Exploring Barriers to Pediatric Cancer Clinical Trials: The Role of a Networked, Just-in-Time Study Program
Clin Ther. 2023 Sep 30:S0149-2918(23)00342-9. doi: 10.1016/j.clinthera.2023.08.022. Online ahead of print.ABSTRACTThe Research to Accelerate Cures and Equity (RACE) for Children Act mandates that newly developed targeted oncology drugs be tested in children when molecular targets are relevant to pediatric cancers. In its first year, the RACE for Children Act was effective in creating novel drug development opportunities for children with cancer; however, significant barriers to clinical trial enrollment persist. Pediatric cancer clinical trials are impacted by challenges surrounding logistics, complexity, and access. As su...
Source: Clinical Therapeutics - October 2, 2023 Category: Drugs & Pharmacology Authors: Zachary Rivers Ben Hyde Karyn Ronski Duncan Stearns Stephanie Toll Kevin Ritt Matthew Cooney Halla Nimeiri Noah Federman Kristiyana Kaneva Source Type: research
Use of Silica Nanoparticles for Drug Delivery in Cardiovascular Disease
This article reviews recent progress and advancement in targeted delivery for drugs and diagnostic and theranostic agents using silica nanoparticles to achieve therapeutic efficacy and improved detection of CVD in clinical and preclinical settings.METHODS: A search of PubMed, Scopus, and Google Scholar databases from 1990 to 2023 was conducted. Current clinical trials on silica nanoparticles were identified through ClinicalTrials.gov. Search terms include silica nanoparticles, cardiovascular diseases, drug delivery, and therapy.FINDINGS: Silica nanoparticles exhibit biocompatibility in biological systems, and their shape, ...
Source: Clinical Therapeutics - October 2, 2023 Category: Drugs & Pharmacology Authors: Haritha Kirla David J Henry Shirley Jansen Peter L Thompson Juliana Hamzah Source Type: research
Pituitary Apoplexy-Associated Cerebral Salt Wasting Syndrome: A Case Report and Literature Review
Clin Ther. 2023 Sep 29:S0149-2918(23)00357-0. doi: 10.1016/j.clinthera.2023.09.012. Online ahead of print.ABSTRACTPURPOSE: This is a case report of a patient experiencing hyponatremia who was ultimately diagnosed with pituitary apoplexy-associated cerebral salt wasting syndrome (CSWS).METHODS: Laboratory tests, clinical evaluations, and magnetic resonance imaging were performed by specialists.FINDINGS: The patient presented with severe headache, thirst, and polyuria. Results of laboratory tests indicated hyponatremia, decreased plasma osmolality, and elevated urine osmolality. Fluid restriction worsened the situation, and ...
Source: Clinical Therapeutics - October 1, 2023 Category: Drugs & Pharmacology Authors: Jialu Wu Zhe Yan Bo Li Xijie Yu Hui Huang Source Type: research
Dorzagliatin for Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Phase II/III Trials
This study included a meta-analysis on the efficacy and safety of dorzagliatin in the treatment of T2DM.METHODS: The Cochrane Central Registry of Controlled Trials, PubMed, and Embase were searched from inception to July 25, 2022. A total of 3 studies including 1333 patients were identified in this meta-analysis.FINDINGS: Overall, the meta-analysis showed that dorzagliatin remarkably reduced glycated hemoglobin levels versus placebo by 0.66%. The results of the meta-analysis showed a significant reduction in fasting plasma glucose of 6.77 mg/dL between dorzagliatin and placebo. In addition, dorzagliatin reduced 2-hour post...
Source: Clinical Therapeutics - September 30, 2023 Category: Drugs & Pharmacology Authors: Fei Lin Rong He Baodong Ling Lin Wang Ting Jiang Bin Yu Source Type: research
Compatibility of Omadacycline With Select Parenteral Products in Simulated Y-Site Administration
The objective of this work was to determine the intravenous compatibility of omadacycline with commonly used intravenous fluids and medications using simulated Y-site administration.METHODS: Omadacycline was prepared at concentrations consistent with a maintenance dose (1 mg/mL) and a loading dose (2 mg/mL) with 0.9% sodium chloride according to the prescribing information. Compatibility via simulated Y-site administration was assessed with selected crystalloids (lactated Ringer's solution, magnesium sulfate, and normal saline with potassium chloride) and intravenous medications (bumetanide, furosemide, heparin, and insuli...
