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East of England Respiratory Programme

BMJ study reinforces safety concerns for Tiotropium mist inhaler

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BMJ study reinforces safety concerns for Tiotropium mist inhaler

A new BMJ meta-study has reinforced the safety concerns around the Tiotropium mist inhaler (marketed as Spiriva Respimat), showing a 52% increased risk of all-cause mortality, compared with placebo.

The study, published in the BMJ on  14 June 2011 (BMJ 2011;342:d3215) conducted a systematic analysis and meta-review of 6522 patients with COPD.

The study:

  • found a 52% increased risk of all cause mortality compared with placebo
  • suggests a possible dose-response increased risk of mortality associated with tiotropium mist inhaler
  • showed an increased risk of cardiovascular mortality associated with tiotropium mist inhaler

 

In a BMJ Editorial reviewing the research (http://www.bmj.com/content/342/bmj.d2970.full) Christopher Cates, of St George's Medical School, said:
"The indirect evidence that is currently available suggests that the Handihaler is a safer bet than the Respimat. If patients have a strong preference for the mist inhaler, the possible increased risk in mortality will need to be shared with them."

 

In November 2010 (before this study was published) the MHRA issued the following advice in a Drug Safety Update (http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON099869):

 

Information and advice for healthcare professionals:  

  • Recent analyses found that Spiriva Respimat was associated with a non-significant increase in all-cause mortality compared with placebo. By contrast, Spiriva HandiHaler was associated with a decrease in all-cause mortality compared with placebo. The underlying reasons for the apparent difference are unclear, and may be a chance finding; further studies are ongoing
  • Spiriva Respimat should be used with caution in patients with known cardiac rhythm disorders
  • Patients with COPD who use tiotropium should be reminded not to exceed the recommended once-daily dose of:
    • one Spiriva HandiHaler 18-microgram capsule, or
    • two puffs Spiriva Respimat 2.5 micrograms
 
  • Please remember to report suspected adverse reactions to Spiriva HandiHaler or Spiriva Respimat on a Yellow Card at www.yellowcard.gov.uk