Efficacy

CARDIZEM LA delivered significant blood pressure reduction

When dosed in the PM, CARDIZEM LA delivered effective blood pressure management in the early morning hours.^1-3

Significant BP reduction between 6 AM and 12 NOON²

Baseline BP between 6 AM and 12 NOON: CARDIZEM LA 360 mg PM 156/100 mm Hg (n=103); 360 mg AM 161/100 mm Hg (n=102).

Study Design: Randomized, double-blind, placebo-controlled, parallel-group, multicenter, dose-response, 10-week study in 478 patients with moderate-to-severe hypertension (baseline SBP <200 mm Hg, DBP >100 to <114 mm Hg). Six treatment arms included placebo, 120 mg PM, 240 mg PM, 360 mg PM, 360 mg AM, and 540 mg PM. The 540 mg treatment group received 360 mg QD for 1 week followed by forced titration to 540 mg. Results were measured by ambulatory blood pressure monitoring.

CARDIZEM LA is indicated for the treatment of hypertension

• Whether the time of administration impacts the clinical benefits of antihypertensive treatment is not known.
• Primary outcome measure included the change from baseline to endpoint in trough diastolic blood pressure and was associated with a reduction of (-6.4 mm Hg) for the 360 mg AM dose and (-3.3 mm Hg) for the 360 mg PM dose of CARDIZEM LA (P<0.05 for change from baseline and compared to placebo).

CARDIZEM delivered blood pressure reductions at 24 hours²

• CARDIZEM LA 360 mg AM mean 24-hour SBP -10.1 mm Hg*^†; PM mean 24-hour SBP -8.2 mm Hg.*^†
• CARDIZEM LA 360 mg AM mean 24-hour DBP -8.1 mm Hg*^†; PM mean 24-hour DBP -6.6 mm Hg.*^†
  
  

  * P<0.05 for change from baseline to endpoint.
  ^† P<0.05 vs placebo.

CARDIZEM LA demonstrated improvement of chronic stable angina (placebo corrected) between 7 AM and 11 AM

2-fold to 4-fold improvement with PM vs AM dosing ^‡1,4

Study Design: 3-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial of 311 patients with chronic stable angina. 10 PM doses of 180, 360, and 420 mg were compared with placebo and with 360 mg QD administered at 8 AM. Patients in the 360 mg or 420 mg groups were initiated with CARDIZEM LA 240 mg QD for 1 week and then force-titrated to their assigned dose.

^‡ For the CARDIZEM LA 360 mg PM dose, measurements were assessed at 9 to 13 hours postdose. For the CARDIZEM LA 360 mg AM dose, measurements were assessed at 23 to 27 hours postdose.

INDICATIONS
CARDIZEM LA is indicated for the treatment of hypertension and management of chronic stable angina.

IMPORTANT SAFETY INFORMATION
CARDIZEM LA is contraindicated in patients with sick sinus syndrome or 2° or 3° AV block (except in the presence of a functioning ventricular pacemaker), hypotension (<90 mm Hg systolic), demonstrated hypersensitivity to the drug, and acute myocardial infarction and pulmonary congestion documented by x-ray on admission.

Worsening of congestive heart failure has been reported in patients with pre-existing impairment of ventricular function. Caution should be exercised in these patients when diltiazem is used in combination with β-blockers. In rare instances, elevations in LFT enzymes have been noted.

Concomitant use of diltiazem with ß-blockers or digitalis may result in additive effects on cardiac conduction. Patients taking buspirone, quinidine and drugs that are substrates or inhibitors of CYP450 3A4 (i.e. cimetidine, midazolam, triazolam, cyclosporine, carbamazepine, lovastatin, rifampin), or patients with renal and/or hepatic impairment should be monitored and may require dosage adjustment when starting or stopping concomitantly administered diltiazem.

In hypertension, the most common adverse events (greater than placebo) reported for the 120 mg to 360 mg dose were lower-limb edema (5%), sinus congestion (1%), and rash (1%).

In chronic stable angina, the most common adverse events (>2% and greater than placebo) were lower-limb edema (6.8%), dizziness (6.4%), fatigue (4.8%), bradycardia (3.6%), and 1° AV block (3.2%).

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