Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
Combined Bronchodilators in Chronic Obstructive Pulmonary Disease and the Risk of Adverse Cardio-pulmonary Events: A Population-based Observational Study
Background: Recent observational studies have reported possible arrhythmogenic effects with
long-acting beta-agonists (LABA), while the long-acting anticholinergic tiotropium has been
associated with cardiovascular and cerebrovascular events. Finally, pneumonia was the object
of a recent signal in trials of LABAs submitted for marketing approval.
Aim: To assess the potential cardio-pulmonary risk arising from the concurrent use of two
long-acting bronchodilators as well as from monotherapy use of each of the long-acting
bronchodilators.
Methods: A series of population-based cohort studies, using both cohort and nested
case-control analyses will be conducted using data from the United Kingdom's Clinical
Practice Research Datalink (CPRD). The base cohort will consist of new users of long-acting
bronchodilators from Jan 2002 until Aug 2012, age >= 55 with chronic obstructive pulmonary
disease (COPD) and at least two years of baseline medical history information. The
high-dimensional propensity score technique will be used to match new users of each
long-acting bronchodilator and new users of two bronchodilators with comparable subjects
from the base cohort, with one-year follow-up for outcomes of acute myocardial infarction,
stroke, heart failure, arrhythmia and community acquired pneumonia. Data will be analysed
using time-dependent Cox proportional hazard regression models and conditional logistic
regression models.
Purpose: ;
Observational Model: Cohort, Time Perspective: Retrospective
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