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例A:以下のPICOの患者に対して、以下の論文の結果から、使うことを薦めるかどうかを、医師のあなたとタレントを目指す姪の会話形式で、論文の批判的吟味を行って、その結果を含めて回答して。なおタレントを目指す姪に対して、痩せ過ぎの弊害などを理論的に説明すると反発する可能性があります。できるだけ姪に共感しながら、エビデンスが不確実な薬を使わない事と、痩せ過ぎの弊害も話してください。姪は、真剣にタレントを目指しており思い詰めているので、健康な体型より痩せているのを希望しています。
#PICO:P: 身長164㎝の20歳女性
I: GLP-1ダイエット(exenatide, liraglutideなどのGLP-1受容体作動薬)の使用
C: GLP-1ダイエット未使用のコントロールグループ
O1: 体重減少
O2: 血糖値の改善
O3: 副作用(例えば、吐き気、下痢、膵炎など)
重要なアウトカム:O1, O2
重要でないアウトカム:なし
代替アウトカム:ダイエットには様々な方法があり、食事制限や運動などのアプローチもあるため、体重減少や血糖値改善以外の指標も考えられるが、本シナリオではGLP-1ダイエットに限定している。
#論文 :
Weghuber D, Barrett T, Barrientos-Pérez M, Gies I, Hesse D, Jeppesen OK, Kelly AS, Mastrandrea LD, Sørrig R, Arslanian S; STEP TEENS Investigators. Once-Weekly Semaglutide in Adolescents with Obesity. N Engl J Med. 2022 Dec 15;387(24):2245-2257. doi: 10.1056/NEJMoa2208601. Epub 2022 Nov 2. PMID: 36322838; PMCID: PMC9997064.
BACKGROUND
A once-weekly, 2.4-mg dose of subcutaneous semaglutide, a glucagon-like peptide-1 receptor agonist, is used to treat obesity in adults, but assessment of the drug in adolescents has been lacking.
METHODS
In this double-blind, parallel-group, randomized, placebo-controlled trial, we enrolled adolescents (12 to <18 years of age) with obesity (a body-mass index [BMI] in the 95th percentile or higher) or with overweight (a BMI in the 85th percentile or higher) and at least one weight-related coexisting condition. Participants were randomly assigned in a 2:1 ratio to receive once-weekly subcutaneous semaglutide (at a dose of 2.4 mg) or placebo for 68 weeks, plus lifestyle intervention. The primary end point was the percentage change in BMI from baseline to week 68; the secondary confirmatory end point was weight loss of at least 5% at week 68.
RESULTS
A total of 201 participants underwent randomization, and 180 (90%) completed treatment. All but one of the participants had obesity. The mean change in BMI from baseline to week 68 was −16.1% with semaglutide and 0.6% with placebo (estimated difference, −16.7 percentage points; 95% confidence interval [CI], −20.3 to −13.2; P<0.001). At week 68, a total of 95 of 131 participants (73%) in the semaglutide group had weight loss of 5% or more, as compared with 11 of 62 participants (18%) in the placebo group (estimated odds ratio, 14.0; 95% CI, 6.3 to 31.0; P<0.001). Reductions in body weight and improvement with respect to cardiometabolic risk factors (waist circumference and levels of glycated hemoglobin, lipids [except high-density lipoprotein cholesterol], and alanine aminotransferase) were greater with semaglutide than with placebo. The incidence of gastrointestinal adverse events was greater with semaglutide than with placebo (62% vs. 42%). Five participants (4%) in the semaglutide group and no participants in the placebo group had cholelithiasis. Serious adverse events were reported in 15 of 133 participants (11%) in the semaglutide group and in 6 of 67 participants (9%) in the placebo group.
CONCLUSIONS
Among adolescents with obesity, once-weekly treatment with a 2.4-mg dose of semaglutide plus lifestyle intervention resulted in a greater reduction in BMI than lifestyle intervention alone. (Funded by Novo Nordisk; STEP TEENS ClinicalTrials.gov number, NCT04102189. opens in new tab.)