June 26, 2002 -- Millions of American children take Ritalin and other stimulants to control symptoms of attention deficit hyperactivity disorder (ADHD). Now, research suggests that a different type of medicine may work just as well -- even for adults.
"A major potential advantage is that this medication would not require monthly trips to a doctor's office for a new prescription, because it would not be a controlled substance like [Ritalin]," lead researcher Christopher J. Kratochvil, MD, tells WebMD.
The new study showed that the experimental drug atomoxetine works as well as Ritalin for reducing ADHD symptoms, including hyperactivity, impulsivity, and difficulty paying attention. Larger studies are needed to confirm the findings, but researchers say atomoxetine may prove to be an effective alternative to stimulants.
Ritalin and atomoxetine work differently in the brain. Ritalin affects two different chemical pathways in the brain, but atomoxetine's effects are limited to only one particular brain chemical -- norepinephrine.
In the multicenter study, sponsored by atomoxetine manufacturer Eli Lilly and Company, a WebMD sponsor, 44 school-aged children were treated with Ritalin and 184 with the experimental drug.
The two groups had similar improvements in attention and hyperactivity, as measured by parents and researchers. Overall scores on an ADHD rating scale improved by an average of 19 points for the children on atomoxetine and 18 points for those on Ritalin. Side effects were similar between the two drugs as well.
"In order to compare these two drugs head to head you would need a much larger, double-blind study [where neither the investigators or patients knew which drug they were getting]," Kratochvil says. "But we now have preliminary evidence that the therapeutic effects of atomoxetine are comparable to that of [Ritalin]." Kratochvil is an assistant professor at the University of Nebraska Medical Center.
Lilly had originally hoped for FDA approval for atomoxetine by late this year, but company spokesman David Shaffer tells WebMD that a ruling probably won't come until the spring of 2003. Shaffer says the federal agency has asked for additional data to support the company's claim that atomoxetine has no potential for abuse and should not be a controlled substance.
"There is nothing in the science that would indicate to us that [atomoxetine] has any potential for abuse," Shaffer says. "But when you are talking about a medication given to children, it is appropriate for them to be extraordinarily cautious."
The company is seeking approval for the treatment of adults, as well as children and adolescents. If granted, it would be the first medication approved for use in adults with ADHD.
ADHD expert Martin T. Stein, MD, says atomoxetine may prove to be an effective treatment approach for the 15% of children who do not respond to either Ritalin or other stimulants. But he says there is, as yet, no reason to believe that children doing well on Ritalin would fare as well or better on the new drug.
"We will really only be able to compare these two drugs after several years of clinical use outside of studies," he says.
Stein, professor of pediatrics at the University of California, San Diego, was co-chairman the American Academy of Pediatrics committee that published new guidelines for the treatment of ADHD late last year. The group concluded that the available stimulant drugs are highly effective, but it added that behavioral techniques should also be used in school-aged children with ADHD.
"Drugs are used far more often than behavioral modification because there is good evidence that they work and they are much easier to administer," he tells WebMD. "But behavior modification can be very effective, and that is a main message in our statement. I would definitely encourage parents to seek out these treatments, whether their child is on medication or not."