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Source: Drug Safety
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Total 32 results found since Jan 2013.
Impact of Lifestyle and Socioeconomic Position on the Association Between Non-steroidal Anti-inflammatory Drug Use and Major Adverse Cardiovascular Events: A Case-Crossover Study
ConclusionsThe relative increase in cardiovascular risk associated with NSAID use was not modified by lifestyle or socioeconomic position.
Source: Drug Safety - May 2, 2023 Category: Drugs & Pharmacology Source Type: research
Development and Evaluation of the Algorithm CErtaInty Tool (ACE-IT) to Assess Electronic Medical Record and Claims-based Algorithms ’ Fit for Purpose for Safety Outcomes
ConclusionThe ACE-IT supports a structured, transparent, and flexible approach for decision-makers to appraise whether electronic health record or medical claims-based algorithms for safety outcomes are FFP for a specific decision context. Reliability and validity testing using a larger sample of participants in other therapeutic areas and further modifications to reduce the time needed to complete the assessment are needed to fully evaluate its utility for regulatory decision-making.
Source: Drug Safety - November 17, 2022 Category: Drugs & Pharmacology Source Type: research
Efficacy and Safety of Anticoagulants in Patients with Atrial Fibrillation and History of Falls or Risk of Falls: A Systematic Review and Multilevel Meta-Analysis
ConclusionNOACs were associated with less intracranial hemorrhages and ischemic strokes/systemic embolisms than VKAs in AF patients at risk of falls. These findings suggesting preferred use of NOACs over VKAs have clinical implications for physicians, patients and policy makers.
Source: Drug Safety - October 21, 2022 Category: Drugs & Pharmacology Source Type: research
Cardiovascular Risk in Users of Mirabegron Compared with Users of Antimuscarinic Treatments for Overactive Bladder: Findings from a Non-Interventional, Multinational, Cohort Study
ConclusionsThis large, multinational study found no higher risk of MACE, AMI, stroke, CV mortality or all-cause mortality among users of mirabegron relative to users of antimuscarinics.
Source: Drug Safety - August 1, 2021 Category: Drugs & Pharmacology Source Type: research
Identification and Validation of Major Cardiovascular Events in the United Kingdom Data Sources Included in a Multi-database Post-authorization Safety Study of Prucalopride
ConclusionsGiven the limitations of relying solely on computer algorithms to identify cardiovascular outcomes, validation with clinical review is essential to guide interpretation.
Source: Drug Safety - February 19, 2021 Category: Drugs & Pharmacology Source Type: research
Neuroprotective Cationic Arginine-Rich Peptides (CARPs): An Assessment of Their Clinical Safety
AbstractCationic arginine-rich peptides represent a novel class of peptides being developed as neuroprotective agents for stroke and other acute and chronic neurological disorders. As a group, cationic arginine-rich peptides have a diverse range of other biological properties including the ability to traverse cell membranes, modulate immune responses, antagonise ion channel receptor function, as well as possessing cardioprotective, anti-nociceptive, anti-microbial and anti-cancer properties. A sound understanding of their safety profile is essential for the design of future clinical trials and for ensuring translational su...
Source: Drug Safety - June 30, 2020 Category: Drugs & Pharmacology Source Type: research
Comparative Outcomes Between Direct Oral Anticoagulants, Warfarin, and Antiplatelet Monotherapy Among Chinese Patients with Atrial Fibrillation: A Population-Based Cohort Study
ConclusionAntiplatelet prescribing and suboptimal warfarin management remain common in Chinese patients with AF at high risk of stroke. DOAC use may be associated with a lower risk of ischemic stroke and all-cause mortality when compared with antiplatelets and with a lower risk of ICH when compared with warfarin.
Source: Drug Safety - June 17, 2020 Category: Drugs & Pharmacology Source Type: research
Channeling Bias in the Analysis of Risk of Myocardial Infarction, Stroke, Gastrointestinal Bleeding, and Acute Renal Failure with the Use of Paracetamol Compared with Ibuprofen
ConclusionsFor paracetamol versus ibuprofen, when using LSPS methods in the CPRD, it is only possible to distinguish true effects if those effects are large (hazard ratio > 2). Due to their smaller hazard ratios, the outcomes under study cannot be differentiated from null effects (represented by negative controls) even if there were a true effect. Based on these data, we conclude that we are unable to determine whether paracetamol is associated with an increased ris k of myocardial infarction, stroke, GI bleeding, and acute renal failure compared to ibuprofen, due to residual confounding.
Source: Drug Safety - June 3, 2020 Category: Drugs & Pharmacology Source Type: research
A Post-Authorization Safety Study of Quetiapine as Antidepressant Treatment in Sweden: Nested Case –Control Analyses of Select Outcomes
ConclusionRisks for all-cause mortality, self-harm and suicide, and stroke in older patients may be higher among patients treated with quetiapine and antidepressant combination therapy.
Source: Drug Safety - December 16, 2019 Category: Drugs & Pharmacology Source Type: research
Measuring the Effectiveness of Safety Warnings on the Risk of Stroke in Older Antipsychotic Users: A Nationwide Cohort Study in Two Large Electronic Medical Records Databases in the United Kingdom and Italy
ConclusionAntipsychotic safety warnings were followed by a reduction in stroke incidence among older antipsychotic users in the UK, but not Italy.
Source: Drug Safety - September 24, 2019 Category: Drugs & Pharmacology Source Type: research
Comparative Effectiveness and Safety of Direct Oral Anticoagulants: Overview of Systematic Reviews
AbstractDirect oral anticoagulants are now recommended by major guidelines as first-choice agents for both stroke prevention in non-valvular atrial fibrillation and treatment/prevention of venous thromboembolism in non-cancer patients. Although there are no published head-to-head trials comparing different direct oral anticoagulants, a growing body of evidence from indirect comparisons and observational studies is suggesting that each direct oral anticoagulant may have a specific risk profile. This review aims to (1) synthesize and critically assess the latest evidence in comparative effectiveness and safety research in th...
Source: Drug Safety - September 23, 2019 Category: Drugs & Pharmacology Source Type: research
