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SPIRIVA® in COPD improves his quality of life

Effect of survival

Effect on on-treatment survival1-3*†‡

SPIRIVA® 18 µg via HandiHaler® demonstrated 16% reduced risk of mortality vs control
Study Design

Similar effect on survival seen in both devices (mean follow-up of 2.3 years)4

SPIRIVA® demonstrated a similar mortality effect seen on both HandiHaler® and Respimat®

SPIRIVA® Respimat® vs SPIRIVA® 18 μg via HandiHaler®

Adapted from Wise et al, N Engl J Med. 2013.

Study Design

*SPIRIVA® 18 µg via HandiHaler® did not alter the rate of decline in lung function, a coprimary study endpoint in the UPLIFT® trial.

In UPLIFT®, a trial of nearly 6,000 COPD patients, SPIRIVA® 18 µg via HandiHaler® reduced risk of on-treatment mortality vs control (placebo). While SPIRIVA® 18 µg via HandiHaler® did not alter the rate of decline in lung function, a coprimary study endpoint in the UPLIFT® trial, it sustained greater improvements in lung function vs control (placebo). Mortality, a secondary safety endpoint, was evaluated in 3 analyses: 1) on treatment; 2) intention to treat at protocol-defined end of treatment period (Day 1,440); and 3) intention to treat after 30-day follow-up (Day 1,470). A significantly reduced risk was seen on-treatment (pre-specified) and extended to the end of treatment period (Day 1,440, post-hoc). In the ITT analysis there was no significant difference in risk of mortality between the treatment arms within the pre-specified 30-day follow-up period (Day 1,470).1-3

Effect extended to end of treatment period (Day 1,440), as defined by protocol. Effect became nonsignificant within the 30-day follow-up period (Day 1,470), when, according to protocol, patients were discontinued from their study medication (ITT analysis endpoint).

1. Tashkin DP, Celli B, Senn S, et al; for the UPLIFT Study Investigators. A 4-year trial of tiotropium in chronic obstructive pulmonary disease. N Engl J Med. 2008;359(15):1543-1554. 2. SPIRIVA® HandiHaler® summary of product characteristics. Boehringer Ingelheim International GmbH; May 2016. 3. Celli B, Decramer M, Kesten S, Liu D, Mehra S, Tashkin DP; on behalf of the UPLIFT Study Investigators. Mortality in the 4-year trial of tiotropium (UPLIFT) in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009;180(10):948-955. 4. Wise RA, Anzueto A, Cotton D, et al; for the TIOSPIR Investigators. Tiotropium Respimat inhaler and the risk of death in COPD. N Engl J Med. 2013;369(16):1491-1501.