PubMed:27430612 JSONTXT

{"target":"https://pubannotation.org/docs/sourcedb/PubMed/sourceid/27430612","sourcedb":"PubMed","sourceid":"27430612","text":"ATX-101 for reduction of submental fat: A phase III randomized controlled trial.\nBACKGROUND: ATX-101, an injectable form of deoxycholic acid, causes adipocytolysis when injected subcutaneously into fat.\nOBJECTIVE: We sought to evaluate the efficacy and safety of ATX-101.\nMETHODS: In this phase III trial (REFINE-2), adults dissatisfied with their moderate or severe submental fat (SMF) were randomized to ATX-101 or placebo. Coprimary end points, evaluated at 12 weeks after last treatment, were composite improvements of 1 or more grades and 2 or more grades in SMF observed on both the validated Clinician- and Patient-Reported SMF Rating Scales. Other end points included magnetic resonance imaging-based assessment of submental volume, assessment of psychological impact of SMF, and additional patient-reported outcomes.\nRESULTS: Among those treated with ATX-101 or placebo (n = 258/treatment group), 66.5% versus 22.2%, respectively, achieved a composite improvement of 1 or more grades (Mantel-Haenszel risk ratio 2.98; 95% confidence interval 2.31-3.85) and 18.6% versus 3.0% achieved a composite improvement of 2 or more grades in SMF (Mantel-Haenszel risk ratio 6.27; 95% confidence interval 2.91-13.52; P \u003c .001 for both). Those treated with ATX-101 were more likely to achieve submental volume reduction confirmed by magnetic resonance imaging, greater reduction in psychological impact of SMF, and satisfaction with treatment (P \u003c .001 for all). Overall, 85.7% of adverse events in the ATX-101 group and 76.9% in the placebo group were localized to the injection site.\nLIMITATIONS: Follow-up was limited to 44 weeks.\nCONCLUSION: ATX-101 is an alternative treatment for SMF reduction.","tracks":[]}