CardioExchange Archive

June 22nd, 2011

Apixaban (Eliquis) Meets Primary Endpoint in ARISTOTLE

Larry Husten, PHD

Pfizer and Bristol-Myers Squibb said that their new oral direct Factor Xa drug apixaban, which will be marketed under the brand name of Eliquis, had met the primary endpoint of the ARISTOTLE study. The Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation (ARISTOTLE) study was designed to compare the factor Xa inhibitor apixaban with […]

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February 10th, 2011

Apixaban Better Than Aspirin for Stroke Prevention in AF Patients Unable to Take Warfarin

Larry Husten, PHD

A new trial presented at the American Stroke Association’s International Stroke Conference and published online in the New England Journal of Medicine demonstrates that the novel factor Xa inhibitor apixaban is better than aspirin for the prevention of stroke in AF patients who are unable to take warfarin. Stuart Connolly and investigators in the AVERROES (Apixaban […]

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December 22nd, 2010

Apixaban Beats Enoxaparin for Thromboprophylaxis After Hip Replacement

Larry Husten, PHD

In the ADVANCE-3 trial 5,407 hip replacement patients were randomized to receive thromboprophylaxis with either the new oral factor Xa inhibitor apixaban or enoxaparin. The rate of DVT, nonfatal PE, or death from any cause was 1.4% in the apixaban group compared to 3.9% in the enoxaparin group (RR 0.36, CI 0.22-0.54, P<0.001), thereby demonstrating […]

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November 18th, 2010

APPRAISE-2 Apixaban in ACS Study Discontinued Due to Increased Bleeding

Larry Husten, PHD

Bristol-Myers Squibb announced on Thursday evening the discontinuation of APPRAISE-2, the phase 3 trial comparing apixaban to placebo in patients with acute coronary syndrome. The decision was based on a recommendation from the data monitoring committee based on “a clinically important increase in bleeding among patients randomized to apixaban,” according to the company press release. Robert […]

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August 31st, 2010

Apixaban Beats Aspirin for Stroke Prevention in AF

Larry Husten, PHD

The AVERROES (Apixaban Versus Acetylsalicylic Acid (ASA) to Prevent Strokes) trial randomized 5600 AF patients who were unable to take warfarin to receive either aspirin or apixaban, a factor Xa inhibitor. (Another trial still underway, ARISTOTLE, is a direct comparison of warfarin and apixaban in AF.) AVERROES was stopped early after the Data Monitoring Committee […]

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March 4th, 2010

Thursday, March 4 News: Apixaban Advances

Larry Husten, PHD

Apixaban, a new factor Xa inhibitor under development, was compared with enoxaparin for thromboprophylaxis following knee replacement surgery in the ADVANCE-2 trial. The new report appears in the Lancet. In the primary efficacy analysis, the primary outcome — the composite of asymptomatic and symptomatic deep vein thrombosis, nonfatal pulmonary embolism, and all-cause death during treatment — was reached in 15% […]

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May 7th, 2015

Selections from Richard Lehman’s Literature Review: May 7th

Richard Lehman, BM, BCh, MRCGP

This week’s topics are a comparison of a retrievable inferior vena cava filter plus anticoagulation vs. anticogulation alone for recurrent PE, the cost effectiveness and population impact of statins for primary prevention in U.S. adults age 75 and older, and more.

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January 9th, 2015

FDA Approves New Oral Anticoagulant from Daiichi Sankyo

Larry Husten, PHD

And then there were four. Late Thursday the FDA announced that it had approved edoxaban, the new oral anticoagulant manufactured by Daiichi Sankyo. The drug will be marketed under the brand name of Savaysa and joins three other new drugs in the large and important new oral anticoagulant marketplace: dabigatran (Pradaxa), rivaroxaban (Xarelto), and apixaban (Eliquis). All four drugs were […]

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October 31st, 2014

FDA Advisory Panel Gives Tepid Support to New Anticoagulant

Larry Husten, PHD

On Thursday the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-1 in favor of approval for Daiichi Sankyo’s edoxaban (Savaysa). The outcome will likely result in a drug that will be on the market, but that few physicians will prescribe until further studies are performed. Edoxaban will almost certainly become the fourth new oral anticoagulant (NOAC) to […]

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July 23rd, 2014

More Questions Raised About Dabigatran

Larry Husten, PHD

Once again, dabigatran (Pradaxa) has raised the wrath of the critics. Several articles (see here, here, and here) and an editorial published today in The BMJ raise more questions and concerns about the drug, which is the first of the new oral anticoagulants. Relying on new evidence along with previously disclosed data, Deborah Cohen, the investigations editor for The […]

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