Results 61 to 70 of about 35,320 (249)

Patients on statins with elevated transaminases: Frequency of follow‐up creatine kinase testing and gastroenterology referral

British Journal of Clinical Pharmacology, EarlyView.
Abstract Purpose To quantify how often creatine kinase (CK) is measured after newly elevated aminotransferases in statin users, and whether absent CK data are associated with gastroenterology (GI) referrals. Methods Retrospective chart review of adult outpatients on statins with a first alanine/aspartate aminotransferase (ALT/AST) elevation during a 5 ...
Faris Shweikeh, Anas Kartoumah, Rajshri Joshi, Anjali Nadihaan, Mohammed Mouchli, Inderprit Singh   +5 more
wiley   +1 more source

Can Pharmacovigilance Data Represent a Potential Tool for Early Detection of the Antibiotic Resistance Phenomenon?

Pharmacoepidemiology
Background: Antibiotic resistance represents a growing concern. A new strategy developed to treat severe infections is represented by ceftazidime/avibactam (CZA/AVI).
Cecilia Cagnotta, Alessia Zinzi, Francesca Gargano, Valerio Liguori, Maria Rosaria Campitiello, Alessandro Perrella, Annalisa Capuano, Concetta Rafaniello, Ugo Trama   +8 more
doaj   +1 more source

Psychiatric adverse events in oseltamivir prophylaxis trials: Novel comparative analysis using data obtained from clinical study reports [PDF]

, 2018
PURPOSE: Estimating the rate of adverse events (AEs) caused by a treatment in clinical trials typically involves comparing the proportions of patients experiencing AEs in intervention and control groups.
Bender, Doshi, Gravenstein, Hayden, Jefferson, Jefferson, Jones, Lineberry, Patel, Peters, Simmonds, Toovey, Welliver   +12 more
core   +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

Cardiovascular Adverse Events Associated with Prostate Cancer Treatment: A Disproportionality Analysis from the Food and Drug Administration Adverse Event Reporting System Database

Pharmacoepidemiology
Background/Objectives: Several drugs used to treat prostate cancer have been reported to cause cardiovascular adverse events, and this study sought to identify the real-world risk.
Connor Frey
doaj   +1 more source

Assessing recording delays in general practice records to inform near real-time vaccine safety surveillance using the Clinical Practice Research Datalink (CPRD). [PDF]

, 2017
PURPOSE: Near real-time vaccine safety surveillance (NRTVSS) is an option for post-licensure vaccine safety assessment. NRTVSS requires timely recording of outcomes in the database used.
Andrews, Nick J, Leite, Andreia, Thomas, Sara L   +2 more
core   +1 more source

Impact of empiric potassium supplementation on mortality, sudden cardiac arrest and stroke in furosemide initiators

British Journal of Clinical Pharmacology, EarlyView.
Aim A prior non‐randomized study suggests that potassium supplementation may improve survival among furosemide initiators, and a randomized trial suggests that salt substitutes containing potassium might lower stroke risk. We conducted a retrospective cohort study using health‐care data to confirm or refute these associations among new users of ...
Thanh Phuong Pham Nguyen, Sean Hennessy, Colleen M. Brensinger, Warren B. Bilker, Laura M. Dember, Todd A. Miano, Tat‐Thang Vo, Allison W. Willis, Charles E. Leonard   +8 more
wiley   +1 more source

DARE-SAFE: Denominator-Adjusted Rate Estimates of Substance Adverse Events Frequency Evaluation in Pharmaceuticals and Vaccines

Pharmacoepidemiology
Background/Objectives: Controversy exists over the use of passive reporting systems, especially the Vaccine Adverse Event Reporting System, in risk assessment.
Matthew Halma, Joseph Varon
doaj   +1 more source

Matching Methods for Causal Inference: A Review and a Look Forward [PDF]

, 2009
When estimating causal effects using observational data, it is desirable to replicate a randomized experiment as closely as possible by obtaining treated and control groups with similar covariate distributions. This goal can often be achieved by choosing
Bloomberg School, Elizabeth A. Stuart, Johns Hopkins, Public Health   +3 more
core   +3 more sources

Artificial Intelligence for Regulatory Evidence: A Systematic Document Analysis of European Medicines Agency Regulatory Advice and Public Reports

Clinical Pharmacology &Therapeutics, EarlyView.
Artificial intelligence (AI) is receiving increasing attention across the entire lifecycle of medicines, from early development to postauthorization use. While various AI tools have been developed in commercial and academic settings, the extent of their use in regulatory contexts within the European Union remains unknown.
Lucina‐May Nollen, Gerard J.P. van Westen, Gabriel Westman, Anna M.G. Pasmooij   +3 more
wiley   +1 more source