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EINSTEIN DVT: Oral rivaroxaban versus standard therapy in the initial treatment of symptomatic deep vein thrombosis and long-term prevention of recurrent venous thromboembolism

Embargoed for release: Tuesday 31 august 2010 at 0800hrs



Results of the Phase III EINSTEIN-DVT study show that the oral anticoagulant rivaroxaban achieved the primary efficacy and safety outcomes in the treatment of patients with acute, symptomatic deep vein thrombosis (DVT).

The study showed that rivaroxaban demonstrated non-inferior efficacy in the treatment of DVT compared with initial enoxaparin treatment followed by a vitamin K antagonist (VKA), the current standard therapy for the treatment of DVT. Recurrent symptomatic venous thromboembolism (ie, the composite of recurrent DVT, non-fatal or fatal pulmonary embolism) occurred in 2.1% of the rivaroxaban recipients and 3.0% of the subjects receiving standard therapy (p<0.0001 for non-inferiority).

The EINSTEIN-DVT study also demonstrated similar rates of major and clinically relevant non-major bleeding, the principal safety outcome, for rivaroxaban compared with the current standard therapy (8.1% vs. 8.1%, respectively). No liver signal attributable to rivaroxaban was observed in the study.

“The results of the EINSTEIN-DVT trial indicate that rivaroxaban is an effective and safe treatment for acute symptomatic DVT,” said principal investigator, Professor Harry R. Büller, Academic Medical Center, Amsterdam, the Netherlands. “The single-drug approach with rivaroxaban will provide clinicians and patients with an attractive, simple, alternative regimen for the initial and long-term treatment of deep vein thrombosis.”

The multinational EINSTEIN-DVT study was designed to investigate a new single-drug approach with rivaroxaban in comparison to standard therapy in a randomised, open-label, non-inferiority study. The trial involved more than 3,400 patients with acute symptomatic DVT, but without any symptoms of pulmonary embolism, across 253 sites in 32 countries worldwide. Patients received either oral rivaroxaban (15 mg twice-daily for the first three weeks, followed by 20 mg once daily) or body weight-adjusted subcutaneous enoxaparin followed by warfarin or acenocoumarol (dose adjusted to maintain a therapeutic normalised ratio) for three, six or 12 months, based on the attending physician’s assessment at baseline.

The primary efficacy outcome was the cumulative incidence of symptomatic recurrent venous thromboembolism (non-fatal or fatal). The principal safety outcome was the composite of major and clinically relevant non-major bleeding.

* The EINSTEIN DVT study was sponsored by Bayer Schering Pharma

Notes to editor

About the European Society of Cardiology
The European Society of Cardiology (ESC) represents more than 62,000 cardiology professionals across Europe and the Mediterranean. Its mission is to reduce the burden of cardiovascular disease in Europe.

About ESC Congress 2010
ESC Congress 2010 will take place from 28 August to 1 September at the Stockholmsmässan, Stockholm. Information on the scientific programme is available at http://spo.escardio.org/Search.aspx?eevtid=40. More information on ESC Congress 2010 is available from the ESC's press office at press@escardio.org

This press release accompanies both a presentation and an ESC press conference given at the ESC Congress 2010. The press release has been written and/or edited by the ESC from information provided by the investigator on 29 August and does not necessarily reflect the opinion of the European Society of Cardiology. The content of the press release has been approved by the investigator.

Joint Statement from the European Society of Cardiology (ESC) and Bayer concerning the “ad hoc release” on the EINSTEIN-DVT study

The EINSTEIN-DVT study, investigating rivaroxaban, was deemed to be materially important to Bayer AG and thus to have the potential to affect the publicly traded securities of the company.  Because of this, Bayer had a legal obligation to initiate a pre-defined and formal process, which required it to notify the Financial Markets.
 
This requirement is in conflict with the regulations of the European Society of Cardiology governing prior disclosure of studies scheduled for presentation at the Hot Line Sessions of the Congress made without prior communication to the ESC.

The European Society of Cardiology regrets this early and partial disclosure of information. The full data of the EINSTEIN-DVT study – having been selected for its scientific value by the ESC Congress Programme Committee – should be presented during the relevant Hot Line session at the ESC Congress.

The society has decided that both the study investigators and the academic community should have appropriate and early access to the above.

Bayer recognises that it did not adequately discuss the situation with the ESC prior to issuing the “ad hoc release” and has unreservedly apologised for this omission.

Stockholm, 30 August 2010