The COVID-19 pandemic has stimulated the rapid development and large-scale use of technologically innovative vaccines, such as the mRNA vaccines Spikevax (Moderna) and Comirnaty (Pfizer-BioNTech). This unprecedented deployment has challenged pharmacovigilance, requiring combined skills in safety monitoring, prompt data analysis and continuous dissemination of knowledge. Main recognised adverse events of these vaccines are moderate and transient, linked to their significant reactogenicity. Active post-marketing surveillance has identified rare adverse events such as myopericarditis and a variety of skin reactions. A number of potential rare adverse events are being evaluated and could be retained at the individual level, but do not question the overall safety of these vaccines.
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http://dx.doi.org/10.53738/REVMED.2022.18.767.190 | DOI Listing |
Adv Ther
December 2024
Global Medical and Patient Affairs, Servier, Suresnes, France.
Introduction: The aim of the observational SIMPLE study was to assess real-life effectiveness and safety of a single-pill combination (SPC) of perindopril arginine/amlodipine in a broad range of subjects with newly diagnosed mild-to-moderate hypertension treated in Canadian general practice.
Methods: Treatment-naïve participants aged 18-65 years with mild-to-moderate hypertension, whose physicians decided to initiate the perindopril/amlodipine SPC, were recruited from Canadian clinical practice from October 2017 to February 2019. Participants were followed at 3- (M3) and 6-month (M6) visits after treatment initiation.
Cardiovasc Drugs Ther
December 2024
Department of Cardiology, Qingdao University, Qingdao, Shandong, China.
Intern Emerg Med
December 2024
Department of Emergency Medicine, JPS Health Network, 1500 S. Main St., Fort Worth, TX, 76104, USA.
The accuracy of using HEART (history, electrocardiogram, age, risk factors, and troponin) scores with high-sensitivity cardiac troponin (hs-cTn) to risk stratify emergency department (ED) chest pain patients remains uncertain. We aim to compare the performance accuracy of determining major adverse cardiac event (MACE) among three modified HEART (mHEART) scores with the use of hs-cTn to risk stratify ED chest pain patients. This retrospective single-center observational study included ED patients with suspected acute coronary syndrome who had HEAR scores calculated and at least one hs-cTnI result.
View Article and Find Full Text PDFEur J Clin Pharmacol
December 2024
Center for Pharmacometrics, Institute of Interdisciplinary Integrative Medicine Research, Shanghai University of Traditional Chinese Medicine, No.1200 Cailun Road, Shanghai, 201203, China.
Objectives: This study aimed to quantitatively evaluate the efficacy and safety of first-line systemic therapies for treating advanced hepatocellular carcinoma (aHCC).
Methods: The study included clinical trials of first-line systemic therapies for aHCC since the approval of sorafenib in 2007. Hazard function models were used to describe changes in overall survival (OS) and progression-free survival (PFS) over time.
Pacing Clin Electrophysiol
December 2024
Department of Cardiology, Medical University of Lublin, Lublin, Poland.
Transvenous extraction of the leads in children is associated with a higher risk of serious complications, that is why it is reluctantly performed. Unfortunately, this conservative approach has been associated with secondary complications (tricuspid valve dysfunction and bilateral venous obstruction), adverse events during lead removal procedure and recanalization and stenting of chest veins. We present a case of a 27-year-old female with a pacemaker and insertion of two new leads on the opposite side of the chest leaving the old ones in place.
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