Vela, Driton Vela-Gaxha, Zana Rexhepi, Mjellma Olloni, Rozafa Hyseni, Violeta Nallbani, Rajmonda
Published in
British journal of clinical pharmacology
Tocilizumab has emerged as an important therapy in treating patients with coronavirus disease (COVID-19). Our purpose was to evaluate the efficacy and safety of tocilizumab versus standard care/placebo in patients with COVID-19. We searched a variety of sources from 1 January 2020 to 5 May 2021. All randomized controlled trials that reported tocili...
Istvan, Marion Laforgue, Edouard-Jules Guerlais, Marylène Jolliet, Pascale Victorri-Vigneau, Caroline
Published in
British journal of clinical pharmacology
Wang, Zhenlei Zeng, Zhijun Ye, Lijun Zhu, Xiaohong Pei, Yuwen Wang, Yongsheng Zheng, Li
Published in
British journal of clinical pharmacology
The pharmacokinetics (PK) of hetrombopag were found to be nonlinear across evaluated dose ranges. The aim of this study was to develop a mechanism-based population pharmacokinetic/pharmacodynamic (PopPK/PD) model and to provide a reasonable expected therapeutic dose for a future confirmatory clinical study of hetrombopag. Nonlinear mixed-effects mo...
Edlund, Helena Buil-Bruna, Núria Vishwanathan, Karthick Wei, Helen Raman, Rakesh de Kock, Miné He, Zhongqing Liu, Huan Baek, Marshall Ware, Joseph
...
Published in
British journal of clinical pharmacology
Examine relationships between the systemic exposure of acalabrutinib, a highly selective, next-generation Bruton tyrosine kinase inhibitor, and its active metabolite (ACP-5862) vs. efficacy and safety responses in patients with B-cell malignancies who received acalabrutinib as monotherapy or in combination with obinutuzumab. For exposure-efficacy a...
Thai, Hoai-Thu Gaudel, Nadia Cerou, Marc Ayral, Geraldine Fau, Jean-Baptiste Sebastien, Bernard van de Velde, Helgi Semiond, Dorothée Veyrat-Follet, Christine
Published in
British journal of clinical pharmacology
Addition of isatuximab (Isa) to pomalidomide/dexamethasone (Pd) significantly improved progression-free survival (PFS) in patients with relapsed/refractory multiple myeloma (RRMM). We aimed to characterize the relationship between serum M-protein kinetics and PFS in the phase 3 ICARIA-MM trial (NCT02990338), and to evaluate an alternative dosing re...
Delanaye, Pierre Björk, Jonas Courbebaisse, Marie Couzi, Lionel Ebert, Natalie Eriksen, Björn O Dalton, R Neil Dubourg, Laurence Gaillard, Francois Garrouste, Cyril
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Published in
British journal of clinical pharmacology
The Cockcroft-Gault (CG) creatinine-based equation is still used to estimate glomerular filtration rate (eGFR) for drug dosage adjustment. Incorrect eGFR may lead to hazardous over- or underdosing. In a cross-sectional analysis, CG was validated against measured GFR (mGFR) in 14 804 participants and compared with the Modification-of-Diet-in-Renal-D...
Hamimed, Mourad Gattacceca, Florence André, Nicolas Tresch-Bruneel, Emmanuelle Probst, Alicia Chastagner, Pascal Pagnier, Anne De Carli, Emilie Entz-Werlé, Natacha Grill, Jacques
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Published in
British journal of clinical pharmacology
There is a crucial need for pharmacokinetic (PK) data on oral vinorelbine (VNR) in the paediatric population. The aim of this work was to assess the PK profile of orally administered VNR in children with recurrent/progressive primary low-grade glioma (LGG). A multicentre, open-label, single-arm intervention phase II study was conducted. Patients, a...
Myers, Rachel A Ortel, Thomas L Waldrop, Alexander Dave, Sandeep Ginsburg, Geoffrey S Voora, Deepak
Published in
British journal of clinical pharmacology
Aspirin has known effects beyond inhibiting platelet cyclooxygenase-1 (COX-1) that have been incompletely characterized. Transcriptomics can comprehensively characterize the on- and off-target effects of medications. We used a systems pharmacogenomics approach of aspirin exposure in volunteers coupled with serial platelet function and purified plat...
Hwang, Jun Gi Lee, Seung Hwan Huh, Wan Han, Jumi Oh, Jaeseong Jang, In-Jin Yu, Kyung-Sang
Published in
British journal of clinical pharmacology
DWP16001 is a novel sodium-glucose cotransporter-2 (SGLT-2) inhibitor under development for the treatment of type 2 diabetes mellitus. This study was conducted to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and safety of DWP16001 after single and multiple doses in healthy subjects. A randomized, double-blind, placebo- and active-cont...
Højen, Anette Arbjerg Nielsen, Peter Brønnum Riahi, Sam Jensen, Martin Lip, Gregory Y H Larsen, Torben Bjerregaard Søgaard, Mette
Published in
British journal of clinical pharmacology
Schizophrenia is associated with poor anticoagulation control and clinical prognosis in patients with atrial fibrillation (AF). Little is known about initiation of oral anticoagulation therapy (OAC) in this patient population. In the nationwide Danish health registries, we identified all patients with incident AF and schizophrenia with indication f...
