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| |  FDA Approves Mevacor In People With Average Cholesterol Levels WEST POINT, PA -- March 16, 1999 -- The cholesterol-lowering medicine Merck & Co. Inc.’s Mevacor(R) (lovastatin) in addition to diet may now help lower the risk of a first heart attack for millions of Americans -- many of whom were never considered eligible for drug therapy because their total cholesterol levels are considered average. The United States Food and Drug Administration has approved a new use for Mevacor in people without symptoms of cardiovascular disease, with average to moderately elevated levels of total and LDL cholesterol and below average HDL cholesterol. Mevacor is now indicated to reduce the risk of first heart attack, unstable angina and coronary revascularisation procedures. Mevacor should be used in addition to diet and other lifestyle changes as part of a risk-reduction strategy to lower total and LDL cholesterol in patients at risk for atherosclerotic vascular disease when response to diet and other non-drug measures alone has not been adequate. "The new indication for Mevacor is important because it identifies a population of generally healthy middle-aged and older Americans who may benefit from cholesterol-lowering treatment," said Antonio Gotto, Jr., M.D., D.Phil., The Stephen and Suzanne Weiss Dean of the Weill Medical College of Cornell University, New York. Dr. Gotto served as the chairman of the steering committee for the Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS), the results of which are the basis for the new Participants in the study did not have symptomatic heart disease. In addition to age, 63 percent had at least one other risk factor for heart disease. The study population had average to moderately elevated total and bad cholesterol levels, below average levels of good cholesterol and were at higher risk of cardiovascular disease based on an elevated total cholesterol-to-good cholesterol ratio. Almost all study participants had a total cholesterol to HDL ratio of more than 4:1 (for example, if a person has a total cholesterol of 200 mg/dL and an HDL cholesterol level of 50 mg/dL, the ratio would be stated as 4:1). "Many people don't worry about heart attacks because they are told that they have average cholesterol. But if their HDL levels are too low, they may actually be at relatively high risk," Dr. Gotto said. "In order to know their risk for developing heart disease, people need to know about their good and bad cholesterol levels in addition to their total cholesterol. If good cholesterol levels are too low in people with average and moderately elevated levels of bad cholesterol, treatment with Mevacor in addition to diet can significantly reduce the risk of first heart attack." It's important to note that while many people may fit the patient profile for AFCAPS/TexCAPS, a person's overall risk factors for heart disease would enter into the decision as to whether he or she would be deemed a candidate for treatment with Mevacor in addition to diet for the primary prevention of coronary heart disease. In AFCAPS/TexCAPS, researchers studied 6,605 patients for a median of 5.1 years. All participants received regular instruction regarding a prudent diet and risk factor modification before and during the study. The entry criteria for total cholesterol for study participants was 180-264 mg/dL. The entry criteria for the other lipid parameters were 130-190 mg/dL for LDL; 45 mg/dL or less for HDL in men and 47 mg/dL or less for women trial participants; and 400 mg/dL or less for triglycerides. Of the study participants, 3,304 were randomised to Mevacor, while 3,301 patients were assigned to the placebo group. The study showed that treatment with Mevacor 20 or 40 mg daily reduced the risk of a first major coronary event by 37 percent compared to placebo. In absolute terms, during the study period, 3.5 percent of participants taking Mevacor experienced a coronary event, compared with 5.5 percent of those taking placebo. Additionally, Mevacor: -- reduced risk of first heart attack by 40 percent (event rates: Mevacor 1.7 percent; placebo 2.9 percent); Mevacor should not be used by anyone allergic to any of its components, people with liver disease, or by women who are pregnant, breast-feeding or likely to become pregnant. Muscle pain or weakness in patients taking Mevacor should be reported to a doctor, because these could be signs of a serious side effect. Because of a risk of liver problems, it is recommended that liver function tests be performed before initiation of treatment, at six and 12 weeks after initiation of therapy or elevation of dose and periodically thereafter (for example, semi-annually). Patients should tell their doctors about other medications they are taking in order to avoid possible drug interactions. The adverse experiences reported in AFCAPS/TexCAPS were similar to those reported in the Expanded Clinical Evaluation of Lovastatin (EXCEL) trial. In the 8,245-patient EXCEL trial, there were no clinical adverse experiences reported where the difference between incidence on drug and placebo was statistically significant. The most common adverse events reported with the recommended starting dose of Mevacor 20 mg taken once a day were diarrhea (2.6 percent on Mevacor versus 2.3 percent on placebo), flatulence (3.7 percent on Mevacor versus 4.2 percent on placebo), headache (2.6 percent on Mevacor versus 2.7 percent on placebo) and myalgia (2.6 percent on Mevacor versus 1.7 percent on placebo). Related Links: Mevacor, Merck & Co. Inc.
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