Source: Clinical Therapeutics - September 30, 2023 Category: Drugs & Pharmacology Authors: David A Butler Kelly Moolick Donavon McCray Maxwell Gifford Source Type: research
Dorzagliatin for Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis of Randomized Phase II/III Trials
This study included a meta-analysis on the efficacy and safety of dorzagliatin in the treatment of T2DM.METHODS: The Cochrane Central Registry of Controlled Trials, PubMed, and Embase were searched from inception to July 25, 2022. A total of 3 studies including 1333 patients were identified in this meta-analysis.FINDINGS: Overall, the meta-analysis showed that dorzagliatin remarkably reduced glycated hemoglobin levels versus placebo by 0.66%. The results of the meta-analysis showed a significant reduction in fasting plasma glucose of 6.77 mg/dL between dorzagliatin and placebo. In addition, dorzagliatin reduced 2-hour post...
Source: Clinical Therapeutics - September 30, 2023 Category: Drugs & Pharmacology Authors: Fei Lin Rong He Baodong Ling Lin Wang Ting Jiang Bin Yu Source Type: research
Compatibility of Omadacycline With Select Parenteral Products in Simulated Y-Site Administration
The objective of this work was to determine the intravenous compatibility of omadacycline with commonly used intravenous fluids and medications using simulated Y-site administration.METHODS: Omadacycline was prepared at concentrations consistent with a maintenance dose (1 mg/mL) and a loading dose (2 mg/mL) with 0.9% sodium chloride according to the prescribing information. Compatibility via simulated Y-site administration was assessed with selected crystalloids (lactated Ringer's solution, magnesium sulfate, and normal saline with potassium chloride) and intravenous medications (bumetanide, furosemide, heparin, and insuli...
Source: Clinical Therapeutics - September 30, 2023 Category: Drugs & Pharmacology Authors: David A Butler Kelly Moolick Donavon McCray Maxwell Gifford Source Type: research
Telepharmacy Model of Care
This study assessed the feasibility of the Telepharmacy Model of Care, a medication review and deprescribing model for use in older adults, with innovations in cognitive and functional evaluation, in telemedicine delivery, and in the use of a pharmacy technician.METHODS: This retrospective medical record review/abstraction analyzed (from March 1, 2022, to December 31, 2022) data from US veteran participants in a pilot implementation (April 13, 2021, to May 20, 2022) of the Telepharmacy Model of Care at the Veterans Affairs Ann Arbor Healthcare System (Ann Arbor, Michigan). The project team assessed and made recommendations...
Source: Clinical Therapeutics - September 29, 2023 Category: Drugs & Pharmacology Authors: Christine Cigolle Kristin Phillips Source Type: research
Atherosclerotic Cardiovascular Disease in Women: Providing Protection With Lipid-Altering Agents
Clin Ther. 2023 Sep 26:S0149-2918(23)00325-9. doi: 10.1016/j.clinthera.2023.08.021. Online ahead of print.ABSTRACTPURPOSE: Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of death in women, yet it remains underdiagnosed, undertreated, and understudied in women compared with men. Although estrogen has provided observational evidence of cardioprotection, randomized controlled trials using hormone replacement therapy have generally produced unfavorable results.METHODS: For this narrative review, a literature search was performed using the key words cardiovascular disease, women, and dyslipidemia in PubMed ...
Source: Clinical Therapeutics - September 28, 2023 Category: Drugs & Pharmacology Authors: Megan Hiles Ashley Simmons Daniel Hilleman Cheryl A Gibson James M Backes Source Type: research
Adverse Events During Dosing of Delayed-Release/Extended-Release Methylphenidate: Learnings From the Open-Label Phase of a Registration Trial and a Real-World Postmarketing Surveillance Program
Clin Ther. 2023 Sep 26:S0149-2918(23)00354-5. doi: 10.1016/j.clinthera.2023.09.009. Online ahead of print.ABSTRACTPURPOSE: Delayed-release/extended-release methylphenidate (DR/ER-MPH) (formerly HLD200) is an evening-dosed agent used for the treatment of attention-deficit/hyperactivity disorder. Postmarketing surveillance data from approximately 74,000 patients exposed to DR/ER-MPH (up to June 17, 2022) were reported and compared with the open-label, treatment-optimization phase of a Phase III clinical trial to derive possible learnings on how to approach adverse events (AEs) that emerge during dose titration.METHODS: An an...
