Pradaxa cleared for new indications in Europe Boehringer drug set for use in deep vein thrombosis and pulmonary embolism The European Commission has given a green light to Boehringer Ingelheim's Pradaxa for use to treat deep vein thrombosis DVT and pulmonary embolism PE , setting it on a par with rival anticoagulants. Share Print Friendly. PME Digital Edition.
Omnichannel Strategy Consultant Competitive Salary. Atrial fibrillation AF is commonly occurring arrhythmia in clinical practice. AF is easy to recognize but difficult to treat. Stroke is the most devastating complication of AF and is associated with a huge disease burden on the society. Summary of Product Characteristics.
References Connolly SJ, et al. N Engl J Med. Connolly SJ, et al. Data on file. Boehringer Ingelheim Pharmaceuticals, Inc. Gorst-Rasmussen A, et al. Pharmacoepidemiol Drug Saf. Pradaxa contains the active substance dabigatran etexilate. Pradaxa is taken by mouth and it is available as capsules for adults and children above 8 years of age, granules for children less than 12 years of age and a powder and solvent to be made into a solution to drink for children less than 1 year of age.
Pradaxa can only be obtained with a prescription. For children the dose also depends on their weight. When changing between the different forms of the medicine, the doctor may need to alter the dose. All patients at increased risk of bleeding should be monitored closely and the doctor may reduce the dose of Pradaxa. In all patients, kidney function should also be assessed before starting treatment to exclude patients with severely reduced kidney function, and should be re-assessed during treatment if any worsening is suspected.
When Pradaxa is used long term in patients with non-valvular atrial fibrillation, or when it is used in patients with DVT or PE, kidney function should be assessed at least once a year if their kidney function is mildly to moderately reduced or if they are over 75 years old. For more information about using Pradaxa, see the package leaflet or contact your doctor or pharmacist. This means that it is converted into dabigatran in the body. Dabigatran is an anticoagulant, meaning that it prevents the blood from coagulating clotting.
It blocks a substance called thrombin, which is central to the process of blood clotting. Pradaxa or mg a day was as effective as enoxaparin an anticoagulant given by injection in preventing formation of blood clots or death in patients who had undergone hip or knee replacement in two main studies. The first study involved a total of 2, patients who had had a knee replacement operation. The second study involved a total of 3, patients who had had a hip replacement.
In both studies, there was some evidence that a mg dose of Pradaxa may be more effective than a mg dose. Pradaxa mg or mg twice a day was as effective as warfarin another anticoagulant given by mouth in preventing stroke or a blood clot blocking blood vessels in other parts of the body in a study of patients with non-valvular atrial fibrillation who were considered to be at risk of stroke.
In the study, around 18, adults were treated for one to three years. The proportion of patients who had a stroke or other problems caused by blood clots each year was around 1. Pradaxa was as effective as warfarin in reducing formation of blood clots in the veins DVT or lungs PE , or blood-clot-related death during treatment.
Two main studies in over 5, adults with symptoms of DVT or PE, and who were initially treated with an injectable anticoagulant, compared Pradaxa with warfarin.
Blood clots or blood-clot-related death occurred in 2.
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