Clinical Trial Examines Therapy for High Cholesterol

cholesterolCINCINNATI—If left untreated, high cholesterol, whether genetically inherited or the result of an unhealthy lifestyle, could lead to heart attack or stroke.

This becomes even more relevant in patients who experience a heart attack and need to prevent a second one from occurring.

Mouhamad Abdallah, MD, assistant professor in the division of cardiovascular diseases and UC Health interventional cardiologist, says that keeping high cholesterol controlled is important but that sometimes conventional therapies are not effective in certain patients.

A clinical trial, led by Abdallah, is looking at a medication that could be an alternative for controlling cholesterol in patients who survived recent heart attacks.

“Cholesterol is a waxy substance that’s found in the fats, or lipids, in your blood,” he says. “While your body needs cholesterol to continue building healthy cells, having high cholesterol can increase your risk of heart disease.

“When you have high cholesterol, you may develop fatty deposits in your blood vessels, making it difficult for enough blood to flow through your arteries which could eventually deprive your heart and brain of oxygen and cause a heart attack or stroke.”

Abdallah says medications like statins and niacin are traditionally used to lower cholesterol levels, but some patients do not respond to these medications or cannot tolerate them; additionally, side effects of these drugs can include muscle pain, flushing and in extreme cases severe muscle damage.

“Traditional medications lower cholesterol by 25 to 40 percent,” he adds. “This clinical trial, called the Odyssey outcomes trial, is looking at a medication—Alirocumab or PCSK antibody—that could reduce bad cholesterol levels to as much as 70 to 80 percent, as seen in preliminary studies.

“This study will only enroll patients who suffered from a heart attack within the past three months and who fail to lower cholesterol levels with conventional therapy or in patients who have serious side effects with conventional therapy.”

Abdallah says that PCSK is an enzyme that is thought to “devour cholesterol receptors” and that “the antibody neutralizes these enzymes, therefore leading to persistent reduction in cholesterol levels.”

The PCSK antibody or a placebo (the study is double blind, meaning neither patient nor researcher will know which is being administered) will be delivered to participants twice monthly via injection for 64 months with seven years of follow-up.

Abdallah says this could lead to an alternative therapy for patients who are difficult to treat.

“However, everyone should be aware of their risks for high cholesterol, and if possible, do whatever is necessary to lower those risks, including smoking cessation, a healthy diet and plenty of exercise,” he says. “If high cholesterol runs in your family, be aware of this, and take the proper precautions to avoid health complications and maintain the best quality of life.”

Sanofi U.S. is sponsoring the trial. Abdallah cites no conflict of interest.

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