Bayer pools RECORD trial data for report

Germany's Bayer HealthCare reported pooled data from three Phase III trials of Xarelto (rivaroxaban), jointly developed with Johnson & Johnson, at the International Congress on Thrombosis in Athens, Greece.

The pre-specified pooled analysis was based on the data from three studies of the RECORD program: RECORD1, 2 and 3 (Marketletters passim). These evaluated a one-tablet, once-daily, dose of Xarelto for the prevention of venous thromboembolism (VTE) after total hip or knee replacement surgery in nearly 10,000 patients. The key endpoint was the composite of symptomatic VTE and all-cause mortality within a 12-day treatment phase. This allowed a comparison across all three trials as it reflects the end of the enoxaparin-controlled period in RECORD2 and RECORD3. The results showed that Xarelto significantly reduced this composite endpoint by 56% compared with enoxaparin (0.4% versus 0.8%, respectively; odds ratio: 0.44; p<0.005), while maintaining a similar safety profile. Adverse events that may affect surgical outcomes, ie bleeding, were not significantly increased, the drugmaker said.

Bayer believes the results of this new analysis reinforce the findings from the individual RECORD studies which, it says, were further validated by a recent publication of RECORD2 in The Lancet and of RECORD1 and 3 in the New England Journal of Medicine.