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Fluticasone, Salmeterol Combination Increases Survival in Moderate-Severe COPD: Presented at CHEST

By John Gever

SALT LAKE CITY, UT -- October 25, 2006 -- Three years of treatment combining a corticosteroid drug with a long-acting beta agonist cut the death rate from chronic obstructive pulmonary disease (COPD) by 17%, according to a large, multinational, placebo-controlled study presented here at CHEST 2006, the annual meeting of the American College of Chest Physicians.

The data, from the TOward a Revolution in COPD Health (TORCH) study, were presented by Bartolome Celli, MD, professor of medicine, Tufts University, and chief of pulmonary medicine, Caritas-St. Elizabeth's Medical Center, Boston, Massachusetts.

"I think it is a landmark trial," Dr. Celli said in a press briefing on October 23^rd, describing the results at a press briefing prior to the formal presentation.

Celli noted that in the primary statistical analysis, the mortality reduction fell just short of significance (P = .052). "This is a point of contention," he acknowledged. But Celli said a secondary analysis with Cox's proportional hazards test, which accounts for co-variables such as age, supported the main finding, with a statistically significant P = .031.

The randomized, double-blind trial involved 6,112 patients with moderate to severe COPD from 42 countries. They received 500 mcg fluticasone proprionate, 50 mcg salmeterol, a combination of the 2 drugs or placebo twice daily for 3 years. The primary outcome measure was death from all causes.

On an intent-to-treat basis, 15.2% of patients in the placebo group died, versus 12.6% of those assigned to the fluticasone-salmeterol combination. There was no important difference in death rates between placebo and either of the drugs alone.

The chief adverse effect seen with the combination therapy was hoarseness and thrush. Dr. Celli said the incidence of pneumonia was also increased in the combination group, but without an associated increase in deaths. Pneumonia diagnoses were not confirmed with X-rays and it may be that many were actually less severe respiratory infections.

Commenting on the study, Ronald Grossman, MD, chief of medicine, Credit Valley Hospital, Mississauga, Ontario, Canada, suggested that the 17% advantage for the combination is probably an underestimate. The extremely rigorous criteria used in the mortality analysis made the placebo results appear better than they really were, he said; most participants who withdrew from treatment were in the placebo group, and most of the dropouts later received active treatment outside the trial. Had they stayed in the trial receiving placebo, it's likely more of them would have died, he said.

Other analyses of TORCH data were also presented at the meeting, and the researchers reported that the combination decreased the rate of COPD exacerbations and improved health status over 3 years of treatment.

The fluticasone-salmeterol combination is sold in the U.S. under the name Advair and in Europe as Seretide. In the U.S., the 500/50 dosage is approved for asthma but not COPD. GlaxoSmithKline is the manufacturer and sponsored the TORCH study.


[Presentation title: The TOward a Revolution in COPD Health (TORCH) Study: Fluticasone Proprionate/Salmeterol Improves Survival in COPD Over Three Years, Abstract 3374]

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