Division of Endocrinology and Metabolism, Department of Internal Medicine, Chosun University Hospital, Gwangju, Republic of Korea.
Department of Statistics, Dongguk University, Seoul, Republic of Korea.
Drug Des Devel Ther. 2024 Nov 19;18:5255-5268. doi: 10.2147/DDDT.S492913. eCollection 2024.
To investigate the safety and effectiveness of naltrexone-bupropion in Korean adults with obesity.
This was a prospective, observational multicenter study from April 29, 2016, to April 28, 2022. Individuals with obesity with a body mass index of ≥30 kg/m or ≥27 kg/m who had obesity-related comorbidities were included. The naltrexone-bupropion dose was gradually titrated weekly from 8/90 to 32/360 mg and maintained at the maximum tolerated dose. In total, 612 and 300 individuals were evaluated for safety and effectiveness, respectively.
In total, 41.34% individuals reported drug-related adverse reactions, such as nausea (19.12%), headache (7.68%), and dizziness (5.23%). Older age and comorbidities were significantly associated with adverse events. At 12 weeks after reaching the maintenance dose, naltrexone-bupropion 32/360 mg resulted in the greatest weight reduction (-7.21%) compared with other doses, which persisted at week 24 (-7.69%). The naltrexone-bupropion 16/180 mg resulted in significant weight reduction, achieving -5.99% and -9.18% reductions at weeks 12 and 24, similar to that with naltrexone-bupropion 32/360 mg. Young age and no comorbidities were significantly associated >5% weight reduction.
Naltrexone-bupropion demonstrated marked stability and weight loss effectiveness, particularly in young individuals with obesity without comorbidities. Therefore, individualized treatment is necessary when prescribing naltrexone-bupropion.
研究纳曲酮-安非他酮在韩国肥胖成年人中的安全性和有效性。
这是一项从 2016 年 4 月 29 日至 2022 年 4 月 28 日进行的前瞻性、观察性多中心研究。纳入了体重指数（BMI）≥30kg/m或≥27kg/m且伴有肥胖相关合并症的肥胖患者。纳曲酮-安非他酮的剂量每周逐渐滴定，从 8/90mg 增至 32/360mg，并维持在最大耐受剂量。共有 612 名和 300 名患者分别进行了安全性和有效性评估。
共有 41.34%的患者报告了药物相关不良反应，如恶心（19.12%）、头痛（7.68%）和头晕（5.23%）。年龄较大和合并症与不良事件显著相关。在达到维持剂量后的 12 周，与其他剂量相比，纳曲酮-安非他酮 32/360mg 组的体重减轻最显著（-7.21%），这一效果在 24 周时仍持续存在（-7.69%）。纳曲酮-安非他酮 16/180mg 也能显著减轻体重，在 12 周和 24 周时体重减轻分别达到-5.99%和-9.18%，与纳曲酮-安非他酮 32/360mg 相似。年龄较小且无合并症与体重减轻超过 5%显著相关。
纳曲酮-安非他酮显示出显著的稳定性和减重效果，特别是在无合并症的年轻肥胖患者中。因此，在开具纳曲酮-安非他酮处方时需要进行个体化治疗。
