Therapeutic Research

Abstract

Background：A post‒marketing surveillance（PMS）of tiotropium/olodaterol（Spiolto® Respimat®；TIO/OLO）, a fixed‒dose combination of a long‒acting muscarinic antagonist and long‒acting β2‒agonist （LAMA/LABA）, approved for chronic obstructive pulmonary disease（COPD）, was conducted（NCT02850978）.　　Objective：To investigate baseline characteristics in patients with COPD who require LABA and LAMA for maintenance treatment other than TIO/OLO assessed in parallel with the PMS of TIO/OLO.　　Methods：The non‒interventional cross‒sectional survey（BCS；UMIN000023629） was conducted in parallel with the PMS to collect baseline characteristics for COPD patients newly prescribed LAMA/LABA other than TIO/OLO, in the same sites and physicians as the PMS. Baseline characteristics of the PMS and BCS were compared.　　Results：Mild COPD was slightly higher in the BCS（26.58％）than in the PMS （19.96％）. The mean post‒dose ％FEV1 and FEV1/FVC were numerically slightly higher in the BCS（62.14％ and 59.03％, respectively）than in the PMS （60.48％ and 55.84％, respectively）. The proportion of comorbidities, benign prostatic hyperplasia（BPH）and gastroesophageal reflux disease, was numerically higher and lower, respectively, in the BCS（6.53％ and 4.95％, respectively）than in the PMS（3.52％ and 7.83％, respectively）. The proportion of previously received respiratory medication（LAMA, LABA, or inhaled corticosteroids）was higher in the BCS（62.16％）than in the PMS（41.49％）. 　　Conclusions：Patient baseline characteristics of the PMS and BCS were different. BPH was numerically more prevalent in the BCS than in the PMS, indicating that the channeling bias regarding the contraindication（patients with micturition disorder due to prostatic hyperplasia etc.）of TIO/OLO probably affected the PMS.