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Source: Clinical Pharmacology and Therapeutics
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Total 27 results found since Jan 2013.

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

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

The Impact of Longitudinal Data-Completeness of Electronic Health Record Data on the Prediction Performance of Clinical Risk Scores
Clin Pharmacol Ther. 2023 Apr 7. doi: 10.1002/cpt.2901. Online ahead of print.ABSTRACTThe impact of electronic health record (EHR) discontinuity, i.e., receiving care outside of a given EHR system, on EHR-based risk prediction is unknown. We aimed to assess the impact of EHR-continuity on performance of clinical risk scores. The study cohort consisted of patients aged ≥65 years with ≥1 EHR encounter in the two networks in Massachusetts (MA, 2007/1/1-2017/12/31, internal training and validation dataset), and one network in North Carolina (NC, 2007/1/1-2016/12/31, external validation dataset) that were linked with Medica...
Source: Clinical Pharmacology and Therapeutics - April 7, 2023 Category: Drugs & Pharmacology Authors: Yinzhu Jin Janick G Weberpals Shirley V Wang Rishi J Desai David Merola Kueiyu Joshua Lin 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

The Impact of Longitudinal Data-Completeness of Electronic Health Record Data on the Prediction Performance of Clinical Risk Scores
Clin Pharmacol Ther. 2023 Apr 7. doi: 10.1002/cpt.2901. Online ahead of print.ABSTRACTThe impact of electronic health record (EHR) discontinuity, i.e., receiving care outside of a given EHR system, on EHR-based risk prediction is unknown. We aimed to assess the impact of EHR-continuity on performance of clinical risk scores. The study cohort consisted of patients aged ≥65 years with ≥1 EHR encounter in the two networks in Massachusetts (MA, 2007/1/1-2017/12/31, internal training and validation dataset), and one network in North Carolina (NC, 2007/1/1-2016/12/31, external validation dataset) that were linked with Medica...
Source: Clinical Pharmacology and Therapeutics - April 7, 2023 Category: Drugs & Pharmacology Authors: Yinzhu Jin Janick G Weberpals Shirley V Wang Rishi J Desai David Merola Kueiyu Joshua Lin 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

The Impact of Longitudinal Data-Completeness of Electronic Health Record Data on the Prediction Performance of Clinical Risk Scores
Clin Pharmacol Ther. 2023 Apr 7. doi: 10.1002/cpt.2901. Online ahead of print.ABSTRACTThe impact of electronic health record (EHR) discontinuity, i.e., receiving care outside of a given EHR system, on EHR-based risk prediction is unknown. We aimed to assess the impact of EHR-continuity on performance of clinical risk scores. The study cohort consisted of patients aged ≥65 years with ≥1 EHR encounter in the two networks in Massachusetts (MA, 2007/1/1-2017/12/31, internal training and validation dataset), and one network in North Carolina (NC, 2007/1/1-2016/12/31, external validation dataset) that were linked with Medica...
Source: Clinical Pharmacology and Therapeutics - April 7, 2023 Category: Drugs & Pharmacology Authors: Yinzhu Jin Janick G Weberpals Shirley V Wang Rishi J Desai David Merola Kueiyu Joshua Lin 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

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

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