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Tiotropium reduced acute exacerbations among patients with COPD
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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.
Perspective
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Tim Scialla, MD
This study will not change how I currently treat my COPD patients. The Holy Grail in COPD management is to find a medication such as an inhaler that will change the natural history of COPD; such a treatment would slow the progression of the disease. About a decade ago, there were several large landmark trials to study this. These trials were unsuccessful in showing that inhalers slow the rate of decline in lung production or improve mortality. In contrast, smoking cessation has been shown to slow the rate of decline in lung function and should remain the emphasis of every [medical professional] caring for patients with COPD.
This is an interesting and novel study in that it takes patients with a mild form of COPD and with very few symptoms and gives them a long-acting bronchodilator called tiotropium to see if it improves their lung function and slows its rate of decline.
The study shows what we already know about the drug: It increases your FEV1 (a measure of lung function) compared to placebo and decreases your chances of having a COPD exacerbation. The bigger question was would the study demonstrate that asymptomatic patients with mild COPD have a decrease in the rate of decline of lung function compared to those patients taking a placebo inhaler. The study did show that there was a statistically significant improvement in the loss of lung function over time in the group of patients who received tiotropium. This loss appeared to be about 20 mLs per year over the 2-year study. This is not a long enough time from which to make major conclusions.
It is also worth noting that the study was performed in China, so whether the results can be generalized to patients in the U.S. is always a big question mark. In addition, the patients in this study were screened for COPD, whereas currently, we don’t recommend routine COPD screening for asymptomatic patients.
To put some [further] perspective on this, if you took an asymptomatic patient with mild disease and put them on this medication and we slow the rate of lung decline by 20 mL per year; conservatively, this medication costs $2,000 to $3,000 a year. If a patient takes this medication for 15 years, that is probably a $30,000 investment. At the end of that 15-year treatment, if you’re still asymptomatic, you have received the equivalent of a soda can full of air. The tradeoff there is a big question mark, especially if you are asymptomatic. For symptomatic patients, it is an entirely different story. Current COPD guidelines already recommend using long-acting bronchodilators like tiotropium in COPD patients with a high symptom burden.
Will I give an asymptomatic patient an expensive medication like this? No, hopefully I can convince them to stop smoking, and to exercise and eat right.
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