CHICAGO – Patients with chronic obstructive pulmonary disease treated with roflumilast had fewer all-cause hospital readmissions and monthly COPD exacerbations than nonusers in two real world database analyses.
Among 1,400 patients, all-cause, 30-day hospital readmissions were 6.9% for those using once-daily oral roflumilast (Daliresp) and 11.1% for nonusers (P = .021).
COPD-related hospital readmissions were also lower with roflumilast, but these findings did not reach statistical significance (6.3% vs. 9.2%; P = .086), Dr. Alpesh N. Amin reported at the annual meeting of the American College of Chest Physicians.
He noted that Medicare recently fined 230 hospitals $227 million for high readmission rates.
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Dr. Alpesh Amin
"Heart failure, MI, and pneumonia are first on the list, but COPD is right behind that in terms of the penalty issues," said Dr. Amin, chair of the department of medicine and executive director of the hospitalist program at the University of California, Irvine.
Roflumilast, a selective phosphodiesterase-4 inhibitor, was approved in May 2011 to reduce the frequency of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.
Dr. Amin's retrospective study used data from MarketScan, a large U.S. commercial health insurance claims database, and Medicare supplemental data to evaluate hospitalizations among 15,755 patients discharged for COPD between July 1, 2011, and Dec. 31, 2011. Patients had to have used roflumilast within 14 days after hospitalization or be discharged for COPD without roflumilast use during the entire study period.
After propensity score matching and logistic regression to control for confounding by indication and baseline characteristics, a matched cohort of 350 roflumilast and 1,050 nonroflumilast patients remained.
Conditional logistic regressions showed that roflumilast use is associated with a significantly lower likelihood of all-cause 30-day hospital readmission (odds ratio, 0.59), and a trend toward decreased COPD 30-day readmission (OR, 0.66; P = .089), Dr. Amin said.
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Dr. Andrew Shorr
All patients in the study were covered by large employer-sponsored private health insurance programs, so generalization of the results to the Medicare and Medicaid populations cannot be assumed, he noted. During the same session, a second database analysis showed that despite being sicker at baseline, adults treated with roflumilast along with other COPD medications had significantly fewer monthly exacerbations than those receiving at least three other COPD maintenance medications.
During the 12-month baseline period, roflumilast patients used significantly more COPD drugs than nonroflumilast patients (mean 3.2 vs. 2.6), were on those drugs significantly longer (mean, 187 days vs. 166 days), and had significantly more baseline ER visits (mean, 0.5 vs. 0.3), and hospitalizations (79% vs. 72%).
The benefit was mainly driven by a reduction in moderate exacerbations, said Dr. Andrew Shorr, a critical care pulmonologist at Washington (D.C.) Hospital Center.
In unadjusted models, rates of combined monthly moderate and severe exacerbations fell 11.1% in the roflumilast group and rose 15.9% among controls, a significant difference.
When looked at separately, the difference was statistically significant for moderate exacerbations (–11.8% vs. +20.7%; P = .001), but not for severe exacerbations requiring hospitalization (–8.8% vs. –5.3%), he said.
After the investigators adjusted for baseline characteristics in a difference-in-difference model, the reduction remained significant for monthly severe/moderate (–0.0160) and moderate exacerbations (–0.0149), but not for severe exacerbations (–0.0012; P = .63).
"We estimated that the magnitude of the effect, after adjusting for baseline imbalances and natural time trends, was about a 23% absolute reduction in monthly exacerbations for the roflumilast group over controls," Dr. Shorr said.
The analysis was based on medical and pharmacy claims in the IMS LifeLink PharMetrics Plus database from May 2010 to December 2012. Data were for 710 COPD patients receiving roflumilast plus other COPD medications and 13,501 patients receiving at least two COPD maintenance medications and prescribed a third maintenance drug during the study index period of May 2011 and September 2012. Patients with asthma or who were corticosteroid dependent were excluded.
Forest Research Institute sponsored the studies. Dr. Amin and Dr. Shorr reported research support and other remuneration from Forest. Some coauthors in each study are Forest employees.