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][1]. Data are available upon reasonable request. The data that support the findings of this study are available from the corresponding author upon reasonable request. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03204396&atom=%2Fbmjnph%2F6%2F2%2F301.atom

中文翻译：

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度拉鲁肽治疗尝试和成功戒烟期间体重增加的性别差异：随机试验的预定义二次分析


背景 女性似乎比男性更难戒烟。这尤其令人担忧，因为吸烟使女性患与吸烟相关疾病的风险更高。人们认为，可能的解释是对女性戒烟后体重增加的更大担忧。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定义的二次分析，该试验纳入了 255 名每天吸烟的成年人（155 名女性，100 名男性）。参与者在 12 周内每周接受度拉鲁肽（1.5 毫克）或安慰剂（0.9% 氯化钠）以及标准化戒烟护理（伐尼克兰 2 毫克/天加行为咨询）。我们的目的是调查度拉鲁肽辅助戒烟后体重变化的性别差异。基线和第 12 周之间的体重变化被分析为绝对体重变化和相对体重变化以及显着体重增加（定义为增加 >6%）。结果无论是度拉鲁肽还是安慰剂治疗，在绝对或相对体重变化方面均未观察到性别差异。然而，安慰剂组中女性体重大幅增加（定义为增加>6%）的频率几乎是男性的五倍（24% vs 5%）。与安慰剂相比，女性患者服用度拉鲁肽后体重大幅增加的可能性较小（1% (n=1/83) vs 24% (n=17/72)；p<0.001），而这种度拉鲁肽效应在男性中不太明显（0%（n=0/44）与 5%（n=3/56）；p=0.333）。结论 度拉鲁肽可减少男女戒烟后体重增加，并且在防止体重大幅增加方面非常有效，这似乎是针对女性的特殊观察结果。试用注册号[NCT03204396][1]。数据可根据合理要求提供。 支持本研究结果的数据可根据合理要求从通讯作者处获得。 [1]：/lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT03204396&atom=%2Fbmjnph%2F6%2F2%2F301。原子