Atherosclerosis: More Challenging and Complex Than We Thought
Clin Ther. 2023 Nov 4:S0149-2918(23)00403-4. doi: 10.1016/j.clinthera.2023.10.012. Online ahead of print.NO ABSTRACTPMID:37932153 | DOI:10.1016/j.clinthera.2023.10.012 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - November 6, 2023 Category: Drugs & Pharmacology Authors: Peter L Thompson Juliana Hamzah Source Type: research
Clinically Approved Monoclonal Antibodies-Based Immunotherapy: Association With Glycemic Control and Impact Role of Clinical Pharmacist for Cancer Patient Care
This study provides a narrative review of clinically approved mAbs in cancer treatment and focuses on the development of hyperglycemia and DM arising from using these therapies. Furthermore, it highlights the critical role of oncology clinical pharmacists in the management of autoimmune DM and patient care while using these medications in an oncology setting.METHODS: An extensive literature search was conducted using various sources of electronic databases, such as Scopus, Embase, Web of Science, and PubMed, and search engines, such as Google Scholar, for studies on mAb classification, types, mechanisms of action, pharmaco...
Source: Clinical Therapeutics - November 6, 2023 Category: Drugs & Pharmacology Authors: Anmar Al-Taie Najat Sheta Source Type: research
Clinical Bridging From Prefilled Syringe to On-Body Injector for Risankizumab in Crohn's Disease
This article describes the clinical development bridging strategy and key data to support the marketing application of the risankizumab on-body injection (OBI) system for the treatment of moderately to severely active Crohn's disease (CD), even though the OBI was not evaluated directly in the pivotal Phase III studies in CD.METHODS: Three studies were conducted as part of the clinical bridging strategy. The pilot pharmacokinetics (PK) study was a Phase I, single-dose, 4-arm, open-label, randomized, parallel-group exploratory PK and tolerability study that assessed the effect of rate and volume of administration on the bioa...
Source: Clinical Therapeutics - November 6, 2023 Category: Drugs & Pharmacology Authors: Yinuo Pang Ronilda D'Cunha Afroz Shareef Mohammad Zhiwen Wang Rachel Duan Jasmina Kalabic Toni Anschutz Sai Nudurupati Kori Wallace Manuela Jaeschke Sujani Nannapaneni Ji Zhou Wei Liu Patrick Marroum Source Type: research
Atherosclerosis: More Challenging and Complex Than We Thought
Clin Ther. 2023 Nov 4:S0149-2918(23)00403-4. doi: 10.1016/j.clinthera.2023.10.012. Online ahead of print.NO ABSTRACTPMID:37932153 | DOI:10.1016/j.clinthera.2023.10.012 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - November 6, 2023 Category: Drugs & Pharmacology Authors: Peter L Thompson Juliana Hamzah Source Type: research
Clinically Approved Monoclonal Antibodies-Based Immunotherapy: Association With Glycemic Control and Impact Role of Clinical Pharmacist for Cancer Patient Care
This study provides a narrative review of clinically approved mAbs in cancer treatment and focuses on the development of hyperglycemia and DM arising from using these therapies. Furthermore, it highlights the critical role of oncology clinical pharmacists in the management of autoimmune DM and patient care while using these medications in an oncology setting.METHODS: An extensive literature search was conducted using various sources of electronic databases, such as Scopus, Embase, Web of Science, and PubMed, and search engines, such as Google Scholar, for studies on mAb classification, types, mechanisms of action, pharmaco...
Source: Clinical Therapeutics - November 6, 2023 Category: Drugs & Pharmacology Authors: Anmar Al-Taie Najat Sheta Source Type: research
Clinical Bridging From Prefilled Syringe to On-Body Injector for Risankizumab in Crohn's Disease
This article describes the clinical development bridging strategy and key data to support the marketing application of the risankizumab on-body injection (OBI) system for the treatment of moderately to severely active Crohn's disease (CD), even though the OBI was not evaluated directly in the pivotal Phase III studies in CD.METHODS: Three studies were conducted as part of the clinical bridging strategy. The pilot pharmacokinetics (PK) study was a Phase I, single-dose, 4-arm, open-label, randomized, parallel-group exploratory PK and tolerability study that assessed the effect of rate and volume of administration on the bioa...
Source: Clinical Therapeutics - November 6, 2023 Category: Drugs & Pharmacology Authors: Yinuo Pang Ronilda D'Cunha Afroz Shareef Mohammad Zhiwen Wang Rachel Duan Jasmina Kalabic Toni Anschutz Sai Nudurupati Kori Wallace Manuela Jaeschke Sujani Nannapaneni Ji Zhou Wei Liu Patrick Marroum Source Type: research
The Impact of Artificial Intelligence on Coronary Imaging … and Beyond
Clin Ther. 2023 Nov 3:S0149-2918(23)00404-6. doi: 10.1016/j.clinthera.2023.10.011. Online ahead of print.NO ABSTRACTPMID:37926629 | DOI:10.1016/j.clinthera.2023.10.011 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - November 5, 2023 Category: Drugs & Pharmacology Authors: Paul Beninger Source Type: research
Antithrombotic Treatment After Transcatheter Valve Interventions: Current Status and Future Directions
This article appraises the current evidence on this topic.METHODS: This narrative review presents key research findings and guideline recommendations, as well as highlights areas for future research.FINDINGS: After TAVR, randomized trial evidence suggests that single antiplatelet therapy is reasonable for patients without pre-existing indications for oral anticoagulation (OAC). If there is a concurrent indication for OAC, the addition of antiplatelet therapy increases bleeding risk. Whether direct oral anticoagulants achieve better outcomes than vitamin K antagonists is uncertain in this setting. Although OAC has been show...
