We are looking at patients from the general population, which is why it is so important to look at data from multiple countries. 'OHDSI has the power to investigate this question in a very thorough way and to go through rigorous steps. 'At medical school we were taught to ‘first do no harm’ and to me, our study focuses on this core belief of modern medicine,' said Jennifer Lane, MD, NDORMS, who served as co-lead author on this study along with Jamie Weaver, from Janssen Research and Development. Records were collected from 14 different databases spanning six nations (Germany, Japan, Netherlands, Spain, United Kingdom, United States) and then mapped to the OMOP Common Data Model to generate this large-scale analysis. The OHDSI community examined more than 950,000 hydroxychloroquine users through de-identified electronic health records and administrative claims data over a 20-year period. This is the first published study to be generated from the OHDSI COVID Study-a-thon, a global effort in March to set the foundation for OHDSI efforts to design and execute network observational studies around characterisation, patient-level prediction and population-level effect estimation to inform decision-making around the global pandemic. However, when prescribed in combination with azithromycin, it may induce heart failure and cardiovascular mortality and we would urge caution in using the two together.' 'We had access to an unprecedented amount of data on this drug, and we were relieved to find no worrying side effects in the short-term use of hydroxychloroquine. 'Hydroxychloroquine, both alone and in combination with azithromycin, gained strong consideration as a potential COVID-19 treatment without a large-scale study of its overall safety profile,' said Daniel Prieto-Alhambra, Professor of Pharmaco- and Device Epidemiology at the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), and co-senior author on this study. Hydroxychloroquine, a drug commonly used in the treatment of malaria and lupus in addition to rheumatoid arthritis, gained early attention during the pandemic as a potential COVID-19 treatment. This treatment also produced a 15-20% increased rate of angina/chest pain and heart failure. Hydroxychloroquine and azithromycin together had a cardiovascular mortality risk that was more than twice (2.19) as high as the comparative treatment even in the short term based on findings from more than 320,000 users of that combination therapy. In patients with rheumatoid arthritis, hydroxychloroquine treatment in the short term (30 days) was found to not carry excess risk of complications associated with its use, but hydroxychloroquine treatment in the long term had a 65% relative increase in cardiovascular-related mortality, compared to sulfasalazine, a similar rheumatoid arthritis drug. This network study, led by the Observational Health Data Sciences and Informatics (OHDSI) community, was recently published in Lancet Rheumatology. Hydroxychloroquine is commonly used to treat rheumatoid arthritis, while azithromycin is a frequently-prescribed antibiotic to treat infections such as pneumonia, chest and sinus infections, etc.
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