Chengu Niu, Jing Zhang, Mahesh Napel, Leela Krishna Teja Boppana, Hashem Anas, Nagesh Jadhav, Karin Dunnigan, Patrick I Okolo
BACKGROUND: In the panorama of therapeutic strategies for inflammatory bowel diseases, oral upadacitinib stands out for its potential to improve short-term and long-term patient outcomes. OBJECTIVE: This meta-analysis aspires to collate and assess the available evidence regarding the efficacy and safety of upadacitinib in managing moderate-to-severe Crohn's disease and ulcerative colitis. METHODS: A meta-analysis was conducted using studies sourced from MEDLINE/PubMed, Cochrane Library, Scopus, and Embase, published from January 2010 to March 2024...
May 23, 2024: Clinical Drug Investigation
Lei Dong, Jianxing Xiang, Michael Babcock, Yuanzhi Cheng, Yan Wang, Yuqiao Shen, Li Li, Liping Tan, Marvin Garovoy, Wei Hu, Jianhong Zheng
BACKGROUND AND OBJECTIVE: Aberrant accumulation of glycosphingolipids (GSLs) in the lysosome leads to GSL storage diseases. Glucosylceramide synthase inhibitors (GCSi) have the potential to treat several GSL storage diseases by reducing the synthesis of the disease-causing GSLs. AL01211 is a potent oral GCSi under investigation for Type 1 Gaucher disease and Fabry disease. Here, we evaluate the pharmacokinetics, pharmacodynamics, safety, and tolerability of AL01211 in healthy Chinese volunteers...
May 2, 2024: Clinical Drug Investigation
Noriaki Matsumoto, Tomohiro Mizuno, Yosuke Ando, Koki Kato, Masanori Nakanishi, Tsuyoshi Nakai, Jeannie K Lee, Yoshitaka Kameya, Wataru Nakamura, Kiyoshi Takahara, Ryoichi Shiroki, Shigeki Yamada
BACKGROUND: Chemotherapy-induced thrombocytopenia is often a use-limiting adverse reaction to gemcitabine and cisplatin (GC) combination chemotherapy, reducing therapeutic intensity, and, in some cases, requiring platelet transfusion. OBJECTIVE: A retrospective cohort study was conducted on patients with urothelial cancer at the initiation of GC combination therapy and the objective was to develop a prediction model for the incidence of severe thrombocytopenia using machine learning...
April 29, 2024: Clinical Drug Investigation
Matt Shirley
PB006 (Tyruko® ) is the first biosimilar of the reference monoclonal anti-α4-integrin antibody natalizumab. It is approved for use in the same indications for which reference natalizumab is approved, as a single disease-modifying therapy in adults with highly active relapsing-remitting multiple sclerosis (RRMS). PB006 has similar physicochemical and pharmacodynamic properties to those of reference natalizumab, and the pharmacokinetic similarity of the agents has been demonstrated in a study in healthy subjects...
April 29, 2024: Clinical Drug Investigation
Nikolaos Giannelos, Bernard Francq, Desmond Curran
BACKGROUND AND OBJECTIVE: Recombinant zoster vaccine (RZV) is approved in adults for the prevention of herpes zoster. The effect of RZV in moderating the severity of breakthrough cases of herpes zoster has been noted but not explicitly quantified before. In this study, a meta-analysis was undertaken to estimate differential utility losses between unvaccinated (Placebo) and vaccinated (RZV) subjects in breakthrough cases of herpes zoster from three RZV clinical trials. METHODS: Differential utility losses between the two groups were estimated in units of quality-adjusted life-years (QALYs), leveraging aggregate patient data from the ZOE-50 (NCT01165177), ZOE-70 (NCT01165229), and ZOE-HSCT (NCT01610414) clinical trials...
April 25, 2024: Clinical Drug Investigation
Jangsoo Yoon, Vikas Sharma, Akiko Harada
UNLABELLED: BACKGROUND AND OBJECTIVES: BI 1358894, a novel small-molecule inhibitor of transient receptor potential canonical ion channels, is under development for treatment of major depressive disorder. Phase I trials assessing the safety and pharmacokinetics of BI 1358894 in Caucasian male healthy volunteers (HVs) have been performed. This Phase I, double-blind, placebo-controlled, parallel-group trial assessed the safety, tolerability and pharmacokinetics of BI 1358894 in Japanese male HVs...
