Long-term effectiveness and safety of metreleptin in the treatment of patients with partial lipodystrophy.

ABSTRACT:

Purpose

To evaluate the effects of metreleptin in patients with partial lipodystrophy (PL).

Methods

Patients aged ≥ 6 months with PL, circulating leptin < 12.0 ng/mL, and diabetes mellitus, insulin resistance, or hypertriglyceridemia received metreleptin doses (once or twice daily) titrated to a mean of 0.124 mg/kg/day. Changes from baseline to month 12 in glycated hemoglobin (HbA1c) and fasting serum triglycerides (TGs; co-primary endpoints), fasting plasma glucose (FPG), and liver volume were evaluated. Additional assessments included the proportions of patients achieving target decreases in HbA1c or fasting TGs at month 12, long-term treatment effects, and treatment-emergent adverse events (TEAEs).

Results

Significant (p < 0.05) reductions in HbA1c (-0.6%), fasting

SUBMITTER: Oral EA 

PROVIDER: S-EPMC7340120 | biostudies-literature | 2019 Jun

REPOSITORIES: biostudies-literature