Antiarrhythmic and doac dosing in obesity american. Additionally, the dosing of apixaban and rivaroxaban for patients was not. Antiarrhythmic and doac dosing in obesity american college of. Proposed mechanism activity of the endocannabinoid system in obese patients 1. Dec 24, 2018 the study reported that none of the patients who had available clinical data n 2238 had recurrent vte or stroke, though information surrounding follow. Doacsdabigatran, apixaban, edoxaban and rivaroxaban are approved for the treatment of venous thromboembolism vte, prevention of. The use of anticoagulants in morbidly obese patients via medica. Weight categories and number of obese patients in major phase iii trials. Antiarrhythmic and doac dosing in obesity medpage today.
Direct oral anticoagulants in extremely obese patients. Due to its constantly growing incidence, obesity is an increasingly serious social and medical problem. While traditional anticoagulant therapy often requires pharmacodynamic pd monitoring e. Direct oral factor xa inhibitors in patients with morbid obesity the. Comparative efficacy and safety associated with apixaban and. A clinical experience using the plasmatic drug evaluation vincenzo russo, 1 andrea paccone, 2 anna rago, 1 valeria maddaloni, 3 dario iafusco, 4 riccardo proietti, 5 umberto atripaldi, 3 antonio donofrio, 1 paolo golino, 1 and gerardo nigro 1. Apixiban 5mg or less dose or rivaroxaban 10mg or less dose. Apr 15, 2018 the lmwh agent enoxaparin lovenox has no official dosing recommendations for these patients,3 but data in this population suggest that a reduced weightbased dose less than 1 mg per kg is.
Apixabans package insert states that patients with atrial fibrillation may receive full dose apixaban 5 mg twice daily while on hemodialysis as long as they are under the age of 80 and weigh above 60 kg. Evaluation of antixa levels in morbidly obese patients. Inhibition of cardiac myocyte and fibroblast death 5. Weighing the options for anticoagulation in obesity. Apixaban was the most commonly used anticoagulant in each class, followed by rivaroxaban. Discuss dosing and monitoring strategies when using low molecular weight heparin outline evidence and recommendations for utilization of direct oral anticoagulants. Use is not recommended moderate to severe hepatic impairment associated with coagulopathy and clinically relevant bleeding risk. A new anticoagulant blood thinner that reduces the risk of stroke blood. Sep 20, 2019 nonvalvular atrial fibrillation patients. Department of internal medicine, university of utah, usa. Dec 15, 2010 aggressive weightbased dosing guidelines help achieve prompt therapeutic anticoagulation in patients with venous thromboembolism vte. This guideline should be used in conjunction with therapeutic goods administration tga approved product information, clinical. Our institution developed an inpatient protocol with reduced enoxaparin doses 0.
Drugs that commonly require dose adjustment in obese patients include lowmolecularweight heparins, 8 aminoglycoside antibiotics, 9 some anaesthetics, 10 monoclonal antibodies and chemotherapeutics. Hence, there may be at least 70 000 extremely obese patients in the. People who take eliquis, and have medicine injected into their spinal and epidural area, or have a spinal puncture have a risk of forming a blood clot that can cause longterm or permanent loss of the ability to move paralysis. Weighing the options for anticoagulation in obesity caitlin s. Age 80 years or olderbody weight 60 kg or lessserum creatinine 1. Background vitamin k antagonists have been shown to prevent stroke in patients with atrial fibrillation. Noac prescription were available for 1144 patients 85%. The major outcome was the composite of new or recurrent vte, stroke. Aggressive weightbased dosing guidelines help achieve prompt therapeutic anticoagulation in patients with venous thromboembolism vte. Increased risk of major bleeding in underweight patients. Monitoring of apixaban in a super obese patient the american. The initial dose should be taken 12 to 24 hours after surgery. If a patient is on dialysis and is above the age of 80 or weighs. Safety of doacs in patients of extreme weight blood.
The safety and effectiveness of the reduced dose of apixaban appeared to be unchanged from the standard dose of apixaban in patients with. This limits the strength of conclusions about the safety and efficacy of rivaroxaban in the extremely obese patients. Efficacy and safety of apixaban versus warfarin in. This was a retrospective, single center analysis of morbidly obese mo compared to nonobese patients no prescribed apixaban or rivaroxaban for vte or nvaf between august 2016 and august 2017.
