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Spiriva Safe, Effective for COPD Patients

However, treatment does not slow disease progression, researchers say

SUNDAY, Oct. 5, 2008 (HealthDay News) -- For patients suffering from chronic obstructive pulmonary disease (COPD), tiotropium (Spiriva) improves lung function and quality of life but does not significantly slow progression of the disease, a new study finds.

Spiriva and a similar drug, Atrovent, are the most commonly prescribed once-daily treatments for COPD, a respiratory illness that's the fourth largest killer in the United States. Recently, studies have associated these medications with a 58 percent increased risk of heart attack, stroke and other cardiovascular problems.

"We found that patient-centered outcomes such as health-related quality of life, exacerbations, and even mortality were better in the treated versus the control group," said study co-author Dr. Bartolome R. Celli, chief of pulmonary care at St. Elizabeth's Medical Center in Boston. "In addition, there were no increased numbers of cardiovascular events or stroke in treated versus controls."

This is the longest multi-center trial evaluating the effect of a long-acting bronchodilator compared with usual care in COPD patients, Celli said. Tiotropium is in a class of drugs called anticholinergic bronchodilators, which prevent the airway spasms that can make breathing difficult.

"Patients with COPD respond to therapy," Celli said. "The rate of decline of lung function is similar between patients treated with tiotropium and patients treated with usual long-acting medications, and tiotropium is safe," he added.

The report was published in the Oct. 5 online edition of the New England Journal of Medicine and coincided with a presentation of the study at the European Respiratory Society's Annual Congress, in Berlin.

For the study, Celli and his colleagues randomly assigned 5,993 COPD patients to treatment with tiotropium or placebo. In addition, patients were allowed to take all of their other respiratory medicines, except for other inhaled anticholinergic bronchodilators.

Over the four years of the trial, the researchers found that patients treated with tiotropium had better scores on the St. George's Respiratory Questionnaire, a measure of lung function, compared with patients taking placebo. Those receiving tiotropium also had reductions in the risk of exacerbations, hospitalization and respiratory failure.

Exacerbations associated with COPD include worsening symptoms such as shortness of breath. Often these worsening symptoms require hospitalization and changes in medication.

However, treatment with tiotropium did not improve forced expiratory volume (FEV1), which is a measure of breathing and a marker for the progression of COPD. Throughout the study, FEV1 continued to decline in both groups.

"However, the rate of decline of lung function may have reached a ceiling as the values observed were lower than those reported in other trials," Celli said.

Dr. Barry Make, director of the COPD program at National Jewish Health in Denver, thinks the study demonstrates the safety and effectiveness of tiotropium in improving patient's lives.

"Tiotropium, when added to usual therapy, did not demonstrate a reduction in the normal decline in FEV1," Make said. "But the study did confirm other findings from the past, including improved quality of life and reductions in exacerbations."

Exacerbations affect quality of life, decrease lung function, and have significant long-term and short-term consequences, Make said. "So, exacerbations are a major issue," he added.

"What limits patients, and what patients complain about, is the shortness of breath and the associated detriments to the quality of life," Make said. "So, from a patient perspective, these are two things important things that modify the impact of the disease."

Make noted that there have been questions about the side effects associated with tiotropium, including an increased risk of heart attack and stroke, but this study lays these fears to rest. "In this large study, there are no safety signals," he said.

More information

For more about COPD, visit the U.S. National Heart, Lung, and Blood Institute.

SOURCES: Bartolome R. Celli, M.D., chief, pulmonary care, St. Elizabeth's Medical Center, Boston; Barry Make, M.D., professor, medicine, and director, COPD program, National Jewish Health, Denver; Oct. 5, 2008, New England Journal of Medicine, online
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