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Roflumilast Shows Reduced Readmissions and Exacerbations

      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), Alpesh N. Amin, MD, reported at the latest annual meeting of the American College of Chest Physicians. He is the chair of medicine at the University of California, Irvine.
      Roflumilast, a selective phosphodiesterase-4 inhibitor, was approved in 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.
      During the same session, a second database analysis showed that despite being sicker at baseline, 710 adults treated with roflumilast along with other COPD medications had significantly fewer monthly exacerbations than did 13,501 people receiving at least three other COPD maintenance medications.
      PA/LTC Perspective
      “Roflumilast looks like a promising treatment option in patients with moderate-to-severe COPD in light that it is a once daily convenient oral dosage form. Yet it is important to note that within the updated Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, roflumilast is indicated as an appropriate add-on to a long-acting bronchodilator in patients with forced expiratory volume in 1 second (FEV1) <50% predicted, chronic bronchitis, and frequent exacerbations,” said Nicole Brandt, PharmD, CGP, associate professor of pharmacy practice and science at the University of Maryland School of Pharmacy.
      According to the treatment guideline recommendations, COPD patients typically are on either dual or triple therapy including a long-acting beta-2 agonist, long-acting anticholinergic, and/or an inhaled corticosteroid. Therefore, said Dr. Brandt, “It is imperative to evaluate the role of roflumilast's place in combination with the standard of care before patients are routinely prescribed this new drug. …
      “Furthermore, tolerability concerns – namely diarrhea, weight loss, and nausea – and potential drug interactions need to be considered before adding treatments and further complicating polypharmacy concerns.”
      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 emergency room visits (mean, 0.5 vs. 0.3), and hospitalizations (79% vs. 72%), said Andrew Shorr, MD, MPH, a critical care pulmonologist at Washington (DC) 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.
      “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.
      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.