Tiotropium reduced acute exacerbations among patients with COPD
Tiotropium use was effective in improving lung function and quality of life and reduced the frequency of acute exacerbations compared with placebo in patients with early-stage COPD, according to findings recently published in The New England Journal of Medicine.
“Patients with mild or moderate COPD rarely receive medications, because they have few symptoms,” Yumin Zhou, MD, PhD, of the National Center for Respiratory Diseases, Guangzhou, China, and colleagues wrote. “We hypothesized that long-term use of tiotropium would improve lung function and ameliorate the decline in lung function in patients with mild or moderate COPD.”
To test their theory, researchers arbitrarily designated 841 patients with COPD of Global Initiative for Chronic Obstructive Lung Disease, or GOLD, stage 1 (mild) or 2 (moderate) severity to receive an inhaled dose (18 mcg) of tiotropium (n = 419) or identical placebo (n = 422) daily for 2 years. A full analysis was conducted on 771 of these patients, 388 of whom had received tiotropium.
The primary endpoint was the between-group difference in the change from baseline to 24 months in forced expiratory volume in 1 second (FEV1) preceding bronchodilator use. Secondary endpoints included the between-group differences in the change from baseline to 24 months in FEV1 after bronchodilator use and the yearly decline in FEV1 before and after bronchodilator use from day 30 to month 24, according to study methodology.
Results indicated that the FEV1 in patients who received tiotropium was higher vs. those receiving placebo, with a range of mean difference of 127 to 169 mL before bronchodilator use and 71 to 133 mL after bronchodilator use. There was no significant improvement in mean yearly decline of FEV1 before bronchodilator use (tiotropium, 38±6 mL vs. placebo, 53±6 mL).
Conversely, researchers wrote that the yearly annual decline in FEV1 after bronchodilator use was significantly less in the tiotropium group than in the placebo group (29±5 mL vs. 51±6 mL; P = .006).
Zhou and colleagues also found that the only significant between-group differences regarding adverse events occurred in mild instances, such as oropharyngeal discomfort, which occurred in 63 patients in the tiotropium group and 28 patients in the placebo group (P < .001).
“Tiotropium resulted in a significantly higher FEV1 than placebo at 24 months and ameliorated the annual decline in the FEV1 assessed after bronchodilator use but not the FEV1 assessed before bronchodilator use. Moreover, tiotropium resulted in lower frequency of acute exacerbations of COPD than placebo,” the researchers concluded. “Whether early intervention with tiotropium alters the long-term course of COPD remains an open question.” – by Janel Miller
Disclosures: The researchers report no relevant financial disclosures.