GlaxoSmithKline: Study shows Seretide reduces mortality in patients with pulmonary disease

By E. Janene Geiss

Philadelphia, March 28 - GlaxoSmithKline plc said Tuesday that preliminary results from a study showed a 17% relative reduction in mortality over three years for patients with chronic obstructive pulmonary disease who received Seretide 50/500 mcg (salmeterol/fluticasone propionate) as compared with patients taking a placebo.

This is the first study to investigate the effects of pharmacotherapy on all-cause mortality in patients with the disease, according to a company news release.

The primary comparison was between Seretide, as it's known in the European Union, and a placebo. Seretide is known as Advair in the United States.

Seretide also reduced the rate of chronic obstructive pulmonary disease exacerbations by 25% compared to a placebo and resulted in an improvement in quality of life when compared to a placebo as measured by the St George's Respiratory Questionnaire, officials said.

Adverse events seen in the study generally appear consistent with those seen in previous studies. Despite the reduced rate of exacerbations overall, Seretide was associated with increased reporting of adverse events classified under lower respiratory tract infections, when compared with a placebo, officials said.

GlaxoSmithKline said it believes these data are clinically important and that they will have a positive impact on the future management of pulmonary disease.

The company said it will be working with regulatory authorities to incorporate these study findings into our prescribing information for Seretide (50/500 mcg).

The study was a multi-center, double-blind trial that enrolled more than 6,100 patients with chronic obstructive pulmonary disease into one of four treatment arms; Seretide (50/500 mcg), Serevent (salmeterol) (50 mcg), Flixotide/Flovent (fluticasone propionate) (500 mcg) or a placebo over a treatment period of three years.

The primary endpoint was all-cause mortality comparing Seretide with a placebo, and secondary endpoints were chronic obstructive pulmonary disease exacerbations and quality of life.

GlaxoSmithKline said it will seek publication of the study in a peer-reviewed journal at the earliest opportunity.

Advair 50/500 is not licensed in the United States for patients with chronic obstructive pulmonary disease, officials said.

GlaxoSmithKline is a Philadelphia research-based pharmaceutical and health care company.

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