New medicine a happy news for heart patients

Doctors often recommend that people keep their LDL levels under 100 milligrams per deciliter, and that people at very high risk reduce their LDL under 70. All the patients were taking cholesterol-lowering statins, most at high doses.

Experts said the findings were the most important since the first statins trials were published two decades ago.

Repatha decreased LDL-C from a median of 92 to 30 mg/dL when added to statin therapy, showing a reduction of 59% at week 48 that was continued across the trial.

No one disputes that heart disease is a major medical problem. "However, for lower risk patients this study still leaves payers with significant ammunition to restrict access".

Aiming to address questions about its cognitive effects, researchers at Brigham and Women's Hospital in collaboration with Brown University and the University of Geneva ran cognitive tests on almost 2,000 people enrolled in a two-year study of the drug.

If all 325,000 eligible people in the United Kingdom were to be treated, 2,200 potentially fatal heart emergencies would be avoided every year. The drug's mechanism of action was discovered by studying people with mutations to the gene for PCSK9 that allowed them to maintain exceptionally low cholesterol levels.

Repatha and Praluent, which belong to a class called PCSK9 inhibitors, are especially expensive because they would be taken for such a long time. Those on the highest tier might include specialty medicines that could cost the patient hundreds of dollars even with coverage.

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The new study provides much stronger evidence that it saves lives. After diving deeper into the data, we think it will be sufficient to change treatment guidelines, and our assumptions for net USA prices-going from roughly $10,000 today to $8,000 annually over the next couple of years as payers loosen restrictions-still hold.

The Repatha study results are being presented and discussed today at the American College of Cardiology annual meeting.

Patients who were given Repatha experienced a 27 per cent reduction in the risk of heart attack, 21 per cent reduction in stroke and 22 per cent reduction in coronary revascularization.

The study, in the New England Journal of Medicine, tested Repatha on patients in 49 countries, 1,500 in Britain.

Half of the patients were asked to take optimal quantity of statins along with Repatha. Doctors say some patients have had trouble getting a new cholesterol-lowering drug, Repatha, that costs $14,000 a year, because of the restrictions.

There were no additional side effects beyond those seen with statins alone.

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.

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The drugs work by blocking a protein that affects the liver's ability to remove cholesterol from the blood.

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.

And with a price tag of $15,000 per patient per year, that question for third-party payers will be significant.

The standard treatment for cholesterol, other than diet and exercise, is a generic statin, which costs $250 a year.

Till now, with LDL, "no one was sure whether it was more like blood pressure and needed to be in range, or whether we want to eliminate it like tobacco", Levy said.

But Harvard's Dr Marc Sabatine, who led the trial, said high cholesterol must be treated "more aggressively, and now we have a new validated means to do so".

The British Heart Foundation said the results have shown considerable advancement in fighting against the biggest killer in the world.

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