June 25, 2025

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Long Term Use Of HCQS Linked To Increased Cardiovascular Mortality Risk: Lancet

Delhi: Long term use of hydroxychloroquine for the treatment of rheumatoid arthritis may increase cardiovascular mortality risk but its short-term use appears to be safe, suggests a recent study in The Lancet Rheumatology. Further, it was found that even in the short term the addition of azithromycin increase the risk of cardiovascular mortality and heart failure.
Hydroxychloroquine, a drug used commonly for rheumatoid arthritis treatment has received negative publicity owing to adverse events associated with its authorization for emergency use for treating patients with COVID-19 pneumonia. Jennifer C E Lane, University of Oxford, Oxford, UK, and colleagues studied the safety of hydroxychloroquine, alone and in combination with azithromycin for determining the risk associated with its use in routine care for patients with rheumatoid arthritis.
The researchers compared patients with rheumatoid arthritis aged 18 years or older and initiating hydroxychloroquine with those initiating sulfasalazine and followed up over 30 days, with 16 severe adverse events studied. To further establish safety in wider populations, self-controlled case series were done. It included all users of hydroxychloroquine regardless of rheumatoid arthritis status or indication. The researchers also separately studied severe adverse events associated with hydroxychloroquine plus azithromycin (compared with hydroxychloroquine plus amoxicillin).
The data consisted of 14 sources of claims data or electronic medical records from Germany, Japan, the Netherlands, Spain, the UK, and the USA. It included 956 374 users of hydroxychloroquine, 310 350 users of sulfasalazine, 323 122 users of hydroxychloroquine plus azithromycin, and 351 956 users of hydroxychloroquine plus amoxicillin.
Key findings of the study include:
No excess risk of severe adverse events was identified when 30-day hydroxychloroquine and sulfasalazine use were compared.
Self-controlled case series confirmed these findings.
Long-term use of hydroxychloroquine appeared to be associated with increased cardiovascular mortality (calibrated HR 1·65).
Addition of azithromycin appeared to be associated with an increased risk of 30-day cardiovascular mortality (calibrated HR 2·19), chest pain or angina (1·15 ), and heart failure (1·22).
"Based on the findings we call for careful consideration of the benefit-risk trade-off when counseling those on hydroxychloroquine treatment," concluded the authors.
The study, "Risk of hydroxychloroquine alone and in combination with azithromycin in the treatment of rheumatoid arthritis: a multinational, retrospective study," is published in the journal The Lancet Rheumatology.
DOI: https://doi.org/10.1016/S2665-9913(20)30276-9

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