Clinical trial at UTMC paves way for FDA-approved drug

January 7, 2016 | News, Research, UTMC
By Brandi Barhite



The University of Toledo Medical Center is participating in a clinical study with a cholesterol medication that has been approved by the FDA.

The evolocumab injection, also known by the name brand Repatha-Amgen, is for patients who cannot get their LDL cholesterol low enough with other treatment options. It works best when combined with a healthy diet and statin therapy.

Sheikh

Sheikh

“The evolocumab injection is an effective drug for patients who have very high cholesterol, but statins, such as Lipitor, and following a healthy diet aren’t working for them,” said Dr. Mujeeb Sheikh, assistant professor in the Department of Medicine and principal investigator for the clinical trial. “Cholesterol is a big problem for many patients. It is the root cause for coronary disease. If we can reduce cholesterol, patients are less likely to need stents and other medical procedures.”

The nationwide 18-month clinical trial, which ends in December, includes patients from UTMC who have not been able to reduce their cholesterol with traditional treatment options. Once the double-blind study is complete, they will receive the medication free of cost.

“This is a powerful drug that can reduce cholesterol by 50 or 60 points by simply giving yourself three injections per months,” Sheikh said. “This is a game-changer. I plan to prescribe it to my patients.”

Dr. John Jenkins, director of the FDA’s Office of New Drugs, Center for Drug Evaluation and Research, said in a written statement that “Cardiovascular disease is a serious threat to the health of Americans, and the FDA is committed to facilitating the development and approval of effective and safe drugs to address this important public health problem.”

Sheikh is glad that UTMC can offer people the opportunity to participate in clinical trials. In addition to free medication, they can contribute to the growth of science.

“We are conducting a lot of research at UTMC, and patients can benefit from these cutting-edge developments,” Sheikh said. “We are proud to be a part of important experimental therapies that can improve health care in our city, in our region and even nationwide.”