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Kybella may be an effective alternative to surgical treatment for submental fat
Kybella demonstrated efficacy in treating submental fat, and may be an alternative to surgical treatment, according to recently published study results.
Shannon Humphrey, MD, of the University of British Columbia and Carruthers & Humphrey, Vancouver, British Columbia, and colleagues conducted a phase 3, double-blind trial of 516 adults (86.2% women; mean age, 47.9 years; mean BMI, 29.3 kg/m2) with moderate-to-severe submental fat. Patients were randomly assigned to Kybella (deoxycholic acid, Allergan), also known as ATX-101, or placebo.
Composite improvements of one or more grades and two or more grades in submental fat observed on both validated clinician- and patient-reported submental fat rating scales were used to measure coprimary endpoints. MRI-based measurement of submental volume, measurement of psychological impact of submental fat and other patient-reported outcomes also were endpoints.
Shannon Humphrey
In the ATX-101 treatment cohort, 66.5% of patients achieved a composite improvement of one or more grades, compared with 22.2% in the placebo cohort. In addition, 18.6% of the ATX-101 cohort achieved a composite improvement of two or more grades in submental fat compared with 3% in the placebo cohort (P < .001 for both comparisons).
Submental volume reduction confirmed by MRI, greater reduction in psychological impact of SBF and treatment satisfaction were more likely in the ATX-101 cohort compared with the placebo cohort (P < .001, all).
Adverse events were primarily localized to injection site, including 85.7% in the ATX-101 cohort and 79.6% in the placebo cohort, with most resolved within 14 days.
“The results from REFINE-2 are clinically meaningful, statistically significant, and consistent with efficacy and safety outcomes observed in other phase 3 ATX-101 trials,” the researchers concluded. “The current findings further support ATX-101 as a minimally invasive alternative to aesthetic surgical procedures and liposuction for [submental fat] reduction.” – by Bruce Thiel
Disclosure: Humphrey reports serving as an investigator, speaker, consultant and on the advisory board for Kythera Biopharmaceuticals, an affiliate of Allergan plc. Please see the full study for a list of the other researchers’ relevant financial disclosures.