Spiriva mist inhaler safety concerns raised
pharmafile | June 16, 2011 | News story | Sales and Marketing |Â Â Boehringer Ingelheim, Spiriva, drug safetyÂ
A mist inhaler used to deliver Spiriva to patients with chronic obstructive pulmonary disease (COPD) may be linked to an increased risk of death, a study published in the BMJ suggests.
Tiotropium is available as a powder, delivered with a Handihaler device, and as a mist, delivered with the Respimat Soft Mist Inhaler. It is the newer Respimat inhaler which is causing safety concerns.
The mist inhaler is available in 55 countries, including England and Scotland, but has yet to gain regulatory approval in the US.
Researchers based at the Johns Hopkins University School of Medicine in Baltimore and St. George’s University of London say the findings add to existing concerns about potentially higher mortality risk associated with the device.
Spiriva (tiotropium) is one of the biggest selling COPD treatments, and Boehringer Ingelheim’s number one product, earning the company 2.86bn euros in sales in 2010.
A team of UK and US researchers analysed data from randomised controlled trials to compare the risk of mortality associated with inhaled tiotropium delivered by the mist inhaler with placebo in patients with COPD.
The team conducted a systematic review and meta-analysis of randomised controlled trials. Five trials involving 6,522 participants met the criteria for analysis. The researchers found that tiotropium delivered with the Respimat Soft Mist Inhaler (5 μg dose) was associated with a 52% increased risk of mortality in patients with COPD compared with placebo.
This means that one excess death would be expected for every 124 patients treated with 5 μg of tiotropium delivered by mist inhaler for one year compared with placebo.
The authors conclude that their analysis explains safety concerns by regulatory agencies regarding the possibility of an increased risk of mortality associated with the device.
The authors say clinicians should inform patients about the possibility of this increased risk and exercise caution when prescribing tiotropium mist inhaler, particularly in patients with possible underlying cardiac disease.
This view is reiterated in an accompanying editorial by Christopher Cates from St George’s University of London who says, pending the results of a head-to-head trial, indirect evidence suggests that the Handihaler is a safer bet than the Respimat.
He adds, if patients have a strong preference for the mist inhaler, the possible increased risk in mortality will need to be shared with them.
Boehringer Ingelheim said in a statement to news outlet Bloomberg that it did not agree with the conclusion that there is an increased mortality risk for Spiriva Respimat in COPD.
It said the treatment’s risks and benefits have been documented in clinical trials and are described in the product’s label, adding that it had access to detailed patient data from the trials which the authors of the study did not have.
Andrew McConaghie
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