Clinical therapeutics
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Clinical therapeutics · Dec 2019
ReviewAngiotensin II: A New Vasopressor for the Treatment of Distributive Shock.
Angiotensin II (ATII) is a potent endogenous vasoconstrictor that has recently garnered regulatory approval for the treatment of distributive shock, including septic shock. Traditional vasoactive substances used in the management of distributive shock include norepinephrine, epinephrine, phenylephrine, and vasopressin. However, their use can be associated with deleterious adverse drug effects, such as splanchnic vasoconstriction and associated hypoperfusion. The purpose of this review is to describe ATII, including its pharmacologic mechanisms, pharmacokinetic profile, evidence of efficacy and tolerability, and potential role in contemporary critical care practice. ⋯ ATII represents a welcome addition to the armamentarium of critical care clinicians. Enthusiasm for the use of ATII should be balanced with the current gaps in our understanding of ATII in patients with shock. Until further evidence provides more clinically meaningful benefits, as well as cost-effectiveness compared with currently available vasopressors, critical care clinicians should reserve ATII for salvage therapy in patients with septic shock.
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Clinical therapeutics · Dec 2019
Clinical Benefit of Direct Oral Anticoagulants Versus Vitamin K Antagonists in Patients with Atrial Fibrillation and Bioprosthetic Heart Valves.
The use of direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF) and bioprosthetic heart valve is still controversial. The aim of this study was to compare the tolerability and effectiveness of treatment with DOACs versus vitamin K antagonists (VKAs) in patients with AF and a bioprosthetic heart valve in clinical practice. ⋯ According to these data from clinical practice, DOACs seem to be associated with a greater NCB versus VKAs in patients with AF with a bioprosthetic heart valve, primarily due to lower rates of both major bleeds and thromboembolic events.
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Clinical therapeutics · Nov 2019
Randomized Controlled Trial Comparative StudyComparison of the Level of Free Hexafluoro-isopropanol in Adults' Blood and the Incidence of Emergence Agitation After Anesthesia With Different Concentrations of Sevoflurane in Laparoscopic Gastrointestinal Surgery: A Randomized Controlled Clinical Trial.
The aim of the study is to compare the free hexafluoro-isopropanol (HFIP) concentration in adults' blood and the incidence of emergence agitation (EA) after inhaled different concentrations of sevoflurane. ⋯ The generation of HFIP would be inhibited when the inhaled sevoflurane concentration increased to 1.5 MAC. However, the incidence of EA during recovery had nothing to do with the inhaled different sevoflurane concentrations (within 1.5 MAC) in adults. ChicCTR.org identifier: ChiCTR-IPD-17011558.
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The industry has adopted Clinical Data Interchange Standards Consortium standards for clinical trial data and the Food and Drug Administration electronic common technical document standard for documents for many years but still faces many challenges. The solutions based on these standards enable integration among solo systems, but the integration needs to be based on business requirements and provides the end-to-end intelligence for the business. ⋯ Automation that uses artificial intelligence and machine learning will be the next game changer in the industry to provide data with higher quality and more efficiency. This article discusses the challenges in managing standards adoption, potential approaches for automation through using robotic processes, artificial intelligence, and the maturity model for metadata-driven automation in clinical research.
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Clinical therapeutics · Oct 2019
Randomized Controlled Trial Multicenter StudyEfficacy and Safety of an Intravenous Acetaminophen/Ibuprofen Fixed-dose Combination After Bunionectomy: a Randomized, Double-blind, Factorial, Placebo-controlled Trial.
Multimodal analgesia with acetaminophen and/or nonsteroidal anti-inflammatory drugs is recommended for the treatment of postoperative pain. Although oral fixed-dose combinations (FDCs) are available, parenteral administration may be clinically justified. The goal of this study was to investigate the clinical efficacy and safety of an intravenous FDC of ibuprofen and acetaminophen after bunionectomy. ⋯ The study found that repeated administration of an intravenous FDC of ibuprofen and acetaminophen provided statistically significant improvement in SPID48 over comparable doses of either monotherapy without an increase in adverse events. ClinicalTrials.gov identifier: NCT02689063.