Cholesterol-Slashing Drug Does Not Harm Brain

Mar 21, 2017, 00:29
Cholesterol-Slashing Drug Does Not Harm Brain

Yet the drug failed to show a statistically significant effect on cardiovascular death, and the risk reductions observed on the primary and secondary endpoints checked in lower than some had hoped to see. Study participants were ages 40 to 85 and already taking statins; most already had suffered a heart attack or stroke. Based on this analysis, Amgen believes that while net prices in the market are variable, they do already exist in a value-based range.

Half of the patients were asked to take optimal quantity of statins along with Repatha. They followed-up these people for two years, from 2013 to 2015.

And the FDA approved evolocumab, made by Amgen in Thousand Oaks, California, only for certain patients, such as those with a hereditary condition that causes extremely high levels of LDL.

Excitement about Repatha - also called evolocumab - has been building in the past three years, with scientists predicting it could "switch off" heart disease.

On Friday, for the first time, we saw the full data from the FOURIER clinical trial of Amgen's cholesterol-lowering antibody, evolocumab (Repatha™).

FOURIER is the first outcomes trial to read out for the PCSK9 class. Sanofi and Regeneron are conducting their own study, dubbed ODYSSEY, to test Praluent's cardiovascular benefit.

Professor Peter Sever of Imperial College London, whose results were presented to the American College of Cardiology yesterday, said: 'This is one of the most important trials of cholesterol-lowering since the first statin trial published 20 years ago.

"Our results suggest this new, extremely potent class of drug can cut cholesterol dramatically, which could provide great benefit for a lot of people at risk of heart disease and stroke", said Professor Peter Sever from Imperial College London, and the United Kingdom branch lead of the study, according to The New Daily. Also, in some patients cholesterol levels can remain high despite being given the maximum doses of statins.

But they were approved only for those with a genetic condition that means they have dangerously high cholesterol, and people with heart disease who can not cope with the side effects of statins.

But it comes at a hefty price tag of more than $14,000 per year, raising concerns about how many patients could benefit.

This treatment has not been approved for all kind of patients.

"In general, the drugs will probably be reserved for patients at high risk who will have a bigger treatment effect", Stone said.

Repatha is a human monoclonal antibody, which supressess proprotein convertase subtilisin/kexin type 9 (PCSK9). But some people can not take them without significant side effects such as muscle pain, and in most people they do not lower LDL cholesterol as significantly as the new drugs.

The larger reductions in heart attacks and strokes drove the drug's performance on the MACE measure, and on the primary endpoint, which comprised the MACE numbers as well as hospitalization for unstable angina and coronary revascularization procedures, Levy said. It is called evolocumab and it functions by changing the way the liver works to also cut bad cholesterol. Amgen released data to coincide with the American College of Cardiology conference, but the data will be enough to boost sales. "We did not find evidence for a decline in neurocognitive function after almost two years of treatment with evolocumab using a dedicated series of neuropsychologic tests".

"The drug was safe and well-tolerated", said lead study author Marc Sabatine, chair of cardiovascular medicine at Brigham and Women's Hospital in Boston.

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