Source: Clinical Therapeutics - September 28, 2023 Category: Drugs & Pharmacology Authors: Martin A Katzman Victor Otcheretko Michelle D Po Cassandra L Uchida Bev Incledon Source Type: research
Pathology, Progression, and Emerging Treatments of Peripheral Artery Disease-Related Limb Ischamia
Clin Ther. 2023 Sep 26:S0149-2918(23)00351-X. doi: 10.1016/j.clinthera.2023.09.005. Online ahead of print.ABSTRACTPURPOSE: This narrative review summarizes recent research examining treatment targets for peripheral artery disease (PAD)-related limb ischemia.METHODS: Targeted searches of the PubMed and clinical trial registry databases were performed to identify recent findings from animal models of limb ischemia and clinical studies examining PAD progression and treatment. Ongoing clinical trials testing new treatments for PAD were also reviewed. Relevant full-text articles were retrieved and critically reviewed. Where ind...
Source: Clinical Therapeutics - September 28, 2023 Category: Drugs & Pharmacology Authors: Jonathan Golledge Source Type: research
Cognition and Cerebral Blood Flow After Extracranial Carotid Revascularization for Carotid Atherosclerosis: A Systematic Review
Clin Ther. 2023 Sep 26:S0149-2918(23)00346-6. doi: 10.1016/j.clinthera.2023.09.001. Online ahead of print.ABSTRACTPURPOSE: Extracranial atherosclerotic carotid stenosis is associated with inadequate cerebral blood flow (CBF) and cognitive dysfunction. The impact of extracranial carotid revascularization on cognition and how any cognitive change relates to changes in CBF are less clear. This review examines the effects of revascularization of extracranial carotid disease by carotid endarterectomy (CEA) or carotid stenting (CAS) on cognition, and how this relates to changes in CBF.METHODS: A systematic review of existing rep...
Source: Clinical Therapeutics - September 28, 2023 Category: Drugs & Pharmacology Authors: C H Ricky Kwok Jun Cheul Park Simon Z Joseph Jonathan K Foster Daniel J Green Shirley J Jansen Source Type: research
Atherosclerotic Cardiovascular Disease in Women: Providing Protection With Lipid-Altering Agents
Clin Ther. 2023 Sep 26:S0149-2918(23)00325-9. doi: 10.1016/j.clinthera.2023.08.021. Online ahead of print.ABSTRACTPURPOSE: Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of death in women, yet it remains underdiagnosed, undertreated, and understudied in women compared with men. Although estrogen has provided observational evidence of cardioprotection, randomized controlled trials using hormone replacement therapy have generally produced unfavorable results.METHODS: For this narrative review, a literature search was performed using the key words cardiovascular disease, women, and dyslipidemia in PubMed ...
Source: Clinical Therapeutics - September 28, 2023 Category: Drugs & Pharmacology Authors: Megan Hiles Ashley Simmons Daniel Hilleman Cheryl A Gibson James M Backes Source Type: research
Adverse Events During Dosing of Delayed-Release/Extended-Release Methylphenidate: Learnings From the Open-Label Phase of a Registration Trial and a Real-World Postmarketing Surveillance Program
Clin Ther. 2023 Sep 26:S0149-2918(23)00354-5. doi: 10.1016/j.clinthera.2023.09.009. Online ahead of print.ABSTRACTPURPOSE: Delayed-release/extended-release methylphenidate (DR/ER-MPH) (formerly HLD200) is an evening-dosed agent used for the treatment of attention-deficit/hyperactivity disorder. Postmarketing surveillance data from approximately 74,000 patients exposed to DR/ER-MPH (up to June 17, 2022) were reported and compared with the open-label, treatment-optimization phase of a Phase III clinical trial to derive possible learnings on how to approach adverse events (AEs) that emerge during dose titration.METHODS: An an...
Source: Clinical Therapeutics - September 28, 2023 Category: Drugs & Pharmacology Authors: Martin A Katzman Victor Otcheretko Michelle D Po Cassandra L Uchida Bev Incledon Source Type: research
Pathology, Progression, and Emerging Treatments of Peripheral Artery Disease-Related Limb Ischamia
Clin Ther. 2023 Sep 26:S0149-2918(23)00351-X. doi: 10.1016/j.clinthera.2023.09.005. Online ahead of print.ABSTRACTPURPOSE: This narrative review summarizes recent research examining treatment targets for peripheral artery disease (PAD)-related limb ischemia.METHODS: Targeted searches of the PubMed and clinical trial registry databases were performed to identify recent findings from animal models of limb ischemia and clinical studies examining PAD progression and treatment. Ongoing clinical trials testing new treatments for PAD were also reviewed. Relevant full-text articles were retrieved and critically reviewed. Where ind...
Source: Clinical Therapeutics - September 28, 2023 Category: Drugs & Pharmacology Authors: Jonathan Golledge Source Type: research
