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Preliminary data from one major study has revealed that Spiriva HandiHaler (tiotropium bromide), an inhaled anticholinergic, poses no increased risk of stroke when compared to placebo. The four-year clinical trial, known as UPLIFT (Understanding the Potential Long-Term Impacts on Function with tiotropium), involved approximately 6,000 patients with chronic obstructive pulmonary disease.

An earlier safety review had identified an increased risk of cerebrovascular accident in patients who used tiotropium bromide to treat bronchospasm associated with COPD. The inhaler is used long-term on a once-daily basis for management of both chronic bronchitis and emphysema.

The UPLIFT findings are in contrast to the findings reported in two recent publications that also examined cardiovascular outcomes. Currently, the FDA is completing a review of the UPLIFT results, and it could take several months before final safety recommendations and potential use and labeling changes are announced.

Patient teaching: The ongoing safety concerns provide an excellent opportunity to discuss individual patient risk factors for stroke, especially those that can be modified, including obesity and lipid levels.

A final important reminder: When safety concerns arise, patients and their caregivers may panic and alter their treatment regimen, leading to acute exacerbations. Caution patients not to stop taking Spiriva HandiHaler before talking to their healthcare provider.

Caution: Review current drug information before administering and monitoring medications.

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Drug News is compiled by Susanne J. Pavlovich-Danis, RN, MSN, ARNP-C, CDE, CRRN, who maintains a private practice in Plantation, Fla., and is professor and area chair for nursing at the University of Phoenix, Fort Lauderdale.