An inhaler for chronic bronchitis and emphysema could increase patients’ risk of dying by more than half, according to new research.
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The effects of long-term use of tiotropium respimat (also known as spiriva respimat) was studied by scientists at the University of East Anglia and three US universities.
There are three million people in the UK suffering from chronic obstructive pulmonary disease (COPD). It was responsible for 24,000 deaths in 2005 - the latest year for which figures are available.
The majority of sufferers use inhalers to combat the effects of the COPD and more than 500,000 prescriptions for Tiotropium inhalers were issued in the UK last year.
The new tiotropium respimat inhaler was launched recently and licensed for use in the UK and Europe. However, the US Food and Drug Administration (FDA) has not granted approval for because of the need for further testing.
Dr Yoon Loke, of Norwich Medical School at the University of East Anglia, said: “We analysed five clinical trials involving 6,500 people and the risk of death in patients using this particular inhaler appeared to be 52% higher.
“We estimate that there will be one additional death for every 124 patients treated for a year with tiotropium respimat. Some of this risk appears to stem from patients dying of heart trouble, especially for those with existing heart problems that may be worsened because of a potential adverse effect of tiotropium on the heart rhythm.”
However, in a response statement the product’s manufacturers Boehringer Ingelheim and Pfizer said they did not agree with the authors’ conclusion that there is an increased mortality risk for Spiriva (tiotropium) Respimat in COPD.
They said: “The risk-benefit profile of tiotropium has been well characterised by prospective, placebo-controlled clinical studies.
“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 S, et al. Mortality associated with tiotropium mist inhaler in patients with chronic obstructive pulmonary disease: systematic review and meta-analysis of randomised controlled trials. BMJ 2011; Advance online publication.
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