Amgen Says Repatha Reduces Risk Of Hard Major Adverse Cardiovascular Events

The study also showed a 15 percent reduction in the risk of an extended major adverse cardiovascular event.

"It is probably the most important trial result of a cholesterol lowering drug in over 20 years".

On the safety side, Amgen spotted no new risks of taking the drug. Investors might not agree, however; Amgen shares dropped in pre-market trading by 6%.

In the United Kingdom, the National Institute for Health and Care Excellence (NICE) has considered the drug for select cases only, such as patients with familial hypercholesterolaemia, a genetic condition that results in high cholesterol levels and which increases the risk of developing coronary heart disease. Evolocumab is a fully human monoclonal antibody that works by blocking proprotein convertase subtilisin-kexin 9 (PCSK9), a protein that reduces the liver's ability to remove LDL cholesterol from the blood. Symphony Health data shows that commercial insurers rejected nearly three-fourths of PCSK9 requests previous year, and Medicare coverage was denied at a rate of 61%.

Hegele has been studying PCSK9 inhibitors for several years and says while it has been known for some time that the drugs reduce cholesterol levels, there's been doubt about whether they actually cut the risk of heart attacks and deaths. Some cardiologists and researchers had anxious that very low LDL might have deleterious effects, just as excessively low blood pressure can.




"The unique dosing regimen virtually eliminates variability in LDL-C levels over time and inclisiran may, therefore, solve one of the most vexing challenges of cardiovascular medicine-namely, how to make sure everyone responds to treatment", said John J.P. Kastelein, MD, PhD, a professor of medicine and the chairman of the Department of Vascular Medicine at the Academic Medical Center at the University of Amsterdam. Earlier guidelines set an LDL target of 70 for such high-risk patients. "We really should be trying to get it as low as possible".

He prescribes the drug for patients who can't be helped by statins or other cholesterol-lowering drugs and said he would likely stick with that prescribing pattern.

Dr. Seth Baum, president of the American Society for Preventive Cardiology, said records from IMS Health, an information services company, show 83 percent of patients had claims rejected in the first year Repatha and Praluent were sold, and 26 percent of them won on appeal.

A key secondary endpoint of the study narrows the list of bad patient outcomes to cardiovascular death, heart attack and stroke. Almost half the patients saw LDL levels fall below 50, well below the common target of 70 for patients at high risk of a heart attack or stroke. The median baseline LDL cholesterol was 92 mg/dL. The benefit grew with longer use, and was 25 percent the second year, said Sabatine, who consults for Amgen and other drugmakers. It also cut the risk of hospitalization for chest pain or the need for angioplasty (an artery-opening procedure) by 15 per cent. When examining individual outcomes, there was no effect on cardiovascular mortality by itself, but there was a statistically significant 27 percent reduction in heart attack and a 21 percent reduction in stroke. Sixty-nine percent of patients were on a high-intensity statin and 30 percent were on moderate-intensity statin.

On November 1, 2016, the entire SPIRE clinical trials program was stopped when the sponsor, Pfizer, who manufactures bococizumab, discontinued the development of the drug when initial results from the LDL cholesterol lowering trials indicated that some trial participants had developed anti-drug antibodies, an immunologic response to the drug. Blood pressure has to be treated to a "normal range", not too high or low, while smoking is toxic and should be stopped altogether.

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