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https://www.readbyqxmd.com/read/30093297/establishing-therapeutic-equivalence-of-complex-pharmaceuticals-the-case-of-dabigatran
#1
Jeffrey I 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 uses 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 intake of proton pump inhibitors (PPIs). Unfortunately, current bioequivalence criteria do not mandate testing of the generic formulations with food or with concomitant intake of PPIs; thus, the only data available for the approved generic products are in fasted, healthy volunteers...
June 5, 2018: Canadian Journal of Cardiology
https://www.readbyqxmd.com/read/30074534/effect-of-bisoprolol-on-the-level-of-dabigatran
#2
Frantisek Nehaj, Juraj Sokol, Jela Ivankova, Michal Mokan, Marian Mokan
BACKGROUND: Many patients receiving dabigatran treatment might also require bisoprolol therapy. However, there is a possibility that bisoprolol as significant P-glycoprotein inhibitor might interact with dabigatran. STUDY QUESTION: To investigate the impact of concomitant bisoprolol therapy on dabigatran plasma level in patients with nonvalvular atrial fibrillation. STUDY DESIGN: A pilot drug interaction study in 29 patients with nonvalvular atrial fibrillation on dabigatran therapy...
July 12, 2018: American Journal of Therapeutics
https://www.readbyqxmd.com/read/29898846/time-to-therapeutic-range-tttr-anticoagulation-control-and-cardiovascular-events-in-vitamin-k-antagonists-naive-patients-with-atrial-fibrillation
#3
Daniele Pastori, Pasquale Pignatelli, Francesco Cribari, Roberto Carnevale, Mirella Saliola, Francesco Violi, Gregory Yh Lip
BACKGROUND: Vitamin K antagonists (VKAs) reduce cardiovascular events (CVEs) in atrial fibrillation (AF) when a time in therapeutic range (TiTR) >70% is achieved. Factors affecting the time to achieve the TR (TtTR) are unknown. METHODS: Prospective observational study including 1,406 nonvalvular AF patients starting VKAs followed for a mean of 31.3months (3,690 patient/year); TiTR, TtTR, and SAMe-TT2 R2 score were calculated, and CVEs were recorded. RESULTS: Median TtTR was 8...
June 2018: American Heart Journal
https://www.readbyqxmd.com/read/29722860/oesophageal-injury-following-magnetically-guided-single-catheter-ablation-for-atrial-fibrillation-insights-from-the-magna-af-registry
#4
Dirk Bastian, Johannes Schwab, Karl-Theodor Steurer, Andrea Brinker-Paschke, Arno Boessenecker, Reinhard Doering, Zeynep Karakurt, Laura Vitali-Serdoz, Matthias Pauschinger, Konrad Göhl
Aims: Oesophagogastroduodenoscopy (OGD) after catheter ablation (CA) of atrial fibrillation (AF) revealed a high rate of procedure related oesophageal lesions. We hypothesized that magnetically guided CA with careful radiofrequency energy titration at the posterior left atrial (LA) wall limits the incidence of oesophageal tissue damage. Methods and results: As a part of the prospective "Remote MAGNetic catheter Ablation for Atrial Fibrillation" (MAGNA-AF) registry, 251 out of 266 consecutive patients underwent OGD after magnetically guided single-CA for AF...
May 1, 2018: Europace: European Pacing, Arrhythmias, and Cardiac Electrophysiology
https://www.readbyqxmd.com/read/29721111/risk-factors-and-prevention-of-dabigatran-related-gastrointestinal-bleeding-in-patients-with-atrial-fibrillation
#5
Teerapat Nantsupawat, Suthipong Soontrapa, Nopakoon Nantsupawat, David Sotello, Saranapoom Klomjit, Selcuk Adabag, Alejandro Perez-Verdia
Introduction: Dabigatran, as compared with warfarin, was associated with lower rates of stroke and systemic embolism with similar rates of major hemorrhage. But it has a significantly higher risk of gastrointestinal bleeding (GIB). There are limited data on how to prevent GIB from dabigatran and what are the risk factors. Methods: We performed a retrospective cohort study of patients with atrial fibrillation who have ever taken dabigatran for thromboprophylaxis from October 2010 to February 2013...
