The timing of initiating short-term treatment for COPD exacerbations with oral corticosteroids and/or antibiotic therapy has been shown to influence the recovery time of exacerbations with early initiation of exacerbation therapy having a faster symptom recovery compared to delayed initiation. While oral corticosteroids and/or antibiotic therapy are crucial for immediate exacerbation therapy, maintenance therapy with controller medications for COPD has been recommended to reduce the risk of future exacerbations. The initiation of maintenance therapy after a COPD exacerbation has been shown to be beneficial in the reduction of risk of future exacerbations. However, there is a lack of information on whether the timing of this initiation influences the risk of future exacerbations. The following study evaluates the impact of early versus delayed initiation of controller medication therapy for maintenance treatment following a COPD-related exacerbation on outcomes of future exacerbations and costs in patients with COPD.
Study period for this analysis will range from January 2003 through June 2009. Patients with at least one COPD exacerbation will be selected as the initial population. Three types of COPD exacerbations will be identified: 1) hospitalization with a primary discharge diagnosis code for COPD, 2) an emergency department (ED) visit with a primary diagnosis code for COPD, 3) physician visit with a dispensing of oral corticosteroid (OCS) or antibiotic (ABX) within 5 days of the visit. Only the first two will be selected as index exacerbations, which is defined as the first chronologically occurring exacerbation for a patient. For hospitalization exacerbations the discharge date of the hospitalization will be the index date and for ED exacerbations the date of the visit will be the index date. The pre-index period will be defined as the 1-year period before index date and the post-index period will be defined as 1-year period after index date. The enrollment period will thus range from January 1, 2004 through June 30, 2008. The post-index period will be used to identify the date of receipt of prescription for first COPD maintenance medication. This date of receipt will be used to compute the time to start maintenance treatment. Maintenance treatment refers to the use of controller medications. Specifically the study hypothesis for the primary outcome being tested was: Ho: There is no difference in risk of COPD-related hospitalization/ED visit between early and delayed cohorts Ha: There is a difference in risk of COPD-related hospitalization/ED visit between early and delayed cohorts Hypothesis for the key secondary outcome of COPD-related costs that was tested was: Ho: There is no difference in COPD-related costs between early and delayed cohorts Ha: There is a difference in COPD-related costs between early and delayed cohorts
Study Type
OBSERVATIONAL
Enrollment
3,806
Various classes of COPD maintenance treatment initiated within 30 days post index COPD exacerbation (hospitalization/ED visit)
Various classes of COPD maintenance treatment initiated after 30 days post index COPD exacerbation (hospitalization/ED visit)
COPD hospitalization/ED visit
Risk and number of COPD exacerbations will be computed in the post-index period. Hospitalization with a primary discharge diagnosis code (ICD code 491.xx, 492.xx, and 496.xx) for COPD. ED visit will be defined as COPD related if accompanied by diagnosis code for COPD.
Time frame: Up to 6 years (January 1, 2003 through June 30, 2009)
COPD-related ED visit
The risk and proportion of patients with a COPD-related exacerbation requiring ED visit was defined as a COPD-related ED visit.
Time frame: Up to 6 years (January 1, 2003 through June 30, 2009)
COPD-related hospitalization
risk and number of COPD hospitalizations will be computed in the post-index period. Hospitalization with a primary discharge diagnosis code (ICD code 491.xx, 492.xx, and 496.xx) for COPD will be captured.
Time frame: Up to 6 years (January 1, 2003 through June 30, 2009)
COPD-related Phy+Rx visit
Risk and number of COPD-related physician office visit with a dispensing for oral corticosteroid (OCS) or antibiotic (ABX) within 5 days of the visit
Time frame: January 1, 2003 through June 30, 2009 (up to 6 years)
COPD related Costs
COPD related medical, pharmacy and total costs. Costs were standardized to 2009 US dollars (USD) using consumer price index for US medical care.
Time frame: January 1, 2003 through June 30, 2009 (up to 6 years)
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