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Effectiveness and safety of Dabigatran 110 mg versus 150 mg for Stroke Prevention in Patients with Atrial Fibrillation at High Bleeding Risk
Clin Ther. 2023 Jun 26:S0149-2918(23)00192-3. doi: 10.1016/j.clinthera.2023.05.007. Online ahead of print.ABSTRACTPURPOSE: The effectiveness and tolerability of a reduced dose (110 mg) of dabigatran versus the standard dose (150 mg) were evaluated in subgroups of patients with atrial fibrillation (AF) at high bleeding risk.METHODS: Eligible patients were adults with AF and a creatinine clearance rate ≥30 mL/min who were initiated on treatment with dabigatran (index) between 2016 and 2018. High-bleeding-risk subgroups were identified: (1) age ≥80 years; (2) moderate renal impairment (creatinine clearance rate 30-<50 ...
Source: Clinical Therapeutics - June 28, 2023 Category: Drugs & Pharmacology Authors: Jaejin An T Craig Cheetham Tiffany Luong Daniel T Lang Ming-Sum Lee Kristi Reynolds Source Type: research

Predicting treatment effects of a new-to-market drug in clinical practice based on phase III randomized trial results
Clin Pharmacol Ther. 2023 Jun 26. doi: 10.1002/cpt.2983. Online ahead of print.ABSTRACTTrial results may not be generalizable to target populations treated in clinical practice with different distributions of baseline characteristics that modify the treatment effect. We used outcome models developed with trial data to predict treatment effects in Medicare populations. We used data from the Randomized Evaluation of Long-Term Anticoagulation Therapy trial (RE-LY), which investigated the effect of dabigatran vs. warfarin on stroke or systemic embolism (stroke/SE) among patients with atrial fibrillation. We developed outcome m...
Source: Clinical Pharmacology and Therapeutics - June 27, 2023 Category: Drugs & Pharmacology Authors: HoJin Shin Shirley V Wang Dae Hyun Kim Ethan Alt Mufaddal Mahesri Lily G Bessette Sebastian Schneeweiss Mehdi Najafzadeh Source Type: research

Non-major bleeding risk of direct oral anticoagulants versus vitamin K antagonists for stroke prevention with atrial fibrillation: a systematic review and network meta-analysis
ConclusionsBased on current evidence, for stroke prevention in patients with AF, the safest DOAC is apixaban in terms of non-major bleeding. This suggests that apixaban may have a lower risk of non-major bleeding than other anticoagulants and may help provide some clinical reference for choosing a more appropriate drug for the patient.
Source: European Journal of Clinical Pharmacology - June 13, 2023 Category: Drugs & Pharmacology Source Type: research

DOAC Dosing Discordance Using Different Estimates of Kidney Function and Outcomes
This article is protected by copyright. All rights reserved.PMID:37178305 | DOI:10.1002/jcph.2283
Source: The Journal of Clinical Pharmacology - May 13, 2023 Category: Drugs & Pharmacology Authors: Nauka J Bhalodia Jesse Cheng Connor R Deri Kelsey Stahl Heather Heiney Olivia Marchionda Carlo J Iasella James C Coons Source Type: research

Impact of direct oral anticoagulant concentration on clinical outcomes in Asian patients with atrial fibrillation
In conclusion, trough DOAC concentration measurements should be considered among patients at risk of out-of-expected range DOAC concentrations.PMID:37132484 | DOI:10.1002/cpt.2927
Source: Clinical Pharmacology and Therapeutics - May 3, 2023 Category: Drugs & Pharmacology Authors: Shin-Yi Lin Sung-Chun Tang Ching-Hua Kuo Li-Ting Ho Yen-Bin Liu Yu-Fong Peng Li-Kai Tsai Chih-Fen Huang Jiann-Shing Jeng Source Type: research

Increased major bleeding incidence in atrial fibrillation patients with apixaban: a review of Japanese post-marketing surveillance studies of direct oral anticoagulants
AbstractLarge-scaled post-marketing surveillance studies (PMSSs) of 4 direct oral anticoagulants (DOACs) for stroke prevention in non-valvular atrial fibrillation (AF) were conducted since 2011 in Japan, and the results of the last one have recently been published. Each reported a more than acceptable ischemic stroke prevention. The major bleeding rates were also acceptably low and comparable to each other in the PMSSs of dabigatran (J-dabigatran), rivaroxaban (XAPASS), and edoxaban (ETNA-AF-Japan). However, the incidence in PMSS of apixaban (STANDARD) was more than double the others. This finding appeared to contradict th...
Source: European Journal of Clinical Pharmacology - April 25, 2023 Category: Drugs & Pharmacology Source Type: research

Dabigatran Dosing Proposal for Adults with Atrial Fibrillation: Stress-testing Renal Function Range in Real World Patients
Clin Pharmacol Ther. 2023 Apr 7. doi: 10.1002/cpt.2902. Online ahead of print.ABSTRACTDabigatran is the first of four direct-acting oral anticoagulants approved to prevent stroke in adult patients with atrial fibrillation using a fixed 2-dose scheme compared to warfarin dosing adjusted to a prothrombin time range associated with optimal risk reduction in stroke and serious bleeding. The pivotal phase 3 trial found dabigatran, depending on dose, is superior to warfarin in stroke reduction and similar in bleeding risk while also showing dabigatran efficacy and safety correlate with steady-state plasma concentrations. Since t...
Source: Clinical Pharmacology and Therapeutics - April 7, 2023 Category: Drugs & Pharmacology Authors: J Robert Powell Farah Al Qaraghuli Jill Fiedler-Kelly Daniel Gonzalez Daniel Weiner Source Type: research

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