Kaelen C Dunican1, Dhiren K Patel2. 1. MCPHS University, Worcester, MA, USA Kaelen.Dunican@mcphs.edu. 2. MCPHS University, Boston, MA, USA.
Abstract
OBJECTIVE: To review trials evaluating purified synthetic deoxycholic acid (DCA; ATX-101) for the reduction of submental fat (SMF). DATA SOURCES: A literature search was conducted using MEDLINE (1946 to week 4 of April 2016) and Evidence Based Medicine Database (1974 to 6 May, 2016). Keywords searched included deoxycholic acid, ATX-101, and submental fat. STUDY SELECTION AND DATA EXTRACTION: All human studies published in English that addressed the effects of DCA for the reduction of SMF were selected for analysis. DATA SYNTHESIS: Five phase III, multicenter, randomized, double-blinded clinical trials enrolling more than 1700 patients have demonstrated the efficacy of ATX-101 in the reduction of SMF via a variety of validated scales as well as objective measurements. Purified synthetic DCA 2 mg/cm(2) injected monthly for 4 to 6 treatment sessions demonstrated improvement in scales evaluated by both clinicians and patients. Improvement in skin caliper measurements of SMF and Magnetic Resonance Imaging (MRI) provide objective evidence of the efficacy of ATX-101. Adverse events (AEs) are very common but are transient and localized to the treatment area. Pain at the injection site is the most common AE, occurring in more than 80% of patients treated. Other common AEs include swelling, bruising, numbness, and induration. Appropriate injection technique is patient specific and requires detailed knowledge of the submental anatomy to minimize AEs. CONCLUSIONS: ATX-101 is the first pharmacological intervention approved for the reduction of SMF and offers an alternative to invasive measures to improve the submental profile and positively affect patient self-image.
OBJECTIVE: To review trials evaluating purified synthetic deoxycholic acid (DCA; ATX-101) for the reduction of submental fat (SMF). DATA SOURCES: A literature search was conducted using MEDLINE (1946 to week 4 of April 2016) and Evidence Based Medicine Database (1974 to 6 May, 2016). Keywords searched included deoxycholic acid, ATX-101, and submental fat. STUDY SELECTION AND DATA EXTRACTION: All human studies published in English that addressed the effects of DCA for the reduction of SMF were selected for analysis. DATA SYNTHESIS: Five phase III, multicenter, randomized, double-blinded clinical trials enrolling more than 1700 patients have demonstrated the efficacy of ATX-101 in the reduction of SMF via a variety of validated scales as well as objective measurements. Purified synthetic DCA 2 mg/cm(2) injected monthly for 4 to 6 treatment sessions demonstrated improvement in scales evaluated by both clinicians and patients. Improvement in skin caliper measurements of SMF and Magnetic Resonance Imaging (MRI) provide objective evidence of the efficacy of ATX-101. Adverse events (AEs) are very common but are transient and localized to the treatment area. Pain at the injection site is the most common AE, occurring in more than 80% of patients treated. Other common AEs include swelling, bruising, numbness, and induration. Appropriate injection technique is patient specific and requires detailed knowledge of the submental anatomy to minimize AEs. CONCLUSIONS:ATX-101 is the first pharmacological intervention approved for the reduction of SMF and offers an alternative to invasive measures to improve the submental profile and positively affect patient self-image.