The treatments were approved only for specific groups - those with a genetic condition which means they have dangerously high cholesterol, and people with heart disease who can not cope with the side effects of statins. But researchers didn't have evidence then that the drug could also protect against heart attacks or strokes.
"So we expect that this drug also will be embraced by the medical community" and incorporated into clinical guidelines, Levy said.
Those earlier trials were with statins, drugs that even when they were on-patent were much less expensive than evolocumab, which has an estimated annual cost of $15,000 per patient. 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.
The Fourier trial was the first PCSK9 outcomes study to wrap up-a similar trial of Sanofi and Regeneron's rival drug Praluent is due to finish at the end of this year-and, perhaps more importantly to the broader field of CV research, the first outcomes trial to test the power and safety of lowering LDL to previously unheard-of levels. All of them were already receiving statin therapy. Patients were given different doses of inclisiran or placebo via subcutaneous injection, either via a single dose, or via a dose on day one and another at three months. They followed-up these people for two years, from 2013 to 2015. Those who are at risks reduce their LDL under 70.
After a median of 2.2 years of treatment, 1,344 (or 9.8 percent) of the patients treated with a combination of statins and evolocumab suffered heart attacks, strokes, cardiovascular deaths, or were hospitalized for unstable angina or bypass surgery.
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The results of a new study show that, when added to statin therapy, evolocumab reduced LDL cholesterol levels by 59% from baseline levels compared with placebo.
Amgen, though, claims that Repatha is worth the price and its value has been proven conclusively with the study.
Dr Marc Sabatine, from Brigham and Women's Hospital in MA and lead researcher on the study, will present the findings today (17th March) at the American College of Cardiology's (ACC) 66th Annual Scientific Session in Washington. And how will it change management of patients with cardiovascular disease? Like statins, which were introduced in the 1980s, the new class of drugs has the potential to improve the health and longevity of millions of Americans with heart disease, the nation's leading killer, accounting for 1 in 4 deaths. The result? Sales of Repatha came in at $141 million previous year and Praluent made around $112 million, well shy of initial expectations. JP Morgan's view is that, given the data and the current payer environment, physicians will choose to reserve treatment for patients with multiple comorbidities and relatively higher LDLs than the cutoff for FOURIER ( 70mg/dL). Only those diagnosed with a genetic condition that makes them have high cholesterol levels and those who cannot deal with statins' side effects can be treated with Repatha injections.
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. Since PCSK9 is a protease that breaks down the LDL receptor, itself the major clearance mechanism for cholesterol from the blood, blocking PCSK9 increases the level of LDL receptor and therefore dramatically reduces circulating cholesterol, and in particular the triglyceride-rich lipoproteins, such as LDL, that are implicated in causing cardiovascular disease.
According to the Centers for Disease Control and Prevention, around 610,000 people die each year in the United States as a effect of heart disease. It also blocks the capacity of the PCSK9, so there is a high number of receptors to break up cholesterol LDL.