To obtain broad regulatory approval for a new analgesic agent in acute postoperative pain, US and European regulatory authorities require pivotal studies in both hard (bony) tissue pain and soft tissue pain. Bunionectomy is by far the most common hard tissue pivotal trial model, in spite of the fact that the model has limited relevance to clinicians prescribing pain drugs (pain from bunionectomy is not extreme or long-lasting, and is adequately treated by existing drugs). The authors outline the experimental characteristics that make bunionectomy an appealing study model for researchers despite its lack of clinical relevance compared to larger surgeries.
View Article and Find Full Text PDFWe conducted a national in-depth analysis including pharmacovigilance reports and clinical study to assess the reporting rate (RR) and to determine the clinical profile of polymyalgia rheumatica (PMR) and giant cell arteritis (GCA) in COVID-19-vaccinated individuals. First, based on the French pharmacovigilance database, we estimated the RR of PMR and GCA cases in individuals aged over 50 who developed their initial symptoms within one month of receiving the BNT162b2 mRNA, mRNA-1273, ChAdOx1 nCoV-19, and Ad26.COV2.
View Article and Find Full Text PDFIntroduction: Colchicine is a narrow therapeutic margin drug that does not have the adverse effects of corticosteroids and immunosuppressants. Its use in non-severe ocular inflammatory disease excluding Behcet's disease has not been studied.
Methods: We included patients seen in the internal medicine department of Dijon University Hospital consecutively between September 2020 and September 2021 if they had received colchicine during their pathology.
To have a complete understanding of an experimental analgesic's efficacy in treating acute postoperative pain, it is necessary to understand its effect on both hard-tissue pain and soft-tissue pain. For this reason, regulatory bodies including the U.S.
View Article and Find Full Text PDFIntroduction: This study aimed to identify markers of disease worsening in patients hospitalized for SARS-Cov2 infection.
Patients And Methods: Patients hospitalized for severe recent-onset (<1 week) SARS-Cov2 infection were prospectively included. The percentage of T-cell subsets and plasma IL-6 at admission (before any steroid therapy) were compared between patients who progressed to a critical infection and those who did not.