Researchers of Sankyo's failed Pactimibe say it was not only ineffective, but promoted coronary artery disease

By E. Janene Geiss

Philadelphia, Nov. 15 - Researchers of Sankyo Co., Ltd.'s Pactimibe, the first plaque deterring cardiovascular drug to reach phase 3 trials, said they have found that the drug was not only ineffective in reducing the progression of coronary artery disease, but in some cases even promoted it.

The study, led by Steven E. Nissen, medical director of the Cardiovascular Coordinating Center at The Cleveland Clinic, was presented Tuesday at the American Heart Association's Scientific Sessions, according to a news release.

Researchers had hoped this drug would mark the first new approach to treating coronary artery disease since the introduction of statins, a class of drugs that blocks the production of cholesterol in the liver.

Researchers have recently focused on the effectiveness of acyl-coenzyme A:cholesterol O-acyltransferase (ACAT) inhibitors, a new class of drugs intended to slow or reduce the plaque buildup in the artery walls. While statins inhibit cholesterol production in the liver, they are unable to protect at least two thirds of patients from cardiovascular events, researchers said.

Sankyo, the maker of Pactimibe, announced Oct. 26 that it would discontinue all of its ongoing clinical studies after it failed to meet the primary endpoint in the coronary intravascular ultrasound study, according to an Oct. 26 Sankyo news release.

The randomized, controlled study led by Nissen included 354 men and women with established coronary disease at 52 U.S. medical centers. To determine the effectiveness of the drug, Nissen measured the change in the plaque buildup in the artery walls using intravascular ultrasound. In this procedure, an ultrasound probe is attached to a catheter and threaded into the artery. The probe is then drawn back and a series of images of the artery walls is created. Researchers can then measure the thickness of the artery walls.

"We did show the ability of IVUS to discriminate between effective and ineffective therapies. This is an important conclusion as we continue to work to develop new therapies for patients with this disease," Nissen said in the release.

Sankyo Co., Ltd. of Tokyo, one of Japan's largest pharmaceutical companies, is a wholly-owned company of Daiichi Sankyo Co., Ltd. Its product pipeline focuses on cardiovascular disease, metabolic disease, respiratory and immune diseases, bone and joint diseases and oncology.

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