Analysis of the projected utility of dabigatran, rivaroxaban, and apixaban and their future impact on existing Hematology and Cardiology Anticoagulation Clinics at The Johns Hopkins Hospital
Abstract:The purpose of this study is to determine the percentage of patients in the Johns Hopkins Anticoagulation Clinics that are potential candidates for the new oral anticoagulants, dabigatran, rivaroxaban, and apixaban. A retrospective chart review was conducted of patients managed in the Johns Hopkins Cardiology and Hematology Anticoagulation Clinics between November 1, 2009 and October 31, 2010. Data elements collected include demographics, primary indication for anticoagulation, renal function, hepatic function… Show more
“…[77] The prescriber needs to be aware of potential drug-drug interaction, renal and hepatic insufficiency and most of all need for anticoagulation depending on the risk factors. [78,79] There is no data for their use in acute stroke and uncontrolled hypertension; although, all three NOACs have proven to cause significantly less intracranial bleeds. [80] Clinicians should consider avoiding dabigatran in patients who have pre-existing dyspepsia as it is one of the major non-bleeding cause of patient non-compliance.…”
Section: Noacs In Perioperative Settingsmentioning
With the adoption of dabigatran, rivaroxaban, and apixaban into clinical practice, a new era has arrived in the practice of oral anticoagulants. Venous thromboembolism (VTE) has traditionally been underdiagnosed and under treated in Asia. With increasing longevity, the diagnosis and the need for management of atrial fibrillation (AF) and VTE is likely to increase significantly. The new orally active anticoagulants (NOACs) have reasonably filled the lacunae that clinicians traditionally faced when treating patients with vitamin K antagonist (VKA). Unlike VKA, NOACs do not need frequent monitoring. Therefore, more patients are likely to get therapeutic effects of anticoagulation and thus reduce morbidity and mortality associated with VTE and AF. However, the clinicians need to be circumspect and exercise caution in use of these medications. In particular (in geriatric population), the clinicians should look out for drug-drug interactions and underlying renal insufficiency. This would ensure therapeutic efficacy and minimize bleeding complications. Here, it is important to note that the antidote for NOACs is not available and is a major concern if emergency surgical procedure is required in their presence.
“…[77] The prescriber needs to be aware of potential drug-drug interaction, renal and hepatic insufficiency and most of all need for anticoagulation depending on the risk factors. [78,79] There is no data for their use in acute stroke and uncontrolled hypertension; although, all three NOACs have proven to cause significantly less intracranial bleeds. [80] Clinicians should consider avoiding dabigatran in patients who have pre-existing dyspepsia as it is one of the major non-bleeding cause of patient non-compliance.…”
Section: Noacs In Perioperative Settingsmentioning
With the adoption of dabigatran, rivaroxaban, and apixaban into clinical practice, a new era has arrived in the practice of oral anticoagulants. Venous thromboembolism (VTE) has traditionally been underdiagnosed and under treated in Asia. With increasing longevity, the diagnosis and the need for management of atrial fibrillation (AF) and VTE is likely to increase significantly. The new orally active anticoagulants (NOACs) have reasonably filled the lacunae that clinicians traditionally faced when treating patients with vitamin K antagonist (VKA). Unlike VKA, NOACs do not need frequent monitoring. Therefore, more patients are likely to get therapeutic effects of anticoagulation and thus reduce morbidity and mortality associated with VTE and AF. However, the clinicians need to be circumspect and exercise caution in use of these medications. In particular (in geriatric population), the clinicians should look out for drug-drug interactions and underlying renal insufficiency. This would ensure therapeutic efficacy and minimize bleeding complications. Here, it is important to note that the antidote for NOACs is not available and is a major concern if emergency surgical procedure is required in their presence.
