Pfizer and Boehringer Ingelheim Present Positive Results of COPD Study
Pfizer Canada and Boehringer Ingelheim, a German drug company, have announced positive results of the Uplift trial, which showed that when patients with chronic obstructive pulmonary disease received tiotropium, there was a statistically significant 16% decrease in the risk of death.
The study showed sustained improvements in lung function for up to four years (p<0.001) although it did not alter the rate of decline in lung function. The study also showed reduced respiratory (p<0.05) and cardiac morbidity (p<0.05) therefore reaffirming the safety profile of tiotropium, the two companies said.
Tiotropium, a long-acting inhaled anticholinergic medication, also provided statistically significant improvements in health-related quality of life, as measured by the St George’s Respiratory Questionnaire (SGRQ, p<0.001). Throughout the four-year trial period, patients in the tiotropium group consistently reported a better quality of life than at study initiation.
Uplift also demonstrated that tiotropium produced a significant reduction in the number of exacerbations per patient year (14%; p<0.001) and a significant delay in time to first exacerbation by a median of 4.1 months (p<0.001). In addition, tiotropium significantly reduced the risk of exacerbations leading to hospitalizations (hazard ratio 0.86; p<0.002) versus the control group, according to the two companies.
Within the four-year treatment period of the trial, 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 was assessed for the 30 days following the conclusion of the treatment period, and the study revealed an 11% reduced risk of death, although it did not meet statistical significance (p=0.086).
Marc Decramer, a study author and professor of medicine at the Catholic University Hospital in Leuven, Belgium, said: “In Uplift, tiotropium performed very well over the long term by improving survival rates, lung function, exacerbation rates, and patients’ quality of life, while also confirming its favorable safety profile.
“The Uplift data adds to the growing knowledge of how treatment can impact the clinical course of chronic obstructive pulmonary disease (COPD). This will allow physicians to prescribe a long-term maintenance treatment early on with confidence.”