Increased mortality with tiotropium mist inhaler use

January 01, 0001

Increased mortality with tiotropium mist inhaler use

These US and UK researchers performed a systematic review to examine the mortality risk with tiotropium mist inhaler use in chronic obstructive pulmonary disease. They searched Medline, Embase, the pharmaceutical company clinical trials register, the US Food and Drug Administration website, and ClinicalTrials.gov for placebo controlled parallel group randomized controlled trials of tiotropium solution using a mist inhaler.

The researchers found: "Five randomised controlled trials were eligible for inclusion. Tiotropium mist inhaler was associated with a significantly increased risk of mortality (90/3686 v 47/2836, relative risk 1.52). Both 10 µg (2.15) and 5 µg (1.46) doses of tiotropium mist inhaler were associated with an increased risk of mortality. The overall estimates were not substantially changed by sensitivity analysis of the fixed effect analysis of the five trials combined using the random effects model (1.45), limiting the analysis to three trials of one year’s duration each (1.50), or the inclusion of additional data on tiotropium mist inhaler from another investigational drug programme (1.42). The number needed to treat for a year with the 5 µg dose to see one additional death was estimated to be 124 based on the average control event rate from the long term trials."

The researchers concluded: "This meta-analysis explains safety concerns by regulatory agencies and indicates a 52% increased risk of mortality associated with tiotropium mist inhaler in patients with chronic obstructive pulmonary disease."

This meta-analysis of high quality trials finds that tiotropium delivered via mist inhaler is associated with increased mortality risk

For the full abstract, click here.

BMJ 342:d3215, 14 June 2011 © 2011 BMJ Publishing Group Ltd.
Mortality associated with tiotropium mist inhaler in patients with chronic obstructive pulmonary disease: systematic review and meta- analysis of randomised controlled trials. Sonal Singh, Yoon K Loke, Paul L Enright, and Curt D Furberg. Correspondence to S Singh: [email protected]

Category: R. Respiratory. Keywords: tiotropium, mist-inhaler, COPD, chronic obstructive pulmonary disease, mortality, systematic review with meta-analyis, journal watch.
Synopsis edited by Dr Paul Schaefer, Toledo, Ohio. Posted on Global Family Doctor 5 July 2011

Pearls are an independent product of the Cochrane primary care group and are meant for educational use and not to guide clinical care.

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