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Concerns over risk from inhaler

People suffering from chronic bronchitis and emphysema could be using an inhaler that is doing them more harm than good.

Findings published in the BMJ suggest long-term use of tiotropium Respimat to help with breathing problems could be increasing the patient's risk of death by more than half.

There are three million chronic obstructive pulmonary disease (COPD) sufferers in the UK, and last year more than half a million prescriptions for tiotropium inhalers were issued across the country.

Although tiotropium inhalers have been available globally for a while, a new device known as Respimat, which was licensed for use in the UK and Europe, was not approved by regulators in the US due to a need for further testing.

Commenting on the analysis of five clinical trials relating to the inhaler, Dr Yoon Loke, of Norwich Medical School at the University of East Anglia, said it was estimated that there will be one additional death for every 124 patients treated for a year with tiotropium, although some of this risk appears to stem from patients dying from heart disease.

The latest figures show that COPD caused 24,000 deaths in 2005.

Boehringer Ingelheim and Pfizer later responded:

"When analysing the clinical data, Boehringer Ingelheim and Pfizer, unlike the authors of the BMJ publication, have access to detailed patient level data. A thorough analysis of these data revealed a statistically non-significant, numerical imbalance in number of fatal events with Spiriva® Respimat®. These data have been submitted to regulatory authorities worldwide and are appropriately reflected in the Spiriva® Respimat® Summary of Product Characteristics.
"Singh et al appropriately note the limitations of their analysis, which are due to several factors. These factors may include, but are not limited to, differences in the populations studied, doses of tiotropium using the Respimat® device, and the length of follow-up. In addition, the estimates noted in the analysis are 'imprecise owing to the fairly low incidence rates'.
"Boehringer Ingelheim conducts ongoing pharmacovigilance monitoring, including randomised clinical trials (RCT), pooled clinical databases, epidemiological studies, spontaneously reported events, literature reports and prescription monitoring. Results from Boehringer Ingelheim's pharmacovigilance monitoring are shared regularly with regulatory authorities worldwide and the Summary of Product Characteristics is continuously updated, if important new information becomes available."

Copyright © Press Association 2011

Your comments (terms and conditions apply):

"When I read in the newspapers about the concerns regarding the use of Spiriva Respimat, I brought it to the attention of my wife as she is a user for her COPD. She wanted to raise her concerns with her doctor on Wednesday but was advised that there would not be a Doctor in the surgery until Friday which concerns us more than the Spiriva scare. At the moment she is awaiting a reply call from her doctor. A surgery without any
doctors for two days, now that is what I call scary" - Bill Spence, Blantyre