Efficacy in BP – Norvasc vs. Other Agents

NORVASC significantly reduced SBP vs hydrochlorothiazide (HCTZ)

Reductions in SBP from baseline in older patients

Results of a randomized, single-blind, multicenter trial of 197 patients (184 evaluable for final results) 60 years of age (67% female) with SBP 160 mm Hg and DBP 95 mm Hg. Mean baseline for both NORVASC and HCTZ: 178/87 mm Hg. A 4-week placebo run-in was followed by 8 weeks of treatment with either NORVASC 5 mg/day or HCTZ 50 mg/day. If goal SBP (150 mm Hg) was not achieved by week 4, doses were doubled. (Adapted from Calvo et al, Clin Drug Invest, 2000.⁴)

NORVASC significantly reduced DBP compared with HCTZ (8 mm Hg vs 5 mm Hg, P<.001)^2,4

NORVASC delivered significantly greater SBP reductions compared with valsartan

Results of a multicenter, double-blind, randomized, comparative trial of 246 patients with mild to moderate hypertension. Baseline BP: NORVASC, 157/99 mm Hg; valsartan, 156/99 mm Hg. Following a 4-week placebo washout period, patients were randomized to receive NORVASC 5 mg or valsartan 40 mg. After 6 weeks, dosage was increased to NORVASC 10 mg or valsartan 80 mg for patients not at BP goal. BP goal was defined as DBP <90 mm Hg or decrease in DBP 6 mm Hg. (Data on file.²)

NORVASC reduced DBP 12.7 mm Hg compared with 10.9 mm Hg for valsartan (P=.06)²
In another study, NORVASC (2.5 mg/day to 10 mg/day) demonstrated significant ambulatory SBP reductions compared with valsartan (40 mg/day to 160 mg/day) (P=.001)⁵

NORVASC significantly reduced BP compared with valsartan in the recent VALUE trial.
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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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