Newly-presented data from the TORCH trial of GlaxoSmithKline’s combination respiratory drug Advair/Seretide prove that the drug can improve survival in patients with chronic obstructive pulmonary disease.
The data should go some way to convince clinicians of the value of Advair in COPD, which is the fourth leading cause of death in the Western world.
"The combination therapy of salmeterol and fluticasone is the first intervention since oxygen therapy or smoking cessation to show improved survival in patients with COPD," said lead study author Bartolome Celli of Caritas-St Elizabeth's Medical Centre, in Boston, USA.
"The improvement was comparable with that produced by statins in cardiovascular mortality,” he pointed out. There was a non-statistically significant trend towards reducing all-cause mortality, but Celli insisted that this was ‘clinically significant’,
More than 6,100 patients with moderate-to-severe COPD were enrolled in TORCH and randomly assigned to one of four groups – fluticasone alone, salmeterol alone, a both drugs in combination, and placebo.
Over a period of three years, the group that received both medications experienced an 18 % decline in deaths compared to the placebo patients. In contrast, death rates were similar to patients on a placebo for those groups taking just one of the drugs.
In addition, patients on dual therapy had significantly fewer disease flare-ups, improved lung function, and did better on quality-of-life scores compared to the other groups.
GSK plans to file for approval to include the new data on the label, and analysts at Collins Stewart believe this could boost take up of the drug to £4.8 billion ($8.97bn) by 2009. Advair is currently GSK’s biggest selling product, posting sales of $2.93 billion in the first half of 2006.
The updated results from TORCH were reported at CHEST 2006, the 72nd annual international scientific assembly of the American College of Chest Physicians (ACCP).