Results 21 to 30 of about 19,579 (254)

Blood Pressure Control in the DIAbetes and LifEstyle Cohort Twente (DIALECT): The Role of Patient Adherence and Physician’s Follow-Up Action

Pharmacoepidemiology, 2023
We studied the role of adherence to antihypertensive drug therapy (AHT) in blood pressure (BP) control in a type 2 diabetes (T2D) population treated in secondary care in the DIAbetes and LifEstyle Cohort Twente-1 (DIALECT-1). In addition, intensification
Simone L. Dam, Heleen M. Masselink-Haverkate, Christina M. Gant, Stephan J. L. Bakker, Roos M. Nijboer, Willemien J. Kruik-Kollöffel, Gozewijn D. Laverman   +6 more
doaj   +1 more source

Analyzing Black Market Sales of the Second-Line ADHD Medication Atomoxetine

Pharmacoepidemiology, 2023
Research Question and Objective: While the number of pharmacoepidemiological studies on stimulant-based ADHD medications has expanded rapidly in recent years, likely due to the stimulant shortage, few studies have analyzed non-stimulant ADHD medications ...
Sophie A. Roe, Dayna S. DeSalve, Brian J. Piper   +2 more
doaj   +1 more source

Trends in 25 years of antihypertensive agent utilization in Croatia – an alert for scientific community and healthcare providers

British Journal of Clinical Pharmacology, EarlyView.
Aims Hypertension is a leading modifiable risk factor for cardiovascular mortality worldwide. This study aimed to evaluate 25‐year trends in antihypertensive agent (AHA) utilization in Croatia between 2000 and 2024. Methods We conducted a national, population‐based analysis using IMS and IQVIA pharmaceutical databases.
Andrej Belančić, Marta Kučan Štiglić, Ana Jelaković, Bojan Jelaković, Dinko Vitezić   +4 more
wiley   +1 more source

Helpful, Unnecessary, or Harmful: A Systematic Review of the Effects of Prescription Drug Monitoring Program Use on Opioid Prescriptions

Pharmacoepidemiology, 2023
Prescription drug misuse is a global problem, especially in the United States (US). Clinician involvement is necessary in this crisis, and prescription drug monitoring programs (PDMPs) are a recommended tool for the prevention, recognition, and ...
Nina Z. Y. Smith, J. Douglas Thornton, Susan H. Fenton, Debora Simmons, Tiffany Champagne-Langabeer   +4 more
doaj   +1 more source

Through the lens of marketing authorization holders: experience in use of real‐world data and real‐world evidence in drug development and regulatory submissions in EU

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim The aim of this study was to assess the general and product‐specific experiences of MAHs use of RWD/RWE in medicines development and in their regulatory submissions, and to explore organizational aspects of MAHs related to RWD/RWE. Methods An electronic survey was conducted, and information collected directly from MAHs.
Sini M. Eskola, Aleksandar Gigov, Hubertus G. M. Leufkens, Andrew Bate, Marie Louise De Bruin, Helga Gardarsdottir   +5 more
wiley   +1 more source

Decoding RNA regulation: Challenges and opportunities for RNA‐based therapies in Europe

British Journal of Clinical Pharmacology, EarlyView.
Abstract RNA‐based medicinal products represent a promising frontier in personalised medicine, offering sequence‐specific disease targeting at various molecular levels, yet their clinical translation in the European Union (EU) may be hindered by regulatory uncertainty around definitions and evidence requirements; this study therefore aims to identify ...
Olivia C. Lewis, Christine Leopold, Joyce M. Hoek, Raymond M. Schiffelers, Marie L. De Bruin   +4 more
wiley   +1 more source

Evaluating the (comparative) safety profile of the novel oral polio vaccine type 2 using individual case safety reports in VigiBase

British Journal of Clinical Pharmacology, EarlyView.
Aim Novel oral polio vaccine type 2 (nOPV2) was used under the WHO emergency use listing for circulating vaccine‐derived polio virus (cVDPV) outbreaks from 2021 to 2023. We assessed nOPV2 adverse events following immunization (AEFIs) and compared its safety profile to other vaccines using VigiBase.
Comfort Kunak Ogar, Malede Mequanent Sisay, Leonardo Roque‐Pereira, Christine Leopold, Patrick C. Souverein, Aukje K. Mantel‐Teeuwisse, Marie L. De Bruin   +6 more
wiley   +1 more source

Identification of major congenital malformations based on healthcare databases in France: A proof‐of‐concept study using the epi‐meres nationwide mother–child register

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Besides registries, healthcare databases can provide useful information for assessing the frequency of major congenital malformations (MCMs) and investigating their risk factors, particularly medication exposures. This study aimed to assess the validity of MCMs identification based on French national, comprehensive healthcare databases ...
Tom Duchemin, Lise Marty, Jérôme Drouin, Sara Miranda, Jérémie Botton, Valérie Olié, Alain Weill, Rosemary Dray‐Spira   +7 more
wiley   +1 more source

Supratherapeutic drug concentration triggers: A novel data‐driven approach to assess their value for medication safety surveillance in intensive care

British Journal of Clinical Pharmacology, EarlyView.
Aims Electronic triggers (e‐triggers) are used as screening signals to detect potential adverse drug events (ADEs) and offer an effective system level approach for medication safety surveillance. Their clinical utility is typically evaluated through time‐consuming manual chart review by experts, limiting implementation.
Anne Paulien Langermans, Izak A. R. Yasrebi‐de Kom, Dylan Wayne de Lange, Nicolette Fransisca de Keizer, Joanna E. Klopotowska, on behalf of the RESCUE Study group, C. S. C. Bouman, E. N. van Roon, P. F. Schutte, J. ten Cate, D. van Balen, S. Hendriks, C. Lau, W. J. Vermeijden, A. Beishuizen, J. B. Masselink, P. E. Spronk, H. J. M. van Kan, P. W. de Feiter, E. J. Wils, A. Wieringa, A. J. Valkenburg, W. M. van den Bergh, M. H. Renes, W. Bult, E. de Jonge, M. Hoeksema, E. J. Wesselink, I. M. Purmer, B. E. Bosma, S. H. W. van Bree, H. J. W. Lammers, R. J. Bosman, E. J. F. Franssen, A. Karakus, M. Sigtermans, E. M. Kuck, D. A. Dongelmans, M. J. H. Aries, E. V. Uijtendaal, M. C. Reuland   +40 more
wiley   +1 more source

Characteristics and temporal trends of EU teratological safety signals and information dissemination to healthcare professionals in the Netherlands—A contribution of the ConcePTION project

British Journal of Clinical Pharmacology, EarlyView.
Abstract Aim Although regulatory responses to safety signals have been studied, pregnancy‐specific data and their dissemination to medical professionals remain unclear. This study examined the characteristics and temporal trends of teratological safety signals prompting the European Medicines Agency to implement risk minimization measures.
Yrea R. J. van Rijt‐Weetink, Rosanne E. Huisman, Jan‐Peter van Wieringen, H. J. M. J. (Ineke) Crijns, Florence P. A. M. van Hunsel, Anneke L. M. Passier, Sander Borgsteede, A. C. G. (Toine) Egberts, Laura M. Yates, Eugène P. van Puijenbroek   +9 more
wiley   +1 more source