UK-based drug major GlaxoSmithKline says that trial data, published in the New England Journal of Medicine, demonstrate that its product, Seretide Diskus (fluticasone) reduced the risk of all-cause mortality by 17.5% in patients suffering from chronic obstructive pulmonary disease (p=0.052).
The researchers explained that, while the results were short of the pre-defined level of statistical significance (p=0.050), they do indicate that the drug has some efficacy as a treatment for COPD. They said that the lower-than-anticipated number of deaths, coupled with a high withdrawal rate for patients in the placebo group, may explain why the final results did not reach the pre-defined goal.
The authors added that the product was associated with a 25% reduction in the risk of COPD exacerbations compared with placebo, and that it brought about an improvement in health-related quality of life and forced expiratory volume capacity. GSK said that data from the study has been submitted to regulatory authorities worldwide for inclusion in the product's prescribing information.
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