Johnson and Johnson presents phase III rivaroxaban results

At the annual congress of the International Society on Thrombosis and Haemostasis, Johnson & Johnson has presented phase III clinical study results assessing the use of rivaroxaban as a preventative treatment for venous thromboembolism (VTE) in patients undergoing knee replacement surgery.

The Record [regulation of coagulation in major orthopaedic surgery reducing the risk of DVT (deep vein thrombosis) and PE (pulmonary embolism)] study found that the compound was superior to enoxaparin – the existing standard of care – for the prevention of VTE when measured in a head-to-head comparison.

Patients administered with rivaroxaban saw a 49 per cent drop in the relative risk of contracting DVT, non-fatal PE and all-cause mortality – the composite primary endpoint of the study.

The compound is being co-developed by Johnson & Johnson Pharmaceutical Research & Development and Bayer HealthCare.

Michael R Lassen, of Hoersholm Hospital and lead trial investigator, said: “The Record3 results are exciting, as they indicate that rivaroxaban may better meet the needs of many patients undergoing orthopaedic surgery.”

He added that that the trial marks key progress for this type of medication, with a once-daily orally-administered treatment outperforming the current standard of care as a preventative treatment for VTE, while showing a “promising” safety profile.

Earlier this week, Bayer stated that the compound has shown “great promise” in clinical trials with its balancing of efficacy and safety as an anticoagulation therapy.