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| |  LIPID Study Closed Early, Data Favor Pravastatin in CHD PRINCETON, N.J., May 23, 1997 -- Bristol-Myers Squibb, makers of the lipid-lowering drug Pravastatin, announced the early closing of its Long-Term Intervention with Pravastatin in Ischemic Disease (LIPID) study because of compelling evidence that therapy with pravastatin significantly reduced the risk of death from coronary artery disease (CHD) in patients who have experienced a heart attack or were hospitalized for unstable angina. The LIPID study is an unprecedented trial involving more than 9,000 patients who are representative of the majority of CHD patients seen by physicians in their everyday practice. The early closing of the LIPID study represents a milestone in the treatment of most patients with CHD. In addition, there were no safety issues related to the trial. The company announced that, based on the study’s finds, it would be inappropriate to continue patients in the trial who were randomized to placebo. The company announced in a statement that it expects approximately 5-10 million CHD patients in the United States to benefits from the clinical advancement that will result from the trial’s results. The LIPID study was designed to examine the use of Pravachol(R) (pravastatin sodium), a member of a class of drugs called HMG-CoA reductase inhibitors, in reducing the risk of death from coronary artery disease in patients who have experienced a heart attack or were hospitalized for unstable angina. Patients enrolled in the study had cholesterol levels in a range similar to that seen in clinical practice. LIPID is the largest trial ever conducted with an HMG and also includes the largest number of women, older patients, and patients with diabetes ever evaluated with a drug of this kind. These subgroups of patients have been underrepresented in previous studies. In addition, LIPID is the first study to examine the use of an HMG in patients with unstable angina, a major risk factor for heart attack. With the combined patient populations from LIPID and other major clinical trials, Pravachol has been more extensively studied than any other drug of its kind. In 1995, the landmark West of Scotland Coronary Prevention study (Pravastatin Primary Prevention study) demonstrated the benefit of Pravachol therapy in reducing the risk of a first heart attack and death from heart disease in patients with elevated cholesterol and no history or symptoms of heart disease. This study was presented at the 1995 annual meeting of the American Heart Association and published in the November 16, 1995 edition of the New England Journal of Medicine. Based on the results of the this study, the FDA cleared Pravachol for use in reducing the risk of a first heart attack and death from heart disease in this patient population. Pravachol is the only drug of its kind indicated for this use. In 1996, the Cholesterol and Recurrent Events (CARE) trial showed that Pravachol reduced the risk of a second heart attack or death from heart disease in patients with CHD and average cholesterol levels. The results of this trial were presented at the 1996 annual meeting of the American College of Cardiology and published in the October 3, 1996 issue of the New England Journal of Medicine. The results of the LIPID study are expected to be presented later this year at a major medical congress and will be submitted for publication in a peer-reviewed journal. Pravachol therapy is well tolerated by most patients. The most common side effects include mild skin irritation and transient rash and gastrointestinal upset. Pravachol should not be used by people with active liver disease or liver problems, women who are pregnant or breast feeding, or people who are allergic to any component of the medication.
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