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Published on 11 May 2009

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Hundreds may die from hospital-acquired blood clots

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Data published today in The Journal of Bone and Joint Surgery show that oral Xarelto is significantly more effective at reducing the incidence of the composite of symptom-causing blood clots, known as venous thromboembolism (VTE), and death, than injectable enoxaparin following elective orthopaedic surgery.

These findings make Xarelto the only oral anticoagulant to significantly reduce clinically relevant blood clots when compared with the current standard of care.

With publication of these data marking the start of National Thrombosis Week (11 – 15th May), Professor Beverley Hunt, Consultant Haematologist and Medical Director of Lifeblood: The Thrombosis Charity, comments: “hospital-acquired blood clots are the leading cause of preventable death, killing hundreds of people every week. Lifeblood support Thrombosis Awareness Week as a means of highlighting the need for suitable preventative treatment for every adult admitted to hospital. We welcome rivaroxaban which in clinical trials, has been proven to be superior to the gold standard after major orthopaedic surgery and has the advantage of being an easy-to-take tablet.”

The pooled analysis of three pivotal phase III trials, RECORD1, 2 & 3, involved 9,581 patients and showed that two weeks therapy with Xarelto (10 mg tablet, once-daily) provided patients with a 56% relative risk reduction in the incidence of the composite of symptom-causing VTE and death from all causes, when compared to two weeks therapy with enoxaparin (40 mg injection, once-daily) (0.4% versus 0.8% respectively, p<0.005; odds ratio (OR) 0.44; p=0.005). Importantly, both treatment options demonstrated similar and low bleeding rates (0.2% in both groups, p=0.662).

Xarelto, the only anticoagulant to show a significant reduction in the incidence of the composite of symptomatic VTE and all-cause mortality, is the first in a new class and works by inhibiting a pivotal stage in the blood clotting process – enzyme Factor Xa.

In addition to these efficacy advantages, Xarelto has a number of other benefits compared with the current standard of care as the patient only needs to take one tablet, once-daily (at home and in hospital), and requires no routine coagulation monitoring.

Professor Ajay Kakkar, Professor of Surgical Sciences at the Barts and the London School of Medicine and Dentistry, and Director of the Thrombosis Research Institute, London said “blood clots after major orthopaedic surgery remain a serious clinical concern. These pooled data help us understand more fully the balance between efficacy and safety of rivaroxaban and highlight the role it may play in reducing the risk of potentially fatal blood clots. Rivaroxaban will add to our armamentarium of thrombosis-preventing strategies and help in their use after hospital discharge.”

The primary endpoint for the pooled RECORD1-3 analysis was symptomatic VTE – defined as symptomatic deep vein thrombosis (DVT) and symptomatic non-fatal pulmonary embolism – and all-cause mortality, measured within a 12-day treatment phase to incorporate the enoxaparin-controlled period across all three studies and allow for an unbiased comparison.

Data also showed that patients treated with Xarelto experienced significant reductions in the incidence of the composite of symptomatic VTE and all-cause mortality at the end of the planned medication period. This was measured at five weeks (up to day 42) in RECORD1 and 2, which included the placebo-controlled period in RECORD2, and two weeks (up to day 17) in RECORD3.

The complete RECORD clinical trial programme comprised four Phase III trials (RECORD1, 2, 3 & 4) which involved more than 12,500 total hip replacement (THR) or total knee replacement (TKR) surgery patients.

RECORD1 & 3 compared Xarelto to the current standard of treatment for VTE prevention (known as thromboprophylaxis) after THR and TKR surgery respectively. The RECORD2 trial compared extended duration treatment (five-weeks) for blood clot reduction in THR patients with Xarelto to short duration enoxaparin (two-weeks) followed by placebo.

Data from RECORD1-3 supported the approval of Xarelto by the European Commission in October 2008 for the prevention of VTE in adult patients undergoing elective hip or knee surgery, and positive recommendations from the Scottish Medicines Consortium (SMC) and the National Institute for Health and Clinical Excellence (NICE) in December 2008 and April 2009 respectively.

The positive results of the pooled analysis of RECORD1-3 have also been confirmed in the RECORD4 trial, recently published in The Lancet. The full RECORD data set was also used to support the new drug application for Xarelto in the U.S. in 2008, as well as additional filings that are under review with regulatory agencies around the world.

VTE is a leading cause of preventable hospital deaths in the UK, causing 10 per cent of all deaths from hospital stays – up to 32,000 people each year – more than HIV/AIDS, breast cancer and road traffic accidents combined.1 Major orthopaedic surgery is associated with a particularly high risk of hospital-acquired VTE – more than half of the 90,434 people undergoing elective hip or knee replacement every year in England8 could develop a potentially fatal blood clot if no preventative treatment is given.

VTE costs the NHS an estimated £640 million per year. A further £19 million of NHS money is spent on litigation from patients who have developed blood clots as a result of a hospital stay or procedure.

Bayer



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