McDiarmid James, Ruiz Jesus Benito, Lee Daniel, Lippert Susanne, Hartisch Claudia, Havlickova Blanka
McDiarmid-Hall Clinic, Derriford, Plymouth, UK.
Aesthetic Plast Surg. 2014 Oct;38(5):849-60. doi: 10.1007/s00266-014-0364-9. Epub 2014 Jul 2.
The injectable adipocytolytic drug ATX-101 is the first nonsurgical treatment for the reduction of submental fat (SMF) to undergo comprehensive clinical evaluation. This study aimed to confirm the efficacy and safety of ATX-101 for SMF reduction through a post hoc pooled analysis of two large phase 3 studies.
Patients with unwanted SMF were randomized to receive 1 or 2 mg/cm(2) of ATX-101 or a placebo injected into their SMF during a maximum of four treatment sessions spaced approximately 28 days apart, with a 12-week follow-up period. The proportions of patients with reductions in SMF of one point or more on the Clinician-Reported SMF Rating Scale (CR-SMFRS) and the proportions of patients satisfied with the appearance of their face and chin [Subject Self-Rating Scale (SSRS) score ≥4] were reported overall and in subgroups. Other efficacy measures included improvements in the Patient-Reported SMF Rating Scale (PR-SMFRS), calliper measurements of SMF thickness, and assessment of skin laxity [Skin Laxity Rating Scale (SLRS)]. Adverse events and laboratory test results were recorded.
Significantly greater proportions of the patients had improvements in clinician-reported measures (≥1-point improvement in CR-SMFRS: 58.8 and 63.8 % of the patients who received ATX-101 1 and 2 mg/cm(2), respectively, and 28.6 % of the placebo recipients; p < 0.001 for both ATX-101 doses vs. placebo) and patient-reported measures (≥1-point improvement in PR-SMFRS: 60.0 and 63.1 % of the patients who received ATX-101 1 and 2 mg/cm(2), respectively, vs. 34.3 % of the placebo recipients; p < 0.001 for both), analyzed alone or in combination, with ATX-101 versus placebo. These improvements correlated moderately with patient satisfaction regarding face and chin appearance (SSRS score ≥4: 60.8 and 65.4 % of the patients who received ATX-101 1 and 2 mg/cm(2), respectively, vs. 29.0 % of the placebo recipients; p < 0.001 for both). In this study, ATX-101 was effective irrespective of gender, age, or body mass index. Reduction in SMF with ATX-101 was confirmed by calliper measurements (p < 0.001 for both doses vs. placebo) and generally did not lead to worsening of skin laxity (SLRS improved or was unchanged: 91.3 and 90.5 % of the patients who received ATX-101 1 and 2 mg/cm(2), respectively, and 91.6 % of the placebo recipients). Adverse events were mostly transient, mild to moderate in intensity, and localized to the treatment area.
The findings show ATX-101 to be an effective and well-tolerated pharmacologic treatment for SMF reduction.
注射用溶脂药物ATX-101是首个接受全面临床评估的用于减少颏下脂肪（SMF）的非手术治疗方法。本研究旨在通过对两项大型3期研究进行事后汇总分析，确认ATX-101减少SMF的疗效和安全性。
有多余SMF的患者被随机分组，在间隔约28天的最多4次治疗期间，接受1或2mg/cm²的ATX-101或安慰剂注射到其SMF中，并进行为期12周的随访。报告了在临床医生报告的SMF评分量表（CR-SMFRS）上SMF减少1分或更多的患者比例，以及对面部和下巴外观满意的患者比例[受试者自评量表（SSRS）评分≥4]，整体及各亚组情况均有报告。其他疗效指标包括患者报告的SMF评分量表（PR-SMFRS）的改善、用卡尺测量SMF厚度以及评估皮肤松弛度[皮肤松弛度评分量表（SLRS）]。记录不良事件和实验室检查结果。
在临床医生报告的指标方面（CR-SMFRS改善≥1分：接受1mg/cm²和2mg/cm²ATX-101的患者分别为58.8%和63.8%，接受安慰剂的患者为28.6%；两种剂量的ATX-101与安慰剂相比，p均<0.001）以及患者报告的指标方面（PR-SMFRS改善≥1分：接受1mg/cm²和2mg/cm²ATX-101的患者分别为60.0%和63.1%，接受安慰剂的患者为34.3%；两种情况p均<0.001），单独分析或综合分析时，接受ATX-101治疗的患者改善比例均显著高于接受安慰剂的患者。这些改善与患者对面部和下巴外观的满意度中度相关（SSRS评分≥4：接受1mg/cm²和2mg/cm²ATX-101的患者分别为60.8%和65.4%，接受安慰剂的患者为29.0%；两种情况p均<0.001）。在本研究中，ATX-101无论性别、年龄或体重指数如何均有效。通过卡尺测量证实ATX-101可减少SMF（两种剂量与安慰剂相比，p均<0.001），且一般不会导致皮肤松弛度恶化（SLRS改善或不变：接受1mg/cm²和2mg/cm²ATX-101的患者分别为91.3%和90.5%，接受安慰剂的患者为91.6%）。不良事件大多为短暂性，强度为轻度至中度，且局限于治疗区域。
研究结果表明ATX-101是一种有效且耐受性良好的用于减少SMF的药物治疗方法。
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