CenterWatch - Cardiovascular Update

The American Heart Association estimates that 61 million Americans have one or more forms of cardiovascular disease. Cardiovascular disease is the most common cause of mortality in men and women, causing about one million deaths each year. Another way of highlighting this statistic is understanding that one out of every 2.5 deaths each year is secondary to cardiovascular disease. About half of the subjects who succumb from Cardiovascular Disease have coronary artery disease; this makes coronary artery disease the single leading cause of death in America today. This year, an estimated 1.1 million Americans will have a new or recurrent coronary attack, which will cause the death of more than 40% of the people experiencing it.

The prevalence of the three most common types of cardiovascular disease is as follows:

Condition	Prevalence
Hypertension	50 million
Coronary artery disease	12.4 million
- Myocardial infarction	7.3 million
- Angina pectoris	6.4 million
Strokes	4.5 million

In addition to coronary artery disease, cerebrovascular disease and strokes are the third most common cause of death, causing more than 150,000 deaths each year. Moreover, cardiovascular disease causes significant disability from strokes, congestive heart failure, peripheral vascular disease, venous insufficiency and multi-infarct dementia.

Most cardiovascular disease is a direct result of atherosclerosis of the arteries. Atherosclerosis involves the deposition of fatty substances, cholesterol, cellular waste products, calcium and fibrin within the inner lining of an artery. This build-up of material (called plaque) results in thickening of the artery and narrowing of the lumen. When bleeding takes place within a plaque or a blood clot forms on the plaque's surface, the blood flow to the tissues supplied by that organ is stopped; this results in heart attack, stroke or leg gangrene.

Drugs in development that target cardiovascular conditions try to reverse or halt the atherosclerotic process as well as inhibit or reverse thrombosis in an atherosclerotic artery. Drugs that halt or inhibit atherosclerosis include those that control the risk factors related to atherosclerosis, including drugs that improve the management of hypertension, of diabetes, of hyperlipidemia, smoking cessation, and other preventive strategies that seem to limit the atherosclerotic process.

There are approximately 250 drugs in development for cardiovascular disease:

While there were many drugs that were approved by the FDA in 2001 for the treatment of cardiovascular disease, most are similar in function or are reformulations of established drugs. Diovan and Teveten-Hct are new drug approvals and both are Angiotensin II receptor blockers.

Two drugs use new strategies in the management of cardiovascular disease. The first has the role of improving the morbidity that accompanies acutely decompensated congestive heart failure. Natrecor is a recombinant human B-type natriuretic peptide (BNP). A number of published studies indicate that endogenous levels of BNP are elevated in overload states such as congestive heart failure. Two pivotal studies demonstrated that Natrecor significantly improved hemodynamic function and seems to represent a new treatment strategy for congestive heart failure.

The second drug, Definity by Dupont Pharmaceuticals, branches out into the field of cardiovascular imaging. Definity is indicated for use in subjects with suboptimal echocardiograms to improve delineation of the left ventricular chamber. About 20% of the 17 million echocardiograms performed in the United States in 2000 failed to provide sufficient information. With the use of Definity, a perlutren lipid microsphere, an evaluable echocardiogram was achieved in 91% of subjects tested. It produced more accurate assessment of segmental wall motion abnormalities and better delineation of endocardial structures. While there are many contrast agents in the drug development pipeline for cardiovascular disease, Definity is the first one approved for use with ultrasound imaging.

In summary, drug development for cardiovascular diseases remains the most active in pharmaceutical research. Future research will be targeting the atherosclerotic process, identifying ways of decreasing tissue damage during an acute thrombotic episode, and genetic/cellular research aimed at restoring cellular function in major organs.

Directory of Drugs Therapeutic Area Updates