Concerns about the safety of long-acting antimuscarinic agents for the treatment of COPD, particularly the use of tiotropium through the Respimat device, led to the TIOSPIR study.

This large well-conducted randomised study compared the use of tiotropium through the Handihaler (18 µg) with tiotropium at two doses (2.5 µg and 5.0 µg) through the Respimat in over 17 000 patients with COPD. It showed no difference in mortality or efficacy between the two delivery systems, nor even a trend for a mortality difference. It is now worth reviewing the data that led to these concerns and the lessons that may be learned.

Two systematic reviews played a key role in raising concerns over tiotropium. Antimuscarinic agents were generally considered safe and well tolerated until a meta-analysis of trials that included short-acting and long-acting antimuscarinic agents suggested an increase in cardiac events and mortality.

Authors : Barnes, N. C., Jones, P

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