Bayer and partner Johnson & Johnson have been boosted by data which shows that that a combination of its oral anticoagulant Xarelto taken twice-daily with standard antiplatelet therapy significantly reduced cardiovascular death, myocardial infarction and stroke in patients with acute coronary syndrome.
Results from the Phase III ATLAS ACS 2-TIMI 51 study presented at the American Heart Association meeting in Orlando, Florida and published by the New England Journal of Medicine also showed that Xarelto (rivaroxaban) significantly increased the rate of major bleeding, but did not increase the risk of fatal bleeding over standard therapy alone.
Bayer quoted Michael Gibson of the Harvard Medical School, and principal investigator in the ATLAS ACS studies of rivaroxaban. said that for more than a decade patients have been effectively treated with a low-dose aspirin given in combination with a thienopyridine to help reduce their risk of a recurrent cardiovascular event. This study showed that by adding Xarelto, an oral Factor Xa inhibitor, to standard therapy, "this risk is greatly reduced, resulting in a significant reduction in mortality", and if the data were extrapolated into clinical practice, "we could potentially see one life saved for every 56 patients treated with this combination of therapies over a two-year period".
The US Food and Drug Administration has granted rivaroxaban 'fast track' designation for ACS and Bayer said a marketing authorisation will be filed by the end of this year. Earlier this month, the agency backed Xarelto to prevent stroke in people with irregular heartbeat and drug is going up against Boehringer Ingelheim's Pradaxa (dabigatran).
However, also at the AHA meeting, there was disappointing news for another oral Factor Xa inhibitor, Bristol-Myers Squibb/Pfizer's Eliquis (apixaban).
Results from the Phase III ADOPT trial, which evaluated Eliquis versus Lovenox (enoxaparin) in acutely ill medical patients, show the drug did not meet the primary efficacy outcome of superiority to the latter, a Sanofi drug, for the endpoint of venous thromboembolism and VTE-related death at day 30.
The apixaban arm had a 13% lower rate of events than enoxaparin followed by placebo, which was not statistically significant and thus no clinically directive conclusion can be drawn. The key safety outcome of major bleeding was low in both groups but occurred in more patients treated with the B-MS/Pfizer drug than with enoxaparin.
Samuel Goldhaber, professor of medicine at Harvard Medical School,said that "solving the problem of VTE post-hospitalisation remains a critical unmet need in preventing medically ill patients from developing deep vein thrombosis and pulmonary embolism". He added that ADOPT "provides important insights for clinical triallists designing studies of extended duration VTE prophylaxis among medically-ill hospitalised patients".