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Title: Tiotropium Cuts COPD Flare-Ups and Hospital Stays: Presented at ATS

"Tiotropium Cuts COPD Flare-Ups and Hospital Stays: Presented at ATS"

By Jill Stein SAN DIEGO, C.A. -- May 25, 2006 -- Patients with chronic obstructive pulmonary disease (COPD) who are treated with tiotropium for at least 6 months experience dramatic reductions in the rate of disease-related exacerbations and hospitalizations, investigators reported here at the International Conference of the American Thoracic Society (ATS). David M. G. Halpin, MD, consultant pulmonologist, Royal Devon & Exeter Hospital, Exeter, United Kingdom, and associates conducted a pooled analysis of all 9 completed randomized, placebo-controlled, parallel-group tiotropium trials with a duration of at least 6 months in which tiotropium was administered via the HandHalerR. A total of 6171 patients were included in the analysis. "Numerous trials with tiotropium have shown beneficial effects in exacerbations and associated hospitalizations as secondary outcomes, and more recently as a primary outcome," Dr. Halpin commented. Pooling data from multiple trials has many benefits, he added. "It reduces the probability of false-negative results, uncertainty, and disagreement, and it allows the exploration of a prior hypothesis regarding treatment effects in subgroups and enables exploration of heterogeneity among studies," he explained. Pooled analyses can be prone to inherent biases within trials, such as selected populations and permitted interventions, as well as bias from the publication of only positive trials, he continued. For exacerbations, variation between trials in the definition of an exacerbation is also a limitation. Dr. Halpin said that prior tiotropium studies used similar inclusion criteria and standardized interventions, and original data for each patient were available to standardize the definition of endpoints. In the study he presented on May 23[^rd, exacerbations were defined as an increase or new onset of at least 2 of the following: cough, sputum, wheezing, dyspnea, or chest tightness with a duration of at least 3 days requiring treatment with antibiotics or systemic steroids, or hospitalization.

Exacerbations were determined from the records of adverse events or via case report form, depending on the study.

Results showed that the overall exposure-adjusted incidence of COPD exacerbations per 100 patient-years was 85.0 with placebo versus 65.8 with tiotropium (P <.0001). The exposure-adjusted incidence of COPD-related hospitalizations per 100 patient-years was 12.5 with placebo and 9.9 with tiotropium (P =.011).

The study also found that the time to first exacerbation and hospitalization was prolonged with tiotropium (P <.0001).

The study was funded by Boehringer Ingelheim and Pfizer Inc.

[Presentation title: Pooled Analysis of Effect of Tiotropium on COPD Exacerbations and Related Hospitalizations. Abstract H17]

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