New drug breakthrough dramatically cuts cholesterol
- Author: Carolyn Briggs Mar 20, 2017,
Mar 20, 2017, 12:40
Cardiologists not involved with the study say this is a big deal but caution it may be a big disappointment to insurers reluctant to pay for the pricey drug which costs $14,000 a year. He suggests that high-risk patients, or those who can't tolerate statins, talk to their doctor about possibly taking the cholesterol drug as an alternative.
Evolocumab is a fully human monoclonal antibody that works by blocking proprotein convertase subtilisin-kexin 9 (PCSK) - a protein that reduces the liver's ability to remove LDL cholesterol from the blood.
Excitement about Repatha - also called evolocumab - has been building in the past three years, with scientists predicting it could "switch off" heart disease. They were taking optimal doses of inexpensive, cholesterol-lowering statins, which gave them an average LDL of 92, well within the range - an LDL of under 100 - that has been advised for high-risk patients.
"It makes you scared, with lots of anxiety, knowing you had a heart attack and the statins are supposed to help people but aren't doing it".
The latest trial, involving 27,500 patients and led by Harvard Medical School and Imperial College London, provides that evidence.
Amgen, which on presented data showing for the first time that Repatha cuts the risk of heart attack and stroke, said in a related presentation for investors that it is netting between $7,700 to $11,200 per annual treatment after discounts and rebates and believes those prices represent good value.
"What this trial shows is that if you achieve these really low levels of cholesterol, you get the additional benefit, and you get that without any apparent adverse effects".
But for some people statins are not strong enough to reduce their levels, meaning the risk to their heart remains.
It shows in high risk patients, there's no number.
The Fourier trial was the first PCSK9 outcomes study to wrap up-a similar trial of Sanofi and Regeneron's rival drug Praluent is due to finish at the end of this year-and, perhaps more importantly to the broader field of CV research, the first outcomes trial to test the power and safety of lowering LDL to previously unheard-of levels.
Repatha, injected either once or twice a month, lowered LDL by about 60 per cent to a median of 30, with a quarter of patients getting below 20, researchers reported.
Those who took both were less likely to suffer a heart attack or stroke than if they took statins alone.
The heart attack and stroke refund isn't the only special offer that Amgen, Inc.is making to get patients to take a risk on Repatha.
PCSK9 inhibitors and statins start lowering LDL cholesterol nearly right away, but the beneficial effects on harder outcomes like heart attack and stroke take longer to emerge in clinical studies.
The results of the large global trial of a drug on 27,000 patients means the drug could soon be used by millions, reports the foreign media.
However, Prof Sever said: "They will probably not [replace statins], there are an very bad lot of people with really quite high cholesterol out there and we'll probably need more than one drug to get their levels down". This drug would cost $14,000 per year, which means that everyone would not be able to acquire it.
"That's a big benefit", said Dr. Marc Sabatine, the study leader, from Brigham and Women's Hospital in Boston.
Prof Sir Nilesh Samani, medical director at the British Heart Foundation, said: "Coronary heart disease is the single biggest killer in the United Kingdom and worldwide and "bad" LDL-cholesterol is a major cause".