February 2018: Journal of Arrhythmia
https://www.readbyqxmd.com/read/29255511/influence-of-proton-pump-inhibitors-on-blood-dabigatran-concentrations-in-japanese-patients-with-non-valvular-atrial-fibrillation
#6
Tasuku Kuwayama, Hiroyuki Osanai, Masayoshi Ajioka, Kotaro Tokuda, Hirofumi Ohashi, Akihiro Tobe, Tatsuya Yoshida, Tomohiro Masutomi, Takahiro Kambara, Yosuke Inoue, Yoshihito Nakashima, Hiroshi Asano, Kazuyoshi Sakai
Background: Dabigatran is a direct thrombin inhibitor used to decrease the risk of ischemic stroke in patients with non-valvular atrial fibrillation (NVAF). Its prodrug, dabigatran etexilate (DE) is often co-administrated with a proton pump inhibitor (PPI) because of its adverse effects on the gastrointestinal tract. Drug-drug interactions between DE and PPIs in daily clinical practice have not been fully elucidated. Methods: Changes in blood dabigatran concentration (DC) were investigated using the dilute thrombin time test in a randomized, open-label, two-period crossover study including 34 Japanese patients with NVAF receiving dabigatran therapy with or without PPI...
December 2017: Journal of Arrhythmia
https://www.readbyqxmd.com/read/29111544/atrioesophageal-fistula-following-radiofrequency-catheter-ablation-of-atrial-fibrillation
#7
Molly Orosey, Lohit Garg, Sahil Agrawal, Jinu J John, David E Haines, Wai Shun Wong
Atrioesophageal fistula (AEF) is a rare but catastrophic complication of catheter ablation of atrial fibrillation (AF), with an incidence of 0.03% to 1.5% per year. We report two cases and review the epidemiology, clinical features, pathogenesis, and management of AEF after AF ablation. The principal clinical features of AEF include fever, hematemesis, and neurologic deficits within 2 months after ablation. The close proximity of the esophagus to the posterior left atrial wall is considered responsible for esophageal injury during ablation and the eventual development of AEF...
2017: Reviews in Cardiovascular Medicine
https://www.readbyqxmd.com/read/29050502/first-evidence-trap-induced-platelet-aggregation-is-reduced-in-patients-receiving-xabans
#8
Frantisek Nehaj, Juraj Sokol, Jela Ivankova, Michal Mokan, Frantisek Kovar, Jan Stasko, Marian Mokan
The availability of direct oral anticoagulants has caused a paradigm shift in the management of thrombosis. Rivaroxaban and apixaban are 2 direct oral anticoagulants whose target specificity is activated factor X (FXa). However, it is still not fully understood if and how xabans impact platelet function. This observational study aimed to assess the in vitro platelet function in patients with atrial fibrillation receiving xabans. This was a single-center study quantifying platelet aggregation in 41 patients treated with apixaban or rivaroxaban by light transmission aggregometry...
September 2018: Clinical and Applied Thrombosis/hemostasis
https://www.readbyqxmd.com/read/28947480/esophageal-injury-and-atrioesophageal-fistula-caused-by-ablation-for-atrial-fibrillation
#9
REVIEW
Sunil Kapur, Chirag Barbhaiya, Thomas Deneke, Gregory F Michaud
Esophageal perforation is a dreaded complication of atrial fibrillation ablation that occurs in 0.1% to 0.25% of atrial fibrillation ablation procedures. Delayed diagnosis is associated with the development of atrial-esophageal fistula (AEF) and increased mortality. The relationship between the esophagus and the left atrial posterior wall is variable, and the esophagus is most susceptible to injury where it is closest to areas of endocardial ablation. Esophageal ulcer seems to precede AEF development, and postablation endoscopy documenting esophageal ulcer may identify patients at higher risk for AEF...