Dec 02, 2016 however, there are no specific dosing recommendations for doacs in patient with extreme body weight because these agents were not well represented in the clinical trials, and no specific trials examining safety or efficacy in patients of extreme weight have been conducted. May 24, 2019 present data for a cohort of 795 morbidly obese patients bmi. No meal requirements or food restrictionsfood does not affect the bioavailability of eliquis. Discontinue eliquis in patients with active pathological hemorrhage. Apixaban over 5 mg dose within last 8 hours, rivaroxaban over 10mg dose within last 8 hours thrombolytic therapy. Effect of extremes of body weight on the pharmacokinetics. The lmwh agent enoxaparin lovenox has no official dosing recommendations for these patients,3 but data in this population suggest that a reduced weightbased dose less than 1 mg per kg is. The 2012 chest guidelines suggest monitoring therapy with antixa levels for obese patients but no definition of obesity is given. The prevalence of obesity is increasing worldwide, and obesity is a known risk factor. The effect of obesity on the pharmacokinetics of enoxaparin is not clearly understood and traditional treatment doses in morbidly obese patients body mass index bmi 40 kgm2 can lead to over anticoagulation. Mar 14, 20 while traditional anticoagulant therapy often requires pharmacodynamic pd monitoring e. While obese patients with vte face an increased risk of recurrence, physicians typically resist prescribing doses two to three times the usual dose because of. The us fda requires a risk evaluation and mitigation strategy rems for apixaban.
Characteristics of patients prescribed the standard and reduced apixaban doses are shown in table viii in the onlineonly data supplement. Apixaban s package insert states that patients with atrial fibrillation may receive full dose apixaban 5 mg twice daily while on hemodialysis as long as they are under the age of 80 and weigh above 60 kg. Evidence from the pivotal trials of doacs suggests that current dosing is safe and effective in obese patients, suggesting that an obesity paradox is present in patients with af. Comparative efficacy and safety associated with apixaban. Apixaban in a morbid obese patient with atrial fibrillation. Apixaban in patients with atrial fibrillation nejm.
Anticoagulant therapies and outcomes in obese patients. The majority of obese patients prescribed doacs received standard doses, whereas the use of traditional therapies demonstrated almost onequarter of patients on a. Increased body weight is associated with 30% lower exposure to standard doses of doacs, raising concerns about adequate dosing in obese. Apixaban oral tablet is a prescription drug used to treat and prevent blood clots such as deep vein thrombosis dvt and pulmonary embolism pe. Four doacs are approved for clinical use in canada. The 2012 chest guidelines suggest monitoring therapy with antixa levels for. There was no significant difference in individual anticoagulant choice by bmi class. Apixaban and rivaroxaban any dose over 8 hours after taking high dose. Advise patients of signs and symptoms of blood loss and to report them immediately or go to an emergency room. For patients receiving eliquis doses of 5 mg or 10 mg twice daily, when eliquis is coadministered with drugs that are combined pgp and strong cyp3a4 inhibitors e. Study intervention weight kg bmi number % of obese patients aristole atrial fibrillation apixaban 5mg bid warfarin na 285 285 bmi. Deep vein thrombosis dvt and pulmonary embolism pe treatment. Apixaban is an oral, direct factor xa inhibitor that inhibits both free and clotbound factor xa, and has been approved for clinical use in several thromboembolic disorders, including reduction of stroke risk in nonvalvular atrial fibrillation, thromboprophylaxis following hip or knee replacement surgery, the treatment of deep vein thrombosis or pulmonary embolism, and prevention of recurrent. Eliquis apixaban is not for patients with artificial heart valves.
Dosing of direct oral anticoagulants in obese patients. Apixaban is a novel oral direct factor xa inhibitor that. Despite recommendations advising against the use of doacs for acute vte in morbidly obese patients, practice patterns in alberta indicate substantial usage of doacs in obese patients. In patients undergoing knee replacement surgery, the recommended duration of treatment is 12 days. However, many patients are not suitable candidates for or are unwilling to receive vitamin k. Anticoagulating obese patients in the modern era patel. Apr 15, 2018 to our knowledge, the only clinical trial that addresses the question of apixaban use for venous thromboembolism in patients with impaired renal function is the amplify study. The study reported that none of the patients who had available clinical data n 2238 had recurrent vte or stroke, though information surrounding follow. Backgroundvitamin k antagonists are highly effective in preventing stroke in patients with atrial fibrillation but have several limitations. Of note, the obese patients were significantly younger, but without difference in cha 2 ds 2vasc score overall average 2. In 2016, the international society on thrombosis and haemostasis isth published a guidance document, use of the direct oral anticoagulants in obese patients. Direct oral factor xa inhibitors in patients with morbid obesity.
