Largest Long-Term Hypertension Study Using Pfizer’s Norvasc Provides New Insights into Cardiovascular HealthLARGEST LONG-TERM HYPERTENSION STUDY USING PFIZER’S NORVASC PROVIDES NEW INSIGHTS INTO CARDIOVASCULAR HEALTH
Norvasc’s Impact on Heart Attacks, Strokes and Death Comparable to a Diuretic in 42,000 Patient ALLHAT Trial
| New York - December 17, 2002 |
Pfizer Inc said today that results from the largest hypertension
trial ever conducted showed that its calcium channel blocker Norvasc (amlodipine
besylate) demonstrated results comparable to a diuretic in the incidence of
fatal coronary heart disease, non-fatal heart attacks, strokes and death.
The results were presented today by the National Heart Lung and Blood Institute
in Washington, D.C.
The landmark Antihypertensive and Lipid Lowering Therapy to Prevent Heart Attack Trial (ALLHAT) began in 1994 and involved over 42,400 high-risk hypertensive patients nationwide. The study compared certain blood pressure lowering medicines and the incidence of heart disease, stroke and early death compared to a diuretic. Patients received either an ACE inhibitor (lisinopril), a calcium channel blocker (Norvasc) or a diuretic (chlorthalidone). Current guidelines suggest that diuretics should be considered first for treating most patients with high blood pressure. However, most patients -- 60 percent in ALLHAT--require multiple blood pressure medications to reach their targeted blood pressure goal.
“We are very pleased with these results,” said Dr. Joseph Feczko, President of Worldwide Development at Pfizer. “ALLHAT further demonstrates the efficacy and safety of Norvasc in a broad range of patients as well as the importance of lowering elevated blood pressure.” Patients taking Norvasc showed results comparable to the diuretic in fatal coronary heart disease, heart attacks and stroke. Norvasc’s results were consistent across all patient groups, including men, women, African Americans, Hispanics, diabetics, and patients over 65. The study found no differences in several areas of safety, including severe kidney disease, gastrointestinal bleeding and cancer. “These results reconfirm Norvasc’s extensive worldwide experience,” Dr. Feczko said. 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 experienced 26 billion patient-days of therapy worldwide. Norvasc has been available in Canada since 1992. High blood pressure affects approximately 22 percent of adult Canadians and is a leading risk factor for heart disease – one of the leading causes of death in Canada. Despite the abundance of available treatments, the majority of patients have not reached their recommended blood pressure goals. If left untreated, high blood pressure can lead to stroke, atherosclerosis, heart attack, congestive heart failure, kidney failure and blindness.
“The ALLHAT results indicate that diuretics should be considered first in the management of high blood pressure,” Dr. Feczko said. “But because blood pressure control must be individualized to suit each patient’s needs, physicians are regularly challenged with identifying the optimal combination of medicines to get their patients to goal.” Risk factors for developing high blood pressure include age, family history, blood pressure in the high-normal range, lack of exercise, obesity, high intake of alcohol and ethnicity.
Pfizer supported the ALLHAT study with a grant to the NIH and contribution of drug. The ALLHAT trial also examined cholesterol lowering. Patients received cholesterol lowering therapy and dietary changes compared to usual care and dietary changes. Patients in the usual care arm also received drug treatment if necessary. The ALLHAT results were published in this week’s issue of the Journal of the American Medical Association. 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%). Pfizer Canada Inc. is the Canadian operation of Pfizer Inc, the world's leading pharmaceutical company. Pfizer discovers, develops, manufactures and markets leading prescription medicines for both humans and animals, as well as many of the world's best-known over-the-counter healthcare products. Pfizer Canada employs more than 2,300 persons across Canada. The headquarters of the Pfizer Pharmaceuticals Group in Canada is in Kirkland, Quebec.
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These press releases were issued in Canada and are intended as reference information for Canadians. The information contained in each press release was accurate at the time of issuance, and Pfizer Canada assumes no responsibility for updating the information to reflect subsequent developments. |
