Commentary on Hey, Hunter, Muller et al. A Never-Ending Story: Evaluating Evidence in Medicinal Product Decision Making
Clin Ther. 2024 Mar 22:S0149-2918(24)00039-0. doi: 10.1016/j.clinthera.2024.02.001. Online ahead of print.NO ABSTRACTPMID:38521732 | DOI:10.1016/j.clinthera.2024.02.001 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - March 23, 2024 Category: Drugs & Pharmacology Authors: Steven Hirschfeld Source Type: research

Commentary on Hey, Hunter, Muller et al. A Never-Ending Story: Evaluating Evidence in Medicinal Product Decision Making
Clin Ther. 2024 Mar 22:S0149-2918(24)00039-0. doi: 10.1016/j.clinthera.2024.02.001. Online ahead of print.NO ABSTRACTPMID:38521732 | DOI:10.1016/j.clinthera.2024.02.001 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - March 23, 2024 Category: Drugs & Pharmacology Authors: Steven Hirschfeld Source Type: research

Commentary on Hey, Hunter, Muller et al. A Never-Ending Story: Evaluating Evidence in Medicinal Product Decision Making
Clin Ther. 2024 Mar 22:S0149-2918(24)00039-0. doi: 10.1016/j.clinthera.2024.02.001. Online ahead of print.NO ABSTRACTPMID:38521732 | DOI:10.1016/j.clinthera.2024.02.001 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - March 23, 2024 Category: Drugs & Pharmacology Authors: Steven Hirschfeld Source Type: research

Explainable and Interpretable Machine Learning for Antimicrobial Stewardship: Opportunities and Challenges
Clin Ther. 2024 Mar 21:S0149-2918(24)00065-1. doi: 10.1016/j.clinthera.2024.02.010. Online ahead of print.ABSTRACTThere is growing interest in exploiting the advances in artificial intelligence and machine learning (ML) for improving and monitoring antimicrobial prescriptions in line with antimicrobial stewardship principles. Against this background, the concepts of interpretability and explainability are becoming increasingly essential to understanding how ML algorithms could predict antimicrobial resistance or recommend specific therapeutic agents, to avoid unintended biases related to the "black box" nature of complex m...
Source: Clinical Therapeutics - March 22, 2024 Category: Drugs & Pharmacology Authors: Daniele Roberto Giacobbe Cristina Marelli Sabrina Guastavino Sara Mora Nicola Rosso Alessio Signori Cristina Campi Mauro Giacomini Matteo Bassetti Source Type: research

Explainable and Interpretable Machine Learning for Antimicrobial Stewardship: Opportunities and Challenges
Clin Ther. 2024 Mar 21:S0149-2918(24)00065-1. doi: 10.1016/j.clinthera.2024.02.010. Online ahead of print.ABSTRACTThere is growing interest in exploiting the advances in artificial intelligence and machine learning (ML) for improving and monitoring antimicrobial prescriptions in line with antimicrobial stewardship principles. Against this background, the concepts of interpretability and explainability are becoming increasingly essential to understanding how ML algorithms could predict antimicrobial resistance or recommend specific therapeutic agents, to avoid unintended biases related to the "black box" nature of complex m...
Source: Clinical Therapeutics - March 22, 2024 Category: Drugs & Pharmacology Authors: Daniele Roberto Giacobbe Cristina Marelli Sabrina Guastavino Sara Mora Nicola Rosso Alessio Signori Cristina Campi Mauro Giacomini Matteo Bassetti Source Type: research

Mavacamten: A Novel Agent for Hypertrophic Cardiomyopathy
Clin Ther. 2024 Mar 19:S0149-2918(24)00062-6. doi: 10.1016/j.clinthera.2024.02.007. Online ahead of print.ABSTRACTPURPOSE: Hypertrophic cardiomyopathy (HCM) is an under-recognized genetic cardiac disorder affecting the muscles and contractility of the heart, which in turn can result in heart failure symptoms, arrhythmia, and sudden cardiac death. Previously, pharmacotherapy options for HCM were not disease-specific, often poorly tolerated, and overall inadequate for optimal management. This narrative review discusses the pharmacology of the novel drug mavacamten, the clinical trials supporting its use, and considerations f...
Source: Clinical Therapeutics - March 20, 2024 Category: Drugs & Pharmacology Authors: J Chase Cole Samantha F Benvie Marci DeLosSantos Source Type: research

