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Introduction: In France, over recent years, the prescription rate of antipsychotic (AP) remained stable in children and adolescents. Prescription of second-generation antipsychotics increased, whereas prescription of first-generation antipsychotics decreased. Off-label prescriptions are very frequent in this population. Adverse events (AEs) in youth treated with AP are common and may be severe. AEs have hitherto been poorly monitored in naturalistic studies independent from industry.
Method And Analysis: We describe a French prospective multicentre study in an AP-naïve paediatric population named Etude de la Tolérance des AntiPsychotique chez l'Enfant (ETAPE). The study started in April 2013. So far, 200 patients have been included. The inclusion criteria are: male or female inpatients aged from 6 to 18 years, treated with an AP drug for less than 28 days, never been treated or having received AP for less than 3 months, discontinued at least 6 months prior to inclusion. These assessments of AE are performed at inclusion, as well as at 3, 6, 9 and 12 months after the introduction of the AP. The monitoring period will end in May 2016.
Ethics And Dissemination: The study protocol was approved by the Ethics Committee 'Sud Méditerrané V' (number 12.082) and by the French National Agency for Medicines and Health Products Safety (number 2012-004546-15). All patients and their parents signed informed consent on enrolment in the study. We will submit the results of the study to relevant journals and offer national and international presentations. This study will enable better characterisation of the prescription of AP drugs. The results will further help to develop quality standards and recommendations for monitoring AE during the prescription of AP.
Trial Registration Number: NCT02007928.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4823442 | PMC |
http://dx.doi.org/10.1136/bmjopen-2015-011020 | DOI Listing |
Expert Opin Drug Saf
December 2024
Department of Biochemistry, Chengde Medical University, Chengde, China.
Objective: The effectiveness and safety of the short-interfering RNA drug inclisiran in lowering patients' lipoprotein cholesterol levels to lower their risk of cardiovascular disease are presently being investigated. Based on the real-world adverse event report record in the FDA Adverse Event Reporting System, this article explores the occurrence and risk of adverse events during inclisiran treatment.
Research Design And Methods: We retrieved and screened all available data from the Food and Drug Administration website for the period from 2009 to the third quarter of 2023.
Breast Cancer Res Treat
December 2024
Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre University Health Network, 700 University Ave, Toronto, ON, M5G 1Z5, Canada.
Purpose: In early-stage breast cancer, steatotic liver disease (SLD) is associated with increased recurrence, cardiovascular events, and non-cancer death. Endocrine therapy (ET) increases the risk of SLD. The impact of cyclin-dependent kinases 4/6 inhibitors (CDK4/6i) on SLD and prognostic association in metastatic breast cancer is unknown.
View Article and Find Full Text PDFAliment Pharmacol Ther
December 2024
Division of Gastroenterology, Baylor University Medical Center and Baylor Scott & White Center for Esophageal Diseases, Dallas, Texas, USA.
Background: Patients with erosive oesophagitis, and those with persistent symptomatic non-erosive gastro-oesophageal reflux disease, require long-term maintenance treatment with acid-suppressing agents.
Aim: To evaluate the safety of vonoprazan, a potassium-competitive acid blocker, in an integrated analysis of data from clinical trials in adults.
Methods: We included 14 clinical trials of vonoprazan conducted in multiple countries.
Liver Int
January 2025
Liver Center, Digestive Diseases Section, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.
Background & Aims: Approximately 40% of patients with Primary Biliary Cholangitis (PBC) show incomplete response to ursodeoxycholic acid, thus needing second-line treatment to prevent disease progression. As no head-to-head comparison study is available, we used a network meta-analysis (NMA) to compare efficacy and safety of available second-line therapies.
Methods: We performed a systematic literature review including randomised, placebo-controlled trials of patients with PBC and incomplete response, or intolerance, to ursodeoxycholic acid, and compared relative risks (RRs) for primary (biochemical response at 52-week) and secondary outcomes [incidence of new-onset pruritus and serious adverse events (SAEs)].
Expert Opin Drug Saf
December 2024
Medical Genetics 8812, University of Alberta, Edmonton, AB, Canada.
Introduction: Duchenne muscular dystrophy (DMD) is a severe X-linked disorder characterized by progressive muscle weakness and eventual death due to cardiomyopathy or respiratory complications. Currently, there is no cure for DMD, with standard treatments primarily focusing on symptom management. Using immunosuppressive measures and optimized vector designs allow for gene therapies to better address the underlying genetic cause of the disease.
View Article and Find Full Text PDFEnter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!