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Impact of Rabeprazole on APO-Dabigatran Exposure in Healthy Volunteers
CONCLUSIONS: When APO-dabigatran is administered with rabeprazole, the exposure to dabigatran is reduced by about 30%, which is similar to the level observed with Pradaxa when it was co-administered with a proton pump inhibitor. However, the finding that one-third of participants had a > 50% reduction in exposure is concerning, and it highlights the need for caution in patients who have, or are at risk of, reduced gastric acidity.PMID:36700178 | PMC:PMC9869351 | DOI:10.1016/j.cjco.2022.09.006
Source: Atherosclerosis - January 26, 2023 Category: Cardiology Authors: Noel Chan Matt Wheeler Vinai Bhagirath Jacqueline Bosch Jutta Heinrich-Nols Debbie Sloane Joanne van Ryn Linda Jefferies Jacqueline Wilkinson Qilong Yi John Eikelboom Source Type: research

Comparative Effectiveness and Safety of Low-Dose Oral Anticoagulants in Patients With Atrial Fibrillation
Conclusions: The results of this population-based study suggest that low-dose dabigatran has a better effective composite than warfarin. Compared with apixaban, low-dose dabigatran had a better effectiveness composite but a worse safety profile. Low-dose apixaban had a better safety composite than warfarin and other low-dose DOACs. Given that the comparative effectiveness and safety seem to vary from one DOAC to another, pharmacokinetic data for specific populations are now warranted.
Source: Frontiers in Pharmacology - January 14, 2022 Category: Drugs & Pharmacology Source Type: research

The Cost Implications of Dabigatran in Patients with Myocardial Injury After Non-Cardiac Surgery
ConclusionDabigatran 110  mg twice daily was cost neutral for patients in the MANAGE trial. Our cost findings support the use of dabigatran 110 mg twice daily in patients with MINS.Trial RegistrationClinicalTrials.gov identifier number NCT01661101.
Source: American Journal of Cardiovascular Drugs - July 26, 2021 Category: Cardiology Source Type: research

Dose Specific Effectiveness and Safety of DOACs in Patients with Non-valvular Atrial Fibrillation: a Canadian Retrospective Cohort Study
Direct oral anticoagulants (DOACs) have been proven to be effective and safe for prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF). However, suboptimal adherence, variable dosing and use in patient populations that otherwise would have been excluded from clinical trials may impact the efficacy and safety profile of DOACs in a routine care setting. We compared stroke, bleeding, and mortality rates on and off therapy for standard and low-dose DOACs (apixaban, rivaroxaban, dabigatran) versus warfarin in a Canadian cohort.
Source: Thrombosis Research - May 10, 2021 Category: Hematology Authors: Elham Rahme, Richard Godin, Hacene Nedjar, Kaberi Dasgupta, Vicky Tagalakis Source Type: research

Early dabigatran treatment after transient ischemic attack and minor ischemic stroke does not result in hemorrhagic transformation.
PMID: 32342831 [PubMed - as supplied by publisher]
Source: The Canadian Journal of Neurological Sciences - April 27, 2020 Category: Neurology Authors: Alrohimi A, Ng K, Dowlatshahi D, Buck B, Stotts G, Thirunavukkarasu S, Shamy M, Kalashyan H, Sivakumar L, Shuaib A, Sharma M, Butcher K Tags: Can J Neurol Sci Source Type: research

Establishing Therapeutic Equivalence of Complex Pharmaceuticals: The Case of Dabigatran
Publication date: Available online 5 June 2018Source: Canadian Journal of CardiologyAuthor(s): Jeffrey Weitz, Karen M. Earl, Kori Leblanc, William Semchuk, Fakhreddin JamaliAbstractDabigatran is widely used for stroke prevention in atrial fibrillation. Dabigatran is no longer patent protected in Canada and 2 generic formulations were recently approved by Health Canada. Branded dabigatran utilizes a complex formulation to maintain the acidic microenvironment required for maximal absorption. Consequently, food does not influence its bioavailability and the efficacy and safety of dabigatran are similar with or without concomi...
Source: Canadian Journal of Cardiology - July 10, 2018 Category: Cardiology Source Type: research

Dabigatran in patients with myocardial injury after non-cardiac surgery (MANAGE): an international, randomised, placebo-controlled trial
Publication date: 9–15 June 2018 Source:The Lancet, Volume 391, Issue 10137 Author(s): P J Devereaux, Emmanuelle Duceppe, Gordon Guyatt, Vikas Tandon, Reitze Rodseth, Bruce M Biccard, Denis Xavier, Wojciech Szczeklik, Christian S Meyhoff, Jessica Vincent, Maria Grazia Franzosi, Sadeesh K Srinathan, Jason Erb, Patrick Magloire, John Neary, Mangala Rao, Prashant V Rahate, Navneet K Chaudhry, Bongani Mayosi, Miriam de Nadal, Pilar Paniagua Iglesias, Otavio Berwanger, Juan Carlos Villar, Fernando Botto, John W Eikelboom, Daniel I Sessler, Clive Kearon, Shirley Pettit, Mukul Sharma, Stuart J Connolly, Shrikant I Bangdiwala, ...
Source: The Lancet - June 8, 2018 Category: General Medicine Source Type: research

Establishing Therapeutic Equivalence of Complex Pharmaceuticals: The Case of Dabigatran
Publication date: Available online 5 June 2018 Source:Canadian Journal of Cardiology Author(s): Jeffrey Weitz, Karen M. Earl, Kori Leblanc, William Semchuk, Fakhreddin Jamali Dabigatran is widely used for stroke prevention in atrial fibrillation. Dabigatran is no longer patent protected in Canada and 2 generic formulations were recently approved by Health Canada. Branded dabigatran utilizes a complex formulation to maintain the acidic microenvironment required for maximal absorption. Consequently, food does not influence its bioavailability and the efficacy and safety of dabigatran are similar with or without concomitant ...
Source: Canadian Journal of Cardiology - June 6, 2018 Category: Cardiology Source Type: research

A Review of the Use of Direct Oral Anticoagulant Use in Orthotopic Heart Transplantation Recipients
Over 60 years ago, the vitamin K antagonist (VKA) warfarin was approved and remained the only oral anticoagulation agent until recently [1]. Currently, within North America and Europe there are four DOACs available. Dabigatran, first approved in Europe and Canada in 2008, then in the United States of America in 2010, followed by rivaroxaban, apixaban, and most recently edoxaban. The introduction of direct oral anticoagulants (DOACs) has been a major advancement and these agents are the preferred to VKAs for many indications [2 –5], including stroke prevention in nonvalvular atrial fibrillation (NVAF), acute treatment and...
Source: Transplantation Reviews - April 16, 2018 Category: Transplant Surgery Authors: Rosaleen Boswell, Glen J. Pearson Tags: Review article Source Type: research

Design of a Randomized Placebo-Controlled Trial to Assess Dabigatran and Omeprazole in Patients with Myocardial Injury after Noncardiac Surgery (MANAGE)
Conclusion MANAGE is the first randomized controlled trial to evaluate a potential treatment of patients who suffered MINS.
Source: Canadian Journal of Cardiology - February 3, 2018 Category: Cardiology Source Type: research