Efficacy In BP – Monotherapy

NORVASC significantly reduced SBP across a broad range of patients

*P<.001 for all NORVASC patients vs placebo. Non–placebo-corrected results of a systematic review of randomized, controlled clinical trials with at least 10 patients, one treatment arm of amlodipine monotherapy, minimum treatment duration of 8 weeks, reported baseline and end-point BP, and presence of baseline hypertension (defined as SBP >140 mm Hg, DBP >90 mm Hg, or both). All reductions were calculated from baseline measurements. Out of 696 citations, 85 trials representing more than 5000 NORVASC-treated patients met all inclusion criteria. Comparable populations were pooled, and weighted means of efficacy results were calculated. In 11 of the 85 trials, there was a placebo group (n=639) and the mean reduction in BP was 4.4/4.9 mm Hg. Mean baseline was 160.7/100.1 mm Hg for NORVASC-treated patients and 153.7/98.2 mm Hg for patients in the placebo group. (Data on file.²)

In patients with mild to moderate hypertension, black patients, and older patients, DBP was lowered by 12.3 mm Hg, 17.1 mm Hg, and 10.8 mm Hg, respectively²
The magnitude of BP reduction with NORVASC is correlated with the height of pretreatment elevation

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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