Safety Profile of Tiotropium + Olodaterol Used as Maintenance Treatment in COPD Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19,467
- 试验地点
- 1
- 主要终点
- Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events
研究概览
简要总结
The aim of this real world study is to assess the safety profile of tiotropium/olodaterol (Tio/Olo).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
COPD patients treated with tiotropium and olodaterol (Tio+Olo)
干预措施: Tiotropium+Olodaterol (Drug)
COPD patients treated with tiotropium and olodaterol (Tio+Olo)
干预措施: Spiolto Respimat (Device)
COPD patients using other Long-acting muscarinic antagonists/Long-acting β2-agonists (LAMA/LABAs)
干预措施: Long-acting muscarinic antagonists (LAMAs) (Drug)
COPD patients using other Long-acting muscarinic antagonists/Long-acting β2-agonists (LAMA/LABAs)
干预措施: Long-acting β2-agonists (LABAs) (Drug)
结局指标
主要结局
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events
时间窗: From index date between 1st January 2014 until 31st December 2019. Up to 2160 days.
Incidence rate of adverse events in patients with COPD treated with Tiotropium+Olodaterol (Tio+Olo) per number of person-years is reported. From the index date until the earliest: Outcome of interest, disenrollment, the end of the study period, death, discontinuation of the index drug, addition of Inhaled corticosteroids mono on top of Tio/Olo. The incidence rate was reported as (Total number of patients in the Tio+Olo cohort experiencing an event of interest for the 1st time during the given time period) / (Total person-time at risk from current use of Tio+Olo during the given period). Urinary tract infection: (1): Diagnosis codes were primary inpatient diagnosis associated with a hospitalization. (2): Diagnosis codes were primary or secondary diagnosis associated with a hospitalization.(3): Diagnosis codes were primary or secondary diagnosis associated with a hospitalization OR associated with at least 2 outpatient/emergency visits within 30 days of each other.
Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Incident Events
时间窗: From index date between 1st January 2014 until 31st December 2019. Up to 2160 days.
Incidence rate of Adverse Events (AEs) in patients with COPD treated with Tiotropium+Olodaterol (Tio+Olo) per number of person-years is reported. From index date until the earliest: Outcome of interest, disenrollment, end of the study period, death, discontinuation, use of Inhaled corticosteroids. Incident events. The incidence rate was reported as (Total number of patients in the Tio+Olo cohort experiencing an event of interest for the 1st time during the given time period) / (Total person-time at risk from current use of Tio+Olo during the given period). Urinary tract infection: (1): Diagnosis codes were primary inpatient diagnosis associated with a hospitalization. (2): Diagnosis codes were primary or secondary diagnosis associated with a hospitalization.(3): Diagnosis codes were primary or secondary diagnosis associated with a hospitalization OR associated with at least 2 outpatient/emergency visits within 30 days of each other.
次要结局
- Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Sex(At index date between 2014-2019. Up to 2160 days.)
- Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Age(At index date between 2014-2019)
- Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Calendar Year of Cohort Entry(At index date between 2014-2019)
- Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Season of Cohort Entry Date(At index date between 2014-2019)
- Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Specific Previous COPD Treatment(Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.)
- Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Use of Other Respiratory Drugs(Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.)
- Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation in 1 Year Prior to Index Date(Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.)
- Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation in 1 Year Prior to Index Date(Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.)
- Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation in 1 Year Prior to Index Date(Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.)
- Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Moderate COPD Exacerbation 30 Days Prior to Index Date(Baseline period: 30 consecutive days ending the day before the index date. Up to 30 days.)
- Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Severe COPD Exacerbation 30 Days Prior to Index Date(Baseline period: 30 consecutive days ending the day before the index date. Up to 30 days.)
- Baseline Period: Characteristics Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All COPD Exacerbation 30 Days Prior to Index Date(Baseline period: 30 consecutive days ending the day before the index date. Up to 30 days.)
- Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Hospitalizations Caused by Exacerbation of COPD in 1 Year Prior to Index Date(Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.)
- Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: All-cause Hospitalizations in 1 Year Prior to Index Date(Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.)
- Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Comorbidities in 1 Year Prior to Index Date(Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.)
- Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: Charlson Comorbidity Index (CCI) in 1 Year Prior to Index Date(Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.)
- Baseline Period: Characteristics 1 Year Pre-index Comparison Between Patients Who Initiated Tio+Olo or Other LAMA/LABA: History of Medications Dispensed in 1 Year Prior to Index Date(Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.)