[Skip to Content]
Access to paid content on this site is currently suspended due to excessive activity being detected from your IP address 34.204.52.4. Please contact the publisher to request reinstatement.
[Skip to Content Landing]
Views 475
Citations 0
Original Investigation
May/Jun 2018

Current Trends in Management of Submental Liposis: A Pooled Analysis and Survey

Author Affiliations
  • 1Facial Plastic Surgery Associates, Houston, Texas
  • 2Department of Otolaryngology–Head and Neck Surgery, University of Texas Health Sciences Center, Houston
JAMA Facial Plast Surg. 2018;20(3):202-206. doi:10.1001/jamafacial.2017.1567
Key Points

Question  Is the treatment of submental liposis with deoxycholic acid superior to submental liposuction?

Findings  Among 1738 unique patients in this pooled analysis of 4 phase 3 clinical trials of deoxycholic acid, a cost analysis demonstrated that each patient in the deoxycholic acid group received a mean of 186 mg of the drug, which equates to a mean cost of $34.55/mg or a mean fee of $6426.35 per patient. Deoxycholic acid is fiscally efficacious for patients with mild to moderate submental liposis who will require 20 to 30 mg of drug per treatment for 3 treatment sessions for a total of 60 to 90 mg.

Meaning  For patients requiring large amounts of deoxycholic acid, surgical liposuctions might be a more economical treatment modality.

Abstract

Importance  Since its approval by the US Food and Drug Administration for treatment of moderate to severe submental liposis in April 2015, deoxycholic acid (Kybella) has received significant media attention as a novel aesthetic treatment. Four phase 3 clinical trials have published data demonstrating the safety and efficacy of the drug compared with placebo; however, no study has juxtaposed the product with submental liposuction.

Objective  To evaluate the efficacy of injectable deoxycholic acid in the treatment of isolated submental liposis.

Evidence Review  A pooled analysis of the data from the 2 European and 2 North American phase 3 clinical trials was performed by grouping the study participants by treatment arm to analyze efficacy, adverse effects, and treatment variables. Members of the American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS) were also surveyed regarding their clinical use of deoxycholic acid, fees, and adverse events.

Findings  The pooled analysis included 1738 unique patients (348 men [20.0%] and 1390 women [80.0%]; mean [SD] age, 47.7 [1.6] years) and revealed that all studies demonstrated efficacy compared with placebo. However, a significant number of patients experienced pain, edema, and numbness after injection. The clinical trial population was injected with a mean (SD) of 186.0 (106.6) mg of drug per patient during the course of treatment. A total of 102 members responded to the survey, representing 4% of AAFPRS membership. Based on the results of the survey, clinicians reported charging a mean (SD) of $691.04 ($168.68) per 20-mg vial of deoxycholic acid, resulting in a cost of $6426.35 per study participant. The survey revealed a mean (SD) total cost to the patient for submental liposuction to be $2976.56 ($1041.62).

Conclusions and Relevance  Although the clinical trials demonstrated functional drug efficacy, the large volume of drug used precluded cost-effectiveness. The survey found clinical practice to differ from the protocols used in the trials. Deoxycholic acid may be only fiscally efficacious for patients with mild to moderate submental liposis who require only 20 to 30 mg of drug per treatment for 3 treatment sessions.

Level of Evidence  1.

×