In amplify, patients in the eliquis arm received eliquis 5 mg twice daily for 6 months. If a patient is on dialysis and is above the age of 80 or weighs under 60 kg then the dose is reduced to 2. Data on the clinical efficacy and safety of doacs in obese patients are limited. However, there are no specific dosing recommendations for doacs in patient with extreme body weight because these agents were not well represented in the clinical trials, and no specific trials examining safety or efficacy in patients of extreme weight have been conducted. Pdf the use of anticoagulants in morbidly obesity patients. The majority of data pertaining to the dosing of lmwh in obese patients for vte prophylaxis has been collected from patients undergoing bariatric surgery, with enoxaparin being the most common agent assessed. Apixaban, like other anticoagulants, is contraindicated in patients at high risk for bleeding pregnantbreastfeeding. The anticoagulant effect of apixaban can be expected to persist for at least 24 hours after the last dose i. In 2002, scholten et al compared enoxaparin 30 mg twice daily vs enoxaparin 40 mg twice daily in a population consisting of 481 patients.
No dose adjustments for patients with renal impairment, including those with endstage renal disease esrd on. Assessing an enoxaparin dosing protocol in morbidly obese. Apixaban pharmacokinetics in bariatric patients apb. To our knowledge, the only clinical trial that addresses the question of apixaban use for venous thromboembolism in patients with impaired renal function is. Pdf dosing of direct oral anticoagulants in obese patients. Eliquis apixaban dosing, indications, interactions. However, due to small cohorts, further investigation is required for those weighing 120 kg or with a bmi. Clarification for apixaban dosing in patients with. Aug 16, 2011 anticoagulating obese patients in the modern era. Apr 02, 2015 to determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in patients with a body mass index bmi of 35 kgm2 or greater following one of two bariatric surgical procedures preoperative versus postoperative vertical sleeve gastrectomy or rouxeny gastric bypass patients. If anticoagulation with apixaban must be discontinued for a reason other than pathological bleeding, coverage with another anticoagulant should be strongly considered see dosing considerations. Given the limitations of its findings, this study does not increase our comfort to use doacs in extremely obese patients. Kido and ngorsuraches also showed no difference in ischemic stroke or major bleeding in doacs compared with warfarin in morbidly obese patients with af.
Discuss why obese patients require different dosing strategies of parenteral anticoagulants than non. Apixaban is safe and effective in morbidly obese patients. An increased rate of stroke was observed following discontinuation of apixaban in clinical trials in patients with nonvalvular atrial fibrillation. Outcomes associated with apixaban use in patients with end. Update on the use of doacs in obese patients thrombosis uk. Dosing of unfractionated heparin in obese patients with. In the apixaban group, 1034 44% patients were prescribed the standard dose 5 mg twice a day, and 17 56% patients were prescribed the reduced dose 2. The data, which are available on the use of novel oral anticoagulants in morbidly obese and. Treatment of venous thromboembolism in patients who are. Use of the direct oral anticoagulants in obese patients.
Dec 24, 2018 in 2016, the international society on thrombosis and haemostasis isth published a guidance document, use of the direct oral anticoagulants in obese patients. Currently, four doacs dabigatran, rivaroxaban, apixaban, and edoxaban. To determine the durability or change in pharmacokinetics and pharmacodynamics of apixaban in patients with a body mass index bmi of 35 kgm2 or greater following one of two bariatric surgical procedures preoperative versus postoperative vertical sleeve gastrectomy or rouxeny gastric bypass patients. We investigated clinical outcomes of vte recurrence, stroke and bleeding in morbidly obese patients on apixaban. In patients undergoing hip replacement surgery, the recommended duration of treatment is 35 days. Currently, four doacs dabigatran, rivaroxaban, apixaban, and. Multiple studies have found decreased mortality among obese patients compared to nonobese patients with vte ii. Due to minimal representation of morbidly obese patients in the.
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