New cholesterol drug lowers LDL when statins aren't enough, study finds
A new medication that combines an already approved drug with a new unapproved one has been shown to cut the level of LDL, or 'bad' cholestero l, when statins aren't helping enough.
In the Phase 3 trial, Cleveland Clinic researchers found that the combination of the new drug, obicetrapib, with an established medication, ezetimibe, reduced low-density lipoprotein (LDL) cholesterol levels by 48.6% after about three months' use — producing more effective results than either drug alone. Ezetimibe is a cholesterol-lowering drug that is often prescribed with statins to reduce LDL even more.
The research was presented Wednesday during a late-breaking science 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 lead researcher, Dr. Ashish Sarraju, a preventive cardiologist at the Cleveland Clinic, and his colleagues enrolled 407 patients with a median age of 68 with LDL cholesterol levels greater than 70 mg/dL even though they had taken medication to lower it.
The participants were randomly assigned to four groups: a group for a pill that combined obicetrapib with ezetimibe, a group for each of the drugs separately and a placebo group. All participants continued on the medications they were taking before they started the trial, along with the medications being studied.
The reason: Some people have to take a number of prescriptions to get LDL down to desired levels.
'We need to give patients and their doctors all the options we can to try to get LDL under control if they are at risk for, or already have, cardiovascular disease,' Sarraju said. 'In higher-risk patients, you want to get LDL down as quickly as possible and keep it there as long as possible.'
High-risk patients either had had strokes or heart attacks or were likely to in the future.
For that reason, the researchers enrolled patients in the trial who, despite already being on statins or even high-intensity statins, still had LDL levels that were too high.
The hope is that lowering LDL levels will reduce the risk of adverse cardiovascular events such as strokes and heart attacks. According to the American Heart Association, the optimal total cholesterol level for an adult is about 150 mg/dL, with LDL levels at or below 100 mg/dL ('dL' is short for 'deciliter,' or a tenth of a liter). For high-risk patients, Sarraju recommends an LDL no higher than 70 mg/dL.
The trial was funded by the maker of obcetrapib, Netherlands-based NewAmsterdam Pharma. It expects to have conversations with the Food and Drug Administration about approval for the new combo drug 'over the course of the year,' a spokesperson said.
A multitude of modifiable factors can result in high LDL, such as a diet high in saturated fats, processed foods and fried foods; being overweight; smoking; and older age.
Dr. Robert Rosenson, director of lipids and metabolism for the Mount Sinai Health System in New York City, said other drugs in the same class have failed to reduce heart attacks or stroke, 'but I am cautiously hopeful.'
The drugmaker is currently running an additional trial to determine if the combo drug not only lowers cholesterol but also protects against adverse heart events.
While lifestyle changes can help bring down LDL, 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, a cardiologist at the Columbia University Vagelos College of Physicians and Surgeons.
Heart disease is the leading cause of death for adults in the United States.
'High LDL is one of the leading risk factors for heart disease, and we have such a poor handle on controlling that risk,' Bradley said. 'Many people have such a high LDL they will require multiple agents to control it.'
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