Drug Utilization Study for Olodaterol

Boehringer Ingelheim GmbH (BI) developed olodaterol, an inhaled long-acting beta2-agonist (LABA), for the indication of chronic obstructive pulmonary disease (COPD). Because the use of LABAs has been associated with increased morbidity and mortality in patients with asthma, the health authorities requested the conduct of a post-approval drug utilisation study to assess potential off-label use of olodaterol in asthma and to characterise the use of olodaterol in clinical practice. The single agent indacaterol, the only other marketed LABA authorised in clinical practice for COPD but not for asthma, will also be assessed. Study objectives include the following: (1) Quantify the frequency of off-label use of olodaterol and indacaterol among new users of these medications; and (2) Describe the baseline characteristics of new users of olodaterol and indacaterol. This cross-sectional study will use information among new users of olodaterol or indacaterol collected in the following healthcare databases: the PHARMO Database Network in the Netherlands, the National Registers in Denmark, and the IMS Health Information Solutions (IMS) Real-World Evidence (RWE) Longitudinal Patient Database (LPD) in France. The source population is all patients enrolled in the selected study databases at the date olodaterol became available in each database's country. The study groups are those patients from the source population who receive a first dispensing for single-agent formulations of olodaterol for the primary objective or indacaterol for the secondary objective and have at least 12 months of continuous enrolment in the study databases. The study will describe the number and proportion of new users by indication and potential off-label use and according to medical history and use of co-medications.

• Olodaterol (Drug), also known as STRIVERDI: Drug
• Indacaterol (Drug): Drug

Primary outcomes

• Percentage of Off-label Use of Olodaterol Among New Users [01March2014 to 30November2017 up to 30 days after index date, up to 1370 days.]: Percentage of off-label use of olodaterol among new users of this medication. Potential off-label are the patients, aged 18 years or older with no recorded Chronic Obstructive Pulmonary Disease (COPD) diagnosis and no asthma diagnosis. Off-label are the patients, aged 17 years or younger or patients aged 18 years or older with no recorded COPD diagnosis but with a diagnosis of asthma. Index date is defined as the date an eligible patient receives the first dispensing of olodaterol or indacaterol during the study period.
• Baseline Characteristics of New Users of Olodaterol: Age [Baseline]: Baseline characteristics of patients in treatment group by data source: Age
• Baseline Characteristics of New Users of Olodaterol: Gender [Baseline]: Baseline characteristics of patients in treatment group by data source: Gender

Secondary outcomes

• Percentage of Off-label Use of Indacaterol Among New Users [01March2014 to 30November2017 up to 30 days after index date, up to 1370 days.]: Percentage of off-label use of Indacaterol among new users of this medication. Potential off-label are the patients, aged 18 years or older with no recorded COPD diagnosis and no asthma diagnosis. Off-label are the patients, aged 17 years or younger or patients aged 18 years or older with no recorded COPD diagnosis but with a diagnosis of asthma.
• Baseline Characteristics of New Users of Indacaterol: Age [Baseline]: Baseline characteristics of patients in treatment group by data source: Age
• Baseline Characteristics of New Users of Indacaterol: Gender [Baseline]: Baseline characteristics of patients in treatment group by data source: Gender

Sex: All, ages: 28 Days to any

Inclusion criteria:

* receive a first prescription/dispensing for single-agent formulations of olodaterol or indacaterol during the study period (no prescriptions/dispensings ever before)
* patients must have at least 12 consecutive months of enrolment in the database before the index date

Exclusion criteria:

\- Individuals with missing or implausible values for age or sex will be excluded.

Participant flow

Outcome results

• Percentage of Off-label Use of Olodaterol Among New Users (Primary), Number, Percentage of participants: Olodaterol - PHARMO Overall 48.6; Olodaterol - PHARMO-GP 19.6; Olodaterol - National Health Databases, Denmark 30.3; Olodaterol - IMS RWE LPD General Practitioner (GP) Panel 33.9; Olodaterol - IMS RWE LPD Pulmonologist Panel 17.3
• Percentage of Off-label Use of Indacaterol Among New Users (Secondary), Number, Percentage of participants: Indacaterol - PHARMO Overall 61.1; Indacaterol - PHARMO-GP 29.2; Indacaterol - National Health Databases, Denmark 66.6; Indacaterol - IMS RWE LPD GP Panel 34.9; Indacaterol - IMS RWE LPD Pulmonologist Panel 20.5
• Baseline Characteristics of New Users of Indacaterol: Age (Secondary), Median, Years: Indacaterol - PHARMO Overall 67 (59.0 to 75.0); Indacaterol - National Health Databases, Denmark 69 (61.2 to 76.5); Indacaterol - IMS RWE LPD GP Panel 63 (53.0 to 73.0); Indacaterol - IMS RWE LPD Pulmonologist Panel 68 (59.0 to 78.0)
• Baseline Characteristics of New Users of Olodaterol: Age (Primary), Median, Years: Olodaterol - PHARMO Overall 68 (60.0 to 75.0); Olodaterol - National Health Databases, Denmark 71 (64.0 to 78.5); Olodaterol - IMS RWE LPD General Practitioner (GP) Panel 63 (53.0 to 72.0); Olodaterol - IMS RWE LPD Pulmonologist Panel 67 (59.0 to 75.0)
• Baseline Characteristics of New Users of Olodaterol: Gender (Primary), Count of participants, Participants: Olodaterol - PHARMO Overall 702; Olodaterol - National Health Databases, Denmark 977; Olodaterol - IMS RWE LPD General Practitioner (GP) Panel 322; Olodaterol - IMS RWE LPD Pulmonologist Panel 129
• Baseline Characteristics of New Users of Indacaterol: Gender (Secondary), Count of participants, Participants: Indacaterol - PHARMO Overall 887; Indacaterol - National Health Databases, Denmark 3324; Indacaterol - IMS RWE LPD GP Panel 696; Indacaterol - IMS RWE LPD Pulmonologist Panel 42

Adverse events

Time frame: Based on the data planned for this study, no suspected adverse events/reactions were expected.

• Study Protocol (PDF, 2014-02-13)
• Statistical Analysis Plan (PDF, 2017-01-16)

• Boehringer Ingelheim, Study chair, Boehringer Ingelheim