If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  LIPITOR Cholesterol-Lowering Medication Cleared By FDA MORRIS PLAINS, N.J., Dec. 18, 1996 -- LIPITOR(TM) (atorvastatin calcium) tablets, an HMG-CoA reductase inhibitor, or "statin," was cleared for marketing by the U.S. Food and Drug Administration, Warner-Lambert Company (NYSE: WLA) announced today. LIPITOR dramatically reduces elevated LDL-cholesterol and is the only drug in its class specifically indicated for lowering both elevated LDL-cholesterol and triglycerides in patients with elevated cholesterol. This makes it an excellent therapy as an adjunct to diet for a broad range of patients. In head-to-head clinical trials comparing starting doses, LIPITOR was superior to other statins (Zocor(R), Pravachol(R), Mevacor(R))(1) at reducing elevated total cholesterol, LDL-cholesterol and triglycerides. Parke-Davis, a division of Warner-Lambert, discovered, developed and is registering LIPITOR for regulatory approval worldwide. Parke-Davis recently entered into an agreement with Pfizer Inc (NYSE: PFE) under which both companies will collaborate on clinical, marketing and sales support for the product in the U.S. and broadly in key international markets. "The ability of LIPITOR(TM) to dramatically reduce both elevated LDL-cholesterol and triglycerides enables the medical community to enter a new era of cholesterol management," said Melvin R. Goodes, chairman and chief executive officer of Warner-Lambert Company. "The introduction of LIPITOR continues Warner-Lambert's proud heritage of producing groundbreaking cholesterol therapies that will significantly impact a broad range of patients." "Strategically, Pfizer seeks those products that are either first in class or best in class," said William C. Steere, chairman and chief executive officer of Pfizer Inc. "LIPITOR is clearly an excellent product and will be a strong addition to our already strong cardiovascular product line. We look forward to working with Parke-Davis to bring the product to a broad range of patients and develop its full medical potential." In multicenter, placebo-controlled, dose-response studies in patients with high cholesterol, LIPITOR significantly reduced elevated LDL-cholesterol ("bad" cholesterol) by about 40% to 60% across the dose range of 10 mg to 80 mg administered once daily. In addition, LIPITOR reduced triglycerides by approximately 20% to 40% across the dosage range. Triglycerides are a fatty substance in the bloodstream. High triglycerides, together with elevated LDL-cholesterol, result in a condition called mixed dyslipidemia, putting patients at greater risk of developing heart disease. The starting dose of LIPITOR(TM) is 10 mg which is taken as a single daily dose at any time during the day, with or without food. In clinical trials, the majority of patients taking LIPITOR achieved their total-cholesterol and LDL-cholesterol targets with the starting dose. Clinical data have established high LDL-cholesterol levels as a major risk factor for coronary heart disease and coronary death and have linked lowering elevated LDL-cholesterol to reducing the risk of these events. Despite these findings, surveys in the United States have shown that while an estimated 52 million Americans may need treatment for high cholesterol, less than one third of those who could benefit from medication are now taking it. Nearly 13.5 million American adults suffer from coronary heart disease, and almost 500,000 people die of heart attacks each year. Cardiovascular disease is the number one cause of death annually in the United States for both men and women. "The National Cholesterol Education Program has set guidelines for reducing cholesterol, yet many of those people receiving treatment are not reaching treatment goals," said Donald Hunninghake, MD, Director of the Heart Disease Prevention Clinic at the University of Minnesota Hospital in Minneapolis, Minnesota. "There is a need for more aggressive management of high cholesterol. The introduction of LIPITOR provides a new option in lipid management because of its ability to lower both elevated LDL-cholesterol and triglycerides at the starting dose, allowing physicians to effectively and conveniently treat a large group of patients." Challenging the "Statin" Quo Statins as a class have emerged as one of the most important tools to help manage elevated cholesterol. Several landmark studies confirm the significant benefits of lowering elevated LDL-cholesterol. Similar to other statins, LIPITOR(TM) works by inhibiting a liver enzyme (HMG-CoA reductase) that the body uses to produce cholesterol. When the liver produces less cholesterol, it uses more of the cholesterol in the blood stream, thereby reducing the amount that may be taken up into the walls of the arteries. LIPITOR is generally well tolerated. Similar to other drugs in the class, adverse reactions usually have been mild and transient. The most frequent adverse effects of LIPITOR are constipation, flatulence, dyspepsia, and abdominal pain. Regulatory submissions for the marketing of LIPITOR are being pursued in all major markets of the world. LIPITOR is already approved in Germany and the United Kingdom. Parke-Davis, a division of Warner-Lambert Company, is devoted to discovering, developing, manufacturing and marketing quality pharmaceutical products. Its central research focus is on heart disease, diabetes, anti-infectives, central nervous system, and women's healthcare. Warner-Lambert Company is a worldwide company employing approximately 37,000 people, and along with Parke-Davis is headquartered in Morris Plains, New Jersey. Pfizer Inc is a research-based, diversified health care company with global operations. The company reported sales of $10 billion for 1995, and is investing approximately $1.7 billion on research and development this year. (1) Zocor and Mevacor are trademarks of Merck & Company, Pravachol is a trademark of Bristol-Myers Squibb.
|
