Value through Innovation24 April 2015

Boehringer Ingelheim has successfully advanced into the therapeutic area of treating and preventing thromboembolic diseases.

Thromboembolic diseases are a leading cause of morbidity and mortality worldwide. These conditions are caused when a blood vessel is obstructed by a blood clot (embolus) that has been carried in the bloodstream from the site of its formation. Thromboembolic disease includes both venous thromboembolism (VTE) and arterial thrombosis. VTE is an general term which refers to mainly two conditions: deep vein thrombosis (DVT) and its potentially fatal acute complication, pulmonary embolism (PE). Arterial embolism is a frequent complication in patients with atrial fibrillation (AF) and can lead to stroke or systemic embolism.

Information on arterial thrombosis in patients with AF

AF is the most common sustained heart arrhythmia , affecting an estimated 4.5 million people in Europe and 5.1 million in the USA. One in four people over the age of 40 will develop AF and the condition occurs in approximately 1% of the total population, rising to 10% in people aged over 80.

Patients with AF are at an increased risk of arterial thrombosis and embolism as their irregular heart rhythm increases the risk of a blood clot forming in the left atrial appendage. This causes patients with AF to have a five-fold increase in the risk of stroke.

Up to three million people worldwide suffer from strokes related to AF each year. These strokes are typically severe and disabling, with one half of this population dying within one year. Compared with other types of stroke, AF-related strokes are associated with an increased likelihood of death (20%) and disability (60%). Many of these strokes can be prevented with appropriate antithrombotic therapy.

Information on venous thromboembolism

VTE has been estimated to be the third most common cardiovascular disorder after ischaemic heart disease and stroke worldwide. PE accounts for 5-10% of deaths in hospitalised patients, making VTE the most common preventable cause of in-hospital death. In Europe, nearly 750,000 VTE events take place each year and approximately 300,000 of these are fatal.

Numerous risk factors are associated with VTE, the most important of which are:

  • Increasing age
  • Immobility
  • Orthopaedic surgery

A DVT results from the formation of a blood clot (thrombus) inside a deep vein which either partially or totally blocks the flow of blood in the vein. Symptoms include pain and swelling in the legs, which in severe cases may cause serious, life-threatening conditions. If a thrombus or a fragment of the thrombus breaks loose, it is called an embolus and can travel to the lungs where it may block circulation and cause a PE. PE is a serious condition that can cause sudden death and permanent damage to the affected lung(s) and other vital organs in the body.

Major orthopaedic surgery without prophylaxis carries a risk of VTE. Three out of five patients develop DVT after major orthopaedic surgery without anticoagulant treatment.

Since up to half of patients have either no symptoms or no specific symptoms, VTE is a challenge to diagnose. As a result, the most economical and effective approach for avoiding clots is via preventive measures.


Pradaxa® (dabigatran etexilate)

Pradaxa® is at the forefront of a new generation of novel oral anticoagulants known as direct thrombin inhibitors (DTI). Potent antithrombotic effects are achieved with DTIs by specifically blocking the activity of thrombin (both free and clot-bound), the central enzyme in the process responsible for thrombus formation.

Dabigatran etexilate is approved for clinical use in stroke risk reduction in non-vavular atrial fibrillation prevention in the US and prevention of stroke and systemic embolism in adults with atrial fibrillation in Canada and Japan (marketed under the names Pradax® and Prazaxa®, respectively).

Dabigatran etexilate has been approved in 75 countries under the trademark Pradaxa® for the primary prevention of venous thromboembolic events (blood clots) in adults who have undergone elective total hip or knee replacement surgery.

Further indications

The efficacy and safety of Pradaxa® is being evaluated in the RE-VOLUTION® clinical trial programme which encompasses studies planned in more than 40.000 patients:

  • Primary VTE prevention
  • Stroke prevention in patients with atrial fibrillation
  • Secondary VTE prevention
  • Acute VTE treatment
  • Secondary prevention of cardiac events in patients with Acute Coronary Syndrome (ACS)


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