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FDA approves new statin

Pitavastatin joins a growing family of drugs approved for lowering cholesterol.

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A new statin designed to treat high cholesterol in patients with elevated or abnormal cholesterol levels has received approval from the FDA.

Pitavastatin (Livalo, Kowa Pharmaceuticals), a HMG-CoA reductase inhibitor, was approved as a primary treatment for hypercholesterolemia and combined dyslipidemia. According to the manufacturer, pitavastatin has a unique cyclopropyl group on its base structure, giving it the potential for greater LDL clearance and the reduction of plasma cholesterol. The manufacturer also said that pitavastatin is only minimally metabolized by the liver through the cytochrome P450 pathway. Read a recent Cardiology Today article about pitavastatin here.

“Elevated or abnormal cholesterol levels are associated with an increased risk for heart disease and stroke,” Eric C. Colman, MD, deputy director of the division of metabolism and endocrinology products in the FDA’s Center for Drug Evaluation and research, said in a press release. “Today’s approval offers patients and their health care professionals another alternative way to treat high cholesterol.”

Pitavastatin, according to a press release, effectively reduced LDL levels and improved lipid metabolism parameters in elderly patient populations, in patients with diabetes and in patients at high CV risk in phase III trials. Pitavastatin has been used in Japan, South Korea, Thailand and China to treat primary hypercholesterolemia and combined dyslipidemia, and was frequently prescribed as first-line therapy to many elderly patients, to patients with diabetes and to patients with concurrent disease or those taking concomitant medications. The drug will be available in 1 mg, 2 mg and 4 mg doses. – by Eric Raible

It will be interesting to see if this new statin has any advantages in terms of tolerability as compared with the tried and true ones that we already have. It will also be interesting to see if it raises HDL more than the other statins do. It is promising that it is only minimally metabolized through the cytochrome P450 pathway. This also applies to rosuvastatin and pravastatin.

– Roger S. Blumenthal, MD

Cardiology Today Section Editor