The cardiovascular safety of oral alitretinoin. A population-based cohort study involving 19,513 patients exposed to oral alitretinoin

International audienceBACKGROUND: Oral alitretinoin is a retinoid used for severe chronic hand eczema. Although caution is recommended for patients with uncontrolled dyslipidaemia or cardiovascular risk factors, the actual atherothrombotic risk has not been investigated thus far. OBJECTIVES: Our aim was to detect any excess of atherothrombotic events among patients exposed to alitretinoin, during the treatment or in the 2 years following initiation. METHODS: Using the French Health Insurance database, we compared the number of patients having had an atherothrombotic event (coronary artery disease, ischemic stroke or peripheral artery disease requiring revascularisation) in the population exposed to oral alitretinoin versus the general population of the same age, gender and baseline cardiovascular risk, using standardized morbidity ratios (SMRs). RESULTS: Between 2009 and 2017, 19,513 patients were exposed to oral alitretinoin in France. Sixty-four (0.3%) patients had an atherothrombotic event while on alitretinoin. Patients receiving alitretinoin experienced no more atherothrombotic events than the general population: patients without cardiovascular risk factors or previous atherothrombotic events reached a SMR of 0.65, 95%CI [0.26-1.34] during alitretinoin treatment, and 1.21, 95%CI [0.90-1.59] in the 2 years following initiation; patients with cardiovascular risk factors or previous atherothrombotic events reached a SMR of 0.82, 95%CI [0.60-1.08] during alitretinoin treatment, and 0.95, 95%CI [0.82-1.09] in the 2 years following initiation. Taken separately, SMRs for each outcome did not increase either. CONCLUSIONS: These data from an exhaustive nationwide population-based study did not support an increase in the incidence of atherothrombotic events under alitretinoin, regardless of the baseline cardiovascular risk of the patient