Efficacy in Angina – Beta-Blocker

For angina patients, when a ß-blocker is not enough—the goal is control

NORVASC provides significant, additional antianginal control when added to a ß-blocker¹⁰

Mean change in symptom-limited exercise time and time to angina onset

Results of a randomized, double-blind, multicenter trial of 134 patients with chronic stable angina who had been receiving ß-blocker therapy for at least 4 weeks. Baseline values (in seconds, NORVASC vs placebo): exercise time, 518 vs 498; angina onset, 400 vs 367. A 2-week placebo run-in (with uninterrupted ß-blocker therapy) was followed by 4 weeks of treatment with NORVASC 2.5-10 mg/day (patients taking 2.5 mg/day were excluded from this analysis) or placebo. (Data on file.²)

Exercise time (ETT) improved significantly with NORVASC vs placebo—the
5-mg dose improved ETT by 9.5%, and the 10-mg dose improved ETT by 7.6% (P<.01)

NORVASC was well tolerated, and patients felt significantly better with NORVASC.

Patient self-assessment of angina severity revealed improvements of up to 50% when taking NORVASC vs placebo (P<.01)

NORVASC has no effect on heart rate or cardiac conduction, even when coadministered with ß-blockers.

"In general, in combination with beta-blockers, calcium antagonists produce greater antianginal efficacy in patients with stable angina."
—ACC, AHA, and ACP-ASIM Guidelines.¹¹

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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