Purpose: We determined a level of short-acting B2-agonist (SABA) use associated with increased acute exacerbations and healthcare cost.
Methods: Retrospective analysis of 2 databases with linked medical and pharmacy data covering 37 million lives, similar to the US population. Each enrollee had at least 2 claims for chronic obstructive pulmonary disease (COPD) during 1/1/2008-3/31/2010; and SABA use. Medical and pharmacy claims were used to calculate puffs and nebulization vials/day (90 mcg and 2.5 mg albuterol, respectively or equivalent). COPD-related exacerbations included inpatient, emergency department, and urgent care events and new claims for systemic corticosteroids or antibiotics proximal to a COPD outpatient encounter. Descriptive and multivariate techniques examined the association between SABA use and outcomes. Sensitivity and specificity were examined by demographics, insurance type, and concomitant therapy.
Results: There were 66,004 patients who met study criteria (mean [SD] age: 66.9 [10.3] years; 44% male; 56% commercial insurance, 44% Medicare). Of all, 20.5%, 56.6%, and 22.9% used nebulized SABA, metered-dose inhaler (MDI), or both, respectively. Incidence of exacerbations was significantly higher in patients using ≥1.5 vials or ≥3 puffs of SABA on average/day (2.5 exacerbations/year vs 1.9 for nebulized SABA and 1.7 vs 1.4 for MDI SABA; p<0.05 for both); these patients also had higher annual healthcare costs ($19,459 vs $11,862 and $10,779 vs $8,555; p<0.05 for both).
Conclusion: SABA use ≥1.5 times/day (≥1.5 vials of nebulization/day or ≥3 puffs of MDI/day) was associated with more exacerbations and higher costs. This translates to “The Rule of 3-2” (3 times in 2 days) to identify COPD patients needing treatment re-evaluation.