The patients with coronary artery disease (CAD) who took Pfizer's blood pressure lowering medicine Norvasc (amlodipine besylate) had 31 per cent fewer major cardiovascular events compared to patients who received standard care. The results were published recently in the current issue of the Journal of the American Medical Association, the company announced here.
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 per cent of the Camelot patients received treatment for high cholesterol and 20 per cent 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 per cent fewer hospitalizations for chest pain and 27 per cent fewer coronary revascularization procedures, such as angioplasty and coronary artery bypass surgery, compared to patients receiving placebo. Patients treated with enalapril experienced 15 per cent fewer cardiovascular events compared to patients treated with placebo, which was not significant, according to the release from Pfizer.
"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.
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.
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.
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.