Sadie Picardo, 73, is losing her battle with cholesterol.
She eats low-fat meals, exercises, and still she wonders, "What's going on? I'm doing everything I'm supposed to do and it's still not going down."
Artery-clogging cholesterol is one of the biggest risk factors for heart attack and stroke. And unfortunately for some, stubborn cholesterol levels refuse to fall despite a careful diet, exercise, and even cholesterol-lowering statin drugs.
Now, on the cutting edge of medicine, emerges a potential solution: a vaccine designed to keep cholesterol levels low and arteries open.
Twice a Year Versus Twice a Day
For a while, Picardo tried statins to lower her cholesterol but shortly gave up, explaining, "I don't like taking pills to begin with, and when I would take this I would wake up the next morning and my muscles would be sore."
According to Dr. Michael Davidson of Rush Medical College in Chicago, Picardo is like many others who start and, citing side effects, stop their statin medications. "Roughly 50 percent of people who start on a statin pill are not taking it a year later," says Davidson.
In response to poor patient compliance and cholesterol levels that just won't budge, Avant Immunotherapeutics has been working to develop a cholesterol vaccine.
The biotechnology firm's solution is a twice a year injection designed to alter the balance of cholesterol in the body. Compared to statin drugs, which are taken twice daily, the vaccine is expected to be a welcome convenience for thousands of Americans.
Coaxing the Body to Produce 'Good' Cholesterol
Cholesterol comes in two basic forms, the "good" and the "bad." Bad cholesterol, technically know as low density lipoproteins, or LDL, causes arterial disease problems by depositing fatty plaques the walls of the blood vessels.
Good cholesterol, called high density lipoproteins, or HDL, helps unclog arteries by carrying some of the harmful cholesterol out of the bloodstream and into the liver where it is no longer a threat.
The new vaccine is designed to coax the body into producing more of the protective HDL cholesterol. According to Davidson, the vaccine will raise HDL levels by roughly 40 percent to 50 percent.
The vaccine takes "a very new approach to treating cholesterol," says Ronald Krauss of the American Heart Association. "It's a very new approach that has a lot of potential."
In rabbits, placed on high-fat diets, the vaccine raised HDL 42 percent, lowered LDL by 24 percent and reduced fatty plaque in the arteries by 40 percent. These results are so promising that the Food and Drug Administration has allowed the vaccine to be tested in people.
Early trial results suggest that the vaccine is safe, and researchers have now turned to the task of determining the most effective dose.
Scientists will follow patients such as Picardo over the next several years to see whether this vaccine controls cholesterol in humans and actually reduces the risk of heart disease.
Davidson says the trials are expected to be completed by May 2003.