Source: Clinical Therapeutics - November 5, 2023 Category: Drugs & Pharmacology Authors: Annette Maznyczka Thomas Pilgrim Source Type: research
The Impact of Artificial Intelligence on Coronary Imaging … and Beyond
Clin Ther. 2023 Nov 3:S0149-2918(23)00404-6. doi: 10.1016/j.clinthera.2023.10.011. Online ahead of print.NO ABSTRACTPMID:37926629 | DOI:10.1016/j.clinthera.2023.10.011 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - November 5, 2023 Category: Drugs & Pharmacology Authors: Paul Beninger Source Type: research
Antithrombotic Treatment After Transcatheter Valve Interventions: Current Status and Future Directions
This article appraises the current evidence on this topic.METHODS: This narrative review presents key research findings and guideline recommendations, as well as highlights areas for future research.FINDINGS: After TAVR, randomized trial evidence suggests that single antiplatelet therapy is reasonable for patients without pre-existing indications for oral anticoagulation (OAC). If there is a concurrent indication for OAC, the addition of antiplatelet therapy increases bleeding risk. Whether direct oral anticoagulants achieve better outcomes than vitamin K antagonists is uncertain in this setting. Although OAC has been show...
Source: Clinical Therapeutics - November 5, 2023 Category: Drugs & Pharmacology Authors: Annette Maznyczka Thomas Pilgrim Source Type: research
Ledipasvir/Sofosbuvir in Hepatitis C Virus-Infected Children With Hematological Malignancies: A Pharmacokinetic Study
This study aimed to assess the effect of acute lymphoblastic leukemia (ALL) on the pharmacokinetic (PK) profile of direct-acting antivirals, namely ledipasvir/sofosbuvir (LDV/SOF) and the SOF major metabolite GS-331007.METHODS: This was a 24-week, prospective, controlled, open-label, 2-arm PK study of patients receiving 45/200 mg once-daily LDV/SOF orally for 12 weeks. Eligible patients were HCV-RNA-positive, treatment-naive children aged 6 to <12 years and/or weighing 17 to <35 kg with genotype 4 chronic HCV infection without cirrhosis. The primary efficacy and safety end points were the achievement of sustained vir...
Source: Clinical Therapeutics - November 4, 2023 Category: Drugs & Pharmacology Authors: Aya M AbdelMagid Maggie M Abbassi Fatma S Ebeid Samar F Farid Manal H El-Sayed Source Type: research
Potential Signals of COVID-19 as an Effect Modifier of Adverse Drug Reactions
The objective of this study was to identify potential signals of effect modification of adverse drug reactions by statistical reporting interactions with COVID-19 infection (SRIsCOVID-19) in a large spontaneous reporting database.METHODS: Data from the US Food and Drug Administration Adverse Event Reporting System through the second quarter of 2020 were used. Three-dimensional disproportionality analyses were conducted to identify drug-event-event (DEE) combinations, for which 1 of the events was COVID-19 infection, that were disproportionately reported. Effect size was quantified by an interaction signal score (INTSS) whe...
Source: Clinical Therapeutics - November 2, 2023 Category: Drugs & Pharmacology Authors: Manfred Hauben Eric Hung Yan Chen Source Type: research
Potential Signals of COVID-19 as an Effect Modifier of Adverse Drug Reactions
The objective of this study was to identify potential signals of effect modification of adverse drug reactions by statistical reporting interactions with COVID-19 infection (SRIsCOVID-19) in a large spontaneous reporting database.METHODS: Data from the US Food and Drug Administration Adverse Event Reporting System through the second quarter of 2020 were used. Three-dimensional disproportionality analyses were conducted to identify drug-event-event (DEE) combinations, for which 1 of the events was COVID-19 infection, that were disproportionately reported. Effect size was quantified by an interaction signal score (INTSS) whe...
Source: Clinical Therapeutics - November 2, 2023 Category: Drugs & Pharmacology Authors: Manfred Hauben Eric Hung Yan Chen Source Type: research
Potential Signals of COVID-19 as an Effect Modifier of Adverse Drug Reactions
The objective of this study was to identify potential signals of effect modification of adverse drug reactions by statistical reporting interactions with COVID-19 infection (SRIsCOVID-19) in a large spontaneous reporting database.METHODS: Data from the US Food and Drug Administration Adverse Event Reporting System through the second quarter of 2020 were used. Three-dimensional disproportionality analyses were conducted to identify drug-event-event (DEE) combinations, for which 1 of the events was COVID-19 infection, that were disproportionately reported. Effect size was quantified by an interaction signal score (INTSS) whe...
Source: Clinical Therapeutics - November 2, 2023 Category: Drugs & Pharmacology Authors: Manfred Hauben Eric Hung Yan Chen Source Type: research
Muscle Strength Decline Caused by Eperisone Hydrochloride: A Case Report
Clin Ther. 2023 Oct 30:S0149-2918(23)00395-8. doi: 10.1016/j.clinthera.2023.10.003. Online ahead of print.ABSTRACTA 65-year-old female with thoracic spinal stenosis and incomplete paraplegia underwent T11-T12 posterior thoracic interbody fusion. During postoperative rehabilitation, she experienced thigh pain, involuntary lower limb convulsions, and muscle fatigue. Despite being prescribed eperisone hydrochloride for relief, her muscle strength decreased after 14 doses. This adverse effect, not listed in the latest Chinese medication instructions, subsided 4 days after discontinuation. This case suggests eperisone hydrochlo...
Source: Clinical Therapeutics - November 1, 2023 Category: Drugs & Pharmacology Authors: Junteng Zhu Jiecheng Xiao Jianxiong Hu Jianlin Shen Bai Chen Chengfei Zhao Source Type: research
