For most people struggling with high cholesterol, a prescription for a statin medication is enough to help lower their numbers with relatively few problems. But for some, the side effects outweigh the benefits of statin use.
“There is a tremendous unmet need” beyond statins, said Dr. Robert S. Rosenson, director of the Cardiometabolics Unit at the Icahn School of Medicine at Mount Sinai.
Fortunately, two new cholesterol-busting drugs that could potentially be a helpful alternative to statins have recently been recommended for FDA approval. These medications, alirocumab and evolocumab, could be more effective for patients who have adverse reactions to statins or whose cholesterol levels don’t respond to the medications.
John Mihalopoulos, a mountain biker and father of four, was born with familial hypercholesterolemia—a rare genetic disorder that caused his body to produce too much cholesterol. Typically, statins work to lower cholesterol when diet can’t, but those options produced little, if any, response for John. So five years ago, after extensive investigation, he turned to Baylor Scott & White Health for a research-based alternative that would combat his condition while giving him the strength and endurance to live his life.
“I knew I had to try something if I was going to survive,” said John.
John enrolled in a clinical trial at Baylor Jack and Jane Hamilton Heart and Vascular Hospital. The trial studied Mipomersen, an experimental drug mix for cholesterol management that also served as an alternative to statin medication. The national study, led by principal investigator Cara East, MD, a cardiologist on the medical staff at Baylor Heart and Vascular Hospital, involved six Baylor Scott & White patients, John included, who all experienced genetic cholesterol problems.
Since he enrolled in the trial, he’s noticed a dramatic improvement—not only in his cholesterol numbers, but in his quality of life.
“I feel better,” John said. “I’ve been involved in testing a couple of different drugs within the research study. They’ve all worked great, and it just keeps getting better with each medication that’s been introduced.”
John calls the results nothing short of incredible—and here’s why: a patient is considered “at-risk” if their cholesterol exceeds 200. At 240, the warning bumps up to “high-risk.” John’s cholesterol had reached 500 before he enrolled in the trial. The experimental drugs have helped reduce it to 165, which is within the optimal range, according to the American Heart Association.
Most important, the research provided extra time—not only for him, but for his children, John said. All four of them have inherited John’s high cholesterol gene, so the silver lining of his story extends beyond his own health. By participating in a clinical trial, he potentially helped bring to market a treatment that could someday help his kids.
“Knowing that the drug is being developed gives me a peace of mind for myself and my children,” John said. “Having the research program available gives me hope that there will be a drug for them as they mature.”