Eliquis Study to Evaluate Safety Vs Warfarin For Patients With Acute Coronary Syndrome

A new clinical trial has been launched to test the safety and effectiveness of the controversial blood thinner Eliquis for the treatment of heart attacks, angina and similar acute coronary syndromes. 

Bristol-Myers Squibb issued a press release last week, announcing that it has begun enrolling patients in Phase 4 of the AUGUSTUS clinical trial to evaluate Eliquis as a treatment for patients with recent acute coronary syndrome or who are receiving a coronary stent. The clinical trial will use the safety and effectiveness of warfarin, an older blood thinner, as a comparison.

The study is being conducted by researchers with the Duke Clinical Research Institute (DCRI) and will be a two-by-two factorial, randomized controlled trial. Patients will be given either aspirin or a placebo, either Eliquis or warfarin, and all wil lreceive a P2Y12 inhibitor, like Plavix.

The study ultimately seeks to include about 4,600 eligible subjects from 30 countries. In addition to testing for usefulness in treating heart attacks and unstable angina, the study will also test for the combination of aspirin with Eliquis and its effects on patient bleeding rates.

Eliquis Bleeding Concerns

Eliquis is part of a new class of novel oral anticoagulants introduced in recent years for the prevention of strokes among individuals with atrial fibrillation. While the new treatments have become widely popular, since they are generally easier to use than warfarin, concerns have emerged about the bleeding risks, since the novel oral anticoagulants currently lack an approved antidote that can be used to reverse the blood thinning effects of the medications in an emergency.

Pradaxa (dabigatran) was the first member of this class to hit the market in late 2010, followed by Xarelto (rivaroxoaban) in 2011 and Eliquis (apixaban) in 2012.

The medications are promoted as superior alternatives to Coumadin (warfarin), indicating that they are easier to use since patients do not require the same level of blood monitoring. However, while users of warfarin can be given an antidote to stop bleeding problems, no such reversal agent is available for Pradaxa, Xarelto or Eliquis. As a result, many severe and often fatal injuries have been linked to uncontrollable bleeding on the drugs.

Thousands of Pradaxa lawsuits, Xarelto lawsuits and Eliquis lawsuits have been filed in recent years, alleging that the drug makers failed to adequately warn about the bleeding risk and the lack of an effective reversal agent.

Following several years of litigation over Pradaxa, which was the first medication of the class to hit the market, Boehringer Ingelheim agreed to pay about $650 million in Pradaxa settlements in May 2014, with an average of about $150,000 awarded to former users who experienced bleeding side effects. However, additional cases continue to be filed by individuals who have suffered injuries since the date of the settlement.

There are currently more than 1,200 lawsuits pending throughout the federal court system over Xarelto bleeding injuries, which are currently centralized for pretrial proceedings as part of an MDL, or multidistrict litigation. Unless Xarelto settlements are reached to resolve the litigation, the first trials are expected to begin by August 2016.

In recent months, a growing number of claims have been filed by users of Eliquis, raising nearly identical allegations to those brought against the makers of Xarelto and Pradaxa, alleging that users may have avoided uncontrollable bleeding information if adequate warnings had been provided for users and the medical community.