URI pharmacy researcher seeks participants for Lipitor metabolism study in patients with diabetes

KINGSTON, R.I. – December 1, 2009 – A researcher in the University of Rhode Island’s College of Pharmacy is seeking subjects for a study focusing on the metabolism and side effects of Lipitor™ on patients with diabetes.

Fatemeh Akhlaghi, URI associate professor of biomedical and pharmaceutical sciences, has a $200,000 American Heart Association grant to examine the effects of Lipitor, also known by the generic name of atorvastatin, on 50 patients with diabetes and 50 without the disease.

Study subjects must be 18 to 65 years old, taking Lipitor, and be willing to have their blood drawn at URI Health Services or a South County Hospital laboratory at the South Kingstown Office Park on Salt Pond Road. Each participant will receive $40 compensation.

Akhlaghi said initial lab studies suggest that patients with diabetes are less able to metabolize Lipitor, which can lead to severe muscle pain.

Lipitor is the most frequently prescribed drug to treat high cholesterol, but its effects on diabetic patients have never been studied. Non-diabetic individuals on Lipitor are needed as a control group for the study.

Up to 7 percent of patients treated with statins, drugs that treat high cholesterol, exhibit symptoms of muscle toxicity and 0.5 percent develop potentially fatal severe muscle breakdown, according to Akhlaghi.

Epidemiological evidence suggests that the incidence of severe muscle breakdown requiring hospitalization is three times higher in patients with diabetes, she said.

She will be examining the effect of diabetes on Lipitor in association with the drug-metabolizing enzyme, cytochrome P450 3A. Her central hypothesis is that changes in the enzyme lead to elevated concentrations of the toxic lactone metabolite.

The researcher’s preliminary data on elevated concentrations of lactone in diabetics is unique and warrants further investigation so Lipitor dosing can be individualized to the specific need of each diabetic patient.

When patients now develop severe muscle pain, the remedy is frequently to take them off Lipitor even though they are at risk for heart attack or stroke. Akhlaghi hopes the research leads to more precise dosing so that such a side effect is minimized.

“This (muscle pain) problem is severe in 0.3 percent of patients with diabetes, and 20 percent of diabetics report mild muscle discomfort,” Akhlaghi said.

To participate in the study, please contact Akhlaghi at 401-874-2899 or through email, diabetesstudy@etal.uri.edu. The study coordinator is Joyce Macwan, a doctoral student in the College of Pharmacy. After contacting the research team by phone or email, the subjects will be asked to visit one of the labs between 8 and 11 a.m. on a mutually convenient day where blood and urine samples will be collected. Study subjects will then be asked to complete a short questionnaire on the use of medications other than Lipitor.

Akhlaghi said she is grateful for the participation of South County Hospital and URI Health Services. “Without their support, we would be unable to proceed with this study in a timely and efficient manner,” Akhlaghi said.