What is Spiriva? Tiotropium bromide is a long-acting, 24 hour, anticholinergic bronchodilator used in the management of chronic obstructive pulmonary disease (COPD). Tiotropium bromide capsules for inhalation are co-promoted by Boehringer-Ingelheim and Pfizer under the trade name Spiriva. It is also manufactured and marketed by Cipla under trade name Tiova. Source.
The study is titled, "Mortality associated with tiotropium mist inhaler in patients with chronic obstructive pulmonary disease: systematic review and meta-analysis of randomised controlled trials."
From the FDA in 2008:
Update 10/07/2008: FDA’s Early Communication About an Ongoing Safety Review issued on March 18, 2008 stated that Boehringer Ingelheim, the maker of Spiriva HandiHaler (tiotropium bromide), had conducted a pooled analysis of 29 trials that suggested a small excess risk of stroke (2 cases per 1000) with tiotropium bromide over placebo. FDA has now received preliminary data from UPLIFT (Understanding the Potential Long-Term Impacts on Function with Tiotropium), a large, 4-year, placebo controlled clinical trial with Spiriva HandiHaler in approximately 6000 patients with chronic obstructive pulmonary disease (COPD). The preliminary results of UPLIFT reported by Boehringer Ingelheim to the FDA showed that there was no increased risk of stroke with tiotropium bromide (Spiriva HandiHaler) compared to placebo.
Two recent publications1, 2 reported increased risk for mortality and/or cardiovascular events in patients who received tiotropium or inhaled anticholinergics. Both studies examined cardiovascular outcomes. Singh et al.1 performed a systematic review and meta-analysis of 17 clinical trials enrolling 14,783 patients treated with inhaled anticholinergic drugs used for the treatment of chronic obstructive lung disease. Lee et al.2 performed a case-control study of 32,130 patients (320,501 controls) treated with inhaled medications, including an anticholinergic, for the treatment of chronic obstructive lung disease.
FDA expects to receive the complete report for UPLIFT in November 2008. Results from this trial will also help to address some issues raised about tiotropium in the two recent publications. Due to the amount of data collected in UPLIFT, a complete review of the results could take several months, at which time FDA will update this communication with the final results of the UPLIFT analysis, as well as all the available data regarding tiotropium and stroke risk.
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: 380-39