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Concomitant Anticoagulant and Antidepressant Therapy in Atrial Fibrillation Patients and Risk of Stroke and Bleeding.
In conclusion, concomitant use of an OAC and an AD is associated with an increased bleeding risk. PMID: 31506933 [PubMed - as supplied by publisher]
Source: Clinical Pharmacology and Therapeutics - September 9, 2019 Category: Drugs & Pharmacology Authors: Komen JJ, Hjemdahl P, Mantel-Teeuwisse AK, Klungel OH, Wettermark B, Forslund T Tags: Clin Pharmacol Ther Source Type: research

Thromboembolic and hemorrhagic outcomes in the direct oral anticoagulant trials across the spectrum of kidney function.
Abstract Chronic kidney disease (CKD) is a common comorbidity among patients taking direct-acting oral anticoagulants (DOACs). Herein, we evaluate the influence of kidney function on Stroke/SEE, hemorrhage and composite endpoints (Stroke/SEE/hemorrhage/death and Stroke/SEE/death) among patients on DOACs and warfarin. Baseline kidney function was categorized as GFR≥60 (reference), 45-59 and <45ml/min/1.73m2 for participants in the RE-LY (n=18,049), ARISTOTLE (n=18,187), and ENGAGE AF (n=20,798) trials. Incidence of events was compared across GFR categories. Hazard ratios for events was estimated using Cox regr...
Source: Clinical Pharmacology and Therapeutics - December 5, 2020 Category: Drugs & Pharmacology Authors: Limdi NA, Beasley TM, Sun J, Stockbridge N, Pacanowski M, Florian J Tags: Clin Pharmacol Ther 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

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

Simulation for predicting effectiveness and safety of new cardiovascular drugs in routine care populations.
This article is protected by copyright. All rights reserved. PMID: 29424437 [PubMed - as supplied by publisher]
Source: Clinical Pharmacology and Therapeutics - February 9, 2018 Category: Drugs & Pharmacology Authors: Najafzadeh M, Schneeweiss SS, Choudhry NK, Wang SV, Gagne JJ Tags: Clin Pharmacol Ther Source Type: research

Personalizing Direct Oral Anticoagulant Therapy for a Diverse Population: Role of Race, Kidney Function, Drug Interactions and Pharmacogenetics
Clin Pharmacol Ther. 2022 Jul 20. doi: 10.1002/cpt.2714. Online ahead of print.ABSTRACTOral anticoagulants (OACs) are commonly used to reduce the risk of venous thromboembolism (VTE) and the risk of stroke in patients with atrial fibrillation (AF). Endorsed by the American Heart Association, American College of Cardiology, and the European Society of Cardiology, direct oral anticoagulants (DOACs) have displaced warfarin as the OAC of choice for both conditions, due to improved safety profiles, fewer drug-drug and drug-diet interactions, and lack of monitoring requirements. Despite their widespread use and improved safety o...
Source: Clinical Pharmacology and Therapeutics - July 20, 2022 Category: Drugs & Pharmacology Authors: Lorenzo E Thompson Brittney H Davis Renuka Narayan Blake Goff Todd M Brown Nita A Limdi Source Type: research

Comparison of Efficacy and Safety of Direct Oral Anticoagulants and Warfarin between Patients in Asian and non-Asian Regions: A Systematic Review and Meta-Regression Analysis
Clin Pharmacol Ther. 2023 Mar 2. doi: 10.1002/cpt.2881. Online ahead of print.ABSTRACTDirect oral anticoagulants (DOACs) have increasingly replaced warfarin for treating patients with non-valvular atrial fibrillation (NVAF). DOACs have been demonstrated to be more useful than warfarin which was highlighted at its ethnic differences in efficacy and safety; however, the regional differences of DOACs remain unclear. We conducted a systematic review, meta-analysis, and meta-regression to evaluate the efficacy and safety of DOACs in patients from Asian and non-Asian regions with NVAF. We systematically searched randomized contr...
Source: Clinical Pharmacology and Therapeutics - March 2, 2023 Category: Drugs & Pharmacology Authors: Kaori Ambe Ayu Akita Jie Wei Yuka Yoshii Mayu Onishi Masahiro Tohkin Source Type: research