September 26, 2017: Circulation
https://www.readbyqxmd.com/read/28642210/rationale-and-design-for-a-randomized-comparison-of-efficacy-and-safety-between-aspirin-and-clopidogrel-in-atrial-fibrillation-patients-with-low-stroke-risk-cesac-af-trial
#10
RANDOMIZED CONTROLLED TRIAL
Sang Min Park, Haemin Jeong, Mi-Hyang Jung, Kyung Soon Hong, Myeong-Ki Hong, Chang Seok Bang, Christopher Y Kim
BACKGROUND: Atrial fibrillation (AF) increases the risk of thromboembolic stroke. An oral anticoagulant should be administrated to prevent stroke in patients with moderate stroke risk (ie, CHA2 DS2 -VASc score>2). If the stroke risk is low (i.e. the score=1), however, antiplatelet agent such as aspirin is widely used. Aspirin can cause peptic ulcer disease (PUD) while its alternative, clopidogrel, theoretically does not. OBJECTIVE: To elucidate the efficacy and safety between aspirin and clopidogrel, a multicenter randomized controlled trial was designed in AF patients with low stroke risk...
September 2017: Contemporary Clinical Trials
https://www.readbyqxmd.com/read/28452843/the-impact-of-proton-pump-inhibition-on-dabigatran-levels-in-patients-with-atrial-fibrillation
#11
Tomáš Bolek, Matej Samoš, Lucia Stančiaková, Jela Ivanková, Ingrid Škorňová, Ján Staško, Peter Galajda, Peter Kubisz, Marián Mokáň
BACKGROUND: Proton pump inhibition (PPI) administrated together with dabigatran reduces the risk of gastrointestinal hemorrhage. However, there is a discussion regarding possible PPI-dabigatran interaction that may reduce the efficacy of this therapy. STUDY QUESTION: To determine the impact of concomitant PPI on dabigatran plasma levels in patients with nonvalvular atrial fibrillation (NV-AF). STUDY DESIGN: A pilot prospective study in patients with NV-AF on dabigatran therapy was performed; 31 patients were enrolled...
April 25, 2017: American Journal of Therapeutics
https://www.readbyqxmd.com/read/28340150/severe-conduction-defects-requiring-permanent-pacemaker-implantation-in-patients-with-a-new-onset-left-bundle-branch-block-after-transcatheter-aortic-valve-implantation
#12
V J Nijenhuis, V F Van Dijk, S M Chaldoupi, J C Balt, J M Ten Berg
Aims: Transcatheter aortic valve implantation (TAVI) is frequently associated with cardiac conduction defects (CCD) requiring permanent pacemaker implantation (PPI). Although new-onset left bundle branch block (LBBB) is often seen, the rate of progression to severe CCD is unclear. We aimed to find clinical and electrocardiographic (ECG) parameters associated with severe CCD requiring PPI in patients with a new-onset LBBB after TAVI and assess its effect on clinical outcome. Methods and results: All consecutive patients undergoing TAVI who developed a new-onset LBBB were retrospectively analysed...
June 1, 2017: Europace: European Pacing, Arrhythmias, and Cardiac Electrophysiology
https://www.readbyqxmd.com/read/28339750/downstream-overdrive-pacing-and-intracardiac-concealed-fusion-to-guide-rapid-identification-of-atrial-tachycardia-after-atrial-fibrillation-ablation
#13
Chirag R Barbhaiya, Samuel H Baldinger, Saurabh Kumar, Jason S Chinitz, Alan D Enriquez, Roy John, William G Stevenson, Gregory F Michaud
Aims: Atrial tachycardia (AT) related to atrial fibrillation (AF) ablation frequently poses a diagnostic challenge. Downstream overdrive pacing (DOP) can be used to rapidly detect reentry and assess proximity of a pacing site to an AT circuit or focus. We hypothesized that systematic DOP using multielectrode catheters would facilitate AT mapping. Methods and results: DOP identified constant fusion when the post-pacing interval (PPI)-tachycardia cycle length (TCL) <40 ms and stimulus to adjacent upstream atrial electrogram interval >75% of TCL...
April 1, 2018: Europace: European Pacing, Arrhythmias, and Cardiac Electrophysiology
https://www.readbyqxmd.com/read/28316184/-research-update-on-the-relationship-between-gastroesophageal-reflux-disease-and-atrial-fibrillation-and-treatment-efficacy-by-proton-pump-inhibitors
#14
F W Liu, L Huang, J H Yu
No abstract text is available yet for this article.
