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Amlodipine-Atorvastatin Combination Pill Launched

NEW YORK, June 23, 2004 -- Pfizer Inc announced today that Caduet (amlodipine besylate and atorvastatin calcium), the first single pill that treats both high blood pressure and high cholesterol, has been made widely available for prescription to patients throughout the United States. Caduet (pronounced Ca-du-et) combines two of the world's leading medications in a single pill: Norvasc (amlodipine besylate), to treat high blood pressure and angina (chest pain), and Lipitor (atorvastatin calcium), to treat high cholesterol.

High blood pressure and high cholesterol are two of the major, controllable risk factors for heart disease, the leading cause of death in the United States. An estimated 30 million Americans are diagnosed with both risk factors.1 When the two conditions co-exist, they compound the risk for heart disease.2 However, fewer than 10 percent of patients are at both recommended goals for cholesterol and blood pressure.3

"High blood pressure and high cholesterol often occur together and treating them with multiple medications is a struggle for many patients and physicians—it's quite complex," said Roy Blank, M.D., Presbyterian Healthcare Associates of Monroe, NC. "Caduet offers a new, effective method of addressing two separate medical problems with one pill, and has a number of dose strengths that allows physicians the flexibility they need to tailor treatment for individual patient needs."

Undertreatment of High Blood Pressure and High Cholesterol High blood pressure and high cholesterol are two highly prevalent, yet commonly under-treated, conditions in the United States. More than two-thirds of Americans with high blood pressure do not have their blood pressure in control—this includes 25 percent on blood pressure-lowering medication, 11 percent who are not on medication, and 30 percent who remain undiagnosed.4

Among people with high cholesterol, more than 80 percent are not adequately controlling their cholesterol in accordance with nationally recommended levels.5 Less than half of those who require cholesterol-lowering medication are receiving treatment6 and fewer than half of the highest risk patients are being treated.7 Overall, an estimated 55 percent of people with high blood pressure also have high cholesterol and 43 percent with high cholesterol have high blood pressure.8

"The commonality and connectedness of high blood pressure and high cholesterol led us to the conclusion that the two conditions are intrinsically linked," said Craig Hopkinson, M.D., Medical Director, Pfizer Cardiovascular. "Therefore, it makes perfect sense that the medications be linked. That's when we decided to take a new approach to cardiovascular risk management through Caduet," he added.

Many people being treated for more than one medical condition appreciate the benefits of a single pill combination therapy such as Caduet. "Treating my high blood pressure and high cholesterol with one pill is a big improvement for me," said R. Elbert Holt, a Charlotte, NC patient, who was involved in the clinical trials and is currently taking Caduet. "This new medication means that I have to remember to take one less pill every day, which makes it simpler to lower my blood pressure and cholesterol to the goals my doctor recommends."

About Caduet
Caduet is taken orally either with or without food at any time of day. It is available in tablets combining Norvasc/Lipitor in the following doses of 5mg/10mg, 5mg/20mg, 5mg/40mg, 5mg/80mg, 10mg/10mg, 10mg/20mg, 10mg/40mg, and 10mg/80mg.

Caduet (amlodipine besylate/atorvastatin calcium) is a prescription medication for adults who have both high blood pressure (hypertension) or angina (chest pain) and high cholesterol. It should be used with diet and exercise.

Caduet is not for everyone. It is not for those with liver problems. And it is not for women who are nursing, pregnant, or may get pregnant. It has not been shown to prevent heart disease or heart attacks.

The most common side effects are edema, headache, and dizziness. They tend to be mild and often go away. Tell your doctor about all the medicines you take. This may help avoid serious drug-drug interactions. Your doctor may do blood tests to check your liver function before and during treatment. If you take Caduet, tell your doctor if you feel any new muscle pain or weakness. This could be a sign of serious side effects.

1 Pfizer Internal Document. NHANES III, Phase 2, Home & Mec. Among Those Aged 20 or older. January 2004.
2 Neaton et al. Archives of Internal Medicine. 1992; 152:56-64.
3 Blank Roy, LaSalle James, Reeves Russell, Piper Beth Ann, Sun Franklin. Amlodipine/Atorvastatin Single Pill Therapy Improves Goal Attainment in the Treatment of Concomitant Hypertension and Dyslipidemia: The Gemini Study. Poster presented at: American College of Cardiology Scientific Session 2004; March 7, 2004 ; New Orleans , LA.
4 Heart Disease and Stroke Statistics 2004; High Blood Pressure. American Heart Association. 2004.
5 The Burden of Chronic Diseases and Their Risk Factors. Center for Disease Control. 2004.
6 Heart Disease and Stroke Statistics 2004; High Blood Cholesterol and Other Lipids. American Heart Association. 2004.
7 Heart Disease and Stroke Statistics 2004; High Blood Cholesterol and Other Lipids. American Heart Association. 2004.
8 Pfizer Internal Document. Caduet Draft Media Messaging. December 15, 2003

Source: Pfizer

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