Severe adverse events with hydroxychloroquine in rheumatoid arthritis
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Severe adverse events with hydroxychloroquine in rheumatoid arthritis Although short-term hydroxychloroquine treatment of patients with rheumatoid arthritis does not appear to be associated with an increased risk of severe adverse events compared with sulfasalazine treatment, according to study results reported in The Lancet Rheumatology, long-term use or combination with azithromycin appears to be associated with an increased risk of cardiovascular disorders. Data was obtained from 14 databases in six countries from September 2000. The retrospective study1 compared the incidence of 16 severe adverse events over 30 days in patients initiating hydroxychloroquine (n=956 374) or sulfasalazine (n=310 350).* There was no significantly excess event risk for hydroxychloroquine recipients. For long-term users, hydroxychloroquine was associated with an increased risk of cardiovascular-related mortality versus sulfasalazine users (4.39 vs 2.00 per 1000 person-years; meta-analysis calibrated hazard ratio [HR] 1.65; 95% CI 1.12, 2.44). Results of a self-controlled cases series in all hydroxychloroquine users regardless of indication which compared periods on and off treatment "confirmed these findings", note the authors. Additionally, severe adverse events were compared in the patients who received hydroxychloroquine and azithromycin (n=323 122) versus hydroxychloroquine and amoxicillin (n=351 956). The risk of cardiovascular-related mortality was significantly increased (HR 2.19; 1.22, 3.95), as was the risk of chest pain/angina (HR 1.15; 1.05, 1.26) and heart failure (HR 1.22; 1.02, 1.45). The authors note that this was "probably arising through their synergistic effects on QT length and subsequent induction of fatal arrhythmia". "The collective experience of almost a million patients builds our confidence in the evidence around the safety profile of hydroxychloroquine", conclude the authors, who add that "a cautious assessment of cardiovascular risk is needed before initiating high-dose hydroxychloroquine plus azithromycin combination therapy, and in long-term monitoring of patients with rheumatoid arthritis, especially those with cardiovascular risk factors". In an accompanying comment reported in The Lancet Rheumatology,2 Tom Huizinga (Leiden University Medical Center) and Rachel Knevel (Brigham and Women’s Hospital) note that although the study "provides a relevant guide for researchers in the field of electronic medical record analyses", the "question remains whether the results should guide our current standards of care". They add that as the cardiovascular mortality rate was very low, "one needs to consider that if bias between the groups exists, then the differences between 4 per 1000 and 2 per 1000 years of observation might also be caused by bias". They conclude that "it is difficult to weigh the current data in the context of daily care of patients with SLE, in which so much convincing evidence exists for the positive effects of hydroxychloroquine as recommended by EULAR". * EUPAS34497 1. Lane JCE, et al. Risk
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