Combination Therapy Reduces COPD Exacerbations

January 15, 2007

FRANKFURT, Germany -- Therapy with inhaled corticosteroids plus a long-acting bronchodilator appears to significantly improve exacerbations and other outcomes for chronic obstructive pulmonary disease (COPD), according to German researchers.

FRANKFURT, Germany, Jan. 15 -- Therapy with inhaled corticosteroids plus a long-acting bronchodilator appears to significantly improve exacerbations and other outcomes for chronic obstructive pulmonary disease (COPD), according to researchers here.

Among patients with severe COPD prone to frequent exacerbations, Advair Diskus 500/50 (fluticasone plus salmeterol) reduced these episodes by 35% compared with Serevent (salmeterol) alone, said Peter Kardos, M.D., of Maingau Hospital in Frankfurt am Main, and colleagues.

Combination therapy also significantly improved time to first exacerbation, health-related quality of life, peak expiratory flow, and use of rescue medication, they said in the Jan. 15 issue of the American Journal of Respiratory and Critical Care Medicine.

The findings support recommendations in the joint American Thoracic Society and European Respiratory Society guidelines that suggest combination therapy for patients FEV1 less than 50% of predicted, with repeated exacerbations.

Because evidence of an additive benefit for inhaled corticosteroids has been conflicting for exacerbations, the study answered an important clinical question, according to an accompanying editorial by Dennis E. Niewoehner, M.D., of the Veterans Affairs Medical Center, and Timothy J. Wilt, M.D., M.P.H., of the University of Minnesota, both in Minneapolis.

"Whether these pharmacologic agents confer additive effects when used in combinations is a very important clinical question, because the drugs are costly and there are residual safety concerns," they wrote.

Clinicians should focus this combination strategy on a "small minority" of COPD patients, Drs. Niewoehner and Wilt wrote.

"Decisions to initiate [combination therapy] should focus on severely symptomatic and exacerbation-prone patients and balance the recently demonstrated benefits against increased drug costs and adverse effects," they said.

The double-blind, parallel-group study included 994 clinically stable patients with an FEV1 of 50% or less and who were exacerbation prone (two or more moderate to severe exacerbations in the prior year). Half the patients were randomized to receive Advair Diskus 500/50 (50 ?g salmeterol with 500 ?g fluticasone) twice daily and the other half received 50 ?g Serevent twice daily.

During the 44 weeks of follow-up, there were 334 exacerbations in the combination therapy and 464 in the Serevent group (P

However, they noted an additional safety concern -- a significant increase in the incidence of pneumonia -- that has not been previously reported with combination therapy.

The researchers reported 23 cases of suspected pneumonia in the combination group compared to 7in the Serevent group (P