The Effect of Defining COPD by the Lower Limit of Normal of FEV1/FVC Ratio in TIOSPIR Participants
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Using the lower limit of normal to define airflow obstruction would have excluded patients in TIOtropium Safety and Performance In Respimat study with a higher risk of nonfatal major adverse cardiovascular events and a lower risk of exacerbation; study outcomes by treatment arm (tiotropium Respimat 2.5 μg/5 μg vs. HandiHaler 18 μg) remained similar. A total of 17,072 patients were analyzed; of these, 1,807 (10.6%) patients had a ratio greater than or equal to LLN. Patients with a ratio greater than or equal to LLN had similar risks of death from any cause and fatal major adverse cardiovascular (CV) event as those below LLN.