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Pfizer's Norvasc Demonstrates Significant Reductions in Major Cardiovascular Events in Patients With Coronary Artery Disease

Posted on: Tuesday, 9 November 2004, 18:00 CST

NEW YORK, Nov. 9 /PRNewswire-FirstCall/ -- Pfizer Inc said today that patients with coronary artery disease who took its blood pressure lowering medicine Norvasc (amlodipine besylate) had 31 percent fewer major cardiovascular events compared to patients who received standard care. The results were published today in the current issue of the Journal of the American Medical Association.

In the two-year Comparison of Amlodipine vs Enalapril to Limit Occurrences of Thrombosis (CAMELOT) trial, 1,997 patients with coronary artery disease and normal or well-controlled hypertension received either Norvasc, the ace-inhibitor enalapril (Vasotec) or placebo to compare the medicines' effectiveness in reducing major cardiovascular events. Eighty-five percent of the Camelot patients received treatment for high cholesterol and 20 percent of these patients had diabetes. Patients also received standard care which included aspirin, beta-blockers, other antihypertensive medications and statins.

Norvasc-treated patients experienced 42 percent fewer hospitalizations for chest pain and 27 percent fewer coronary revascularization procedures, such as angioplasty and coronary artery bypass surgery, compared to patients receiving placebo.

Patients treated with enalapril experienced 15 percent fewer cardiovascular events compared to patients treated with placebo, which was not significant.

Major cardiovascular events included cardiovascular-related death, non-fatal heart attacks or stroke, resuscitated cardiac arrest, coronary revascularization procedures, hospitalization for angina (or chest pain), congestive heart failure or procedures to treat peripheral vascular disease.

"The results of CAMELOT further confirm what has been shown in previous studies -- that Norvasc provides cardiovascular benefits to patients with coronary artery disease in addition to effectively and safely reducing blood pressure levels," said Dr. Joseph Feczko, president of Worldwide Development at Pfizer. "This gives healthcare professionals important information on the best long-term care treatment for patients with coronary artery disease. These patients are often taking multiple therapies to treat other serious cardiovascular conditions."

An intravascular ultrasound (IVUS) sub-study of 274 patients from the CAMELOT trial demonstrated that patients who received Norvasc showed no significant increase in the progression of plaque build-up in coronary arteries. The aim of the IVUS sub-study, The Norvasc for Regression of Manifest Atherosclerotic Lesions by Intravascular Sonographic Evaluation (NORMALISE) was to examine whether these patients would experience a reduction in build-up of plaque in the arteries. Patients receiving placebo showed a significant increase in plaque.

"CAMELOT indicates that the anti-anginal and anti-hypertensive effects of amlodipine (Norvasc) may contribute to the overall reduction in cardiovascular events in patients with coronary artery disease," said Dr. Peter Libby, M.D., Chief of Cardiovascular Medicine at the Brigham and Women's Hospital, Boston MA and Harvard Medical School Professor who served on the CAMELOT steering Committee. "In addition, the IVUS sub-study has shown that amlodipine may also slow plaque progression in the coronary arteries of certain patients, which may further contribute to improved clinical outcomes. As the people with coronary artery disease in this study had "normal" blood pressures at the outset, we may need to rethink whether levels of blood pressure we consider normal today are really optimal for this group of patients."

Researchers in NORMALISE used technology known as intravascular ultrasound, which is a three-dimensional method of imaging, to measure the total plaque volume in a cross-section of the artery wall over the length of the vessel. The total plaque volume of the patients was measured at the beginning and at the conclusion of the study.

Coronary artery disease (CAD) is the development of atherosclerosis in the coronary arteries. CAD is the most common form of cardiovascular disease. Atherosclerosis, which is a leading cause of death from heart attack and stroke, occurs when there is a build-up of cholesterol-rich fatty areas called plaques in the arteries. The break-up and dispersal of these plaques can block the blood flow throughout the body, which can be fatal. It is estimated that atherosclerosis accounts for more than 75 percent of all deaths from cardiovascular disease.

Since its introduction in 1990, Norvasc has become the world's most-prescribed branded antihypertensive therapy. Norvasc has been studied in over 400,000 patients and has achieved more than 30 billion patient-days of therapy worldwide.

Norvasc is a major component of Caduet (amlodipine besylate/atorvastatin calcium), the first dual therapy medicine to treat two different conditions -- high blood pressure and high cholesterol. Caduet was approved by the Food and Drug Administration in February 2004. Norvasc is also being studied in the ongoing Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT), which is examining whether the newer classes of antihypertensives are more beneficial in reducing adverse cardiovascular events then older classes. The cholesterol-lowering arm of the study ended nearly two-years earlier than planned, due to the highly significant cardiovascular benefits demonstrated in patients taking Lipitor. In ASCOT, patients with normal or mildly elevated cholesterol levels who took Lipitor had 36 percent fewer fatal coronary events and non-fatal heart attacks than patients treated with placebo. To date, both Norvasc and Lipitor have been shown to reduce the risk of cardiovascular events.

Norvasc is indicated for hypertension and angina. In other clinical trials, the most common side effects for Norvasc 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%).

Lipitor (atorvastatin calcium) is a prescription drug used with diet to lower cholesterol. Lipitor is not for everyone, including those with liver disease or possible liver problems, women who are nursing, pregnant, or may become pregnant. Lipitor is not indicated for the prevention of heart disease or heart attacks.

Patients who take Lipitor should tell their doctors about any unusual muscle pain or weakness. This could be a sign of serious side effects. Patients should also inform their doctor about any medications they are currently taking to avoid possible serious drug interactions. Prescribing physicians may do simple blood tests to monitor liver function before and during drug treatment. The most commonly reported side effects are gas, constipation, stomach pain and indigestion. They are usually mild and tend to go away.

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Pfizer Inc

CONTACT: Vanessa Aristide of Pfizer Inc, +1-212-733-3784

Web site: http://www.pfizer.com/

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Source: PRNewswire-FirstCall

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