Pfizer Inc. Release: New Data Show Hypertensive Patients Taking Norvasc-Based Regimen Achieved Better Central Blood Pressure Control

DALLAS, Nov. 13 /PRNewswire-FirstCall/ -- Pfizer Inc said today that hypertensive patients who received a treatment regimen based on Pfizer's blood pressure lowering medicine Norvasc(R) (amlodipine besylate) had lower central arterial blood pressure readings, which was shown to be an independent predictor of cardiovascular and renal outcomes compared to patients who took a beta blocker-based regimen. The results were presented this week at the annual meeting of the American Heart Association in Dallas.

CAFE (Conduit Artery Function Evaluation) is a sub-study of ASCOT-BPLA (Anglo-Scandinavian Cardiac Outcomes Trial-Blood Pressure Lowering Arm) and is the first trial to evaluate the long-term effects of two anti-hypertensive treatment regimens on central arterial blood pressure compared with peripheral blood pressure measurements. In the Norvasc-based regimen, patients received the ACE-inhibitor perindopril and the alpha-blocker Cardura XL (doxazosin GITS) as add-on therapy if additional blood pressure control was needed. Patients receiving the beta-blocker based regimen of atenolol, received a diuretic (thiazide) and Cardura XL (doxazosin GITS), if needed.

Central arterial blood pressure is the pressure in the aorta, which determines the stress and damage on the heart and central vessels. Peripheral blood pressure measurement, which is taken through the use of an arm cuff, is widely regarded as a practical yet less precise substitute for measuring central arterial blood pressure.

"CAFE demonstrates for the first time in a major clinical outcomes trial that blood pressure lowering drugs have significantly different effects on central arterial blood pressure, despite having a similar impact on peripheral blood pressure," said Bryan Williams, MD, professor of medicine, Department of Cardiovascular Sciences, University of Leicester, United Kingdom. "The amlodipine-based regimen was shown to be more effective at lowering central arterial blood pressure than the atenolol-based regimen. These findings, together with the benefits witnessed in the ASCOT study on cardiovascular and all-cause mortality, may have significant implications for hypertension treatment guidelines."

The CAFE study included approximately 2,200 patients recruited from five ASCOT-BPLA study centers in the United Kingdom and Ireland. In CAFE, central blood pressure was calculated from pulse pressure measurements using a well- established methodology. Pulse pressure is the difference between systolic and diastolic blood pressure.

"CAFE highlights important information about the cardiovascular benefits that are associated with different blood pressure lowering therapies," said Dr. Michael Berelowitz, Pfizer's senior vice president of Worldwide Medical and Outcomes Research. "These findings provide evidence of Norvasc's ability to effectively reduce central arterial blood pressure, which appears to be an important and independent indicator of a patient's cardiovascular risk."

The Norvasc-based regimen lowered central arterial blood pressure significantly more than the atenolol-based regimen approximately 4.3 mm/Hg lower for central systolic blood pressure and 3.0 mm/Hg lower for central pulse pressure. This is a clinically important difference and may help explain the significant difference in cardiovascular outcomes in the ASCOT- BPLA study.

Hypertension is one of the most prevalent risk factors for cardiovascular disease, affecting as many as 800 million people worldwide. It is estimated that at least 80 percent of people with high blood pressure may also have other uncontrolled cardiovascular risk factors with elevated cholesterol being the most common.

The five-year ASCOT Study, which was one of the largest hypertension trials ever conducted, involved over 19,000 patients in Europe who had high blood pressure. The trial compared the cardiovascular effects of a Norvasc- based regimen versus a standard beta-blocker based regimen in reducing cardiac events in patients with hypertension and multiple cardiovascular risk factors. In ASCOT, patients who received the Norvasc-based regimen experienced significant reductions in cardiovascular death, all-cause mortality and total cardiovascular events and procedures, including heart attacks and strokes compared to patients who received a beta blocker-based regimen. Patients receiving the Norvasc-based regimen also experienced a reduction in the primary endpoint of fatal coronary heart disease and non-fatal heart attack, which did not reach statistical significance.

Norvasc (amlodipine besylate) is indicated for high blood pressure and angina. In 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%).

Norvasc is a major component of Caduet (amlodipine besylate/ atorvastatin calcium) the first single pill medicine that combines the proven blood pressure lowering of Norvasc and the LDL-cholesterol lowering benefits of Lipitor. Caduet was approved by the Food and Drug Administration in February 2004. To date, both Norvasc and Lipitor have shown to reduce the risk of cardiovascular events.

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CONTACT: Francisco Gebauer of Pfizer, +1-212-733-5191

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