Norvasc Caduet ®
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Safety—Data in Patients with CHF

In the Prospective Randomized Amlodipine Survival Evaluation (PRAISE) study, no significant difference in the rate of all-cause mortality and cardiac morbidity was found in patients with severe congestive heart failure (CHF) taking NORVASC or placebo

All-cause mortality and cardiac morbidity events

Results of a long-term, placebo-controlled mortality/morbidity trial of NORVASC 5 to 10 mg/day in 1153 patients with New York Heart Association (NYHA) Class III (N=931) or IV (N=222) heart failure. Almost all (99%) were on stable doses of diuretics, digoxin, and ACE inhibitors. Follow-up was at least 6 months, with a mean of about 14 months. The cardiac morbid events represented about 25% of end points in the study. Morbidity was defined as life-threatening arrhythmia, acute myocardial infarction, or hospitalization for worsened heart failure. The CHF patients studied did not necessarily have active angina or hypertension. (Adapted from Packer et al, N Engl J Med, 1996.15)

  • NORVASC is not indicated for the treatment of CHF. In general, CCBs should be used with caution in patients with heart failure. The CHF patients studied did not necessarily have active angina or hypertension
  • In the PRAISE study, patients had NYHA Class III or IV heart failure (dyspnea or fatigue at rest or on minimal exertion) and average ejection fractions of <21%15

NORVASC is indicated for the treatment of hypertension and angina.

In clinical trials, the most common side effects versus placebo were edema (8.3% vs 2.4%), headache (7.3% vs 7.8%), fatigue (4.5% vs 2.8%), and dizziness (3.2% vs 3.4%).

Caduet® (amlodipine besylate/atorvastatin calcium) is a combination of two medications, Norvasc® (amlodipine besylate) and Lipitor® (atorvastatin calcium) and is indicated in patients for whom treatment with both Norvasc and Lipitor is appropriate. Norvasc is indicated for the treatment of hypertension; treatment of chronic stable or vasospastic angina; and to reduce the risk of a coronary revascularization procedure and hospitalization due to angina in patients with recently angiographically documented CAD and without heart failure. Lipitor is indicated to reduce the risk of myocardial infarction, revascularization procedures, angina, and stroke in adult patients with multiple risk factors but without clinically evident CHD; to reduce the risk of myocardial infarction and stroke in patients with type 2 diabetes and without clinically evident CHD, but with multiple risk factors; as an adjunct to diet and exercise to reduce elevated total-C, LDL-C, apo B, and TG levels; and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia.

Caduet is contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases; in women who are pregnant or may become pregnant and/or nurse; in patients with hypersensitivity to any component of this medication.

Rare cases of rhabdomyolysis have been reported with the Lipitor component of Caduet and with other statins. With any statin, tell patients to promptly report muscle pain, tenderness, or weakness. Discontinue drug if myopathy is suspected, if creatine phosphokinase (CPK) levels rise markedly, or if the patient has risk factors for rhabdomyolysis.

Due to increased risk of myopathy seen with the Lipitor component of Caduet and other statins, physicians should carefully consider combined therapy with fibric acid derivatives, erythromycin, immunosuppressive drugs, azole antifungals, or niacin and carefully monitor patients for signs or symptoms of myopathy early during therapy and when titrating dose of either drug.

It is recommended that liver function tests be performed prior to and 12 weeks following the initiation of Caduet therapy and any elevation in dose of the Lipitor component, and periodically thereafter. If ALT or AST values >3 X ULN persist, dose reduction or withdrawal of Lipitor is recommended.

Generally CCBs should be used with caution in patients with heart failure. In studies with Norvasc, there has been no evidence of worsened heart failure.

In a controlled clinical trial, the most common adverse events were edema, headache, and dizziness. These were similar to those reported previously with Norvasc and/or Lipitor.


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