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, and concomitant medications. These factors were considered against product labeling guidelines and inclusion/exclusion criteria from clinical studies to derive candidacy status for each oral anticoagulant for each patient. Patients who met at least one caution or contraindication criteria were deemed "non-candidates"; potential dosage reductions of the new oral anticoagulants were not considered. Four hundred ninety-one patients participated in the study. Among participants, 63% would be dabigatran candidates, 62% rivaroxaban candidates, and 70% would be candidates for apixaban. Dabigatran use would be cautioned against in 34%, rivaroxaban in 18 %, and apixaban in 30%. Four percent had contraindications to dabigatran, whereas 21% had contraindications to rivaroxaban. More than 60% of patients in the Johns Hopkins Anticoagulation Clinics appear to be potential candidates for each of the new oral anticoagulants, assuming they are eventually approved for the same indications as warfarin. Many patients fell into the "cautioned" category, which demonstrates the complexity associated with selecting candidates for these new agents.

New orally active anticoagulants in critical care and anesthesia practice: The good, the bad and the ugly

“…[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.…”

“I just didn't want to trust it at all”: Atrial fibrillation patient's treatment experience of rivaroxaban and warfarin

“…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 .…”

“…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.…”

Preclinical safety evaluation of low molecular weight heparin–deoxycholate conjugates as an oral anticoagulant

“…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).…”