Efficacy, patient-reported outcomes and safety profile of ATX-101 (deoxycholic acid), an injectable drug for the reduction of unwanted submental fat: results from a phase III, randomized, placebo-controlled study.
Bottom Line: An approved and rigorously tested non-surgical method for SMF reduction is lacking.Adverse events (AEs) and laboratory test results were monitored.Patient-reported secondary efficacy endpoints showed significant improvements in SMF severity (PR-SMFRS; P = 0.009 for ATX-101 1 mg/cm(2) , P < 0.001 for ATX-101 2 mg/cm(2) vs. placebo) and emotions and perceived self-image (PR-SMFIS; P < 0.001).
Affiliation: Clinic of Aesthetic Surgery IENA, Paris, France.Show MeSH
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Mentions: The proportion of patients in the ATX-101 1 mg/cm2 (58.3%) and 2 mg/cm2 (62.3%) groups showing a ≥1-point improvement in CR-SMFRS score at Visit 7 was significantly higher (P < 0.001) than in the placebo group (34.5%) (Fig.2). The ORs for the improvement in CR-SMFRS were 2.60 (95% CI 1.52–4.43) and 3.13 (95% CI 1.83–5.36) for ATX-101 1 mg/cm2 and 2 mg/cm2, respectively, compared with placebo. Overall, satisfaction with appearance in association with the face and chin (SSRS score of ≥4 at Visit 7) was significantly higher (P < 0.001) in patients receiving ATX-101 1 mg/cm2 and 2 mg/cm2 (68.3% and 64.8% were responders, respectively) than in patients receiving placebo (29.3%) (Fig.3). The corresponding ORs were 5.37 (95% CI 3.06–9.44) and 4.62 (95% CI 2.65–8.04) for ATX-101 1 mg/cm2 and 2 mg/cm2, respectively, compared with placebo. Both ATX-101 dose groups showed statistically significant efficacy according to the predefined confirmatory testing procedure. SMF reduction and associated improvement in submental profile are demonstrated in photographs of representative patients treated with ATX-101 1 mg/cm2 and 2 mg/cm2 (Fig.4).