NCT01086319已完成不适用
Comparison of Risk of Hospitalization for Severe Hypersensitivity (Including Severe Cutaneous Reactions) Between Patients With Type 2 Diabetes Initiating Saxagliptin and Those Initiating Other Oral Antidiabetic Treatments
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 113,505
- 主要终点
- Hospitalizations with any hypersensitivity reaction, including anaphylaxis, angioedema, generalized urticaria, SJS, TEN, and other severe skin reactions (i.e., acute generalized exanthematous pustulosis and drug rash with eosinophilia/systemic symptoms)
研究概览
简要总结
The purpose of this study is to compare the incidence hospitalization for severe hypersensitivity and cutaneous reactions among patients with type 2 diabetes who are new users of saxagliptin and those who are new users of other oral antidiabetic drugs.
详细描述
Prospectively designed retrospective database study. This study will be conducted using administrative claims data and electronic medical records that are collected as part of routine clinical practice
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Newly prescribed saxagliptin or an Oral Anti-diabetic Drug (OAD) in a class other than Dipeptidyl peptidase IV (DPP4) inhibitors
- •Enrolled in the respective database for at least 180 days prior to first prescription of new OAD
- •Have at least one diagnostic code for a type 2 diabetes-related condition
排除标准
- •Patients with an inpatient diagnostic code for any of the conditions of interest within the 180-day baseline period
- •Patients prescribed a DPP4 inhibitor during the baseline period
结局指标
主要结局
Hospitalizations with any hypersensitivity reaction, including anaphylaxis, angioedema, generalized urticaria, SJS, TEN, and other severe skin reactions (i.e., acute generalized exanthematous pustulosis and drug rash with eosinophilia/systemic symptoms)
时间窗: 54-months
次要结局
- Hospitalized for generalized urticaria(54-months)
- Hospitalized for anaphylaxis(54-months)
- Hospitalized for angioedema(54-months)
- Hospitalized for all endpoints(54-months)
- Hospitalized for severe skin reactions(54-months)
- Death from hypersensitivity reactions(54-months)
- Hospitalized for Stevens-Johnson syndrome (SJS)(54-months)
- Hospitalized/emergency room (ER) visits for hypersensitivity reactions(54-months)
- Hospitalized for for toxic epidermal necrolysis (TEN)(54-months)
研究者
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