The first rigorous test of an expensive new drug that radically lowers cholesterol levels has found that it significantly reduces the chance that a high-risk patient would have a heart attack or stroke.
Repatha costs about £4,400 per patient per year, although the NHS has agreed an undisclosed discount. High cholesterol is unsafe in the world of the heart because the fat might build up in your arteries and block blood flow, increasing your risk of a heart attack.
The researchers found an average decline of 59 percent in LDL levels among the 14,000 people in 49 countries who were put on the drug for 48 weeks, when compared with an nearly identical number of patients who received a placebo. By blocking the enzyme, the medications spur the body to screen out more cholesterol. All trial participants had stable atherosclerotic vascular disease, defined as a medical history of heart attack, stroke or symptomatic peripheral artery disease.
Results from the long-awaited Fourier trial, created to test Amgen’s Repatha as a tool to cut cardiovascular risks, showed that the drug cut heart attack risks by 27% over the course of the study, which followed patients for an average of two years.
Repatha, known generically as evolocumab, was approved in 2015 for people who couldn’t manage their cholesterol in any other way – but it wasn’t clear whether cutting LDL blood cholesterol to extremely low levels would protect against further heart attacks or stroke.
There are approximately 2.3 million people living with coronary heart disease in the United Kingdom, according to the NHS.
“The disappointing thing to me was there was absolutely no difference in mortality”, Stone said.
Perry Colangeli, a 51-year-old from Calgary has been taking evolocumab as part of the study.
However, it has been created to target a protein in the liver with the name PCSK9. Spokesmen also said they would work toward payment caps and structure possible risk-sharing agreements to make Repatha more affordable.
Katherine Boothe, who studies pharmacare and drug pricing at McMaster University in Hamilton, Ont. says if these drugs are recommended for large groups of patients, a lot of provinces are going to struggle to afford them. They then could wait up to six months before needing another shot. They received 140 mg Repatha injections every two weeks, 420 mg injections every month, or a placebo injection.
“Now we have more confidence that not only are we are helping on the biochemistry reports numbers, but also helping keep patients out of emergency rooms and cardiac operating theatres”. The researchers randomized patients to receive either injections of Repatha or placebo, and followed them for 2 years to track several cardiovascular events: heart attack, stroke, death, hospitalization for blocked blood flow to the heart, and stent or bypass surgery.
Leading cardiologist Dr. Donald Lloyd-Jones, told the Associated Press that the results are modest and “not quite what we hoped or expected”. Doctors don’t know whether Praluent would also prevent heart attacks, Rind said. In the absence of clinical data, wide adoption of the drug has been resisted by many clinicians and, even more crucially, insurance companies and benefits managers. If patient has a heart attack while on it, the company will offer refunds. This reduction in risk improved over time, increasing from 16 percent in the first year to 25 percent after the first year.
Understandably, this worry has trickled over to The Medicines Company’s stock because it is working with Alnylam Pharmaceuticals on a PCSK9 drug called inclisiran.
Dr Marc Sabatine, from Brigham and Women’s Hospital in MA and lead researcher on the study, will present the findings today (17th March) at the American College of Cardiology’s (ACC) 66th Annual Scientific Session in Washington.