April 24, 2024: Clinical Drug Investigation
Shih-Pei Shen, Li Yan, Tao Wu, Min-Wei Huang, Kuan-Chih Huang, Hong Qiu, Yongjing Zhang, Chao-Hsiun Tang
BACKGROUND: Schizophrenia is one of the leading causes of disability. Paliperidone palmitate once-monthly injection (PP1M) was developed to provide consistent drug delivery and improve medication adherence for maintenance treatment. It is well known that patients with schizophrenia have higher cardiovascular risks, however little is known about the cardiovascular risks of patients with schizophrenia treated with PP1M in Asia. OBJECTIVE: This study aimed to estimate the incidence of cardiovascular events after initiating PP1M treatment and evaluate the cardiovascular risk associations compared with oral second-generation antipsychotics (SGAs)...
April 15, 2024: Clinical Drug Investigation
Yujing Du, Lixiu Yu, Bin Deng, Qinying Li, Junrui Hu, Linjie Li, Yusen Xu, Liangwei Song, Fang Xie, Yinghui Wang, Yuhao Chen, Chengxin Liu, Xuejia Zhai, Yongning Lu
BACKGROUND: Tegoprazan is a potassium-competitive acid blocker that inhibits gastric acid and which may be used for eradicating Helicobacter pylori. This study focuses on the pharmacokinetic interaction and safety between tegoprazan and the combination of clarithromycin, amoxicillin and bismuth in healthy Chinese subjects. METHODS: An open-label, three-period, single-center, multiple-dosage, single-sequence, phase I trial was conducted in 22 healthy subjects...
April 13, 2024: Clinical Drug Investigation
Zhao Wang, Tesfaye Liranso, Zulane Maldonado-Cruz, Alisa R Kosheleff, Azmi Nasser
BACKGROUND AND OBJECTIVE: Viloxazine extended-release (ER) [Qelbree® ] is a nonstimulant attention-deficit/hyperactivity disorder (ADHD) treatment. In vitro studies suggested potential for viloxazine to inhibit cytochrome 450 (CYP) enzymes 1A2, 2B6, 2D6 and 3A4. This clinical study therefore evaluated viloxazine ER effects on index substrates for CYP1A2, 2D6, and 3A4, and secondarily evaluated the impact of CYP2D6 polymorphisms on viloxazine pharmacokinetics. METHODS: Thirty-seven healthy subjects received a modified Cooperstown cocktail (MCC; caffeine 200 mg, dextromethorphan 30 mg, midazolam 0...
April 10, 2024: Clinical Drug Investigation
María Chaparro, Daniel Ceballos, Raquel Vicente, Javier P Gisbert
No abstract text is available yet for this article.
March 19, 2024: Clinical Drug Investigation
Upinder Kaur, Bhairav Kumar Pathak, Tharik Jalal Meerashahib, Dondapati Venkata Vamshi Krishna, Sankha Shubhra Chakrabarti
Despite 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...
March 9, 2024: Clinical Drug Investigation
Teppei Hagino, Risa Hamada, Mai Yoshida, Hidehisa Saeki, Eita Fujimoto, Naoko Kanda
BACKGROUND: Atopic dermatitis is characterized by persistent eczema and pruritus. Janus kinase inhibitors, including upadacitinib, are effective treatments for moderate-to-severe atopic dermatitis. If patients do not respond well to a certain dose of a Janus kinase inhibitor, increasing the dose may improve their treatment responsiveness. OBJECTIVES: We assessed the outcomes of a dose increase in upadacitinib from 15 mg to 30 mg for Japanese patients with moderate-to-severe atopic dermatitis...
March 6, 2024: Clinical Drug Investigation
Gianni Carraro, Valentina Di Vico, Loris Martinetti, Elisabetta Bettin, Martina Cacciapuoti, Lucia Federica Stefanelli, Laura Gobbi, Federico Nalesso, Francesca Katiana Martino, Lorenzo A Calò
No abstract text is available yet for this article.
