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For Lung Disorder, Spiriva Beat Serevent in Head-to-Head Trial
Date:3/23/2011

By Steven Reinberg
HealthDay Reporter

WEDNESDAY, March 23 (HealthDay News) -- People with moderate-to-severe chronic obstructive pulmonary disease (COPD) use inhaled long-acting bronchodilators to control symptoms and reduce flare-ups, but which type of drug is best hasn't been clear.

Now results have arrived from a new study that pitted two different popular COPD drugs against each other to determine their effectiveness at controlling the disease, which interferes with the flow of air through the lungs and airways. One of the drugs was tiotropium (Spiriva), an anticholinergic, and the other was salmeterol (Serevent), a beta-agonist.

The outcome of the trial suggests that Spiriva is more effective at preventing flare-ups, also called exacerbations.

"Prevention of exacerbations is a critical treatment goal in the care of COPD patients due to the [illness and death] attributed to exacerbations," said lead study author Dr. Claus Vogelmeier, who is from the pulmonary diseases division at University Hospital Marburg in Germany.

"The results of this trial provide data on which to base the choice of long-acting bronchodilator therapy," he added.

The report is published in the March 24 issue of the New England Journal of Medicine.

For the trial, in which neither the patients nor investigators knew which medications were assigned to the participants, Vogelmeier's group randomly assigned 7,376 patients with moderate-to-severe COPD to one of the two drugs.

During the one-year study, participants took either 18 micrograms (mcg) of Spiriva once daily or 50 mcg of Serevent twice daily. The researchers found patients using Spiriva had a lower risk of flare-ups than those using Serevent. In fact, Spiriva users reduced their risk of a first incident by 17 percent.

Spiriva also cut the number of severe flare-ups in a year and reduced the number of moderate-to-severe flare-ups compared with Serevent. However, the incidence of serious adverse events and events leading to the discontinuation of therapy were similar in both study groups, the researchers noted. Adverse events included worsening of disease, infections, heart problems, other complications or death.

For patients with mild COPD, both drugs appear equally effective, the study authors noted.

"These data suggest that, in patients with moderate-to-very severe COPD and a history of exacerbations, tiotropium [Spiriva] should be considered first choice over salmeterol [Serevent] as maintenance treatment," Vogelmeier said.

Why one medication is better than the other at reducing flare-ups isn't clear, said senior study author Dr. Leonardo Fabbri, a professor of respiratory medicine at the University of Modena and Reggio Emilia in Modena, Italy.

There is a place for both drugs and even using both together, Fabbri noted. "Guidelines recommend the use of both medications when one is deemed not to be adequately effective," he said. "But this recommendation is based on little evidence. Usually, we have to add an inhaled steroid instead of another bronchodilator."

Fabbri also pointed out that neither drug cures COPD or slows its progression. "These are purely drugs [that treat symptoms]," he said.

The study was funded by Boehringer Ingelheim and Pfizer, the makers of Spiriva. Spiriva can cost over $200 a month, but a generic is available for around $30 to $40 a month, and it is also covered by Medicare. Serevent, made by GlaxoSmithKline, can cost over $100 a month, depending on the dose and how the medication is delivered, and is also covered by Medicare drug plans.

Dr. Jadwiga A. Wedzicha, a professor of respiratory medicine at University College London Medical School of University College London in the United Kingdom and author of an accompanying journal editorial, said that a bronchodilator "is really just the start of treatment."

Many COPD patients will need both anticholinergics and beta-agonists, as well as an inhaled corticosteroid. In addition, new drugs are being developed so there will be more choices in the future, Wedzicha said.

"COPD is treatable," Wedzicha added. "We know outcomes can be improved."

Commenting on the study, Dr. Len Horovitz, a pulmonary specialist at Lenox Hill Hospital in New York City, said that "in COPD there is a paucity of medications, and because one works to prevent exacerbations doesn't mean you eliminate your other choices."

Horovitz said COPD patients who are well controlled are taking several drugs. "I don't want anyone to take away from this study that we don't need anything but tiotropium. That's just not so," he said.

COPD, which generally consists of chronic bronchitis or emphysema, is a progressive disease that causes increasing damage to the lungs, making breathing difficult. Most COPD is caused by chronic exposure to lung irritants such as cigarette smoke, but it can also be caused by long-term exposure to other environmental toxins.

More information

For more information on COPD, visit the U.S. National Heart, Lung, and Blood Institute.

SOURCES: Leonardo Fabbri, M.D., professor of respiratory medicine, University of Modena and Reggio Emilia, Modena, Italy; Claus Vogelmeier, M.D., division of pulmonary diseases, University Hospital Marburg, Germany; Jadwiga A. Wedzicha, M.D., professor of respiratory medicine, University College London Medical School, University College London, U.K.; Len Horovitz, M.D., pulmonary specialist, Lenox Hill Hospital, New York City; March 24, 2011, New England Journal of Medicine


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