High cholesterol is a major risk factor for cardiovascular disease. Every 40 seconds, an American adult dies of a heart attack, stroke, or related vascular disease. And with nearly half the US population expected to have some form of cardiovascular disease in the next 15 years, Americans desperately need to find ways to control risk factors like high cholesterol.
Statins — a class of drugs that inhibits cholesterol production in the liver — can be very effective in lowering cholesterol levels, especially when combined with lifestyle changes.
But not for everyone. As many as 10 million Americans have uncontrolled cholesterol despite existing treatments such as statins.
Doreen is one of them. At age 39, she found herself struggling to take care of her diabetes, which she had developed in her early 20's. "In the meantime, I knew nothing about cholesterol," she says. "By 1994, I had a heart attack, and I was told that my cholesterol was totally out of whack."
"I was put on a statin, I was put on a blood thinner, and I was told to follow a diet," Doreen says. But she began experiencing alarming side effects. "I'd get terrific, terrific spasms that were so severe, I'd be in one place, screaming with pain," she says. "I couldn't move my body."
Cholesterol-lowering medicines recently helped bring Americans' average cholesterol levels within an ideal range for the first time in 50 years. With further progress where all forms of cardiovascular disease are eliminated, average life expectancy would rise by nearly seven years.
Yet many patients remain unable to control their cholesterol levels, leaving as many as 2 in 3 Americans with high cholesterol still at risk.
Unfortunately for many patients like Doreen, statins are not an option due to intolerable side effects. And for many others, like those with a certain hereditary condition which causes very high levels of cholesterol known as familial hypercholesterolemia (FH), statins are not enough to get their cholesterol levels sufficiently under control.
For these patients, even following low-fat diets, exercising regularly, and trying a variety of statins and other cholesterol-lowering therapies are often unable to bring down cholesterol levels to a safe range.
FH patients are even sometimes forced to resort to regular, in-hospital procedures to filter cholesterol out of their blood — a time-consuming regimen that can cost up to $100,000 per year.
To fill this unmet medical need, researchers are developing new cholesterol drugs to bring the benefits of statins to those who currently cannot enjoy them.
PCSK9 inhibitors, a new class of medicines, could help patients who face a high risk of developing serious and costly cardiovascular complications like heart attack and stroke. These drugs mimic a natural mutation in the PCSK9 gene, which regulates the breakdown of bad cholesterol in the body.
For Doreen, changes in new drug development and access to information since her heart attack have changed something else: how she can take control of her life.
"I was totally oblivious, and I didn't know where there was help," she says. "Now I know, and I'm learning something new every day to be able to help others. I just think it's a blessing."
Continued innovation may hold the promise of helping millions of Americans who, despite every effort and the best available treatments, are unable to control their cholesterol.
As these drugs enter the market, they will also help lift an enormous financial burden on the health care system. Cardiovascular diseases and stroke are now responsible for 15 percent of U.S. health expenditures — more than any other disease area — and the total costs associated with them are projected to more than double by 2030.
Just as devastating as the cost of treating these conditions are the billions of dollars that heart disease causes in lost productivity every year, making high cholesterol a liability even for Americans who don't suffer from it.
Over the last several decades, doctors and researchers have advanced in the fight against high cholesterol, but too many Americans cannot benefit by the treatments they have produced. For these people, the new drugs now in the pipeline could bring treatments that work, extending the promise of longer, healthier lives.
"There's new technology and research every day," Doreen says today. "That's where the hope comes in, and the faith comes in. It's going to be all right."