on the acuity and severity of the symptoms as well as the
presence of other existing conditions. Cardizem LA, a calcium
channel blocker (CCB) is effective in reducing the frequency and
severity of angina attacks either used alone or in combination with
other medications. In many patients a combination of agents is more
effective than therapy with only one medication.
Clinical study in angina
The effects of Cardizem LA on angina were evaluated in a randomized, double-blind, parallel-group, dose-response trial of 311 patients with chronic stable angina. Evening doses of 180, 360 and 420 mg were compared to placebo and to 360 mg administered in the morning. All doses of Cardizem LA administered at night increased exercise tolerance when compared with placebo after 21 hours. The mean effect, placebo-subtracted, was 20 to 28 seconds for all three doses, and no dose-response was demonstrated. Cardizem LA, 360 mg, given in the morning, also improved exercise tolerance when measured 25 hours later.
The adverse event profile of Cardizem LA was consistent with what has been previously described for Cardizem LA and other formulations of diltiazem HCl. Among the Cardizem LA dose groups, adverse events occurred at a rate equivalent to or less than placebo. Adverse events were generally mild to moderate in nature. The most frequent adverse effects experienced by Cardizem LA-treated patients were lower-limb edema, dizziness, fatigue, bradycardia, first-degree atrioventricular block, and cough.
Chronic oral administration of diltiazem HCl to patients in doses up to 540 mg/day has resulted in small increases in PR interval, and on occasion produces abnormal prolongation. Patients taking other drugs that are substrates of CYP450, especially patients with renal and/or hepatic impairment, may require dosage adjustment when starting or stopping concomitantly administered diltiazem in order to maintain therapeutic blood levels.
For full prescribing information for Cardizem LA, see www.biovail.com
Source: Biovail
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