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FDA approves Caduet for simultaneous treatment of hypertension and high cholesterol

NEW YORK, N.Y., February 2, 2004 -- Pfizer said that it has received approval from the FDA to market its dual therapy medicine Caduet (amlodipine besylate/atorvastatin calcium) for the simultaneous treatment of high blood pressure and high cholesterol.

Caduet is the first medicine to treat two different conditions in one pill. It contains both Norvasc (amlodipine besylate) and Lipitor.

"Caduet is a major advance for the millions of patients who concomitantly suffer from two serious medical conditions, as it combines two leading medications, each with extensive worldwide experience," said Dr. Joe Feczko, president of Worldwide Development at Pfizer. "Despite an abundance of available therapies, millions of patients continue to have uncontrolled hypertension and high cholesterol. By treating both conditions at the same time, physicians can help patients reduce their risk of developing cardiovascular disease."

High blood pressure and high cholesterol are the two leading risk factors for heart disease, which is the leading cause of death worldwide. Approximately 30 million people in the U.S. have both conditions, although fewer than 10 percent have achieved their recommended goal levels of blood pressure or cholesterol.

According to recent guidelines issued by the National Cholesterol Education Program, physicians are encouraged to aggressively treat patients who have both high blood pressure and high cholesterol, especially in those with known coronary heart disease.

"Treating patients with multiple risk factors is extremely challenging, and frankly, we are not doing a good job at getting people like this to their goals and are therefore leaving them at increased risk," said Professor William Frishman, professor and chairman of Medicine at New York Medical College and director of Medicine at Westchester Medical Center. "Therapeutic interventions like this are a significant step forward, and this could be an important new agent for patients and physicians."

Patients who suffer from both hypertension and high cholesterol have a much greater risk of suffering a heart attack or stroke than people who only have one of the conditions. Additionally, 60 percent of all cardiovascular events are experienced by patients who have both conditions.

Currently, more than 3,700 patients with high blood pressure and high cholesterol are enrolled in the Caduet clinical trial program. Recent results of clinical studies have shown that many patients taking Caduet successfully reached both their recommended blood pressure and cholesterol goal levels.

"We know that there is clearly a benefit for patients in treating both conditions, as demonstrated in the recent ASCOT study," Feczko said. "In this study, hypertensive patients with normal- to-mildly elevated cholesterol levels who took Lipitor experienced fewer fatal coronary events and non-fatal heart attacks than patients treated with placebo."

Caduet was well tolerated by patients in clinical trials and has been administered with a variety of anti-hypertensive medications, including thiazide diuretics, beta-blockers, and angiotensin-converting enzyme inhibitors (ACEI). The most common side effects reported by Caduet patients were fluid retention, headache, dizziness, abdominal pain and weakness, and were characterized as mild to moderate.

Caduet is contraindicated in patients with hypersensitivity to any component of this medication; Caduet is contraindicated in patients with active liver disease or unexplained persistent elevations of serum transaminases; in women during pregnancy and in nursing mothers. With any statin, promptly report muscle pain, tenderness, or weakness. This could be a sign of serious side effects.

Caduet will be available in multiple dosing combinations to provide physicians with the greatest flexibility to get patients to their goal levels.

Source: Pfizer Inc

Posted: February 2004