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氯卡色林在不同年龄组中的作用:对BLOOM、BLOSSOM和BLOOM-DM研究中患者的事后分析。

Effect of lorcaserin in different age groups: a post hoc analysis of patients from the BLOOM, BLOSSOM and BLOOM-DM studies.

作者信息

Fujioka K, Malhotra M, Perdomo C, Apovian C M

机构信息

Department of Diabetes and Endocrinology Scripps Clinic La Jolla CA USA.

Neurology Business Group Eisai Inc Woodcliff Lake NJ USA.

出版信息

Obes Sci Pract. 2019 Mar 22;5(2):120-129. doi: 10.1002/osp4.335. eCollection 2019 Apr.

Abstract

INTRODUCTION

The elderly population is projected to be the fastest growing group of individuals with obesity group in the United States. As such, there is merit in examining factors that contribute to healthy aging and weight management. The effects of newer weight loss medications approved after 2013 have been studied but are not often assessed specifically in older persons.

METHODS

This post hoc analysis evaluated the magnitude of weight loss in adults across age quartiles with lorcaserin, a serotonin (5-HT) 2C receptor agonist indicated as an adjunct to a reduced-caloric diet and increased physical activity for chronic weight management. Data from three lorcaserin pivotal phase 3 studies were used in this analysis. Data for patients with overweight/obesity without type 2 diabetes (T2D; BLOOM/BLOSSOM; body mass index [BMI] 27.0-29.9 kg/m and ≥1 comorbidity or BMI 30.0-45.0 kg/m) and patients with overweight/obesity with T2D (BLOOM-DM; BMI 27.0-45.0 kg/m) were used. Patients were randomized to receive lorcaserin 10 mg twice daily or placebo in addition to diet and exercise for 52 weeks. Age quartiles between the studies differed as the T2D population was on average, 9 years older.

RESULTS

This analysis shows that lorcaserin was associated with improved weight loss relative to placebo regardless of age. Importantly, these results were consistent for patients with and without T2D. Interestingly, the magnitude of weight loss for lorcaserin appeared to increase with increasing age. In patients without T2D, odds of achieving ≥5% and ≥10% reduction in body weight at 52 weeks were significantly higher for patients >36 years. Lorcaserin was well tolerated in all patients across all quartiles including the oldest quartile.

CONCLUSIONS

In summary, this post hoc analysis demonstrates that lorcaserin treatment in patients with and without T2D was safe and effective at reducing weight across all age groups analysed. Weight loss appeared to be greater for older patients; additional analyses are warranted to confirm these findings and to better understand the factors for improved weight loss.

摘要

引言

预计老年人群将成为美国肥胖人群中增长最快的群体。因此,研究有助于健康老龄化和体重管理的因素具有重要意义。2013年后批准的新型减肥药物的效果已得到研究,但在老年人中并未经常进行专门评估。

方法

这项事后分析评估了使用氯卡色林的不同年龄四分位数成年人的体重减轻幅度,氯卡色林是一种血清素(5-HT)2C受体激动剂,被指定作为低热量饮食和增加体育活动以进行慢性体重管理的辅助药物。本分析使用了三项氯卡色林关键3期研究的数据。使用了无2型糖尿病(T₂D;BLOOM/BLOSSOM;体重指数[BMI]27.0 - 29.9kg/m²且有≥1种合并症或BMI 30.0 - 45.0kg/m²)的超重/肥胖患者以及患有T₂D(BLOOM - DM;BMI 27.0 - 45.0kg/m²)的超重/肥胖患者的数据。患者被随机分配接受每日两次10mg氯卡色林或安慰剂,同时进行饮食和运动,为期52周。由于T₂D人群平均年龄大9岁,各研究之间的年龄四分位数有所不同。

结果

该分析表明,无论年龄如何,与安慰剂相比,氯卡色林与体重减轻改善相关。重要的是,这些结果在有和没有T₂D的患者中都是一致的。有趣的是,氯卡色林的体重减轻幅度似乎随着年龄的增加而增加。在无T₂D的患者中,年龄>36岁的患者在52周时体重减轻≥5%和≥10%的几率显著更高。氯卡色林在所有四分位数的所有患者中,包括最年长的四分位数,耐受性良好。

结论

总之,这项事后分析表明,氯卡色林治疗对于有和没有T₂D的患者在所有分析的年龄组中减轻体重都是安全有效的。老年患者体重减轻似乎更大;有必要进行进一步分析以证实这些发现并更好地了解体重减轻改善的因素。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e008/6469334/a0271567d379/OSP4-5-120-g001.jpg

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