A new cholesterol medication reduces LDL levels when the statins are not sufficient, the results of the study
It has been shown that a new medication that combines an already approved medication with a new unprecedented reduces the level of LDL, or “bad” cholesterol, when the statins do not help enough.
In phase 3 trial, Cleveland Clinic researchers found that the combination of the new medication, the Obitetrapib, with an established medication, Ezetimibe, reduced the levels of low density lipoprotein cholesterol (LDL) of 48.6% after about three months of use – producing more effective results than one or the other medicine alone. Ezetimibe is a hypocholesterolic drug which is often prescribed with statins to further reduce LDL.
The research was presented Wednesday during a late scientific session at the annual meeting of the European atherosclerosis Society in Glasgow, Scotland, and simultaneously published in The Lancet.
In the multicenter clinical trial, the main researcher, Dr. Ashish Sarraju, preventive cardiologist at the Cleveland Clinic, and his colleagues scored 407 patients with a 68 -year -old median age with LDL cholesterol levels greater than 70 mg / DL even if they had taken drugs to reduce it.
Participants were randomly assigned to four groups: a group for a pill combining the Ouvetrapib with Ezetimibe, a group for each of the drugs separately and a placebo group. All the participants continued the drugs they took before starting the test, as well as the drugs studied.
The reason: some people must take a number of prescriptions to obtain LDLs at the desired levels.
“We need to give patients and their doctors all the options we can try to control LDL if they are at risk or already have cardiovascular disease,” said Sarraju. “In patients at higher risks, you want to lower LDL as quickly as possible and keep it as long as possible.”
High -risk patients had brain vascular accidents or heart attacks or were likely to do so in the future.
For this reason, the researchers have registered patients for trial which, despite already statins or even high intensity statins, always had too high levels of LDL.
Hope is that the drop in LDL levels will reduce the risk of unwanted cardiovascular events such as cerebral vascular accidents and heart attacks. According to the American Heart Association, the optimal rate of total cholesterol for an adult is around 150 mg / dl, with LDL levels or less than 100 mg / dl (“DL” is short to “decilitate”, or a tenth of liter). For high -risk patients, Sarraju recommends an LDL not above 70 mg / dl.
The trial was funded by the manufacturer of Obcetrapib, based in the Netherlands, Newamsterdam Pharma. He plans to have conversations with the Food and Drug Administration on the approval of the new combo drug “during the year,” said a spokesperson.
A multitude of modifiable factors can cause high LDL, such as a diet rich in saturated fats, processed foods and fried foods; be overweight; smoking; and a more advanced age.
Dr. Robert Rosenson, director of lipids and metabolism of the Mount Sinai health system in New York, said that other drugs in the same class had failed to reduce heart attacks or strokes, “but I hopefully.”
The drug manufacturer is currently organizing an additional test to determine whether the combo drug not only lowers cholesterol, but also protects against unfavorable heart events.
Although lifestyle changes can help reduce LDL, the levels remain stubbornly high for some people. Only 20% of patients at high risk of heart disease are able to manage their LDL, said Dr. Corey Bradley, cardiologist at Columbia University Vacelos College of Physicians and Surgeons.
Heart disease is the main cause of death for adults in the United States.
“High LDLs are one of the main risk factors for heart disease, and we have such a bad design on the control of this risk,” said Bradley. “Many people have such a high LDL that they will need several agents to control it.”
“I am very enthusiastic about drugs like Obitrapib,” she said.
