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度拉糖肽治疗期间戒烟尝试及成功过程中体重增加的性别差异:一项随机试验的预设二次分析

Gender differences in weight gain during attempted and successful smoking cessation on dulaglutide treatment: a predefined secondary analysis of a randomised trial.

作者信息

Baur Fabienne, Atila Cihan, Lengsfeld Sophia, Burkard Thilo, Meienberg Andrea, Bathelt Cemile, Christ-Crain Mirjam, Winzeler Bettina

机构信息

Department of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland.

Department of Clinical Research, University of Basel, Basel, Switzerland.

出版信息

BMJ Nutr Prev Health. 2023 Dec;6(2):301-309. doi: 10.1136/bmjnph-2023-000781. Epub 2023 Dec 19.

Abstract

BACKGROUND

Women seem to have more difficulty quitting smoking than men. This is particularly concerning as smoking puts women at a higher risk of developing smoking-associated diseases. Greater concerns about postcessation weight gain in women have been postulated as a possible explanation.

METHODS

Predefined secondary analysis of a placebo-controlled, double-blind, parallel-group, superiority randomised trial including 255 adults who smoke daily (155 women, 100 men). Participants received weekly dulaglutide (1.5 mg) or placebo (0.9% sodium chloride) in addition to standardised smoking cessation care (varenicline 2 mg/day plus behavioural counselling) over 12 weeks. We aimed to investigate gender differences in weight change after dulaglutide-assisted smoking cessation. Weight change between baseline and week 12 was analysed as absolute and revative weight change and as substantial weight gain (defined as >6% increase).

RESULTS

No gender differences were observed in absolute or relative weight change neither on dulaglutide nor placebo treatment. However, substantial weight gain (defined as >6% increase) in the placebo group was almost five times more frequent in females than males (24% vs 5%). Female patients were less likely to have substantial weight gain on dulaglutide compared with placebo (1% (n=1/83) vs 24% (n=17/72); p<0.001), while this dulaglutide effect was less pronounced in males (0% (n=0/44) vs 5% (n=3/56); p=0.333).

CONCLUSION

Dulaglutide reduced postcessation weight gain in both genders and was very effective in preventing substantial weight gain, which seems to be a specific observation in females.

TRIAL REGISTRATION NUMBER

NCT03204396.

摘要

背景

女性戒烟似乎比男性更困难。这尤其令人担忧,因为吸烟使女性患吸烟相关疾病的风险更高。有人推测,女性对戒烟后体重增加的更大担忧可能是一个解释。

方法

对一项安慰剂对照、双盲、平行组、优效性随机试验进行预先定义的二次分析,该试验纳入了255名每日吸烟的成年人(155名女性,100名男性)。参与者在12周内除接受标准化戒烟护理(伐尼克兰2毫克/天加行为咨询)外,每周还接受度拉糖肽(1.5毫克)或安慰剂(0.9%氯化钠)治疗。我们旨在研究度拉糖肽辅助戒烟后体重变化的性别差异。分析了基线至第12周期间的体重变化,包括绝对体重变化和相对体重变化以及显著体重增加(定义为增加>6%)。

结果

在度拉糖肽或安慰剂治疗中,无论是绝对体重变化还是相对体重变化,均未观察到性别差异。然而,安慰剂组中显著体重增加(定义为增加>6%)在女性中的发生率几乎是男性的五倍(24%对5%)。与安慰剂相比,接受度拉糖肽治疗时女性患者显著体重增加的可能性较小(1%(n = 1/83)对24%(n = 17/72);p<0.001),而度拉糖肽的这种作用在男性中不太明显(0%(n = 0/44)对5%(n = 3/56);p = 0.333)。

结论

度拉糖肽可减少两性戒烟后的体重增加,并且在预防显著体重增加方面非常有效,这似乎是女性中的一个特定观察结果。

试验注册号

NCT03204396。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9b84/11009518/b367764af1e1/bmjnph-2023-000781f01.jpg

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