“…DOACs, such as rivaroxaban, dabigatran, and apixaban, are regarded as advantageous alternatives to warfarin due to not normally requiring dosage adjustments or blood test monitoring 5 . Moreover, DOACs have been regarded as safer due to more predictable pharmacokinetics, fewer critical bleeding related side effects, and fewer adverse interactions with food, alcohol, prescribed medications and over the counter remedies 13,14 . Collectively, these factors are believed to contribute to increased uptake and adherence to DOACs when compared to warfarin 15 .…”
Section: Introductionmentioning
confidence: 99%
“…5 Moreover, DOACs have been regarded as safer due to more predictable pharmacokinetics, fewer critical bleeding related side effects, and fewer adverse interactions with food, alcohol, prescribed medications and over the counter remedies. 13,14 Collectively, these factors are believed to contribute to increased uptake and adherence to DOACs when compared to warfarin. 15 DOACs are not without limitations however.…”
Background: In the treatment of atrial fibrillation (AF), anticoagulant medications such as warfarin and rivaroxaban are commonly prescribed to reduce the risk of ischaemic strokes, and other thromboembolic events. Research has highlighted advantages and disadvantages of each of these medications, but there remains an absence of qualitative evidence regarding the lived experiences of AF patients. The present study helps address this gap and obtain a greater understanding of the patient experience and beliefs surrounding their anticoagulant medication.Method: Semi-structured qualitative interviews with a purposive sample of 20 participants (10 warfarin, 10 rivaroxaban). Interviews were transcribed verbatim and thematically analysed.Results: Data analysis led to the generation of three key themes: positive perceptions of medication, distrust of alternatives, and inconsistencies in support experiences.Conclusions: Positive perceptions of one anticoagulant medication (ACM) and distrust of alternatives may influence patients' confidence in switching medications. This is potentially problematic where there is a lack of patient engagement in medication changes, as seen during the COVID pandemic. Gaps in patient understanding of anticoagulation, including lack of clarity around medications selection and misconceptions about treatment, were evident. By addressing these misconceptions, clinicians may be better positioned to support people with AF in self-management of their ACM.
“…For example, some newly developed oral anticoagulants, such as dabigatran (Pradaxa®; Boehringer Ingelheim, Ingelheim, Germany) and rivaroxaban (Xarelto®; Bayer HealthCare AG, Leverkusen, Germany & Johnson) show similar or superior efficacy to warfarin but do not require continual monitoring (Connolly et al, 2009;Hankey et al, 2012). However, contraindications such as active pathological bleeding and severe hypersensitivity reactions coupled with the lack of antidotes are hindering the use of these novel anticoagulants in the clinical setting (Carter et al, 2012;Chen et al, 2012).…”
The preclinical safety of a newly developed oral anticoagulant, the low molecular weight heparin-deoxycholate conjugate (OH09208), was evaluated by a comprehensive evaluating program in compliance with standard guidelines. The single dose oral toxicity study in rats receiving 2000 and 5000 mg kg(-1) of OH09208 did not reveal any mortality, unusual body weight changes or necropsy findings. The results of the 4-week oral toxicity study with a 4-week recovery program in rats receiving OH09208 in doses of 100, 300 and 1000 mg kg(-1) day(-1) did not reveal any mortality, or indicate any unusual clinical signs, or show any toxicokinetic relationships to the administration of OH09208. Although the increase in liver enzymes in one male dog treated with 300 mg kg(-1) day(-1) and one female dog treated with 1000 mg kg(-1) day(-1) could not be excluded from the effect of the test substance, no other toxicologically significant changes were observed in the 4-week oral toxicity study with a 4-week recovery in beagle dogs. Thus, while the no-observed-adverse-effect level value from the 4-week study in both male and female rats was 1000 mg kg(-1) day(-1), those from the 4-week study in male and female beagle dogs were 300 and 1000 mg kg(-1) day(-1), respectively. Furthermore, OH09208 did not induce anaphylactic reactions in guinea pigs, micronucleated bone marrow cells in male ICR mice, chromosomal aberration in Chinese hamster lung cell lines, bacterial reverse mutation, and any abnormalities in hERG current assay, mouse central nervous system and dog cardiovascular studies. Overall, there were no unexpected toxicities in this preclinical study that might have precluded the safe administration of OH09208 to humans.
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