The FDA has recently approved a drug to help patients who have been unable to adequately lower their cholesterol through conventional treatments.
It's going by the brand name Praluent, and it's already creating excitement in the medical community and with patients.
Andrea Citero says she first became aware of her high cholesterol when she was 38 years old.
"I started a job and they had done a physical and I got a form saying that my cholesterol was extremely high and it was about 350 at the time," she shared.
Over the years, Citero saw doctors who put her on various drugs, but nothing seemed to work. Then, at 58, her high cholesterol landed her in the emergency room.
"I had pain in my chest, I had nausea, and I felt like I was going to vomit," she recalled. "So, I woke my husband up and said, 'we have to go to the hospital immediately.'"
After recovering from her heart attack, she came to Duke to see John Guyton, MD, an endocrinologist who enrolled her in a clinical trial for Praluent.
Learn more about Praluent here.
"This new drug is an injectable treatment that is for high cholesterol. It lowers the LDL cholesterol commonly known as the 'bad cholesterol' by about 50 percent," Guyton explained.
He pointed out that this new treatment is the product of genetic research and molecular biology.
"It targets a specific molecule. And in this case, it was first discovered in 2003 in a French family by French researchers," he explained. "It's a molecule that's a protein that's secreted by the liver and it governs the way cells pick up cholesterol and remove it from the circulation."
In a nutshell, the drug targets that molecule that keeps the body from getting rid of LDL on its own, allowing the body to once again do its job.
"These people have a defect in that apparatus for removing the LDL cholesterol from the circulation," Guyton said, explaining that they have a condition called Familial Hypercholesterolemia.
While the drug is intended for this subset of patients, it's not for everyone who suffers from high cholesterol.
"The FDA approval, the indication from the Food and Drug Administration, is for patients with familial hypercholesterolemia, and those with coronary heart disease or previous stroke, or perhaps a blockage of an artery in the leg, who cannot get their cholesterol level down low enough with statins and conventional therapy alone," Guyton reiterated.
Praluent is administered twice a month by self-injection. Guyton describes the cost as "expensive," but worth it for patients like Citero who have been unable to see results any other way.
"This injectable treatment is the strongest treatment we've had for cholesterol since Statins were announced in 1987," he said. "The reaction from the patients is just terrific. They are seeing cholesterol levels that they've never seen in their life."
Citero says she feels as if she's finally taken control of her health. Her cholesterol is down from a peak of 500 to around 120.
"When you have a heart attack it's very scary, and you think you can have another one. And one of my risk factors is going away. That's definitely a big deal. It really has, it really has made a difference. I haven't seen these numbers in like 23 years," Citero said with a laugh.
The makers Sanofi/Regeneron said this regarding the drug's pricing:
"The U.S. WAC (Wholesale Acquisition Cost) price of Praluent is $40 per day ($1,120 every 28 days) for both the 75 mg and 150 mg doses, making Praluent the lowest priced patient-administered monoclonal antibody therapy on an annualized basis. Actual costs to patients, payers and health systems are anticipated to be lower as WAC pricing does not reflect discounts or rebates. Out-of-pocket costs to patients will vary depending on insurance status and eligibility for patient assistance."
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