FDA clears tiotropium of excess CV risk

The US regulatory authority has concluded that tiotropium (Spiriva) is not associated with an increased risk of stroke, MI or cardiovascular death.

    The Food and Drug Administration (FDA) began an investigation in 2008 when data submitted by the manufacturer suggested a possible increased risk of stroke with tiotropium compared with placebo. Analysis of the four-year Under­standing the Potential Long-Term Impacts on Function with Tiotropium (UPLIFT) trial involving nearly 6000 patients (N Engl J Med 2008;359:1543-54) has since shown no increased risk and a significant reduction in the risk of cardiovascular death.