Psy11 - Real-World Experience of Generalized Lipodystrophy Patients Enrolled in the Metreleptin Early Access Program: Initial Results

Abstract

analysis RESULTS: From the obesity cohort 138 subjects had a mean age (46.4 ± 16.5) years, about 90 (65.2%) cases, had UCG, (95% CI: 8.3 e 8.9). However, from 107 normal weight cases, with age (58.7 ± 15.6) years, only 45 (42.1%) patients had UCG, (95% CI: 7.6 e 8.4). T-test explored a statistically significant difference of HbA1c% means among the obesity cohort and normal body weight group [(8.6 ± 1.8) vs. (8 ± 2) respectively, (P-value¼ 0.027)]. Pearson correlation indicated a positive association between BMI and HbA1c% (r¼ 0.144, P-value¼ 0.024) and linear regression confirmed BMI as a predictor of HbA1c (r2¼ 0.021, p-value¼ 0.024). The relative risk of UCG in diabetic obese patients was (RR: 1.55, 95% CI: 1.2 e 2). The excess relative risk was 55%. The absolute risk was 23.2%, and the number needed to harm was 5. CONCLUSIONS: Obese outpatients with type 2 diabetes have a higher HbA1c mean value and higher risk of UCG than subjects with normal body weight. Obese patients need extra diabetic care.

Metreleptin in lipodystrophy: a profile of its use

“…The findings of clinical trials are generally supported by real-world experience in European countries [26,27] and Table 1 Summary of metreleptin administration in lipodystrophy in the EU [8] HbA 1C glycosylated haemoglobin, LD lipodystrophy a Minimum clinical response: ≥ 0.5% reduction in HbA 1C ± ≥ 25% reduction in insulin requirements ± ≥ 15% reduction in triglycerides What is the approved indication for the drug? Adjunct to diet as a replacement therapy to treat complications of leptin deficiency…”

“…Reconstitute in water using a syringe with a 40 mm, 21 Ensure patient is administering metreleptin correctly at an appropriate dose and is adhering to diet Consider dose increase before stopping metreleptin Children Dosage increases are likely necessary with increasing age (particularly at puberty), as abnormalities in HbA 1C and triglycerides increase If metabolic abnormalities are absent, base dose adjustments primarily on weight changes Brazil [28] (n = 9-28). For instance, in the largest analysis (a retrospective collection of data from 28 patients in the metreleptin early access programme in Italy, Spain, France and the UK; treatment duration ≤ 14.7 years) [26], metreleptin significantly (p ≤ 0.001 vs baseline) reduced levels of triglyceride by a median of 61% and HbA 1C by a mean of 1.9% after 12 months of therapy. Moreover, at this timepoint versus baseline, an increased proportion of metreleptin recipients had a triglyceride level of < 2.3 mmol/L (50 vs 5%) or a HbA 1C level of < 8% (70 vs 26%) [26].…”

“…For instance, in the largest analysis (a retrospective collection of data from 28 patients in the metreleptin early access programme in Italy, Spain, France and the UK; treatment duration ≤ 14.7 years) [26], metreleptin significantly (p ≤ 0.001 vs baseline) reduced levels of triglyceride by a median of 61% and HbA 1C by a mean of 1.9% after 12 months of therapy. Moreover, at this timepoint versus baseline, an increased proportion of metreleptin recipients had a triglyceride level of < 2.3 mmol/L (50 vs 5%) or a HbA 1C level of < 8% (70 vs 26%) [26].…”