ATX-MS-1467 for patients with multiple sclerosis (MS)

ATX-MS-1467 is a novel treatment that was developed with the aim of working with the immune system to treat the underlying cause of disease rather than just treating the symptoms or suppressing the...

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Clinical Approvals - news, views, reports and blogs

Clinical trials are a set of procedures in medical research conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and eff...

Cost effectiveness and clinical efficacy of Pradaxa® (dabigatran etexilate) versus rivaroxaban analysed

- Indirect comparison based on the RE-LY® trial (for dabigatran etexilate) and the Rocket AF trial (for rivaroxaban) suggests advantages of Pradaxa® in stroke prevention in patients with atrial fibr...

FDA Contraindicates Dabigatran for Mechanical Heart Valves

The FDA has revealed that the RE-ALIGN trial with dabigatran in patients with mechanical heart valves was stopped early because those taking the newer anticoagulant were more likely to experience stro...

Study of Dabigatran in Mechanical Heart Valve Patients Halted

Boehringer Ingelheim is halting the RE-ALIGN trial investigating the use of dabigatran in patients with artificial heart valves. Heartwire

Dabigatran etexilate found superior to warfarin in study

RE-LY trial has demonstrated that both doses of dabigatran etexilate (150mg bid and 110 mg bid) offer clinical benefits over warfarin when used in stroke prevention in patients with atrial fibrillatio...

Thrombotic events after discontinuing dabigatran: rebound or resumption?

The REMODEL trial has suggested that stopping dabigatran does not produce a rebound thrombotic effect.1 2 However, others have raised the possibility of this.3Such rebound pro-thrombotic activity and....

Prosthetic heart valves increase dabigatran risks

Patients with prosthetic heart valves should not be treated with dabigatran because there is an increased risk of thrombosis and bleeding events, the Medicines and Healthcare products Regulatory Agen...

RE-LY Sub-Analysis Suggests Similar Safety and Efficacy With Pradaxa (dabigatran etexilate mesylate) Versus Warfarin in NVAF Patients With and Without Diabetes

Data Presented During the American Heart Association's Scientific Sessions Comparison of Dabigatran versus Warfarin in Diabetic Patients with Atrial Fibrillation: Results from the RE-LY Trial (Lead Au...

Case building for long-term dabigatran or apixaban to treat VTE

New targeted anticoagulants such as dabigatran and apixaban might be effective options for the extended treatment of venous thromboembolism (VTE), industry-funded research in this week's New England...

Dabigatran or warfarin for the prevention of stroke in atrial fibrillation? A closer look at the RE-LY trial.

Introduction: In the Randomized Evaluation of Long-term Anticoagulant Therapy (RE-LY) trial, dabigatran 150 mg was shown to be superior to warfarin for the prevention of stroke or systemic embolism. H...

Efficacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial fibrillation: an analysis of the RE-LY trial.

BACKGROUND: Effectiveness and safety of warfarin is associated with the time in therapeutic range (TTR) with an international normalised ratio (INR) of 2·0-3·0. In the Randomised Evaluation of Long-...

Dabigatran Etexilate: A Pharmacoeconomic Review of its Use in the Prevention of Stroke and Systemic Embolism in Patients with Atrial Fibrillation.

This article provides an overview of the clinical profile of oral dabigatran etexilate (Pradaxa®, Pradax™) [hereafter referred to as dabigatran] when used for the prevention of stroke and systemic...

A combined pharmacometric analysis of dabigatran etexilate in healthy volunteers and patients with atrial fibrillation or undergoing orthopaedic surgery.

Dabigatran etexilate is the orally bioavailable pro-drug of dabigatran, a direct thrombin inhibitor. Using data from eight clinical studies in healthy volunteers and patients with non-valvular atrial...

Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthroplasty (RE-NOVATE II). A randomised, double-blind, non-inferiority trial.

This trial compared the efficacy and safety of oral dabigatran, a direct thrombin inhibitor, versus subcutaneous enoxaparin for extended thromboprophylaxis in patients undergoing total hip arthroplast...