Single and Combined Inhaled Drug Therapies Similarly Effective in Reducing Exacerbations of Chronic Obstructive Pulmonary Disease: Presented at ERS

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Title: Single and Combined Inhaled Drug Therapies Similarly Effective in Reducing Exacerbations of Chronic Obstructive Pulmonary Disease: Presented at ERS
URL: http://www.pslgroup.com/dg/22E666.htm
Doctor's Guide
October 8, 2008

By Chris Berrie

BERLIN -- October 8, 2008 -- The combination of a long-acting bronchodilator with an inhaled corticosteroid (ICS) enhances the reduction of exacerbations produced by single-agent treatment only in patients with stable chronic obstructive pulmonary disease (COPD) who have a forced expiratory volume in 1 second (FEV₁) no greater than 40% predicted, according to results of a systematic review of randomised trials.

Coinvestigator Patrick Muggensturm, MD, Horten Centre for Patient-Oriented Research and Knowledge Transfer, University of Zurich, Zurich, Switzerland, presented the results here on October 7 at the European Respiratory Society (ERS) 18th Annual Congress.

Although previous conventional meta-analyses have shown that some single-drug regimens are effective over placebo, Dr. Muggensturm and colleagues conducted their network meta-analysis to assess the relative effectiveness of different competing drug regimens for the prevention of exacerbations in COPD patients, he explained.

This review started with a literature search of the relevant electronic databases that included randomised controlled trials (RCTs) looking at the effects of long-acting beta-agonists (LABAs), long-acting anticholinergics (LAACs), ICS, or combination treatments, on patients with stable COPD.

No language restrictions were applied, and the RCTs were specified as 4 weeks or greater in duration, with or without placebo control, and reporting on the proportions of patients with at least 1 exacerbation during follow-up.

From the initial 96 RCTs identified and screened, the required data were extracted from 36 RCTs that fulfilled the inclusion criteria. These were subjected to logistics regression arm-level analysis with presence of exacerbations as the dependent variable and different treatment options as independent variables. Two reviewers evaluated independently the qualities of the RCTs included in the analysis.

In all, 26,860 patients were included, with main median age of 64 years, median FEV₁ of 44% predicted, and median duration of treatment of 52 weeks. Exacerbations were defined as event-based in 87% of the RCTs and symptom-based in 13%.

Within the patient groups, 8,353 received placebo; 6,357 LABAs; 4,764 a LAAC; 3,525 an ICS; and 3,861 combination treatment.

All of these drug regimens were superior to placebo (odds ratio [OR], 95% confidence interval [CI]): LABAs: 0.77, 0.71-0.84; LAACs: 0.71, 0.64-0.78; ICS: 0.78, 0.70-0.86; LABAs/ICS: 0.72, 0.65-0.80.

However, across treatment comparisons, the reductions in the numbers of exacerbations did not show any significant differences, including the LABA/ICS combination.

When the data were stratified according to FEV₁ > or <= 40% predicted, the researchers found that there were no significant differences between treatments for this whole patient population. But within the subgroup with FEV₁ <=40% predicted, the LAAC and the LABA/ICS treatments were both significantly superior to LABAs alone (OR, 0.83; 95% CI, 0.71-0.98; OR, 0.79; 95% CI, 0.67-0.93; respectively). Similarly, treatment with an ICS alone showed near significant superiority to a LABA alone (OR, 0.75; 95% CI, 0.57-1.00).

"It doesn't really matter which one you use for prevention of exacerbations, all [of these] drug regimens are about equal, with the only exception with the patients with FEV₁ below 40% predicted, where in this case the combination therapy is superior over LABAs alone," Dr. Muggensturm said.

He also stressed that patients with FEV₁ <40% predicted is the population that could benefit from combination therapy, with respect to the reduction of exacerbations.

[Presentation title: How to Reduce COPD Exacerbations With Inhaled Drugs - A Network Meta-Analysis. Abstract P3319]

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