Medicos toast tests of new cholesterol drug

Evolocumab and clinical outcomes in patients with CVD

In the study, published today in the New England Journal of Medicine, researchers looked at the protective effect of evolocumab on patients in 49 countries, with a history of atherosclerotic vascular disease, who were already taking statins to reduce their cholesterol. More cautious doctors insisted they needed proof that it prevents heart attacks and strokes. However, most of the patients who require the drug can not afford it because it costs a whopping $ 14,523 every year. The new drug - evolocumab - changes the way the liver works to also cut bad cholesterol. All patients who used Repatha along with statin decreased their LDL for 92 milligrams per deciliter to 30. Despite this, the patients who took evolocumab saw their bad cholesterol levels fall even further.

Dr Sabatine said: "These data show that lowering LDL cholesterol beyond current treatment targets confers significant benefits for our patients with cardiovascular disease who are at a high risk of cardiovascular events".

Because of its unclear benefits and high price insurers are hesitant to cover it.

As Amgen reveals, the study was statistically powered around the hard major adverse cardiovascular event (MACE) composite endpoint of first heart attack, stroke or cardiovascular death.

The new results-from a trial with more than 27,500 participants-vindicate the concept that inhibiting PCSK9 can control cholesterol and heart-disease risk.

The refunds would go to insurance companies, not patients, Ofman said.

They found 34.7% of prescriptions were abandoned by the patients.

Some health care experts weren't impressed by Amgen's offer.

Peter Bach, for instance, director of the Center for Health Policy and Outcomes at Memorial Sloan-Kettering, emphasized that the number of CV events prevented would be too small for payers to save much money. Most trial subjects had had a prior heart attack or stroke. This investigation was also presented in the American College of Cardiology meeting. Due to its steep pricing, most medical insurances do not want to pay for the drug. After a follow-up period of around two years, it showed that the risk of heart attack, stroke and coronary revascularisation was cut by 27%, 21% and 22%, respectively.

"This [result] is probably a little less than we had been hoping for", said Rind, chief medical officer at the Boston-based Institute for Clinical and Economic Review, which evaluates drugs' cost effectiveness. The fresh evidence could mean many more patients become eligible.

Statin is a medicine for cholesterol which is used to treat heart diseases.

Safety-wise, Repatha patients didn't see some of the side effects that other lipid therapies produce, he said.

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

Given its price, doctors aren't likely to give Repatha to everyone with high cholesterol, Patterson said. "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". About 70 million Americans have high cholesterol and 25 million take statins, Nissen said.

Amgen acknowledged during a presentation for investors that it is already selling Repatha at a discount, resulting in net prices between $US7,700 to $US11,200 per annual treatment, and believes those prices represent good value. Pfizer, the drug's manufacturer, halted development of bococizumab in November.