Mavacamten: A Novel Agent for Hypertrophic Cardiomyopathy
Clin Ther. 2024 Mar 19:S0149-2918(24)00062-6. doi: 10.1016/j.clinthera.2024.02.007. Online ahead of print.ABSTRACTPURPOSE: Hypertrophic cardiomyopathy (HCM) is an under-recognized genetic cardiac disorder affecting the muscles and contractility of the heart, which in turn can result in heart failure symptoms, arrhythmia, and sudden cardiac death. Previously, pharmacotherapy options for HCM were not disease-specific, often poorly tolerated, and overall inadequate for optimal management. This narrative review discusses the pharmacology of the novel drug mavacamten, the clinical trials supporting its use, and considerations f...
Source: Clinical Therapeutics - March 20, 2024 Category: Drugs & Pharmacology Authors: J Chase Cole Samantha F Benvie Marci DeLosSantos Source Type: research

Efficacy of Nemiralisib in Chronic Obstructive Pulmonary Disease: A Systematic Review
Clin Ther. 2024 Mar 18:S0149-2918(24)00064-X. doi: 10.1016/j.clinthera.2024.02.008. Online ahead of print.ABSTRACTPURPOSE: Chronic obstructive pulmonary disease (COPD) is a major public health concern. Exacerbation of COPD leads to poor health and frequent episodes of increased systemic and airway inflammation. Immunomodulatory drugs have garnered extensive attention because they may reduce the rate of COPD exacerbation. This review aimed to evaluate the efficacy and safety of nemiralisib in COPD patients.METHODS: Medical databases, including the Cochrane Library, EMBASE, and PubMed, were queried from inception to June 202...
Source: Clinical Therapeutics - March 19, 2024 Category: Drugs & Pharmacology Authors: Hongkuan Yang Shuifeng He Linbao Liang Junjie Pan Source Type: research

Adapting and Advancing the Criteria for Scientific Evidence, Marketing, and Advice in the Changing World
Clin Ther. 2024 Mar 18:S0149-2918(24)00043-2. doi: 10.1016/j.clinthera.2024.02.005. Online ahead of print.NO ABSTRACTPMID:38503630 | DOI:10.1016/j.clinthera.2024.02.005 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - March 19, 2024 Category: Drugs & Pharmacology Authors: Jill L Maron Source Type: research

Efficacy of Nemiralisib in Chronic Obstructive Pulmonary Disease: A Systematic Review
Clin Ther. 2024 Mar 18:S0149-2918(24)00064-X. doi: 10.1016/j.clinthera.2024.02.008. Online ahead of print.ABSTRACTPURPOSE: Chronic obstructive pulmonary disease (COPD) is a major public health concern. Exacerbation of COPD leads to poor health and frequent episodes of increased systemic and airway inflammation. Immunomodulatory drugs have garnered extensive attention because they may reduce the rate of COPD exacerbation. This review aimed to evaluate the efficacy and safety of nemiralisib in COPD patients.METHODS: Medical databases, including the Cochrane Library, EMBASE, and PubMed, were queried from inception to June 202...
Source: Clinical Therapeutics - March 19, 2024 Category: Drugs & Pharmacology Authors: Hongkuan Yang Shuifeng He Linbao Liang Junjie Pan Source Type: research

Adapting and Advancing the Criteria for Scientific Evidence, Marketing, and Advice in the Changing World
Clin Ther. 2024 Mar 18:S0149-2918(24)00043-2. doi: 10.1016/j.clinthera.2024.02.005. Online ahead of print.NO ABSTRACTPMID:38503630 | DOI:10.1016/j.clinthera.2024.02.005 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - March 19, 2024 Category: Drugs & Pharmacology Authors: Jill L Maron Source Type: research

