Inhaled Corticosteroids Won't Prevent Kids' Asthma

(HealthDay News) -- While inhaled corticosteroid medications are a mainstay of effective asthma treatment, they can't prevent the disease from occurring or recurring in high-risk children, new research found.

Two presentations Wednesday at the American Thoracic Society 2007 International Conference in San Francisco included an additional year of information from previous research. The studies confirmed that youngsters given inhaled corticosteroids may do well while they're taking the medications. But the drugs' beneficial effects wear off soon after they're stopped, and they don't appear to have any long-term effects on the progression of asthmatic disease.

"The good news is that you probably don't have to use steroids to prevent the progression of asthma, but inhaled corticosteroids do work when you need them," said one of the study's authors, Dr. Wayne Morgan, a professor of pediatrics and physiology and chief of pediatric pulmonary medicine at the University of Arizona at Tucson. "Inhaled corticosteroids control, but don't prevent, asthma."

Morgan's presentation, and that of his colleague Dr. Theresa Guilbert, assistant professor of pediatrics at the University of Wisconsin-Madison, revisited a clinical trial called PEAK (Prevention of Early Asthma in Kids). In this trial, 285 children at high risk of developing asthma were randomly selected to receive preventive treatment with an inhaled corticosteroid twice daily for two years, or a placebo. The third year of the study included no treatment. For the fourth year -- the year included in the new presentations -- the children's care was returned solely to their own physicians. Therefore, treatment varied and reflected what's going on in real-world clinical practice.

Morgan's presentation focused on specific physiological measures of lung function. During the study treatment period, these measures indicated that the children in the treatment arm were, in fact, taking the medication.

"At the end of the second observation period, there was no difference between the groups," Morgan said.

The information Guilbert presented focused on who responded most to the medications.
"There was a greater response to asthma medication in non-whites and in males. There was a better response in the somewhat older children and a better response in those with a parental history of asthma," said Morgan, who added that "when you use asthma medications, you can control the disease, but you can't cure it."

Pediatric asthma specialist Dr. Alan Khadavi, of New York University Medical Center, said the new findings won't "change my first-line asthma management. Inhaled corticosteroids may not prevent the development of asthma, but children with asthma still need it to decrease exacerbations."

But, another study presented at the same meeting found that inhaled corticosteroids don't help all children with asthma. Even when parents reported that their children consistently used inhaled corticosteroids, as many as one in five youngsters still didn't achieve good asthma control, this research found. The study included 914 children with mild to moderate asthma and compared those using inhaled corticosteroids on a regular basis to those who weren't prescribed an inhaled corticosteroid.

"It is possible that some children are genetically less responsive to steroids," the study's author, Dr. Gregory Sawicki, of Children's Hospital Boston, said in a prepared statement. He added that it was also possible that the children didn't use their medications as often as their parents reported or that the children who didn't respond to the inhaled corticosteroids may simply have been children with more severe asthma.

While the PEAK study failed to find a way to prevent childhood asthma, and there are no other known ways to prevent the development of the disease, Khadavi pointed out that if you have asthma, you can try to prevent exacerbations of the disease. Since most asthma has allergic triggers, he said, it's important to run an air conditioner or a HEPA air cleaner at times of the year when pollen counts are high. If dust mites trigger your child's symptoms, he recommended "removing carpeting and using dust-mite encasements on mattresses and pillows."

Khadavi also said that if you can't avoid allergens altogether, it's a good idea to give your child an antihistamine to lessen the allergy symptoms.

More information
To learn more about Asthma prevention, visit the American Academy of Allergy, Asthma and Immunology.

New Yorkers Get a Sneak Peek at alli®

(HealthDay News) -- Pharmaceutical giant GlaxoSmithKline isn't wasting any time.

On Monday, about a month before its over-the-counter (OTC) weight-loss drug alli® will actually be on store shelves throughout America, the company opened a multimedia exhibit in the much-shopped and often congested Union Square area of Manhattan.

This "look, learn, but don't buy" preview of the only weight-loss medication currently approved by the U.S. Food and Drug Administration and available without a prescription is getting the same sort of advance media play that kicked off campaigns for prescription drugs such as Viagra and the sleeping aid Lunesta.

But is alli being over-hyped? GlaxoSmithKline doesn't think so.

"We're positioning alli as an honest voice in a category known for hype," said Joe Cadle, marketing director of GlaxoSmithKline Consumer Healthcare. "The alli experience will teach people the difference between alli and the rest of the weight-loss category." The OTC dosage of alli (orlistat) is 60 milligrams (mg), a dilution of the prescription amount. Orlistat is not a new weight-loss drug; the FDA approved it in 1999.

