The efficacy and safety of tiotropium in Chinese patients with stable chronic obstructive pulmonary disease: a meta-analysis.

BACKGROUND AND OBJECTIVE: Tiotropium is the only long-acting inhaled anticholinergic bronchodilator currently available in China, but information about its clinical effect in this population is limited. This meta-analysis assessed the efficacy and safety of tiotropium in Chinese patients with stable COPD.

METHODS: An electronic search of the literature was undertaken to identify randomized controlled trials (RCTs) of tiotropium in Chinese patients, which were then assessed for inclusion in a meta-analysis. The efficacy and safety of tiotropium was compared with placebo and ipratropium, using the outcomes of FEV(1), FEV(1)%, symptoms, frequency of exacerbations, adverse events and safety.

RESULTS: Eleven RCTs recruiting 1006 patients were included in the meta-analysis. Compared with both placebo and ipratropium, tiotropium significantly improved FEV(1)[weighted mean difference (WMD) = 304 mL, 95% CI 271-337], FEV(1)% (WMD = 8.35%, 95% CI 5.40-11.31) and symptoms [relative risk (RR) = 2.00, 95% CI 1.61-2.49]. Tiotropium significantly reduced the risk of exacerbations (RR = 0.07, 95% CI 0.01-0.54) compared with placebo, and there was a non-significant reduction in the risk of exacerbations compared with ipratropium (RR = 0.70, 95% CI 0.13-3.75). Tiotropium was well tolerated with a similar safety profile to placebo and ipratropium (RR = 1.16, 95% CI 0.76-1.77, P = 0.49).

CONCLUSIONS: Tiotropium improved pulmonary function and symptoms, reduced exacerbations and was well tolerated and safe. On the basis of its efficacy and safety profile, tiotropium appears to be a reasonable first-line choice for the management of Chinese patients with stable COPD. Additional long-term RCTs are required to further evaluate the efficacy and safety of tiotropium.