Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
1999-09-10
2001-11-27
Henley, III, Raymond (Department: 1614)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C514S165000
Reexamination Certificate
active
06323188
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to a combination of aspirin, certain B vitamins and folic acid to prevent and or decrease cardiovascular diseases, heart attack and stroke, to a stable daily administration pack for such combination to facilitate the patient's compliance with recommendation or instruction to take such combination, and to the method of treating and preventing cardiovascular diseases with the help of such combination.
Cardiovascular disease ranks as the leading cause of mortality and morbidity in the United States today. This year, it is estimated that 1.5 million people will have a heart attack and that one third of those will die as a result of CAD.
The American College of Cardiology recently identified other abnormalities as factors for which intervention is likely to lower stroke and heart disease risk. Elevated total blood cholesterol is frequently considered a risk factor for coronary artery disease (CAD), but it is important to note that in the Framingham study 80% of CAD patients had the same total cholesterol as those who did not develop CAD.
2. Definition of Certain Terms
Throughout the specification and associated claims, terms listed below shall be read as having the meaning here stated:
CAD
Coronary artery disease
LDL
Low density lipoprotein
IDL
Intermediate density lipoprotein
MI
Myocardial infarction
PVD
Peripheral vascular disease
3. State of the Prior Art
Heredity remains the number one risk factor in heart disease; 77% of people in the United States with heart disease have inherited metabolic traits contributing to their atherosclerosis. Lp (a) is a LDL with protein (a) attached, and elevated level of Lp (a) is an inherited trait present in approximately 33% of heart disease patients. Elevated levels of Lp (a) increase the risk of heart disease by 300%, yet Lp (a) is not detected in traditional lipid profile tests. A powerful predictor of heart attacks in young men and of vein graft blockage following bypass surgery, elevated levels of Lp (a) also increase the danger of other risk factors. High Lp (a) can be treated with niacin. Niacin (nicotinic acid) or niacinamide is a member of the Vitamin B-complex group (vitamin B3). Buoyant LDLs are the lighter, larger LDLs found primarily in LDL pattern A people. Dense LDLs are the heavier, smaller LDLs found primarily in LDL pattern B people. LDL density change is the strongest predictor of percent change in coronary artery stenosis.
There is substantial evidence that reduction in small LDL is more important than reduction in LDL-cholesterol in achieving improvements. Following treatment with niacin, small LDL subclass patterns significantly improve with a larger LDL diameter. This is also associated with improvement in other abnormalities such as elevated IDL, elevated LP (a) and enhanced postprandial lipemia.
The chief drawback of using niacin in the treatment of hyperlipidemia is facial and truncal flushing, which occurs in nearly all users shortly after ingestion of a tablet with as small a dosage as 75 mg of niacin. It appears that niacin induces flushing by increasing the formation and/or release of some prostaglandin, which in turn increases the production of cyclic amp. Aspirin is a prostaglandin inhibitor and reduces the incidence and severity of flushing. Aspirin therapy has been well established as a platelet aggregate inhibitor and is now widely used. It has been shown to be the strongest therapeutic known to reduce the risk of a stroke, a first heart attack in healthy individuals, and subsequent heart attacks or strokes.
Recent evidence suggests that elevated blood levels of homocystine, which is derived from the amino acid methionine, is linked to heart disease. Homocystine is a sulfur-containing amino acid formed during the metabolism of methionine.
Homocystine increases the formation of highly atherogenic oxycholesterols, increases lipid peroxidation, and increases the oxidation of LDL in vitro. These observations suggest a potential role for antioxidant therapy in ameliorating homocystine-dependent oxidative vascular injury.
Patients with mild hyperhomocystinemia have none of the clinical signs of severe hyperhomocystinemia and are typically asymptomatic until the third or fourth decade of life when premature CAD develops, as well as recurrent arterial and venous thrombosis. How the body metabolizes, or breaks down, homocystine can be determined genetically. People who inherit a defective gene for homocystine metabolism tend to have elevated homocystine blood levels—a trait found in 20-30% of patients with atherosclerosis.
Three B-vitamins, folate and vitamins B6 and B12, play essential roles as cofactors in homocystine metabolism. Elevated plasma homocystine (even when caused by genetic variants) can usually be normalized by moderate vitamin supplementation. Folic acid alone, folic acid combined with B12 and B6, and vitamins B6 and B12 have all been shown to reduce homocystine concentrations. Normalization of the plasma homocystine concentration usually occurs within four to six weeks after the initiation of therapy, but may occur in as little as two weeks. Interestingly, the reduction in mortality from cardiovascular causes since 1960 has been correlated with the increase in vitamin B6 supplementation in the food supply.
A retrospective analysis of dietary vitamin C and E intake was done in the CLAS trial (n=156) and indicated an association between supplementary vitamin E intake and angiographically demonstrated reduction in coronary artery lesion progression.
The Cambridge Heart Attack and Antioxidant Study studied 2002 CAD patients, randomized to 800 IU vitamin E per day or placebo for 1.5 years, and revealed a significant reduction in non-fatal MI in the vitamin E group.
In recent years, however, awareness has grown that any medication regimen is only as good as the patient's compliance with it, that is that prescribed medications are actually taken at the times and in the amounts prescribed. The problem, and some ingenious but labor intensive and costly attempts to solve it, is well summarized in an article “The Other Drug Problem: Forgetting to Take Them” by science writer Abigail Zuber (New York Times, Jun. 2, 1998), which is here incorporated by reference in its entirety and from which the following is excerpted. “Study after study over the last 20 years has shown that misuse of prescription drugs is a worldwide epidemic every bit as dangerous and costly as an actual medical illness. It was tagged ‘America's other drug problem’ in the early 1990's when researchers consistently found it responsible for 10 to 25 percent of hospital and nursing home admissions studied. In 1984, the National Pharmaceutical Council, an association of pharmaceutical companies, estimated that misuse of prescription drugs had caused 125,000 deaths a year from heart disease alone. In 1993 the same organization calculated that not taking medicines correctly was draining upwards of $100 billion a year from the nation's economy in direct and indirect costs.
And with increased cost consciousness has come a new appreciation of the problem of ‘noncompliance,’ as medicine has labeled the phenomenon of skipping some doses, doubling up on others, forgetting to refill at the end of the month or taking a few of a family member's antibiotics on the chance they will work better than the ones prescribed.
Interest has been sharpened by new studies clearly demonstrating that disorders like elevated blood cholesterol or asthma respond far better when patients take medications as prescribed. And the flip side of the equation has been vividly illustrated by the medications for tuberculosis and AIDS: they may actually damage a patient's health when taken improperly, by inducing drug-resistant disease that may be passed on to others and cannot be treated at all. In fact, improving medication-taking behavior may be one of the few arenas in health care today where widely disparate interest groups—including medical researchers, patient advo
Henley III Raymond
Pillsbury & Winthrop LLP
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