Dayan Steven H, Schlessinger Joel, Beer Kenneth, Donofrio Lisa M, Jones Derek H, Humphrey Shannon, Carruthers Jean, Lizzul Paul F, Gross Todd M, Beddingfield Frederick C, Somogyi Christine
Department of Otolaryngology, University of Illinois and a plastic surgeon in private practice in Chicago, IL.
Dermatologist in Private practice in Omaha, NE.
Aesthet Surg J. 2018 Aug 16;38(9):998-1010. doi: 10.1093/asj/sjy008.
ATX-101 (deoxycholic acid injection) is the only injectable drug approved for submental fat (SMF) reduction. In the phase 3 REFINE trials, adults with moderate or severe SMF who were dissatisfied with the appearance of their face/chin were eligible to receive up to 6 treatment sessions with ATX-101 (2 mg/cm2) or placebo. Primary and secondary endpoints, evaluated at 12 weeks after last treatment, significantly favored ATX-101 supporting its efficacy for reducing SMF and the psychological impact of SMF, and increasing satisfaction with the appearance of the face/chin.
To evaluate the efficacy and safety of ATX-101 by treatment session.
This post hoc analysis used pooled data from the REFINE trials to evaluate efficacy endpoints and adverse events following each treatment session to further characterize the ATX-101 treatment response and safety profile.
In both treatment groups, mean injection volume declined over subsequent treatment sessions, though more markedly in the ATX-101 group. The majority of ATX-101-treated patients achieved a ≥1-grade improvement in SMF within 2 to 4 treatment sessions based on either clinician or patient assessment. Furthermore, 19.1% of ATX-101-treated patients (vs 3.9% of placebo-treated patients) received fewer than 6 treatment sessions owing to patient satisfaction with treatment or lack of sufficient SMF for further treatment. In both treatment groups, the incidence/severity of common injection-site adverse events declined over subsequent treatment sessions.
Although up to 6 treatment sessions were permitted in the REFINE trials, most ATX-101-treated patients achieved an improvement in SMF within 2 to 4 treatment sessions. Level of Evidence: 3.
ATX - 101（脱氧胆酸注射液）是唯一被批准用于减少颏下脂肪（SMF）的注射药物。在3期REFINE试验中，对自己面部/下巴外观不满意的中度或重度SMF成人有资格接受多达6次ATX - 101（2mg/cm²）治疗或安慰剂治疗。在最后一次治疗后12周评估的主要和次要终点显著有利于ATX - 101，支持其减少SMF的疗效以及SMF的心理影响，并提高对面部/下巴外观的满意度。
按治疗疗程评估ATX - 101的疗效和安全性。
这项事后分析使用了REFINE试验的汇总数据，以评估每个治疗疗程后的疗效终点和不良事件，从而进一步描述ATX - 101的治疗反应和安全性。
在两个治疗组中，平均注射量在随后的治疗疗程中均有所下降，不过在ATX - 101组中下降更为明显。根据临床医生或患者评估，大多数接受ATX - 101治疗的患者在2至4个治疗疗程内SMF改善了≥1级。此外，由于患者对治疗满意或SMF不足无法进一步治疗，19.1%接受ATX - 101治疗的患者（相比之下，接受安慰剂治疗的患者为3.9%）接受的治疗疗程少于6次。在两个治疗组中，常见注射部位不良事件的发生率/严重程度在随后的治疗疗程中均有所下降。
尽管REFINE试验允许进行多达6个治疗疗程，但大多数接受ATX - 101治疗的患者在2至4个治疗疗程内SMF得到改善。证据级别：3级。
