The appropriateness of multiple long-acting inhaled medications in treating chronic obstructive pulmonary disease (COPD) is poorly studied. This study evaluated whether combining tiotropium with fluticasone-salmeterol or with salmeterol alone improves clinical outcomes in adult patients with moderate to severe COPD, as compared with tiotropium plus placebo.
This randomized, double-blind, placebo-controlled trial was set in academic and community medical centers in Canada. Researchers monitored 449 patients in the three parallel treatment groups for COPD exacerbations for 52 weeks. Analysis was done on an intention-to-treat basis. The rate of COPD exacerbations within the follow-up period (the primary outcome) was not significantly different among the three treatment groups. However, secondary outcomes, such as rates for hospitalization for COPD exacerbations, all-cause hospitalizations, health-related quality of life and lung function were significantly improved in the group receiving tiotropium and fluticasone-salmeterol.
A notable limitation was that more subjects stopped taking the study medications in the tiotropium-placebo and the tiotropium-salmeterol group. Many crossed over to treatments with inhaled corticosteroids or beta-agonists.
The results are in contrast to current guidelines, which recommend adding inhaled steroids to reduce exacerbations in moderate to severe COPD. Whether these results are due to differing statistical analysis among studies remains unclear. The authors postulate that reduction in secondary outcomes may be related to fluticasone reducing the severity of exacerbations rather than the actual number.
COPD exacerbations are among the most common diagnoses encountered by hospitalists. Most patients are treated with multiple inhaled medications to optimize their pulmonary status. Polypharmacy and the added financial burdens on the patient (particularly the elderly) are important considerations when deciding discharge medications, and the evidence of efficacy for combination inhaled medications had not been assessed as a clinical outcome prior to this study.
Benefits of Rapid Response Teams
Winters BD, Pham JC, Hunt EA et al. Rapid response systems: a systematic review. Crit Care Med. 2007 May;35(5):1238-1243.
Although the Institute for Healthcare Improvement has endorsed rapid response teams, and many hospitalist groups are involved with such systems, quality research is lacking.
Following up on the 2006 “First Consensus Conference on Medical Emergency Teams,” this meta-analysis sought to evaluate current literature to identify the effect of rapid response systems (RRS) on rates of hospital mortality and cardiac arrest.
The authors included randomized trials and observational studies in their analysis. Only eight studies met their inclusion criteria (six observational studies, one multicenter randomized trial, and one single-center randomized trial).
The pooled results did not demonstrate a statistically significant benefit of rapid-response systems in rates of hospital mortality. When rates of in-hospital cardiac arrest were analyzed, there was a weak finding in support of RRS, with the relative risk of 0.70 (confidence interval 0.56-0.92) in favor of RRSs. But the confidence interval was wide, and there was substantial heterogeneity among the included studies.
The authors conclude that “it seems premature to declare RRS as the standard of care,” and that data are lacking to justify any particular implementation scheme or composition of RRS or to support the cost-effectiveness of RRS.
Finally, they recognized the need for larger, better-designed randomized trials. However, in an accompanying editorial, Michael DeVita, MD—a pioneer in the development of RRS—rejects the use of techniques of evidence-based medicine such as multicenter trials and meta-analysis in assessing the utility of RRS. Dr. DeVita essentially says that changing the systems and culture of care within the hospital to accommodate patients with unmet critical needs must be effective in improving outcomes.