2008-09-24

Landmark UPLIFT Study Reaffirms the Safety of Spiriva (tiotropium) in Patients With Chronic Obstructive Pulmonary Disease


Leuven, Belgium (ots/PRNewswire) -

- For Media Outside US and Canada

- Prof. dr. Marc Decramer, Head of Pneumology of the UniversityHospitals Leuven, is Lead Investigator of the International UPLIFTStudy Investigating Treatment of COPD Patients With tiotropium. Todayhe Elaborates on the Results

Placebo-controlled, randomised, double-blind clinical trialsprovide the most comprehensive and strongest evidence of a drug'ssafety profile. The long-term exposure of thousands of patients withCOPD to tiotropium in the UPLIFT study, which has closely andrigorously evaluated both efficacy and safety, provides areaffirmation of the tiotropium safety profile and strong evidencethat tiotropium does not increase the risk of all-cause orcardiovascular mortality.

UPLIFT (Understanding Potential Long-term impacts on Functionwith Tiotropium) is a four-year landmark multinational, multi-centre,randomised, double-blind clinical COPD study trial involving 5,993patients from 37 countries across the globe. This ambitious studyinvestigated the benefits of Spiriva versus placebo over four yearsin a real-life treatment approach, allowing for use of allrespiratory medications throughout the trial, other than inhaledanticholinergics.

The data from UPLIFT indicate that tiotropium does not increasethe risk of death, cardiovascular death, myocardial infarction andstroke. Furthermore, examination of all serious cardiac and allserious lower respiratory tract adverse events indicates thattiotropium is associated with a decreased risk of experiencing aserious adverse event in these organ classes.

In UPLIFT, there were 2,986 tiotropium treated patients and 3006placebo treated patients, who contributed to 9,468 and 8,746 patientyears exposure respectively. Safety was monitored closely through astandardised adverse reporting process. An independent data andsafety monitoring committee reviewed data throughout the trial and anindependent committee adjudicated primary cause of death.

There was no evidence of an increased risk of death during thestudy. During treatment, fatal events occurred in 381 patients(12.8%) in the tiotropium-treated group and 411 (13.7%) in theplacebo group (a 16% risk reduction in the tiotropium group, hazardratio 0.84; 95% CI, 0.73 to 0.97). An intent to treat analysis wasperformed by including vital status information (i.e. alive, dead,and the cause of death) on patients who prematurely discontinued thestudy (i.e. no longer taking study drug). During the protocol definedtreatment period (until day 1440), the hazard ratio was 0.87; 95% CI0.76, 0.99). The corresponding hazard ratio up until the 30 dayfollow-up period (day 1470) was 0.89 (0.79, 1.02.

A specific analysis was conducted for cardiovascular death. Therewas no evidence for an increased risk of cardiovascular death duringtreatment (risk ratio 0.73, 95% CI 0.56, 0.95). As myocardialinfarction and stroke have been discussed, we have specificallyexamined the risk for these events. Myocardial infarction developedin 67 patients in the tiotropium group and 85 in the placebo group(relative risk, 0.73; 95% CI 0.53, 1.00), and stroke developed in 82in the tiotropium group and 80 in the placebo group (relative risk,0.95; 95% CI 0.70, 1.29).

For further support of the safety of tiotropium, we have examinedserious adverse events under the organ classes of cardiac and lowerrespiratory disorders. For total serious cardiac adverse events, therelative risk for tiotropium compared to placebo was 0.84 (95% CI0.73, 0.98). For total serious lower respiratory tract adverse eventsrelative risk for tiotropium verses placebo was 0.84 (95% CI, 0.77,0.92).

Full safety and efficacy data on the UPLIFT study will bepresented at the upcoming Annual Meeting of the European RespiratorySociety in Berlin on October 5, 2008.

Note to Editors:

The UPLIFT study was sponsored by Boehringer Ingelheim and Pfizer

http://www.uzleuven.be

ots Originaltext: UZ LeuvenIm Internet recherchierbar: http://www.presseportal.de

Contact:For more information: Prof. dr. Marc Decramer, head of pneumology (University Hospitals Leuven), Mobile: +32-475-57-06-87

UZ Leuven

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Landmark UPLIFT Study Reaffirms the Safety of Spiriva (tiotropium) in Patients With Chronic Obstructive Pulmonary Disease

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