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Norvasc—Efficacy in Angina

In the Circadian Anti-Ischemia Program in Europe (CAPE) trial, NORVASC significantly reduced angina attacks and nitroglycerin consumption7

Norvasc vs. placebo in CAPE trial

The CAPE trial was a randomized, double-blind, multicountry study of 315 male patients with chronic stable angina. A 2-week placebo run-in was followed by 8 weeks of treatment with NORVASC (5 mg/day titrated to 10 mg at week 4) or placebo. 271 patients were evaluated by diary for angina attack rate. (Adapted from Deanfield et al, J Am Coll Cardiol, 1994.7)

  • 65% of patients in this study were already taking ß-blockers before NORVASC was added
  • Once-daily NORVASC reduced the incidence of angina throughout the 24-hour dosing period
  • Significantly more NORVASC patients (75%) reported an improved ability to perform usual physical activities vs those taking placebo (59%; P=.003)
  • Only 2% of NORVASC patients discontinued therapy because of adverse events vs 4.4% taking placebo (P=NS)

From CAPE II, combination therapy of NORVASC/ß-blocker vs diltiazem/mononitrate8

Change in exercise time and angina onset

CAPE II was a randomized, double-blind, multicountry study of 234 patients with CAD (>4 ischemic events or 20 min of ischemia on 72-hour Holter monitoring). Mean baseline ETT/time to angina onset: NORVASC+atenolol (N+A) 502/447 sec; diltiazem+mononitrate (D+M) 498/441 sec. Patients received either N+A (10 mg and 100 mg, respectively) or D+M (300 mg and 100 mg, respectively) during the 14-week study. (Adapted from Deanfield et al, Eur Heart J, 1994.8)

  • In another study, once-daily NORVASC monotherapy was comparable with tid diltiazem monotherapy in the treatment of angina9

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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