March 24, 2017: Zhonghua Xin Xue Guan Bing za Zhi
https://www.readbyqxmd.com/read/27957111/gut-to-heart-acid-reflux-disease-in-atrial-fibrillation-and-the-role-of-proton-pump-inhibitor
#15
Mohit K Turagam Md, Poonam Velagapudi Md
No abstract text is available yet for this article.
October 2014: Journal of Atrial Fibrillation
https://www.readbyqxmd.com/read/27886825/antiplatelet-and-antithrombotic-therapy-in-patients-with-atrial-fibrillation-undergoing-coronary-stenting
#16
REVIEW
Mikhail S Dzeshka, Richard A Brown, Davide Capodanno, Gregory Y H Lip
Stroke prevention is the main priority in the management cascade of atrial fibrillation. Most patients require long-term oral anticoagulation (OAC) and may require percutaneous coronary intervention. Prevention of recurrent cardiac ischemia and stent thrombosis necessitate dual antiplatelet therapy (DAPT) for up to 12 months. Triple antithrombotic therapy with OAC plus DAPT of shortest feasible duration is warranted, followed by dual antithrombotic therapy of OAC and antiplatelet agent, and OAC alone after 12 months...
January 2017: Interventional Cardiology Clinics
https://www.readbyqxmd.com/read/27709460/a-prospective-randomized-open-label-study-to-evaluate-two-management-strategies-for-gastrointestinal-symptoms-in-patients-newly-on-treatment-with-dabigatran
#17
Daniel O'Dea, Jacqueline Whetteckey, Naitee Ting
INTRODUCTION: In the pivotal RE-LY trial, dabigatran etexilate (DE) at the dose of 150-mg twice daily (BID), significantly reduced total stroke and ischemic stroke compared with warfarin in patients with non-valvular atrial fibrillation (NVAF), while the 110-mg BID dose had efficacy equivalent to warfarin, and major bleeds were significantly reduced. Both DE regimens were generally well tolerated; however, approximately 4% of the patients discontinued treatment with DE due to gastrointestinal (GI) discomfort...
December 2016: Cardiology and Therapy
https://www.readbyqxmd.com/read/27343420/prolonged-utilization-of-proton-pump-inhibitors-in-patients-with-ischemic-and-valvular-heart-disease-is-associated-with-surgical-treatments-weight-loss-and-aggravates-anemia
#18
Marko Boban, Marinko Zulj, Viktor Persic, Igor Medved, Drazen Zekanovic, Aleksandar Vcev
BACKGROUND: Proton pump inhibitors (PPIs) are among the commonest drugs used nowadays. The aim of our study was to analyze prolonged utilization of proton pump inhibitors in medical therapy of patients with ischemic and valvular heart disease. Secondly, profile of utilization was scrutinized to patient characteristics and type of cardiovascular treatments. METHODS: The study included consecutive patients scheduled for cardiovascular rehabilitation 2-6months after index cardiovascular treatment...
September 15, 2016: International Journal of Cardiology
https://www.readbyqxmd.com/read/26930020/a-stunned-esophagus
#19
Sebastian Sennock, Sean Fine, Amanda Pressman
No abstract text is available yet for this article.
April 2016: Gastroenterology
https://www.readbyqxmd.com/read/26847116/predictors-of-permanent-pacemaker-implantations-and-new-onset-conduction-abnormalities-with-the-sapien-3-balloon-expandable-transcatheter-heart-valve
#20
Oliver Husser, Costanza Pellegrini, Thorsten Kessler, Christof Burgdorf, Hannah Thaller, N Patrick Mayr, Albert M Kasel, Adnan Kastrati, Heribert Schunkert, Christian Hengstenberg
OBJECTIVES: This study investigates the influence of implantation depth and prosthesis oversizing on conduction abnormalities (CA) and permanent pacemaker implantation (PPI) after SAPIEN 3 (Edwards Lifesciences, Irvine, California) implantation. BACKGROUND: CA and PPIs are frequent complications after transcatheter aortic valve replacement with a next-generation balloon-expandable transcatheter heart valve (SAPIEN 3). The potential underlying mechanisms are incompletely understood...
February 8, 2016: JACC. Cardiovascular Interventions
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