HIV clinical trials · 2004
Benfluorex as a therapeutic option for insulin resistance in HIV lipodystrophy syndrome.
Клиническое исследованиеСтатьяНазвание и аннотация: Перевод в очереди
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Poizot-Martin I, Marimoutou C, Vion-Dury F, Grégoire R, Dinh T, Djemli K, Di Stefano D, Vague Ph, Gastaut J A
Аннотация
BACKGROUND: HIV lipodystrophy syndrome, characterized by a significant excess of visceral adiposity and a reduced subcutaneous fat mass in association with insulin resistance and dyslipidemia, still affects the majority of antiretroviral-treated HIV-infected patients. The therapeutic management of this syndrome has not yet been well established. Benfluorex is known to decrease insulin resistance with no side effects on lactate levels in HIV-negative patients.
METHOD: We conducted an open-label study of benfluorex (150 mg, 2-3 times a day) that was prescribed for 60 HIV-infected patients who were diagnosed with glucose metabolism abnormalities by oral glucose tolerance test (OGTT); 47 of these patients had visceral fat accumulation measured by computed tomography (VAT). Median follow-up was 12 months (interquartile range [IQR] = 6-12 months). The great majority of patients (90%) were treated with at least triple therapy (in 70% the therapy included at least one PI), with a nonsignificant change over the study period.
RESULTS: Added to antiretroviral therapy, benfluorex improved OGTT in 47/60 cases, including total normalization in 34/60 without lactate concentration modification. A trend toward a decrease in VAT distribution was observed (p =.06). No significant difference was observed in subcutaneous fat distribution, although an increase in subcutaneous thigh adipose tissue was observed in 17/47 (36.2%) cases and 6 patients (12.7%) presented both subcutaneous fat increase and VAT decrease.
METHOD: We conducted an open-label study of benfluorex (150 mg, 2-3 times a day) that was prescribed for 60 HIV-infected patients who were diagnosed with glucose metabolism abnormalities by oral glucose tolerance test (OGTT); 47 of these patients had visceral fat accumulation measured by computed tomography (VAT). Median follow-up was 12 months (interquartile range [IQR] = 6-12 months). The great majority of patients (90%) were treated with at least triple therapy (in 70% the therapy included at least one PI), with a nonsignificant change over the study period.
RESULTS: Added to antiretroviral therapy, benfluorex improved OGTT in 47/60 cases, including total normalization in 34/60 without lactate concentration modification. A trend toward a decrease in VAT distribution was observed (p =.06). No significant difference was observed in subcutaneous fat distribution, although an increase in subcutaneous thigh adipose tissue was observed in 17/47 (36.2%) cases and 6 patients (12.7%) presented both subcutaneous fat increase and VAT decrease.