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Spiriva Mist Inhaler Tied to Early Death in New Study

Jun 15, 2011 | Parker Waichman LLP

A new study has found that a mist formulation of Spiriva (Tiotropium) may be putting patients with chronic obstructive pulmonary disease (COPD) at risk for premature death.  The study, which examined Spiriva delivered via the Respimat inhaler, is published in the British Medical Journal.

Spiriva is available in the U.S. as a powder delivered via a device called the Handihaler.  According to a Bloomberg report, the Spiriva Respimat inhaler is available in 55 countries including the U.K., but has not yet been approved for use in the U.S.  The U.S. Food & Drug Administration has so far declined to approve Spiriva Respimat due to safety concerns, and is requiring that the mist version to undergo a clinical trial involving 17,000 patients.

The new Spiriva study was conducted by researchers in the U.S. and U.K.  The analysis included five clinical trials involving more than 6,500 patients.   According to one of the authors of the study, the risk of early death in patients using the Spiriva inhaler appeared to be 52 per cent higher versus those treated with placebo.

"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," Dr Yoon Loke of Norwich Medical School at the University of East Anglia, said in statement.

"There are alternative inhalers that can help patients with COPD. Patients currently using Tiotropium Respimat should not suddenly stop taking their medication, but I would advise them to make an appointment with their doctor to discuss the possibility of switching to a different drug," Dr. Yoon continued.  "As Tiotropium Respimat can have an adverse effect on the heart rhythm, patients with a history of palpitations or irregular heartbeat (fast or slow) should mention such problems to their doctor."

COPD is a chronic lung disease that causes breathing difficulty.  The disorder affects as many as 24 million Americans, according to the National Heart, Lung and Blood Institute.  COPD is estimated to kill as many as 120,000 Americans every year.




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