Incidence of adverse events
The proportion of all adverse events observed during the study was 69.3% in the placebo group (n=75), 83.6% in the tirzepatide 10 mg group (n=73), and 85.7% in the tirzepatide 15 mg group (n=77). Serious adverse events were observed in 6.7% of the placebo group, 11.0% in the tirzepatide 10 mg group, and 6.5% in the tirzepatide 15 mg group. Adverse events observed in 5% or more of the tirzepatide groups during the study were COVID-19, constipation, fever, nausea, diarrhea, vomiting, decreased appetite, nasopharyngitis, back pain, abdominal discomfort, headache, immune reactions, injection site reactions, and arthralgia. Compared to the placebo group, the incidence of gastrointestinal disorders (e.g., constipation, nausea, and diarrhea) was particularly high.
Adverse reactions recorded in clinical trials
Adverse Reactions in Adults Receiving Zepbound (≥2% and >= placebo)
Table showing the incidence of adverse reactions compiled from the SURMOUNT-1 and SURMOUNT-2 trials
SURMOUNT-1: 2,539 adult patients without diabetes who were obese (BMI ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2)
SURMOUNT-2 study: 938 diabetic patients with a BMI of 27 or higher
In a study in patients with type 2 diabetes, hypoglycemia (plasma glucose < 54 mg/dL) was reported in 4.2% of patients receiving Zepvaun compared with 1.3% of patients receiving placebo.
In a study of obese/overweight adults without type 2 diabetes, hypoglycemia was not systematically captured, with plasma glucose <54 mg/dL reported in 0.3% of Zepvaun-treated patients compared with 0.0% of placebo-treated patients.
This table shows common side effects associated with the use of Zepvaun in two Phase 3 placebo-controlled trials. The percentages indicate the number of adult patients who reported experiencing at least one side effect during treatment.
Treatment discontinuation rates in clinical trials
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副作用のためにゼプバウンドを中止した成人の大多数は、治療開始から数か月以内に胃腸の副作用のために中止した
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プラセボよりもゼプバウンドでより頻繁に発生する最も一般的な副作用は消化器系関連でした
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吐き気、嘔吐、下痢の報告のほとんどは用量増加中に発生し、時間の経過とともに減少した
肥満（BMI ≥ 30 kg/m 2）または少なくとも1つの体重関連合併症を伴う過体重（BMI ≥ 27 kg/m 2 ）の成人を対象に研究されました。
ゼプバウンドの臨床試験では、ゼプバウンドを投与された患者（5 mg 56%、10 mg 56%、15 mg 56%）の方がプラセボ（30%）よりも胃腸の副作用の発生率が高いことが分かりました。
SURMOUNT-1試験およびSURMOUNT-2試験から統合された治療中止率の表
SURMOUNT-1試験：糖尿病を有さない肥満（BMI ≥ 30 kg/m 2）または過体重（BMI ≥ 27 kg/m 2） 2,539 人の成人患者が対象
SURMOUNT-2試験：BMI27以上の糖尿病患者938人を対象