Association Between First-Time Neurologic Events and Metronidazole Treatment: A Case-Time Control Study
This study investigates the association between metronidazole use and first-time neurologic events.METHODS: We conducted a case-time-control study using data from the Danish National Patient Register and the National Prescription Register in years 2013 to 2021. Patients with a first-time diagnosis of encephalopathy, cerebellar dysfunction, or peripheral neuropathy were included. Conditional logistic regression analyses were performed to estimate the risk of neurologic events associated with metronidazole use.FINDINGS: Out of 476,066 first-time metronidazole prescriptions, the 100-day cumulative incidence of peripheral neur...
Source: Clinical Therapeutics - March 16, 2024 Category: Drugs & Pharmacology Authors: Michael Asger Andersen Rasmus Gregersen Tonny Studsgaard Petersen Joanna Nan Wang Janne Petersen Espen Jimenez-Solem Source Type: research

Clinical Impact of Vancomycin MIC on Outcomes in Patients With Coagulase-negative Staphylococcal Bacteremia
Clin Ther. 2024 Mar 15:S0149-2918(24)00021-3. doi: 10.1016/j.clinthera.2024.01.012. Online ahead of print.ABSTRACTPURPOSE: Coagulase-negative staphylococci (CoNS) are Gram-positive organisms that are a known component of normal skin flora and the most common cause of nosocomial bacteremia. For CoNS species, the vancomycin MIC breakpoint for susceptibility set by the Clinical and Laboratory Standards Institute is ≤4 µg/mL. There has been published reports of vancomycin heteroresistance in CoNS with vancomycin MICs of 2 to 4 µg/mL. The aim of this retrospective cohort analysis was to assess the clinical impact of vancomy...
Source: Clinical Therapeutics - March 16, 2024 Category: Drugs & Pharmacology Authors: Wade Wheat Brenda Simiyu Gabriela Andonie Lillian Bellfi Source Type: research

Association Between First-Time Neurologic Events and Metronidazole Treatment: A Case-Time Control Study
This study investigates the association between metronidazole use and first-time neurologic events.METHODS: We conducted a case-time-control study using data from the Danish National Patient Register and the National Prescription Register in years 2013 to 2021. Patients with a first-time diagnosis of encephalopathy, cerebellar dysfunction, or peripheral neuropathy were included. Conditional logistic regression analyses were performed to estimate the risk of neurologic events associated with metronidazole use.FINDINGS: Out of 476,066 first-time metronidazole prescriptions, the 100-day cumulative incidence of peripheral neur...
Source: Clinical Therapeutics - March 16, 2024 Category: Drugs & Pharmacology Authors: Michael Asger Andersen Rasmus Gregersen Tonny Studsgaard Petersen Joanna Nan Wang Janne Petersen Espen Jimenez-Solem Source Type: research

Clinical Impact of Vancomycin MIC on Outcomes in Patients With Coagulase-negative Staphylococcal Bacteremia
Clin Ther. 2024 Mar 15:S0149-2918(24)00021-3. doi: 10.1016/j.clinthera.2024.01.012. Online ahead of print.ABSTRACTPURPOSE: Coagulase-negative staphylococci (CoNS) are Gram-positive organisms that are a known component of normal skin flora and the most common cause of nosocomial bacteremia. For CoNS species, the vancomycin MIC breakpoint for susceptibility set by the Clinical and Laboratory Standards Institute is ≤4 µg/mL. There has been published reports of vancomycin heteroresistance in CoNS with vancomycin MICs of 2 to 4 µg/mL. The aim of this retrospective cohort analysis was to assess the clinical impact of vancomy...
Source: Clinical Therapeutics - March 16, 2024 Category: Drugs & Pharmacology Authors: Wade Wheat Brenda Simiyu Gabriela Andonie Lillian Bellfi Source Type: research