Drugs/Therapy

One-Year Study Finds Amgen’s Drug Effective in Reducing LDL Cholesterol

By Cheri Cheng | Update Date: Nov 20, 2013 09:02 AM EST

High cholesterol is a chronic health condition that can lead to several other problems, such as cardiovascular disease. People with high cholesterol are often prescribed medications. Even though these pills are effective in lowering cholesterol, they do not work for every one, which is why drug-manufacturing companies work hard to create better options. Amgen Inc.'s latest drug called evolocumab was created to treat cholesterol. After a one-year study, results have revealed that the drug reduced low-density lipoprotein (LDL) cholesterol, which is also understood to be "bad" cholesterol, by 52 percent.

Evolocumab is a part of a new class of drugs known as PCSK9 inhibitors. These drugs work by blocking the function of a protein that prevents the liver from getting rid of LDL cholesterol from the blood. The clinical trial, known as the Osler study, lasted 52 weeks and involved 1,104 patients. The patients had received an injection of 420 milligrams of evolocumab once a month. The patients were also given standard care with statins and other medicines while others only received standard care alone.

The researchers calculated that after week 52, the participants' LDL levels reduced by 52 percent when used with statins. Aside form bad cholesterol, evolocumab helped reduced the levels of triglycerides by nine percent. The levels of good cholesterol, properly known as high-density lipoprotein (HDL) cholesterol, increased by nine percent.

 "The results from the Osler study are encouraging as evolocumab may offer a potential treatment option for patients who cannot control their cholesterol levels," Dr. Michael Koren, the lead researchers of the study, said according to Reuters Health.

The researchers reported that serious adverse side effects from receiving the injection of evolocumab occurred in 7.1 percent of the people who took statins and other medicines. 6.3 percent of the people who received only standard care suffered similar side effects as well. Some of the side effects include elevated liver enzymes and elevated kidney problems.

"It did wonderfully. This gives us a much greater comfort level about possible safety signals," Koren expressed. "There's tremendous excitement. This is the biggest thing to happen to lipid treatment since statins."

The results of the study are very promising. If this class of drugs continues to yield positive results with limited consequences, the U.S. Food and Drug Administration (FDA) could approve PCSK9 drugs in the near future. The study's findings were presented at the American Heart Association (AHA) scientific meeting in Dallas, TX.

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