A life saving drug Evolocumab will help in combating world's biggest killers

Evolocumab and clinical outcomes in patients with CVD

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. The Amgen drug and a similar one, sold by Sanofi and Regeneron, were approved by the U.S. Food and Drug Administration in 2015 with the hope - and expectation - that they would lower the risk of heart attacks and strokes, and not just reduce levels of LDL cholesterol, the unsafe kind. They followed-up these people for two years, from 2013 to 2015.

The researchers found that just one month after receiving a single treatment of inclisiran, participants' LDL cholesterol levels had reduced by up to 51 per cent. The results dragged down Amgen's shares and also those of other PCSK9 inhibitor developers, including TMC and Alnylam although the latter two have now bounced back.

Previous research had raised the possibility that evolocumab, sold under the brand name Repatha by Amgen, may have a damaging effect on memory and cognitive function.

Investors greeted the trial results with initial disappointment and appeared to assume that insurers would continue to restrict access to the drug, in part because it did not show a benefit in overall death rates from cardiovascular causes.

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. 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.

Talking about pricing and value, Krumholz posited that the premium annual cost of the cholesterol drug may not be worth it unless it would truly be a form of medication with unprecedented risk reduction capabilities based on its proven ability to reduce bad cholesterol levels.

Coronary heart disease, in which the major arteries become clogged, affects more than 2.3million people in Britain, and 69,000 die from heart attacks every year as a result. Repatha comes for a whopping $14,000 for a year. Some payer coverage decisions come with qualifications like a requirement that patients meet specific criteria or try other treatments first.

Cardiologists have always been taught that CV patients have three risk factors that can be handled with treatment: high blood pressure, smoking and high LDL cholesterol, Levy said. Dr. Donald Lloyd-Jones, preventive medicine chief at Northwestern University and an American Heart Association spokesman, called the results modest and "not quite what we hoped or expected".

The patients in the trial were already taking statins and yet their risk was cut further by the new therapy.

In the United States, heart disease accounts for one in every four deaths, and kills more than 600,000 people every year. It also blocks the capacity of the PCSK9, so there is a high number of receptors to break up cholesterol LDL.

Given these findings, researchers at the American College of Cardiology believe that it could convince more people to start taking the cholesterol drug.

"It's remarkable to see such a large impact in reducing cardiac events given that this patient population was only on Repatha for about two years".

"With this trial, we now have definitive data that by adding evolocumab to a background of statin therapy, we can significantly improve cardiovascular outcomes and do so safely", said lead author Marc S. Sabatine from Brigham and Women's Hospital in Boston.



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