Pharmaceutical Business review

Sciele completes enrollment in pivotal study for dyslipidemia treatment

Mixed dyslipidemia is the presence of elevated levels of bad cholesterol, low-density lipoproteins and triglycerides, and low levels of good cholesterol, high-density lipoproteins in the blood.

The Phase III clinical trial is being conducted at approximately 75 sites in the US. This study compares the combination of pravastatin and fenofibrate to pravastatin alone and fenofibrate alone.

Larry Dillaha, executive vice president and chief medical officer, Sciele Pharma, said: “We are excited about completing the patient enrollment of this Phase III trial using the combination of fenofibrate and pravastatin. Pravastatin is a well-recognized statin that has been used worldwide for the treatment of dyslipidemias.

“A growing number of patients suffer from mixed dyslipidemia, and many of these patients are being treated with the combination of a statin and a fenofibrate. We believe this new combination product is an excellent strategic fit for our cardio-metabolic product portfolio.”