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
The Utility of a Social Listening Program to Support Safety Surveillance of Tozinameran (COVID-19 Vaccine)-a Brief Survey of Pharmacovigilance Professionals
Clin Ther. 2023 Sep 25:S0149-2918(23)00324-7. doi: 10.1016/j.clinthera.2023.08.020. Online ahead of print.NO ABSTRACTPMID:37758532 | DOI:10.1016/j.clinthera.2023.08.020 (Source: Clinical Therapeutics)
Source: Clinical Therapeutics - September 27, 2023 Category: Drugs & Pharmacology Authors: Manfred Hauben Source Type: research
Intersection of Coronavirus Disease 2019 and Alcohol-associated Liver Disease: A Review of Emerging Trends and Implications
Clin Ther. 2023 Sep 25:S0149-2918(23)00323-5. doi: 10.1016/j.clinthera.2023.08.019. Online ahead of print.ABSTRACTPURPOSE: This review will provide an overview of alcohol use and alcohol associated liver disease (ALD) prior to the coronavirus disease 2019 (COVID-19) pandemic and the impact of the pandemic on alcohol use and ALD. Furthermore, this review will explore strategies to mitigate the growing disease burden of AUD and ALD.METHODS: A search using PubMed was performed for articles on topics related to alcohol use, ALD, and COVID-19. The literature was reviewed and pertinent sources were used for this narrative review...
Source: Clinical Therapeutics - September 27, 2023 Category: Drugs & Pharmacology Authors: Elizabeth S Aby Alexander S Vogel Adam C Winters Source Type: research
