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Your Yourlocation: Home > Safety information on tiotropium bromide(136310-93-5) and stroke risk once was published in the United States

The US Food and Drug Administration (FDA) released early warning information on tiotropium bromide(136310-93-5) (trade name: Spiriva HandiHaler) on March 18, 2008, claiming that producer Boehringer Ingelheim has A total of 29 clinical trials were conducted, and the results showed that patients receiving tiotropium had a slightly higher risk of stroke (2 of 1000 patients) than placebo-treated patients. Tiotropium bromide is an inhaled anticholinergic drug used to treat chronic obstructive pulmonary disease associated with bronchospasm.

October 7, 2008 The FDA re-released updated information on tiotropium, saying it has received preliminary data from the UPLIFT study submitted by Boehringer Ingelheim. The results show that compared with placebo, tiotropium bromide(136310-93-5) will increase the risk of stroke. UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium) is a large, placebo-controlled clinical trial involving approximately 6,000 patients with chronic obstructive pulmonary disease for 4 years.

Two recent articles [1, 2] reported the risk of death and / or cardiovascular events in patients receiving tiotropium bromide(136310-93-5) or inhaled anticholinergics, and both studies reviewed the incidence of cardiovascular events. Singh [1] and other clinical trials conducted a systematic review of 17 and summary analysis, these trials were included in 14783 patients, the use of inhaled anticholinergics in the treatment of chronic obstructive pulmonary disease. Lee [2] conducted a case-control study of 32,130 patients who also used inhaled drugs, including inhaled anticholinergics, for chronic obstructive pulmonary disease.

The FDA expects to receive a full UPLIFT report in November 2008. The results of this study will also be helpful in explaining some of the problems with tiotropium bromide(136310-93-5) in the two recent papers. Based on the amount of information available from UPLIFT, a comprehensive analysis of the results of the study will take several months, when the FDA will release the final UPLIFT study results and all data on tiotropium and stroke risk.

Reference Information:

1. Singh S, Loke YK, Furberg CD. Inhaled anticholinergics and risk of major adverse cardiovascular events in patients with chronic obstructive pulmonary disease. JAMA 2008; 300 (12): 1439-1450.

2. Lee TA, Pickard S, et al. Risk of Death Associated with Medications for Recently Diagnosed Chronic Obstructive Pulmonary Disease. Annals of Internal Medicine 2008; 149: 380-390.


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