People taking an experimental drug called Repatha (evolocumab) for high cholesterol were half as likely to die or suffer a heart attack or stroke as those taking conventional statins
New type of cholesterol-lowering drug 'halves the risk of a heart attack or stroke', study reveals
A new type of cholesterol-lowering drug may halve the risk of a heart attack or stroke, new research suggests.People taking the experimental drug for high cholesterol were half as likely to die or suffer a heart attack or stroke as those taking conventional statins.
- New class of drug could help those unable to tolerate regular statins
- Drug used in the trial, evolocumab, works differently to the type currently prescribed, such as Lipitor
- It blocks a harmful protein in the liver, freeing the organ up to remove 'bad' LDL cholesterol from the blood
- US Government to decide in summer whether to approve this type of drug
A new type of cholesterol-lowering drug may halve the risk of a heart attack or stroke, new research suggests.People taking the experimental drug for high cholesterol were half as likely to die or suffer a heart attack or stroke as those taking conventional statins.
The results could offer an alternative to the estimated one in three Westerners with high cholesterol who have been unable to manage their condition with diet, exercise and statin drugs currently on the market.
The results are 'really impressive and very encouraging' for the new drugs, said one independent expert, Dr Judith Hochman of NYU Langone Medical Center.The U.S. government will decide this summer whether to allow two of these drugs on the market.
The drugs are evolocumab, which Amgen wants to call Repatha, and alirocumab, which Regeneron Pharmaceuticals and Sanofi have named Praluent.
They lower LDL or bad cholesterol more powerfully and in a different way than existing drugs, by blocking PCSK9, a substance that interferes with the liver's ability to remove cholesterol from the blood.Side effects remain a question, though, especially on thinking, confusion and memory - problems the FDA has already voiced concern about and asked the companies to track.
The results are 'really impressive and very encouraging' for the new drugs, said one independent expert, Dr Judith Hochman of NYU Langone Medical Center.The U.S. government will decide this summer whether to allow two of these drugs on the market.
The drugs are evolocumab, which Amgen wants to call Repatha, and alirocumab, which Regeneron Pharmaceuticals and Sanofi have named Praluent.
They lower LDL or bad cholesterol more powerfully and in a different way than existing drugs, by blocking PCSK9, a substance that interferes with the liver's ability to remove cholesterol from the blood.Side effects remain a question, though, especially on thinking, confusion and memory - problems the FDA has already voiced concern about and asked the companies to track.
The problems affected only 1 or 2 percent of patients and may be temporary, but they were twice as common among people taking one of the new drugs and need to be closely monitored as studies continue, said Dr. Anthony DeMaria, a University of California at San Diego heart specialist and past president of the American College of Cardiology.
As a patient facing potential side effects, 'the last one I want' is one that affects the brain, he said.
HOW DO THE DRUGS WORK?
Evolocumab works differently than traditional statins.
It is a human monoclonal antibody that blocks a harmful protein in the liver, freeing the organ up to remove 'bad' LDL cholesterol from the blood.
This new class of drug is known as a PCSK9 inhibitor, and three different kinds, including evolocumab, are being studied in large clinical trials.
Previous research has shown evolocumab could lower LDL or 'bad' cholesterol - the kind that contributes to plaque buildup in the arteries - by 61 percent.The findings were based on 4,465 patients who were studied for one year after completing an earlier phase of the drug's safety and efficacy testing.
Patients were selected at random to receive either receive evolocumab, made by the pharmaceutical company Amgen, injected under the skin in addition to standard care.
As a patient facing potential side effects, 'the last one I want' is one that affects the brain, he said.
HOW DO THE DRUGS WORK?
Evolocumab works differently than traditional statins.
It is a human monoclonal antibody that blocks a harmful protein in the liver, freeing the organ up to remove 'bad' LDL cholesterol from the blood.
This new class of drug is known as a PCSK9 inhibitor, and three different kinds, including evolocumab, are being studied in large clinical trials.
Previous research has shown evolocumab could lower LDL or 'bad' cholesterol - the kind that contributes to plaque buildup in the arteries - by 61 percent.The findings were based on 4,465 patients who were studied for one year after completing an earlier phase of the drug's safety and efficacy testing.
Patients were selected at random to receive either receive evolocumab, made by the pharmaceutical company Amgen, injected under the skin in addition to standard care.
Or, they received standard care alone, which meant taking the cholesterol-lowering statin drug recommended by their physician.
The drug has yet to be approved by the US Food and Drug Administration, and more years of study are planned to test its longer term outcomes.
The drug has yet to be approved by the US Food and Drug Administration, and more years of study are planned to test its longer term outcomes.
But after one year, the analysis showed the rate of cardiovascular events - such as death, heart attack, stroke, hospitalisation or surgery to open blocked arteries - in the evolocumab group was 0.95 percent.
This was compared to 2.18 percent in the traditional statin group, most of whom were taking moderate or high intensity regimens of the cholesterol-lowering drugs.
+2High cholesterol is a major risk factor for heart disease, the leading killer worldwide. Yet one in three Westerners are unable to manage their condition with diet, exercise and statin drugs currently on the market
'The reduction in LDL was profound and that may be why we saw a marked reduction in cardiovascular events so quickly,' said lead author Marc Sabatine, senior physician in the Division of Cardiovascular Medicine at Brigham and Women's Hospital in Boston.
'It suggests that if we can drive a patient's LDL cholesterol down a large amount to a very low level, we may start to see a benefit sooner than would be expected with a more modest intervention.'
High cholesterol is a major risk factor for heart disease, the leading killer worldwide.
This was compared to 2.18 percent in the traditional statin group, most of whom were taking moderate or high intensity regimens of the cholesterol-lowering drugs.
+2High cholesterol is a major risk factor for heart disease, the leading killer worldwide. Yet one in three Westerners are unable to manage their condition with diet, exercise and statin drugs currently on the market
'The reduction in LDL was profound and that may be why we saw a marked reduction in cardiovascular events so quickly,' said lead author Marc Sabatine, senior physician in the Division of Cardiovascular Medicine at Brigham and Women's Hospital in Boston.
'It suggests that if we can drive a patient's LDL cholesterol down a large amount to a very low level, we may start to see a benefit sooner than would be expected with a more modest intervention.'
High cholesterol is a major risk factor for heart disease, the leading killer worldwide.
The study, which was funded by the drugmaker, Amgen, showed few cardiovascular events among both groups - just 60 in total, so more data from a long-term study of 27,000 people expected in 2017 should shed more light on the drug's effectiveness.
The FDA may decide to make the treatment available after an expected review of the data later this year.
'We won't have any definitive answers until this larger trial we are doing is complete, but these data now give us a sense for the potential clinical benefit of these drugs,' Sabatine said.
The results were presented at the American College of Cardiology annual conference in San Diego, California, and published simultaneously in the New England Journal of Medicine.source.www.dailymail.co.uk
'We won't have any definitive answers until this larger trial we are doing is complete, but these data now give us a sense for the potential clinical benefit of these drugs,' Sabatine said.
The results were presented at the American College of Cardiology annual conference in San Diego, California, and published simultaneously in the New England Journal of Medicine.source.www.dailymail.co.uk
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