A new gap in the novel anticoagulants’ era

Abstract

After long years of using warfarin for atrial fibrillation, new oral anticoagulants (NOACs) became available for decreasing the risk of ischemic stroke. Our aim was to observe the physicians prescribing patterns of NOACs. This prospective observational study included patients using NOACs applying consecutively to our outpatient clinic. Physical examination was performed, and patient history, electrocardiogram, transthoracic echocardiography, and biochemical results were collected. Bleeding and ischemic stroke risk scores (HAS-BLED and CHA2DS2-VASc scores) were calculated. We evaluated patients' characteristics, risk factors, concomitant drug usage, and physicians' choices. The study consisted of 174 patients using NOACs (dabigatran 113 patients, rivaroxaban 61 patients), with a mean age of 70.7 ± 8.8 years. The mean HAS-BLED score was 1.74 ± 0.9 and the mean CHA2DS2-VASc score was 3.7 ± 1.2. Fifty-three (30.4%) patients were prescribed low-dose NOAC according to the optimal dose, and 12 (6.8%) patients were prescribed high-dose NOAC according to the optimal dose. We compared optimal dose and undertreatment groups to find out if there was any predicting factor for physicians to use low dose of NOACs, but there was no significant difference between the two groups for age, sex, concomitant chronic disease, and CHA2DS2-VASc and HAS-BLED scores. NOACs were prescribed to patients mostly with high CHA2DS2-VASc score and low HAS-BLED score. Low-dose NOAC usage according to the optimal dose was frequent. Frequent coagulation monitoring and drug incompliance are big deficiencies at atrial fibrillation in use of warfarin. NOACs overcome these difficulties; however, physicians' hesitation to use NOACs with the optimal dosage may be another limitation in real-world practice.

Impact of direct oral anticoagulant off‐label doses on clinical outcomes of atrial fibrillation patients: A systematic review

“…(C) Real‐world studies results concerning dose adjustments of apixaban. (D) Results from direct oral anticoagulants overall adjustments regarding dose appropriateness…”

“…However, these recommendations are not uniform worldwide, hampering the selection of the preferable posology and the identification of DOAC suboptimal use. Indeed, the approved doses and dose adjustment criteria defined by European Medicine Agency (EMA) and Food and Drugs Administration (FDA) are summarized in Table while the recommendations reported by Health Canada regulatory agency, European Society of Cardiology and Japanese guidelines, regarding DOAC dose adjustment in patients with AF, are presented in Table . Note that Japanese guidelines mention some differences in relation to EMA and FDA, particularly related to the smaller body size, different pharmacokinetic and genetic profiles of Asian populations when compared with European or American patients.…”

“…Indeed, the approved doses and dose adjustment criteria defined by European Medicine Agency (EMA) and Food and Drugs Administration (FDA) are summarized in Table 1 16,[18][19][20][21][22][23][24][25][26][27][28][29][30][31] while the recommendations reported by Health Canada regulatory agency, European Society of Cardiology and Japanese guidelines, regarding DOAC dose adjustment in patients with AF, are presented in Table 2. 7,19,[32][33][34][35][36][37][38][39][40] Note that Japanese guidelines mention some differences in relation to EMA and FDA, particularly related to the smaller body size, different pharmacokinetic and genetic profiles of Asian populations when compared with European or American patients. All these guidelines were, hence, herein taken into consideration to assess whether DOAC dose adjustment were justified or not and, therefore infer about the impact of DOAC off-label doses on clinical outcomes of patients with AF.…”

Switching, Adverse Effects and Use of Over‐the‐Counter Analgesics among Users of Oral Anticoagulants: A Pharmacy‐based Survey

“…This is accordance with a recent study by Belen et al . reporting inconvenience with warfarin therapy as the main cause of NOAC initiation in 60% of 174 patients. How this information was reported (from patients or physician) is, however, not described in the study.…”

Antithrombotic drug use: scientific breakthroughs, biological limits and physician behaviour

“…6 7 Undertreatment is an additional concern, as data suggest that physicians are prescribing lower doses of the novel anticoagulants to offset the risk of haemorrhage. 8 Given the current body of evidence, these decisions merit scrutiny as the 30-day mortality related to an ischaemic stroke in AF is 24%. A lack of consensus on the burden of AF that mandates lifelong anticoagulation undoubtedly is also contributing to this undertreatment as are the patient-directed 'BAD DRUG' advertisements that permeate the American media.…”