The relationship between early weight loss and weight loss at 1 year with naltrexone ER/bupropion ER combination therapy
The relationship between early weight loss and weight loss at 1 year with naltrexone ER/bupropion ER combination therapy
复制标题
DOI：
10.1038/ijo.2016.67
复制
发表时间：
2016-09-01
影响因子：
4.9
通讯作者：
Greenway, F. L.
中科院分区：
文献类型：
--
作者：
Fujioka, K.;Plodkowski, R.;Greenway, F. L.
背景/目的：体重管理药物增加了患者在心血管、代谢和其他体重相关健康指标方面实现临床有意义改善的可能性。然而，任何体重管理干预措施所达到的体重减轻在个体之间都有很大差异，如果患者对药物治疗没有反应，无法达到临床有意义的体重减轻，则应停止治疗。我们在体重管理药物纳曲酮/安非他酮32/360 mg （NB）的3期临床试验项目中描述了1年的体重减轻，以及早期体重减轻和长期体重减轻之间的关系，特别是对于达到临床推荐阈值的参与者。到第16周减掉5%的体重。参与者/方法：汇总来自四个3期随机、安慰剂对照、56周NB临床试验参与者的数据（修改意向治疗人群；NB N=2043，安慰剂N=1319）。本探索性分析检验了参与者在治疗早期（第8周、第12周或第16周）达到各种减肥阈值与第56周相关体重减轻之间的关系（完成者群体；NB N=1310，安慰剂N=763）。结果：在完成1年治疗的NB参与者中，第16周体重减轻至少5% （n=873）与第56周最小二乘平均体重减轻11.7%相关，其中85%的参与者在第56周体重减轻。5%。80%（95%置信区间：78-82%）的参与者会或不会达到目标。使用临床推荐的阈值，正确地识别出第56周体重减轻5%。第16周5%NB的安全性和耐受性与之前发表的报告相似。结论：符合第16周阈值的受试者。治疗1年后，体重减轻5%的患者有可能保持临床上显著的体重减轻。需要进一步的评估来评估心血管和代谢风险测量的改善。
BACKGROUND/OBJECTIVES: Weight management medications increase the likelihood that patients will achieve clinically meaningful improvements in cardiovascular, metabolic and other weight-related measures of health. However, the weight loss achieved with any weight management intervention can vary widely among individuals, and patients who do not respond to pharmacotherapy by achieving clinically meaningful weight loss should discontinue therapy. We characterized 1-year weight loss in the phase 3 clinical trial program of the weight management medication, naltrexone/bupropion 32/360 mg (NB), as well as the relationship between early weight loss and long-term weight loss, particularly with respect to participants who achieved the clinically recommended threshold of. 5% weight loss by Week 16.PARTICIPANTS/METHODS: Data from participants from each of the four phase 3, randomized, placebo-controlled, 56-week clinical trials with NB were pooled (modified intent-to-treat population; NB N=2043, Placebo N=1319). This exploratory analysis examined the relationship between participant achievement of various weight loss thresholds early in treatment (at Week 8, 12 or 16) and the associated weight loss at Week 56 (Completers population; NB N=1310, Placebo N=763).RESULTS: In the NB participants who completed 1 year of treatment, weight loss of at least 5% at Week 16 (n=873) was associated with least-squares mean weight loss of 11.7% at Week 56 and 85% of these participants had Week 56 weight loss of. 5%. Eighty percent (95% confidence interval: 78-82%) of the participants who would, and would not, achieve. 5% weight loss at Week 56 were correctly identified using the clinically recommended threshold of. 5% at Week 16. Safety and tolerability of NB was similar to previously published reports.CONCLUSIONS: Participants who meet the Week 16 threshold of. 5% weight loss are likely to maintain clinically significant weight loss after 1 year of treatment. Further evaluations are required to evaluate improvements in measures of cardiovascular and metabolic risk.