Asthma
Conditions
Keywords
Asthma, treatment, Advair and inhaled corticosteroids, Medicare, Outcomes, costs
Brief summary
The objective of this study is to compare healthcare utilization and costs in Medicare-eligible asthma patients (aged \>65) who receive fluticasone propionate/salmeterol xinafoate combination or inhaled corticosteroids in a typical clinical practice using a retrospective observational cohort study design of large managed care database. Outcomes on interest include asthma related severe exacerbations defined as asthma related emergency department visits, hospitalizations or combined emergency department/hospitalization. Other outcomes of interest include use of albuterol, oral corticosteroids and overall asthma related costs. Outcomes of interest will be compared between the two treatment cohorts (fluticasone propionate/salmeterol xinafoate combination or inhaled corticosteroids). Dichotomous outcomes (emergency visits, hospitalizations etc) will be compared using Cox regression hazards analysis assessing time to first event for each asthma related endpoint adjusting for differences in baseline demographics such as age, gender, previous asthma medication use, co morbidities, costs, and plan demographics. Total asthma related costs will also be compared using generalized linear models adjusting for baseline differences.
Interventions
Fluticasone propionate/salmeterol xinafoate combination for asthma, all doses (100mcg/50mcg, 250 mcg/50mcg and 500 mcg/50mcg)
Inhaled corticosteroids: beclomethasone dipropionte, mometasone, fluticasone propionate, budesonide, and flunisolide
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with asthma as determined by ICD-9 codes and asthma drug use * at least 65 years of age * prescription for an inhaled corticosteroid
Exclusion criteria
* a diagnosis of chronic obstructive pulmonary disease or * a prescription for a chronic obstructive pulmonary disease treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims | Up to 7 years from July 1, 2001 to June 30, 2008 | Asthma-related events were defined as events with any primary ICD-9 code of 493.xx for hospitalizations, emergency department visits, and combined hospitalization/emergency department visits. The post-index period is defined as 3-12 months after either the first administration of fluticasone propionate and salmetrol or inhaled corticosteroids. Medical and pharmacy claims are recorded healthcare encounters in a large managed care administrative insurance database. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Asthma-related Costs in the Post-index Period | Up to 7 years from July 1, 2001 to June 30, 2008 | Asthma-related costs were calculated as pharmacy costs, medical costs, and total asthma (pharmacy plus medical) costs. Medical costs were made up of asthma-related visits, hospitalizations, emergency department visits, and medical office visits. Pharmacy costs were comprised of all asthma-related medications used during the follow-up period. Medical services were identified by place of service and PharMetrics-specific confinement codes. Prescriptions were counted by 30-day fills, with fills less than 30 days rounded up to indicate one fill. |
| Mean Number of Albuterol (Short-acting β-Agonists) Canisters Dispensed Per Pharmacy Claim Per Participant | Up to 7 years from July 1, 2001 to June 30, 2008 | The number of albuterol canisters dispensed was used as a surrogate marker of asthma symptoms. |
Participant flow
Pre-assignment details
Patients were not recruited for nor enrolled in this study. This study is a retrospective observational study. Data from medical records or insurance claims databases are anonymized and used to develop a patient cohort. All diagnoses and treatments are recorded in the course of routine medical practice.
Participants by arm
| Arm | Count |
|---|---|
| Fluticasone Propionate and Salmeterol Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg | 9,868 |
| Inhaled Corticosteroids Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known. | 7,580 |
| Total | 17,448 |
Baseline characteristics
| Characteristic | Fluticasone Propionate and Salmeterol | Inhaled Corticosteroids | Total |
|---|---|---|---|
| Age, Customized 65-69 years old | 4153 Participants | 3064 Participants | 7217 Participants |
| Age, Customized 70-74 years old | 2694 Participants | 2669 Participants | 5363 Participants |
| Age, Customized 75-79 years old | 3021 Participants | 1847 Participants | 4868 Participants |
| Number of participants with comorbid COPD at baseline | 9227 participants | 7153 participants | 16380 participants |
| Sex: Female, Male Female | 6083 Participants | 4800 Participants | 10883 Participants |
| Sex: Female, Male Male | 3785 Participants | 2780 Participants | 6565 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims
Asthma-related events were defined as events with any primary ICD-9 code of 493.xx for hospitalizations, emergency department visits, and combined hospitalization/emergency department visits. The post-index period is defined as 3-12 months after either the first administration of fluticasone propionate and salmetrol or inhaled corticosteroids. Medical and pharmacy claims are recorded healthcare encounters in a large managed care administrative insurance database.
