Estimation of Carbohydrate Metabolism Disorder Frequency in Hypertriglyceridemia Induced by Bexarotene Treatment of Cutaneous T Cell Lymphoma - Pilote Study
Primary cutaneous lymphomas are the second group of extra nodal lymphomas after
gastrointestinal lymphomas. Bexarotene is licensed for the treatment of epidermotropic
cutaneous T cell lymphoma .The most common side effect of bexarotene is hypertriglyceridemia
(82%) associated with hypercholesterolemia (30 to 40%). Central hypothyroidism is also
present in 40-80% of cases. These adverse effects are dose-dependent. The management of
hyperlipidemia induced by bexarotene is difficult. The mechanism of lipid disorder induced
by bexarotene is not well known. Associated carbohydrate metabolism disorder could be
present and play a role in the bexarotene-induced hyperlipidemia.
The main objective is to estimate the frequency of a carbohydrate disorder in patients with
hypertriglyceridemia (TG> 1.5 g / L) induced by bexarotene treatment of cutaneous T cell
lymphoma, previously free of diabetes, thyroid dysfunction and dyslipidemia.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
glucose intolerance or diabetes
The presence of a carbohydrate disorder is defined by glucose intolerance or diabetes. The diagnosis of glucose intolerance is made for a fasting glucose less than 1.26 g / l glucose and 2 hours (T120mn) after taking 75 g of glucose during an oral glucose tolerance test (OGTT) between 1.4 and 2 g / l and / or a value greater than or equal to 2 g / l between T30 and T90 min. Diabetes is established for a fasting glucose greater than or equal to 1.26 g / l and / or blood glucose greater than or equal to 2 g / l to 2 hours.
At 0, 2, 4, 6, 8 weeks after the administration of bexarotene.
Henri ADAMSKI, MD
Rennes University Hospital
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)