(Circulation. 2001;103:e9045.)
© 2001 American Heart Association, Inc.
Cardiovascular News
New Cholesterol Prevention and Management Guidelines Call for More Aggressive Diagnosis and Treatment
New guidelines from the National Cholesterol Education Program (NCEP) issued May 15, 2001 (JAMA. 2001;285:2486-2497), call for more aggressive cholesterol lowering treatment and better identification of those at high risk for heart attack. The report is the first update of the guidelines issued by this panel of the National Heart, Lung, and Blood Institute (NHLBI) in more than a decade.
"Americans at high risk for a heart attack are too often not identified and so don’t receive sufficiently aggressive treatment," said Claude Lenfant, MD, director of the NHLBI. "Yet, studies show conclusively that lowering the level of low-density lipoprotein, or LDL, the ‘bad cholesterol,’ can reduce the short-term risk for heart disease by as much as 40%. Treatment may lower risk over the long-term (that beyond 10 years) even more. That is why, although the intensity of the treatment in ATP III (the Third Report of the NCEP Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults) is stepped up, its primary aim remains squarely on lowering LDL."
The panel said those at highest risk for a heart attack include those with heart disease, diabetes, and multiple risk factors. Diabetes can pose as great a heart attack risk within a decade as do multiple risk factors and heart disease, according to the panel. As a result, ATP III advises treating individuals in all 3 groups with equal intensity.
A tool developed from the landmark Framingham Heart Study translates lifestyle and clinical conditions into a single, easy-to-understand category of risk. It takes into account risk based on sex, age, total cholesterol, high density lipoprotein (HDL), systolic blood pressure, hypertension treatment, and cigarette smoking.
A profile of the levels of lipoproteins in the blood should be the first test for high cholesterol. That profile should measure levels of LDL, total cholesterol, HDL, and triglycerides. The prior recommendation advised initial screenings for only total cholesterol and HDL. The lipid profile should be repeated every 5 years.
ATP III also reduces the number at which HDL is considered
"low." Instead of the 35 mg/dL recommended previously, the new
panel set the level for "low" at 40 mg/dL. An HDL level 
60 mg/dL
is considered protective against heart disease.
New dietary recommendations from ATP III call for a daily intake of <7% of calories from saturated fat each day and <200 mg of dietary cholesterol each day. It allows as much as 35% of daily calories from total fat, as long as most of it is from unsaturated fat. It also encourages the use of certain foods that contain plant stanols and sterols or are rich in soluble fiber. It is believed that this will boost the LDL-lowering power of the diet.
The guidelines stress the need for weight control and physical activity because these have a beneficial effect on a variety of heart disease risk factors. They also indicate a need to treat elevated triglycerides more vigorously.
Because studies have not shown that hormone replacement therapy in menopausal women protects against heart disease, ATP III recommends that women receive cholesterol-lowering medication rather than hormone replacement as a means of staving off heart attack or coronary events. More information on the guidelines can be found at http://www.nhlbi.nih.gov.
Attorneys General from 15 States and District of Columbia Sue 2 Drugs Firms Over Generic Drugs
The attorneys general of 15 states and the District of Columbia filed suit May 15, 2001, against the French pharmaceutical company Aventis SA and the generic drug maker Andrx Corp, charging in a Detroit federal court that these companies violated anti-trust laws by conspiring to keep a generic form of the blood pressure drug Cardizem CD off the market.
Michigan attorney general Jennifer Granholm told the Associated Press that a suit by Aventis against Andrx in 1996 had been settled when Aventis paid the other company $89 million to keep Andrx’s cheaper generic version of the drug off the market for 11 months beginning in July 1998. That agreement was cancelled after the federal investigation began, according to the Associated Press.
Because the agreement cost consumers hundreds of dollars a year more in drug costs, the states (including Michigan, New York, Arizona, California, Idaho, Indiana, Maine, Minnesota, New Mexico, North Carolina, Oklahoma, Utah, Vermont, Washington, West Virginia, and the District of Columbia) seek at least $100 million restitution because the agreement also raised the costs of state-run health plans such as Medicaid.
Food and Drug Administration Panel Calls for Allergy Drugs to be Available Over-the-Counter
On May 11, 2001, an advisory panel of the US Food and Drug Administration (FDA) said that the popular allergy drugs Claritin, Allegra, and Zyrtec are safe enough to be sold without a prescription, according to the Washington Post.
The panel, which was petitioned on the matter by the managed care organization WellPoint, voted 19 to 4 in favor of giving over-the-counter status to Claritin and Zyrtec and 18 to 5 in favor of changing the status of Allegra. Although not required to do so, FDA leaders usually follow the recommendations of their panels.
The drug companies that manufacture the medications had opposed the move. Francois Nader, senior vice president of medical and regulatory affairs for Aventis SA, called the switch "inappropriate, unnecessary, and potentially" harmful. WellPoint experts pointed out that the drugs are available over-the-counter in Canada, with no known ill effects.
If the FDA follows the panel’s advice, it will be the first time that the agency has made a drug available over-the-counter on the recommendation of a third party or without the cooperation of the drug’s maker. The move could generate considerable challenge in court, according to the Wall Street Journal, which also quoted experts who said that the agency might not have the legal authority to force drug companies to the switch the status of the drugs.
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