Time frame: Up to 7 years from July 1, 2001 to June 30, 2008
Population: Participants contributing to the PharMetrics database (a large, multiplan insurance encounter database) who were identified in the study as having at least one pharmacy claim for fluticasone propionate/salmeterol or inhaled corticosteroids, had an ICD-9 code of 493.xx for asthma, and were at least 65 years of age within the time frame of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluticasone Propionate and Salmeterol | Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims | Inpatient visits | 0.033 Asthma-related events | Standard Deviation 0.21 |
| Fluticasone Propionate and Salmeterol | Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims | Emergency department visits | 0.022 Asthma-related events | Standard Deviation 0.18 |
| Fluticasone Propionate and Salmeterol | Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims | Inpatient/emergency department visits | 0.05 Asthma-related events | Standard Deviation 0.3 |
| Inhaled Corticosteroids | Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims | Inpatient visits | 0.046 Asthma-related events | Standard Deviation 0.25 |
| Inhaled Corticosteroids | Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims | Emergency department visits | 0.027 Asthma-related events | Standard Deviation 0.2 |
| Inhaled Corticosteroids | Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims | Inpatient/emergency department visits | 0.07 Asthma-related events | Standard Deviation 0.35 |
p-value: 0.005195% CI: [0.68, 0.93]Regression, Cox
Secondary
Mean Asthma-related Costs in the Post-index Period
Asthma-related costs were calculated as pharmacy costs, medical costs, and total asthma (pharmacy plus medical) costs. Medical costs were made up of asthma-related visits, hospitalizations, emergency department visits, and medical office visits. Pharmacy costs were comprised of all asthma-related medications used during the follow-up period. Medical services were identified by place of service and PharMetrics-specific confinement codes. Prescriptions were counted by 30-day fills, with fills less than 30 days rounded up to indicate one fill.
Time frame: Up to 7 years from July 1, 2001 to June 30, 2008
Population: Participants contributing to the PharMetrics database (a large, multiplan insurance encounter database) who were identified in the study as having at least one pharmacy claim for fluticasone propionate/salmeterol or inhaled corticosteroids, had an ICD-9 code of 493.xx for asthma, and were at least 65 years of age within the time frame of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluticasone Propionate and Salmeterol | Mean Asthma-related Costs in the Post-index Period | Medical Services Costs | 381 United States dollars | Standard Deviation 2859 |
| Fluticasone Propionate and Salmeterol | Mean Asthma-related Costs in the Post-index Period | Pharmacy Costs | 1128 United States dollars | Standard Deviation 1077 |
| Fluticasone Propionate and Salmeterol | Mean Asthma-related Costs in the Post-index Period | Total Asthma Costs | 1509 United States dollars | Standard Deviation 3832 |
| Inhaled Corticosteroids | Mean Asthma-related Costs in the Post-index Period | Medical Services Costs | 462 United States dollars | Standard Deviation 2859 |
| Inhaled Corticosteroids | Mean Asthma-related Costs in the Post-index Period | Pharmacy Costs | 939 United States dollars | Standard Deviation 1125 |
| Inhaled Corticosteroids | Mean Asthma-related Costs in the Post-index Period | Total Asthma Costs | 1401 United States dollars | Standard Deviation 3151 |
p-value: 0.00195% CI: [731.66, 1041.69]Regression, Linear
Secondary
Mean Number of Albuterol (Short-acting β-Agonists) Canisters Dispensed Per Pharmacy Claim Per Participant
The number of albuterol canisters dispensed was used as a surrogate marker of asthma symptoms.
Time frame: Up to 7 years from July 1, 2001 to June 30, 2008
Population: Participants contributing to the PharMetrics database (a large, multiplan insurance encounter database) who were identified in the study as having at least one pharmacy claim for fluticasone propionate/salmeterol or inhaled corticosteroids, had an ICD-9 code of 493.xx for asthma, and were at least 65 years of age within the time frame of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fluticasone Propionate and Salmeterol | Mean Number of Albuterol (Short-acting β-Agonists) Canisters Dispensed Per Pharmacy Claim Per Participant | 1.01 albuterol canisters | Standard Deviation 2.26 |
| Inhaled Corticosteroids | Mean Number of Albuterol (Short-acting β-Agonists) Canisters Dispensed Per Pharmacy Claim Per Participant | 1.5 albuterol canisters | Standard Deviation 2.95 |
p-value: <0.0001Wilcoxon (Mann-Whitney)