Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
The specific aim of this study is to describe 1 year Advair dispensing rates for patients with COPD, and to measure the association between Advair adherence and healthcare utilization (e.g. emergency room visits and inpatient admissions, etc.). To compare the risk of a COPD exacerbation (moderate or severe) during a 3-month follow-up period between patients thqat are adherent versus those that are not.
Interventions
fluticasone propionate/salmeterol xinafoate combination
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* at least one pharmacy claim for Advair (any strength; Diskus or MDI) during the index year (July 1, 2005 through June 30, 2006). * Continuous medical and pharmacy eligibility for the 12 month Pre-Index year and the 12 month Index year (referred to as the 24 month Observation Period), and the 3 month Post-Index period (referred to as the Outcome Period). * At least one medical claim with a diagnosis (either primary or secondary) of COPD (ICD-9 code 490.xx, 491.xx, 492.xx, and 496), AND at least 1 pharmacy claim for an Anticholinergic medication, both occurring during the12 month pre-index period. * At least 40 years old at index date.
Exclusion criteria
* any medical claim (ever) with a primary or secondary diagnosis of cystic fibrosis (ICD-9 code 277.0x).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Pharmacy Claims by Participants During the Post-Index Period | One Year | The mean number of pharmacy claims incurred by participants during the one-year post-index period was measured. |
| Mean Number of Healthcare Encounters Incurred by Participants During the Post-Index Period | One Year | The mean number of outpatient office visits, inpatient visits, and emergency department visits incurred by participants during the one-year post-index period was measured. |
Participant flow
Pre-assignment details
Participants were not recruited or enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and were used to develop a cohort. All diagnoses and treatments are recorded in the course of routine medical practice.
Participants by arm
| Arm | Count |
|---|---|
| Fluticasone Propionate/Salmeterol (FSC) Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision \[ICD-9\], Clinical Modification \[ICD-9\] codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one1 pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x) | 11,060 |
| Total | 11,060 |
Baseline characteristics
| Characteristic | Fluticasone Propionate/Salmeterol (FSC) |
|---|---|
| Age Continuous | 61.6 Years STANDARD_DEVIATION 9.4 |
| Number of Participants with the Indicated Level of Adherence to FSC High adherence | 4855 participants |
| Number of Participants with the Indicated Level of Adherence to FSC Low adherence | 2726 participants |
| Number of Participants with the Indicated Level of Adherence to FSC Medium adherence | 3479 participants |
| Sex: Female, Male Female | 6103 Participants |
| Sex: Female, Male Male | 4957 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Mean Number of Healthcare Encounters Incurred by Participants During the Post-Index Period
The mean number of outpatient office visits, inpatient visits, and emergency department visits incurred by participants during the one-year post-index period was measured.
Time frame: One Year
Population: Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of COPD (ICD-9 codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluticasone Propionate/Salmeterol (FSC) | Mean Number of Healthcare Encounters Incurred by Participants During the Post-Index Period | Outpatient Office Visits | 2.048 healthcare encounters | Standard Deviation 2.918 |
| Fluticasone Propionate/Salmeterol (FSC) | Mean Number of Healthcare Encounters Incurred by Participants During the Post-Index Period | Emergency Department Visits | 0.145 healthcare encounters | Standard Deviation 0.788 |
| Fluticasone Propionate/Salmeterol (FSC) | Mean Number of Healthcare Encounters Incurred by Participants During the Post-Index Period | Inpatient Visits | 0.078 healthcare encounters | Standard Deviation 0.353 |
Primary
Mean Number of Pharmacy Claims by Participants During the Post-Index Period
The mean number of pharmacy claims incurred by participants during the one-year post-index period was measured.
Time frame: One Year
Population: Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of COPD (ICD-9 codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluticasone Propionate/Salmeterol (FSC) | Mean Number of Pharmacy Claims by Participants During the Post-Index Period | Albuterol Pharmacy Claims | 2.960 pharmacy claims | Standard Deviation 4.627 |
| Fluticasone Propionate/Salmeterol (FSC) | Mean Number of Pharmacy Claims by Participants During the Post-Index Period | Inhaled Corticosteriod Pharmacy Claims | 0.219 pharmacy claims | Standard Deviation 1.092 |
| Fluticasone Propionate/Salmeterol (FSC) | Mean Number of Pharmacy Claims by Participants During the Post-Index Period | Anticholinergic Pharmacy Claims | 5.491 pharmacy claims | Standard Deviation 5.397 |
| Fluticasone Propionate/Salmeterol (FSC) | Mean Number of Pharmacy Claims by Participants During the Post-Index Period | Theophylline Pharmacy Claims | 0.573 pharmacy claims | Standard Deviation 2.188 |
| Fluticasone Propionate/Salmeterol (FSC) | Mean Number of Pharmacy Claims by Participants During the Post-Index Period | Oral Corticosteriod Pharmacy Claims | 1.545 pharmacy claims | Standard Deviation 2.727 |
| Fluticasone Propionate/Salmeterol (FSC) | Mean Number of Pharmacy Claims by Participants During the Post-Index Period | Antibiotic Pharmacy Claims | 2.181 pharmacy claims | Standard Deviation 2.743 |