April 8, 2009 / 9:01 PM / in 10 years

UPDATE 1-Reflux drug Nexium no help against asthma - report

* Nexium does not reduce breathlessness, other symptoms

* Patients without reflux should not take PPIs

By Gene Emery

BOSTON, April 8 (Reuters) - Nexium, AstraZeneca ‘s (AZN.L) (AZN.N) drug developed to fight acid reflux and widely prescribed for decades to quell the symptoms of asthma, does little to help adults breathe easier, researchers reported on Wednesday.

Doctors prescribe the proton pump inhibitor, or PPI, because of the theory there might be a link between stomach acid that backs up into the esophagus and poorly controlled asthma. Many asthma patients also have reflux.

But when researchers tested 412 volunteers with few or no reflux symptoms with either placebo or Nexium, they found the Nexium patients had no better control over their asthma than those given placebo pills.

“The weight of evidence indicates that proton-pump inhibitors should not be routinely prescribed for asthma symptoms if the patient does not have symptoms of gastroesophageal reflux,” Dr. John Mastronarde of Ohio State Medical Center’s asthma center and colleagues wrote in the New England Journal of Medicine.

“This will change clinical practice,” Mastronarde said in a telephone interview.

He said the finding probably applies to all Nexium-type PPIs.

The findings could mean that millions of asthma patients are taking Nexium, known generically as esomeprazole, or a similar drug unnecessarily.

It could also save money, as $10 million is spent each year in the United States treating reflux disease in asthma patients, the researchers said. Proton pump inhibitors cost between $150 and $180 per month for most common brands.

“Asthma patients who take medication for acid reflux but who do not have reflux symptoms should talk with their doctors about whether they should continue the medication,” Dr. Elizabeth Nabel, director of the National Heart Lung and Blood Institute, which helped pay for the study, said in a statement.

NO REASON TO TEST

The researchers also looked in vain to find a subgroup of people the drug might help, even tracking the stomach acid of the volunteers to see if those who had reflux — and 40 percent did — would benefit.

The findings mean there is no reason to test for reflux in patients with asthma unless they report having symptoms, said Dr. Robert Wise of Johns Hopkins University in Baltimore, who worked on the study and who is a consultant to AstraZeneca.

About 20 million Americans suffer with the coughing, breathlessness and chest tightness that comes with asthma.

The researchers in the 20 centers involved in the new study are now looking at the same question in children.

“It’s a different question in kids because their anatomy is a little different and there’s a question of whether this is potentially more of an issue in them,” said Mastronarde. “The majority of pediatricians will tell you they have seen kids with reflux and asthma and when they treat the reflux the asthma gets better.

“So we think that little kids may be more likely to aspirate (acid) and have more changes with bad reflux than an adult does. But there’s never been a big, well-defined study to test that.”

They have enrolled 186 of the 300 youngsters age 5 to 17 they hope to study.

Other proton pump inhibitors include Wyeth’s WYE.N Protonix, Takeda Pharmaceutical Co Ltd’s (4502.T) Prevacid and Eisai Co Ltd’s (4523.T) Aciphex. (Editing by Maggie Fox and Andre Grenon)

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