Safety, Tolerability, and Pharmacokinetics of Oral BI 1358894 in Healthy Japanese Male Volunteers
ConclusionBI 1358894 was well tolerated with a favorable pharmacokinetic profile in Japanese male HVs, similar to findings from a previous study in Caucasian male HVs.Trial RegistrationClinicalTrials.gov (NCT03875001; 08-Mar-2019). (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - April 24, 2024 Category: Drugs & Pharmacology Source Type: research
Risk of Cardiovascular Events in Schizophrenic Patients Treated with Paliperidone Palmitate Once-Monthly Injection (PP1M): A Population-Based Retrospective Cohort Study in Taiwan
ConclusionThis study reported the population-based incidence of cardiovascular events in schizophrenic patients initiating PP1M treatment. PP1M was not associated with increased risks of serious cardiovascular events but was potentially associated with lower risks of cardiovascular hospitalizations compared with oral SGAs. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - April 15, 2024 Category: Drugs & Pharmacology Source Type: research
Pharmacokinetic Interactions Between Tegoprazan and the Combination of Clarithromycin, Amoxicillin and Bismuth in Healthy Chinese Subjects: An Open-Label, Single-Center, Multiple-Dosage, Self-Controlled, Phase I Trial
ConclusionThe plasma exposure of tegoprazan, M1, 14-hydroxyclarithromycin and bismuth was increased after the coadministration of tegoprazan, clarithromycin, amoxicillin and bismuth. The coadministration exhibited favorable safety and tolerability.Clinical Trials RegistrationCTR20230643. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - April 13, 2024 Category: Drugs & Pharmacology Source Type: research
Impact of Viloxazine Extended-Release Capsules (Qelbree ®) on Select Cytochrome P450 Enzyme Activity and Evaluation of CYP2D6 Genetic Polymorphisms on Viloxazine Pharmacokinetics
ConclusionViloxazine ER is a strong CYP1A2 inhibitor and a weak CYP2D6 and CYP3A4 inhibitor. CYP2D6 polymorphisms did not meaningfully alter the viloxazine ER pharmacokinetic profile. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - April 10, 2024 Category: Drugs & Pharmacology Source Type: research
Real-World Effectiveness of Once-Weekly Glucagon-Like Peptide-1 Receptor Agonists (OW GLP-1RAs) in Comparison with Dipeptidyl Peptidase-4 Inhibitors (DPP-4is) for Glycemic Control and Weight Outcomes in Type 2 Diabetes Mellitus (RELATE)
ConclusionThe study reinforces that OW GLP-1RAs are more effective in glycemic control and weight reduction compared with DPP-4is in people with T2DM in the real-world setting. These findings align with the recommendation in the current guidelines for utilizing glucose-lowering treatment regimens that support weight-management goals in people with T2DM. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - March 20, 2024 Category: Drugs & Pharmacology Source Type: research
Experience of Tofacitinib Use in Pregnancy in Patients with Ulcerative Colitis
(Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - March 19, 2024 Category: Drugs & Pharmacology Source Type: research
Should Glucokinase be Given a Chance in Diabetes Therapeutics? A Clinical-Pharmacological Review of Dorzagliatin and Lessons Learned So Far
AbstractDespite advances in the management of type 2 diabetes mellitus (T2DM), one-third of patients with diabetes do not achieve the desired glycemic goal. Considering this inadequacy, many agents that activate glucokinase have been investigated over the last two decades but were withdrawn before submission for marketing permission. Dorzagliatin is the first glucokinase activator that has been granted approval for T2DM, only in China. As overstimulation of glucokinase is linked with pathophysiological disturbances such as fatty liver and cardiovascular issues and a loss of therapeutic efficacy with time. This review aims ...
Source: Clinical Drug Investigation - March 9, 2024 Category: Drugs & Pharmacology Source Type: research
Effectiveness of Dose Increase in Upadacitinib from 15 mg to 30 mg for Patients with Moderate-to-Severe Atopic Dermatitis: A Real-World Clinical Practice in Japan
ConclusionsThese results suggest that upadacitinib 30 mg can ameliorate rash and pruritus insufficiently improved by upadacitinib 15 mg, and that the dose increase to 30 mg may be considered as a treatment option for patients with atopic dermatitis with a limited response to upadacitinib 15 mg. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - March 6, 2024 Category: Drugs & Pharmacology Source Type: research
Tolvaptan Treatment and Long-Term Impact on Quality of Life in Autosomal Dominant Polycystic Kidney Disease Patients: A Pilot Study
(Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - March 2, 2024 Category: Drugs & Pharmacology Source Type: research
An Open-Label Study to Assess Monthly Risperidone Injections (180 mg) Following Switch from Daily Oral Risperidone (6 mg) in Stable Schizophrenic Patients
ConclusionsThe results support the use of 180 mg RBP-7000 in schizophrenic patients stable on 6 mg/day oral risperidone and a second injection site in the upper arm.Trial RegistrationClinicalTrials.gov identifier: NCT03978832. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - February 22, 2024 Category: Drugs & Pharmacology Source Type: research
Cost-Effectiveness Evaluation of Oral CGRP Antagonists, Atogepant and Rimegepant, for the Preventative Treatment of Episodic Migraine: Results from a US Societal Perspective Model
ConclusionsAtogepant and rimegepant were both unable to meet generally accepted cost-effectiveness thresholds< 150,0000/QALY. Additional studies are needed to better guide decision making regarding oral CGRPs ’ place in therapy. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - February 21, 2024 Category: Drugs & Pharmacology Source Type: research
Real-World Effectiveness of Sotrovimab for the Early Treatment of COVID-19: Evidence from the US National COVID Cohort Collaborative (N3C)
ConclusionsSotrovimab demonstrated clinical effectiveness in preventing severe outcomes (hospitalisation, mortality) in the period 27 September 2021 –30 April 2022, which included Delta and Omicron BA.1 variants and an early surge of Omicron BA.2 variant. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - February 20, 2024 Category: Drugs & Pharmacology Source Type: research
Thromboembolic Events Associated with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors: A Pharmacovigilance Analysis of the US FDA Adverse Event Reporting System (FAERS) Database
ConclusionThis study yielded three key findings. Firstly, EGFR-TKIs seem to exhibit prothrombotic effects, elevating the risk of TEEs. Secondly, the clinical outcomes of TEEs associated with EGFR-TKIs were poor. Thirdly, most TEEs occurred within the initial 3 months, and fatal cases occurred earlier than non-fatal cases. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - February 20, 2024 Category: Drugs & Pharmacology Source Type: research
Safety and Efficacy of Biologic Medications and Janus Kinase Inhibitors in Patients with Down Syndrome: A Retrospective Cohort Study
(Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - February 19, 2024 Category: Drugs & Pharmacology Source Type: research
Safety of Intravenous Push Valproate Compared with Intravenous Piggyback at a Tertiary Academic Medical Center
ConclusionIVP valproate administration may be considered safe, allowing for more optimal clinical and operational outcomes in the acute care setting. (Source: Clinical Drug Investigation)
Source: Clinical Drug Investigation - February 16, 2024 Category: Drugs & Pharmacology Source Type: research
