Drug which cuts 'bad' cholesterol can help prevent heart attacks and strokes

But heart experts aren't convinced the benefits of these drugs justify the cost, at least in most patients.

This last result is something insurers care about - preventing costly health care. But he called the study "a solid outcomes trial" and said "we should celebrate" that it showed the drug is capable of reducing risk.

In an interview Thursday, Harper pointed to additional evidence from the study - adjusted for what he calls a "treatment lag" - showing Repatha reduced the risk of heart attack and stroke by 33%. But it's still unclear whether these drugs-which attempt to mimic a beneficial genetic mutation-will be the breakthrough that scientists and pharmaceutical companies had imagined.

Now, payers no longer have that excuse.

A medication that takes a new approach to lowering cholesterol - and that was developed in part thanks to a key Canadian discovery - appears to cut the risk of a heart attack and other heart events by as much as 20 per cent, a large new study has found. "But if the drug performs as we expect, they will not". "The open question was, 'Does this way of lowering [cholesterol] reduce risk of coronary heart disease, '" says Sekar Kathiresan, a cardiologist at the Massachusetts General Hospital in Boston and the Broad Institute in Cambridge, Massachusetts, who was not involved in the study. Some cardiologists and researchers had anxious that very low LDL might have deleterious effects, just as excessively low blood pressure can.

The randomized trial involved 27,564 people who had experienced a prior heart attack or stroke, or who had significantly clogged arteries that limited blood flow to their limbs.

"The idea is that the lower you can get your cholesterol, the better".

There have been claims by insurance companies that the drug is not particularly beneficial to those suffering from high cholesterol.

The FOURIER study evaluated whether treatment with Repatha in combination with statin therapy compared to placebo plus statin therapy reduced cardiovascular events.

At baseline, the average LDL was 92 mg/d, but after 48 weeks the median was just 30 mg/d (P 0.001).

The drug is expected to show even greater reductions as it is taken for a longer time, but even the five-year projected numbers showed a cost of more than a million dollars to prevent one heart attack or other cardiac event.

The research has also shown a 15 percent decrease in cases of hospitalization due to unbalanced angina, heart attacks, revascularization, cardiovascular death and strokes. Injection site reactions were "rare" in both arms of the study, but slightly higher with Repatha patients, Levy said.

PCSK9 inhibitors and statins start lowering LDL cholesterol nearly right away, but the beneficial effects on harder outcomes like heart attack and stroke take longer to emerge in clinical studies. For that reason, Sabatine said the P values for outcomes should be considered "exploratory". Beyond trial design issues, MDCO also noted that the LDL reduction seen with Repatha diminished over time, from 61% to 54%.

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.

"The groundbreaking results from ORION-1 are compelling and affirm inclisiran's unique and highly-differentiated attributes, and its game-changing potential to address the unmet needs of millions of at-risk, often non-adherent, patients worldwide who continue to struggle with high cholesterol given the limitations of available therapies", said Clive Meanwell, MD, PhD, CEO at the Medicines Company. Blood pressure has to be treated to a "normal range", not too high or low, while smoking is toxic and should be stopped altogether. We have to see how patients respond, how practitioners respond, how insurers respond. "This trial proves that it's a poison, like tobacco".

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