Abstract
To characterize the use of olodaterol and indacaterol in clinical practice and to quantify the off-label use in asthma. Drug utilization study of new users of olodaterol or indacaterol between 2014 and 2017 in the PHARMO Database Network in the Netherlands, the Danish population registers, and the IMS Real-World Evidence Longitudinal Patient Database panels in France. On-label use was defined as use among adults with a recorded diagnosis of COPD. Off-label use was defined as use among adults with a recorded diagnosis of asthma without a recorded diagnosis of COPD or as use among patients aged ≤18 years. Potential off-label use was defined as no recorded diagnosis of either COPD or asthma. The study included 4,158 new users of olodaterol and 9,966 new users of indacaterol. Prevalence of off-label use ranged from 3.5% for both drugs to 12.4% for olodaterol and 11.9% for indacaterol. Prevalence of on-label use ranged from 47.8% to 77.7% for olodaterol and from 28.7% to 70.1% for indacaterol. The remaining new users of olodaterol and indacaterol were classified as potential off-label users, with prevalence ranging from 17.3% to 48.6% for olodaterol and from 20.5% to 66.6% for indacaterol. This study provides no evidence of a major concern in Europe for olodaterol or indacaterol for off-label use in asthma or for pediatric use.
Highlights
Www.nature.com/scientificreports olodaterol to treat asthma in three countries in Europe
The study protocol was approved by the Institutional Review Board (IRB) and by the scientific and ethic committees required by each database
Among patients with recorded information on smoking history, the proportion of those who were current smokers was around 50% in PHARMO-GP and in the IMS RWE LPD GP panel and was higher in the IMS RWE LPD pulmonologist panel, which reported that 90.7% of the new users of olodaterol and 72.2% of the new users of indacaterol were current smokers
Summary
The main objectives of the study were to describe the baseline characteristics of patients initiating on olodaterol and to quantify off-label use of
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