By Pamela Bond

Victoria Advocate

Jan. 27, 2008

A Victoria cardiologist participating in the international study of a new drug was the first in the world to induct a patient into the trial last month.

The Borealis study is testing Idraparinux, a substitute for the blood thinner Coumadin. The study, which spans about 800 centers in at least
 countries, started early December and Dr. Harish Chandna inducted the first subject on Dec. 14.

Coumadin, an oral drug taken daily by most patients for the rest of their lives, has interactions with some green vegetables and other food products, Chandna said. Each patient requires a specific dosage, where one person might require one milligram and another 10 milligrams.

“If they take too much, they bleed, and if they don’t take enough it doesn’t do anything and they can have a stroke,” Chandna said.

With Idraparinux, however, everyone requires the same dosage and it does not have the same adverse reactions with foods like Coumadin, Chandna said. Idraparinux is also administered weekly, instead of daily, as an injection into the stomach, such as with insulin shots. Patients can
learn to give themselves the injection into the folds of skin.

“There’s one problem,” Chandna said. “If the drug stays in the system for a week and they start bleeding, it could be dangerous.”

To counteract that situation, an antidote for Idraparinux, called Avidin, is also included in the trial. Patients with atrial fibrillation, which is a common heart rhythm problem, are eligible for the study. About 5 percent of patients over 65 and 10 to 15 percent of patients over 75 have it, Chandna said.

There are strict restrictions in areas such as kidney function to participate, but the trial is looking for high-risk patients, such as those who also have congestive heart failure, hypertension or diabetes.

“The patients that will benefit the most are those with the highest risk,” Chandna said.

The trial study will probably last 12 to 18 months with a six-month follow-up period. Dolores Holly, the primary coordinator for research at the office of Chandna and his colleagues, Drs. Ajay Gaalla and Dakshesh Parikh, said a trial drug can receive Food and Drug Administration approval and become available to the public about two years after a trial ends.

If Idraparinux is approved, anyone taking Coumadin, such as those with valve replacements and not just Atrial Fibrillation, would be eligible for the new drug.