Safety of Tiotropium + Olodaterol in Chronic Obstructive Pulmonary Disease (COPD) Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data

N/ACompletedNCT05393245

Boehringer Ingelheim19,467 enrolled

Overview

The aim of this real world study is to assess the safety profile of tiotropium/olodaterol (Tio/Olo).

Study Type

OBSERVATIONAL

Enrollment

19,467

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium+OlodaterolDRUG

Tiotropium+Olodaterol

Spiolto RespimatDEVICE

Spiolto Respimat Inhaler device

Long-acting muscarinic antagonists (LAMAs)DRUG

Long-acting muscarinic antagonists (LAMAs)

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Patients treated with Tio+Olo: Inclusion criteria: 1. At least one prescription for Tio+Olo (fixed dose combination (FDC) or free combination) as a new initiation between 1st January 2014 and 31st December 2019. 2. Aged ≥ 40 years on the index date. 3. At least one diagnosis of COPD at any time prior to or on the index date. 4. At least one year of continuous medical and health insurance plan prior to the index date will be required to allow for a look-back period for the covariates and identification of new use of the study drugs. 5. At least one record in the health insurance system database. Exclusion criteria: 1. Any use of Tio+Olo in free or fixed form within one year prior to the index date. 2. Individuals with asthma, allergic rhinitis, lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date. Patients using other Long-acting β2-agonists/Long-acting muscarinic antagonists (LAMA/LABAs): Inclusion criteria: 1. At least one prescription for LAMA+LABA (FDC or free combination) other than Tio/Olo as a new initiation between 1st January 2014 and 31st December 2019. 2. Aged ≥ 40 years on the index date. 3. At least one diagnosis of COPD at any time prior to or on the index date- 4. At least one year of continuous medical and health insurance plan prior to the index date will be required to allow for a look-back period for the covariates and identification of new use of the study drugs. 5. At least one record in the health insurance system database. Exclusion criteria: 1. Any use of LAMA+LABA in free or fixed form for one year prior to the index date. 2. Individuals with asthma, allergic rhinitis, lung cancer, interstitial lung disease, or lung transplant identified at any time prior to the index date.

Locations (1)

Health Data Research Center, National Taiwan University

Taiwan, China

Outcomes

Primary Outcomes

Incidence Rate of Adverse Events in Patients With COPD Treated With Tio+Olo: Potentially Recurrent Events

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.

Time frame: 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 Tio+Olo: Incident Events

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.

Time frame: From index date between 1st January 2014 until 31st December 2019. Up to 2160 days.

Secondary Outcomes

Data from ClinicalTrials.gov

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Long-acting β2-agonists (LABAs)

Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Sex

Number of patients by sex according to whether they started Tio+Olo or another LAMA/LABA

Time frame: At index date between 2014-2019. Up to 2160 days.

Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Age

Number of patients by age groups according to whether they started Tio+Olo or another LAMA/LABA. The reported age groups are: 40-59, 60-79 and 80+.

Time frame: At index date between 2014-2019

Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Calendar Year of Cohort Entry

Number of patients by Calendar year of cohort entry according to whether they started Tio+Olo or another LAMA/LABA. The reported year groups are: 2014, 2015, 2016, 2017, 2018 and 2019.

Time frame: At index date between 2014-2019

Baseline Characteristics of Patients Who Initiated Tio+Olo or Other LAMA/LABA: Season of Cohort Entry Date

Number of patients by season of cohort entry date according to whether they started Tio+Olo or another LAMA/LABA. The reported seasons are: Spring (Mar-May), Summer (Jun-Aug), Fall (Sep-Nov) and Winter (Dec-Feb).

Time frame: 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

Number of patients by specific previous COPD treatment during the 1 year pre-index baseline period according to whether they started Tio+Olo or another LAMA/LABA is reported. The treatments were: Long-acting muscarinic antagonists (LAMA) monotherapy, Long-acting β2-agonists (LABA) monotherapy, Inhaled corticosteroids (ICS) monotherapy, ICS containing therapy and LAMA+LABA free combinations.

Time frame: 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

Number of patients by use of other respiratory drugs during the 1 year pre-index baseline period according to whether they started Tio+Olo or another LAMA/LABA is reported. The treatments were: Mucolytics, Theophylline, Short-acting beta-agonists and Short-acting muscarinic antagonists.

Time frame: 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

Number of patients by moderate Chronic Obstructive Pulmonary Disease (COPD) exacerbation in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+ according to the frequency of previous acute COPD exacerbation in 1 year for each patient.

Time frame: 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

Number of patients by severe Chronic Obstructive Pulmonary Disease (COPD) exacerbation in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+.

Time frame: 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

Number of patients by Chronic Obstructive Pulmonary Disease (COPD) exacerbations in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+.

Time frame: 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

Number of patients by moderate Chronic Obstructive Pulmonary Disease (COPD) exacerbation in 30 days prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+.

Time frame: 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

Number of patients by severe Chronic Obstructive Pulmonary Disease (COPD) exacerbation in 30 days prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+.

Time frame: 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

Number of patients by Chronic Obstructive Pulmonary Disease (COPD) exacerbations in 30 days prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+.

Time frame: 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

Number of hospitalizations caused by Chronic Obstructive Pulmonary Disease (COPD) exacerbations in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+.

Time frame: 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

Number of all-cause hospitalizations in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. Categorized as 0, 1, or 2+.

Time frame: 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

Number of participants with comorbidities in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. The following comorbidities are reported: Cardiovascular disease, Cerebrovascular disease, Diabetes, Chronic kidney disease, Pneumonia, Cancer and Cirrhosis.

Time frame: 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

Charlson Comorbidity Index (CCI) according to whether they started Tio+Olo or another LAMA/LABA is reported. The CCI (using Deyo version) is a comorbidity index used to evaluate survival rate in patients with multiple comorbidities. 17 comorbidities were assessed with different weights, and the total score was determined by adding the scores of each comorbidity. The total score goes from 0 to 37, with higher values predicting a higher mortality rate.

Time frame: 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

Number of participants with history of medications dispensed in 1 year prior to index date according to whether they started Tio+Olo or another LAMA/LABA is reported. The following medications are reported: Antihypertensives, Antiarrhythmics, Nitrates, Heart failure medications, Lipid-lowering medications, Blood glucose-lowering medications, Anticoagulants and antiplatelet agents, Antibiotics and Antineoplastic agents.

Time frame: Baseline period: 360 consecutive days ending the day before the index date. Up to 360 days.