Cadle said that people currently spend $1 billion a year on ineffective weight-loss products that make unrealistic claims. "alli is much more than just pills in a bottle," he said, adding that GlaxoSmithKline was offering a companion book called Are You Losing It? Losing Weight Without Losing Your Mind and other weight-loss material.

But the magic question seeking the magic answer for millions of overweight Americans is, "Does it work?"

Not surprisingly, Cadle said it does, but not by itself. "alli is not a magic pill," he said. "You have to eat a reduced-calorie, low-fat diet and be willing to do the work. If you do, you can lose 50 percent more weight. If you lose 10 pounds without taking alli, you could lose 15 when taking it."
Marketed to overweight adults over age 18, alli is expected to cost between $1 and $2 a day. It works by blocking the body's absorption of fat.

It's designed not to have an adverse effect on the cardiovascular system as did other weight-loss products such as ephedra, Cadle said. The FDA banned ephedra after medical evidence indicated it increased heart attack risk.

Alli is not without its critics, however, chief among them Dr. Sidney M. Wolfe, director of Public Citizen's Health Research Group in Washington, D.C., who has spoken against orlistat's side effects before.

When another pharmaceutical company, Roche, marketed orlistat in prescription strength as Xenical, Wolfe spoke out. "Animal studies done by Roche show that rats developed aberrant crypti foci, ACF, precancerous lesions in the colon from Orlistat, which put them at higher risk of colon cancer," Wolfe said in a recent interview. "An independent study by researchers in 2006 found the same thing."

But another expert said Wolfe's concerns are unfounded.

"There are more than 100 clinical studies, including 30,000 clinical trial patients, and nine years of post-marketing surveillance with more than 29 million patient treatments, all showing no such risk with orlistat use," said Dr. Vidhu Bansal, director of medical affairs for GlaxoSmithKline Consumer Healthcare. "The FDA concluded the same in their recent review," she added.

Wolfe maintained that the FDA relied heavily on testimony by a panel comprised of pharmaceutical company representatives. But that is only part of the difficulty, he said. The side effects were embarrassing, dramatic and distasteful enough to cause orlistat to lose popularity.

"The RX (prescription) drug's popularity went down, because it caused all sorts of acute problems, mainly gastrointestinal," Wolfe said. "Twenty-five percent of people got oily spotting (from the rectum), because the fat is going in one end and coming out the other. You definitely wouldn't want to take it while on a first date."

Wolfe said some people also experienced gas, loose or more frequent stools, and inhibition of fat-soluble vitamins. "We wanted the FDA to ban the RX version," he said. "It should never have been approved for over-the-counter sales."

But the FDA denied Public Citizens' petition.

This is precisely why GlaxoSmithKline is strongly recommending that a person adopt a low-fat diet when using alli. "These unwelcome side effects will only occur if people eat too much fat while taking the weight-loss drug, Cadle said. "And if they eat too much fat, then they're not following the program."

Cadle said alli will be sold in drugstores, mass market retailers such as Wal-Mart and Target, club warehouse stores, and some grocery stores.

More information
The FDA has a location on its Web site outlining the approval process for alli®.

Low-Dose CoQ10 Supplements Won't Ease Parkinson's

(HealthDay News) -- Low doses of an antioxidant called coenzyme Q10 (CoQ10), sold as a dietary supplement, do not appear to improve Parkinson's disease symptoms, a German study finds.

It's believed that a malfunction of the mitochondria (the part of a cell that converts food to energy) may play a role in Parkinson's disease. CoQ10 also affects mitochondrial processes, according to background information in the study.

"Because of these functions, CoQ10 has attracted attention concerning neuroprotective actions in neurodegenerative disorders linked to mitochondrial defects or oxidative (oxygen-related) stress, such as Huntington's disease and Parkinson's disease," the study authors wrote.
They noted that previous studies had suggested that high doses (1,200 milligrams) of CoQ10 may slow the physical deterioration (such as tremors and movement problems) in people with Parkinson's disease.

In this new study, researchers at the Technical University of Dresden studied the effects of CoQ10 in Parkinson's patients who did not have changes in their motor function and were on stable treatment for the condition.

The patients were divided into two groups. The treatment group of 55 patients took 100 milligrams of CoQ10 three times a day for three months, followed by a two-month "washout" where they did not take the antioxidant. The other 51 patients took a placebo.

Both groups were assessed for Parkinson's symptoms before the start of the study, each month during treatment, and again after the washout period. After three months, blood levels of CoQ10 in the treatment group increased from an average of 0.99 milligrams per liter to 4.46 milligrams per liter.

But the study found that CoQ10 did not improve Parkinson's disease symptoms.
The findings were published online Monday in the Archives of Neurology and are expected to appear in the July print issue of the journal.

More information
The American Academy of Family Physicians has more about Parkinson's disease.