New Cholesterol Drug Reduces Artery-Clogging Plaque in Study Participants
Repatha reduced "bad" cholesterol levels and plaque when used with statin therapy
A new clinical trial has found that Repatha, a new cholesterol drug made by Amgen, reduced "bad" LDL cholesterol levels as well as the plaque that can clog arteries for most high-risk heart patients after 18 months when used with statin therapy.
Reuters reports that the trial, in which 968 patients participated, compared the effects of Repatha injections in addition to a cholesterol-lowering statin—a class of medications that lower the levels of lipids in the blood, ultimately resulting in lower cholesterol levels—with the use of only statins on plaques that can break off in an artery and cause a heart attack. The measurements of plaque levels were collected by the use of an ultrasound probe that was put inside the affected artery.
Participants all had symptomatic heart disease and artery blockages ranging from 20 percent to 50 percent in the tested artery.
"We saw profound regression," said Dr. Steven Nissen, head of cardiology at Cleveland Clinic, who presented the data at an American Heart Association scientific meeting.
Therapy using the two treatments resulted in an additional 60 percent reduction in levels of LDL cholesterol beyond statin therapy alone, ending with an average LDL level of only 36.6. This meant that there had been a decrease of roughly one percent in the blockage volume when compared with no change for statin therapy by itself.
As WRAL reports, although this percent decrease is small, doctors hope the amount of blockage reduced will increase with longer treatment. And as the news outlet notes, "[A]ny reversal or stabilization of disease would be a win for patients and a long-sought goal."
In total, writes Reuters, 64.3 percent of patients receiving the combination therapy experienced a reduction in plaque levels, while 52.7 percent experienced it using only statin therapy.
"We didn't know what would happen to disease progression at LDL cholesterol levels when we go to below about 60," Nissen explained.
For patients who started the trial with LDL levels below 70—the lowest target guideline for high-risk patients—81 percent saw a reduction in coronary plaque when Repatha was added to their treatment regimen. This compares with 48 percent who received only statins. On average, these Repatha patients experienced a drop in LDL levels to 24 with a low of approximately 15.
"That's unbelievable. So when you get down to 24 you've got a really high chance of your plaques melting away," Nissen said.
Repatha is one in a new drug class known as PCSK9 inhibitors, which have a list price of more than $14,000 per year before discounts and rebates are taken into account.
Numerous cardiologists are upset by the obstacles to access to these medications that are put forward by insurers and pharmacy benefit managers. Such hurdles are experienced even by the sickest patients who meet all Food and Drug Administration-mandated criteria.
According to Amgen, although more than 100,000 prescriptions have been written in the U.S. for Repatha since it was approved, but two-thirds of these patients end up being denied the drug.
"It's crazy what's going on. They've basically destroyed our capacity to treat our patients with the drugs that we need to treat them with," said Dr. Seth Baum, president of the American Society for Preventive Cardiology.
Many believe that payers will not remove restrictions on reimbursements for the medications until results come in from large studies meant to show that the new drugs reduce the risk of heart attacks and death as well as their ability to lower patients' LDL levels. The outcomes data for Repatha is expected in early 2017.
The data on plaque reduction collected from the study may be strongly indicative that such future studies will have a positive outcome.
"These findings suggest that the large clinical outcome trials currently underway are likely to show major benefits," said Dr. Stephen Nicholls, one of the study's lead directors.