March 2, 2024: Clinical Drug Investigation
Xi Tan, Victoria Divino, James Amamoo, Lin Xie, Katharine B Coyle, Cory L Gamble, Mico Guevarra, Yurek Paprocki, Aaron A King
BACKGROUND: The efficacy of once-weekly (OW) glucagon-like peptide-1 receptor agonists (GLP-1RAs) has been established in several trials in people with type 2 diabetes mellitus (T2DM); however, real-world evidence on their effectiveness is limited. This study evaluated the effectiveness of OW GLP-1RA regarding glycemic and weight outcomes, and relative to DPP-4i in a comparator analysis. METHODS: This observational cohort study evaluated glycated hemoglobin (HbA1c ) and weight outcomes in people with T2DM with two or more prescription claims for the same OW GLP-1RA using a pre-post study design (including for a semaglutide OW T2DM subgroup, hereafter referred to as semaglutide)...
April 2024: Clinical Drug Investigation
Wenwang Lang, Lian Deng, Bei Huang, Dongmei Zhong, Gaofeng Zhang, Meijun Lu, Ming Ouyang
BACKGROUND AND OBJECTIVES: Camrelizumab plus rivoceranib showed significant clinical benefits in progression-free survival and overall survival compared to sorafenib in patients with unresectable hepatocellular carcinoma (HCC). This study aimed to assess its cost effectiveness from the perspective of Chinese health care system. METHODS: A Markov state-transition model was developed based on the Phase 3 randomized CARES-310 clinical trial data. Health state utility values were obtained from the CARES-310 clinical trial, and direct medical costs were derived from the relevant literature and local charges...
March 2024: Clinical Drug Investigation
David P Walling, Sunita N Shinde, Janice M Pogoda, Jahnavi Kharidia, Celine M Laffont
BACKGROUND AND OBJECTIVE: Long-acting injectable antipsychotics have shown benefits over oral medications with reduced hospitalization rates and improved health-related quality of life. RBP-7000 (PERSERIS® ) is a monthly risperidone formulation (90 or 120 mg) for the treatment of schizophrenia administered by subcutaneous abdominal injection. The objective of this study was to assess a higher dose of 180 mg RBP-7000 and an alternate injection site. METHODS: Following stabilization on 6 mg/day (3 mg twice daily) oral risperidone, clinically stable schizophrenic participants received 3 monthly doses of 180 mg RBP-7000 in the abdomen followed by a fourth monthly dose of 180 mg RBP-7000 in the upper arm (each dose administered as two 90-mg injections)...
February 22, 2024: Clinical Drug Investigation
Ryan Thaliffdeen, Anthony Yu, Karen Rascati
BACKGROUND AND OBJECTIVES: Two oral calcitonin gene-related peptide (CGRP) antagonists, atogepant and rimegepant, were approved in 2021 for the preventive treatment of episodic migraine (EM), yet no formal cost-effectiveness analysis has been published. The objective of this study was to evaluate the cost-effectiveness of atogepant 60 mg and rimegepant 75 mg compared with placebo. METHODS: A decision tree model was constructed over a 1-year time horizon from a US societal perspective...
February 21, 2024: Clinical Drug Investigation
Christopher F Bell, Priyanka Bobbili, Raj Desai, Daniel C Gibbons, Myriam Drysdale, Maral DerSarkissian, Vishal Patel, Helen J Birch, Emily J Lloyd, Adina Zhang, Mei Sheng Duh
BACKGROUND AND OBJECTIVE: The coronavirus disease 2019 (COVID-19) pandemic has been an unprecedented healthcare crisis, one that threatened to overwhelm health systems and prompted an urgent need for early treatment options for patients with mild-to-moderate COVID-19 at high risk for progression to severe disease. Randomised clinical trials established the safety and efficacy of monoclonal antibodies (mAbs) early in the pandemic; in vitro data subsequently led to use of the mAbs being discontinued, without clear evidence on how these data were linked to outcomes...
February 20, 2024: Clinical Drug Investigation
Xiongwen Yang, Bo Yang, Dan Li, Wei Pan, Qin Tong, Lili Wang, Danjun Chen, Chengxiao Fu
BACKGROUND AND OBJECTIVES: Although thromboembolic events (TEEs) have been reported with the use of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), their association remains largely unknown. In this study, we aimed to provide a comprehensive review of TEEs associated with EGFR-TKIs. METHODS: We collected EGFR-TKIs (gefitinib, erlotinib, afatinib, and osimertinib) adverse reaction reports from 2015 Q1 to 2023 Q1 from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database...
February 20, 2024: Clinical Drug Investigation
Linnea Westerkam, Lauren Pearson, Christopher Sayed
No abstract text is available yet for this article.
February 19, 2024: Clinical Drug Investigation
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