New Cholesterol Drug Called a Game Changer

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Find Out If You’re a Candidate For New Cholesterol-Lowering Medication

By Gina Roberts-Grey, Special to Lifescript
Published July 27, 2015

A new class of drug that battles high cholesterol levels has won approval from the Food and Drug Administration. Read on to learn how the new drug, called a game changer, works and whether it’s right for you…

Patients whose high cholesterol is resistant to most treatments now have a new weapon in their medication arsenal.

The injectable prescription medication alirocumab won Food and Drug Administration (FDA) approval July 24. It’s the first in a new class of drugs aimed at lowering high cholesterol. Although it’s not yet approved for use in all patients, the medicine is creating a great deal of excitement in the medical world.

Who should take it?
Only patients with heterozygous familial hypercholesterolemia – a genetic condition in which you have high cholesterol levels, or have had a prior heart attack or stroke – should take the drug, according to the FDA release.

Not a statin
Typically, high cholesterol is treated with statins such as atorvastatin or simvistatin.

“These medications are effective in most patients, but are not potent enough to lower LDL [bad] cholesterol to target levels in extreme situations, including patients with heterozygous familial hypercholesterolemia,” says Guy Mayeda, M.D., a cardiologist at Good Samaritan Hospital in Los Angeles.

That’s where alirocumab come in.
“This new medication … provides a new alternative for patients with the highest risk of cardiovascular events from inadequately controlled high cholesterol,” Dr. Mayeda says.

Five studies involving nearly 2,500 patients were conducted to test the safety and efficacy of the drug. Alirocumab was found to lower LDL levels between 36% and 59%.

However, that better control comes with big price tag.

Expensive medication
“[Alirocumab] is significantly more expensive than traditional statin medications,” Dr. Mayeda says.

Regeneron, the makers of alirocumab, will sell the drug wholesale for $1,120 for two doses, which lasts 28 days. The annual cost of the drug could cost patients up to $14,560, depending on their health insurance coverage and co-pays.

The drug is not without risks, either.

Side effects
The FDA says the most common side effects include “itching, swelling, pain, or bruising where the injection is given, nasopharyngitis [inflammation of the mucus membranes] and flu.”

Allergic reactions, including vasculitis (a skin rash that appears as purple-colored spots on the skin and is associated with inflammation of the small blood vessels) and hypersensitivity reactions requiring hospitalization have been reported with the use of the drug.

“As with all newly approved medications, patients and their physicians should be diligent in watching for potential side effects,” Dr. Mayeda cautions.

Not a magic bullet
While alirocumab may hold promise, experts caution it’s not a cure-all for high cholesterol.

“[Alirocumab] is a supplemental therapy to diet and statin therapy,” says Robert Greenfield, M.D., a cardiologist, lipidologist and chief of staff at Orange Coast Memorial Medical Center in Fountain Valley, CA.

”This is not meant to replace statins, as statins have decades of outcome data proving that they save lives by reducing heart attack and stroke rates.”

Although positive safety data were presented to the FDA, additional data that will come after many more patients use the medication may reveal “additional adverse side effects,” Dr. Greenfield says.

The next phase of trials will help doctors and their patients know if the drug is as promising as the initial results seem to indicate.
Lifescript
interview with Dr. Guy Mayeda

“Roto-Rooter for the Heart”

Dr. Bruce Hensel reports for the NBC4 News on a newly approved medical device that breaks through blockages of the arteries and gives some patients with heart diseases a minimally-invasive alternative to open heart surgery.



A new medical device is giving some people with heart disease a less invasive alternative to open heart surgery.

Bill Dumbauld, 76, is one of them. He was concerned about shortness of breath and chest pains because of his family history of heart disease.

“On my father’s side, all of his brothers and sisters died of a heart attack. My dad had three heart attacks and he died at 47 and he had a brother who died of a heart attack and he was 44,” Dumbauld said.

Ask Dr. Bruce 

Dr. Guy Mayeda, of Good Samaritan Hospital, diagnosed him with a blockage in his artery.

Normally, Mayeda would use a minimally invasive procedure to insert a stent in the artery and open up the blockage. But Dumbauld’s artery was blocked with hard calcium making it difficult if not impossible to extend the mesh stent.

So Mayeda recommended trying a new device: the Diamondback 360.

“For patients like Mr. Dumbauld, this Roto-Rooter-like device helps the cardiologist safely remove most of the calcium build-up,” Mayeda said.

The device spins or rotates at 60 to 120,000 revolutions per minute; sanding and pulverizing the calcium blockage. While it’s spinning, it also orbits the wall of the artery so it can remove the calcium without damaging the healthy tissue.

“It was a type of blockage that the normal tools wouldn’t work,” Dumbauld said. “So my doctor said there is a new instrument out there that was just approved by the FDA.”

The Diamondback 360 is only available at handful of hospitals across the country. But Dumbauld says it was worth the wait.

“I didn’t realize at the time that the alternative to that was bypass surgery and I started thinking that they’d have to lift my heart out, turn it over and then do the work,” Dumbauld said.

Dr. Bruce Hensel says this is not the procedure of choice for everyone.

Angioplasty or stents without this additional step is easier and may produce fewer risks. But for those with calcified plaque, this new device could reduce the need for open heart surgery.