Chan, Amy Hai Yan Horne, Rob Hankins, Matthew Chisari, Claudia
Published in
British journal of clinical pharmacology
This study aimed to establish the psychometric properties of a questionnaire measure of patients' adherence to medications to elicit patients' report of medication use in a variety of clinical samples. The reliability and validity were assessed in patients with hypertension. Additional analyses were performed on other patient groups. Using a cross-...
Bertani, Lorenzo Baglietto, Laura Antonioli, Luca Fornai, Matteo Tapete, Gherardo Albano, Eleonora Ceccarelli, Linda Mumolo, Maria Gloria Pellegrini, Carolina Lucenteforte, Ersilia
...
Published in
British journal of clinical pharmacology
Vedolizumab (VDZ) prevents migration of activated leucocytes into inflamed mucosa. This study aimed to assess the patterns of serum cytokines in ulcerative colitis (UC) patients at baseline and during VDZ treatment, and to investigate their association with mucosal healing and clinical remission. We enrolled consecutive UC patients eligible for tre...
Vreman, Rick A Belitser, Svetlana V Mota, Ana T M Hövels, Anke M Goettsch, Wim G Roes, Kit C B Leufkens, Hubert G M Mantel-Teeuwisse, Aukje K
Published in
British journal of clinical pharmacology
There is a trend for more flexibility in timing of evidence generation in relation to marketing authorization, including the option to complete phase III trials after authorization or not at all. This paper investigated the relation between phase II and III clinical trial efficacy in oncology. All oncology drugs approved by the European Medicines A...
Pétavy, Frank Guizzaro, Lorenzo Antunes Dos Reis, Inês Teerenstra, Steven Roes, Kit C B
Published in
British journal of clinical pharmacology
There is a key problem in randomised clinical trials as outcomes can be distorted due to informative post-randomisation events. This is inadequately addressed by the use of traditional intention-to-treat or per protocol analysis sets and often either ignored or wrongly labelled as missing data. As a consequence, the treatment effects of interest in...
Dragović, Gordana Dimitrijević, Božana Kušić, Jovana Soldatović, Ivan Jevtović, Djordje Olagunju, Adeniyi Owen, Andrew
Published in
British journal of clinical pharmacology
Lopinavir (LPV) is not a first-line regimen. According to recent WHO data, LPV usage in low- and middle-income countries accounted for approximately 52% of the adult and 23% of the paediatric protease inhibitor market in 2017. Since LPV is a substrate for the SLCO1B1 (OATP1B1) transporter, the aim of this study was to assess the impact of SLCO1B1 p...
Ring, Arne Wolfsegger, Martin J
Published in
British journal of clinical pharmacology
The recently finalised and published guideline ICH E9 (R1) introduced a new framework for the statistical analysis of clinical trials, namely that of "estimands". While the framework was originally developed for the analysis of late-phase trials, it could also provide a rigorous basis for the analysis of clinical pharmacology trials. We illustrate ...
Godinho, Géssica Vasconcelos Paz, Ana Luiza Lima Medeiros de Araújo Gomes, Elâine Patrícia Alves Garcia, Cristiane Loreda Volpato, Luiz Evaristo Ricci
Published in
British journal of clinical pharmacology
A 66-year-old woman diagnosed clinical manifestation of extensive hard palate hyperpigmentation is presented. Due to historic of rheumatoid arthritis and use of chloroquine phosphate for 3 years, exogenous hyperpigmentation associated with the drug was included among the possible diagnoses. Incisional biopsy was performed and the histopathological ...
Ehmann, Falk Aerssens, Jeroen Blanchard, Rebecca
Published in
British journal of clinical pharmacology
The ability to benefit from knowledge of human genomic data in medicine has been anticipated since the sequencing of the human genome [International Human Genome Consortium 2001, Venter 2001]. That promise has experienced some degree of realization, particularly in oncology where biomarker-specific clinical trials and patient treatment specific to ...
Hughes, Dyfrig A
Published in
British journal of clinical pharmacology
Ingrand, Isabelle Defossez, Gautier Lafay-Chebassier, Claire Chavant, François Ferru, Aurélie Ingrand, Pierre Pérault-Pochat, Marie-Christine
Published in
British journal of clinical pharmacology
Pharmaco-epidemiological surveys enable the frequency of serious adverse effects - and also the determining factors of their occurrence and seriousness - to be quantified. Few studies systematically gathering post-chemotherapy adverse effects data have been conducted. The objective was to assess the incidence of post-chemotherapy serious adverse ef...
