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Landmark COPD Trial UPLIFT(R) Shows SPIRIVA(R) HandiHaler(R) Sustained Lung Function Improvements Over Four Years
Date:10/5/2008

change in the color of phlegm, wheezing, breathlessness with a duration of 3 or more days requiring treatment with antibiotics and/or systemic (oral, intramuscular or intravenous) steroids.

SPIRIVA provided statistically significant improvements at all time points in health-related quality of life, as measured by the St. George's Respiratory Questionnaire (SGRQ) total score (median 4.1, p<0.001).(1) SGRQ is a health-related quality of life measure, where a four-point decrease is considered to be a clinically meaningful improvement.

UPLIFT results showed no increased risk in mortality (all-cause). Specifically, a statistically significant 16 percent decrease in the risk of death (p=0.016) was observed in the SPIRIVA group, while patients received treatment. Within the four year trial period, the effect on survival was sustained, even when deaths occurring after early discontinuation of study medication were included in the analysis (p=0.034). Risk of mortality, assessed for the 30 days following the conclusion of the study, revealed an 11 percent reduction that did not meet statistical significance (p=0.086).

"With UPLIFT, the bar was set high, as patients were allowed treatment with all other respiratory medications, except for inhaled anticholinergics," said Dr. Donald Tashkin, lead investigator of the UPLIFT trial and professor at the David Geffen School of Medicine at the University of California at Los Angeles. "So the effects seen over the long term on lung function, exacerbation rates and patients' quality of life and safety are excellent news for patients and physicians."

The data also demonstrate that SPIRIVA provides important respiratory improvements in patients with moderate COPD (GOLD -Global Initiative for Chronic Obstructive Lung Disease- Stage II). Forty-six percent of the patients in the UPLIFT trial were GOLD Stage II. This is one of the largest COPD Stage II patient populations ever studied over four years. The results
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SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.; Pfizer
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