title: Evaluation of Trends of Inpatient Hospitalisation for Significant Haemorrhage in Patients Anticoagulated for Atrial Fibrillation before and after the Release of Novel Anticoagulants.
abstract: Compared to Vitamin K antagonists (VKA), novel oral anticoagulants (NOACs) appear to be safer in terms of major bleeding risks with added advantage of having fixed dosing schedules when used in patients with non-valvular atrial fibrillation (AF). We sought to study the differences as sources and severity of anticoagulant-associated haemorrhage in patients with AF in the year preceding introduction of NOACs (first cohort) as compared to post approval of the NOACs (second cohort) by retrospectively reviewing the hospital admissions, as well as the pharmacodynamic and pharmacokinetic interactions between time periods. There were 359 patients for the first cohort and 405 patients for the second cohort, including 57 patients prescribed NOACs. There was no significant difference in age, deaths, source of bleeding, or rate of pharmacokinetic or pharmacodynamic interaction between the two time periods. Comparing all VKA patients to patients prescribed NOAC's, there were non-significant but higher rates of intracerebral bleed, significantly higher rates of pharmacokinetic (194 (25.4%) versus 0 (0%), p<.001) and similar rates of pharmacodynamic interactions (505 (66.1%) versus 39 (68.4%), p=.70). Drug-renal interactions were seen in 7 of the 57 (12.3%) NOAC-treated patients, in which all seven had acute renal failure that may have prolonged the effects of the anticoagulants. NOACs hold promise in that drug interactions are far less common than those seen in VKAs, and intracerebral bleeds appear to be less common in randomised trials as well as our review. For patients on dabigatran or rivaroxaban, consideration should be given to serial monitoring of renal function.
authors.affiliation: Department of Internal Medicine, Reading Health System, West Reading, PA, USA. Electronic address: badalmadan@gmail.com.
authors.forename: Madan
authors.initials: M
authors.lastname: Badal
authors.affiliation: Department of Internal Medicine, Reading Health System, West Reading, PA, USA.
authors.forename: Madan Raj
authors.initials: MR
authors.lastname: Aryal
authors.affiliation: Department of Pharmacy, Reading Health System, West Reading, PA, USA.
authors.forename: Joan
authors.initials: J
authors.lastname: Mege
authors.affiliation: Department of Cardiology, Thomas Jefferson University Hospital, Philadelphia PA, USA.
authors.forename: Ashok
authors.initials: A
authors.lastname: Chaudhary
authors.affiliation: Department of Internal Medicine, Reading Health System, West Reading, PA, USA.
authors.forename: Anthony A
authors.initials: AA
authors.lastname: Donato
mesh_terms: D000367:Age Factors; D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D001281:Atrial Fibrillation / Q000188:drug therapy / Q000401:mortality; D001562:Benzimidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D015331:Cohort Studies; D000069604:Dabigatran; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced / Q000401:mortality / Q000628:therapy; D006760:Hospitalization; D006801:Humans; D008297:Male; D009025:Morpholines / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D000069552:Rivaroxaban; D013876:Thiophenes / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics; D014812:Vitamin K / Q000037:antagonists & inhibitors*; D015091:beta-Alanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000493:pharmacokinetics
chemical_list: D000925:Anticoagulants; D001562:Benzimidazoles; D009025:Morpholines; D013876:Thiophenes; D015091:beta-Alanine; D014812:Vitamin K; D000069552:Rivaroxaban; D000069604:Dabigatran
keywords: Atrial fibrillation; Bleeding; Dabigatran; Novel anticoagulants; Rivaroxaban; Vitamin K antagonists