Comparative Trial Shows Advantages to Once-Daily Methylphenidate Over Once-Daily Atomoxetine
Paula Moyer
May 5, 2004 (New York) — The first head-to-head comparative study of once-daily atomoxetine (Strattera) with sustained-release methylphenidate (Concerta, OROS methylphenidate) shows that children with attention deficit hyperactivity disorder (ADHD) get more symptom relief from the methylphenidate formulation, according to findings presented here at the 15th annual meeting of the American Psychiatric Association.
“We received a lot of requests for comparison from both parents of children with ADHD and from treating physicians,” said principal investigator Jason Kemner, MPH, in a telephone interview. “We found a significant difference in reduction of symptoms between the two groups. The difference was evident in the first week of the study and widened as the study progressed.” Dr. Kemner is manager of outcomes research at McNeil Consumer and Specialty Pharmaceuticals in Fort Washington, Pennsylvania.
The investigators randomized 1,300 patients with ADHD aged six to 12 years to a three-week trial of either sustained-release methylphenidate or once-daily atomoxetine in an open-label study funded by McNeil. The ratio of children to each group of the study was 2:1 methylphenidate to atomoxetine. The patients were either newly diagnosed or had been suboptimally managed on current treatment. To be included in the trial, participants had to have an Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) score of at least 24 and a Clinical Global Impressions–Severity of Illness (CGI-S) score of more than 3.
All of the subjects have completed the study; the investigators have analyzed the data on 651 subjects. There were 422 patients in the methylphenidate group and 229 in the atomoxetine group. The children in each group had similar ADHD-RS scores, a mean of 39.77 in the methylphenidate group and 38.87 in the atomoxetine group. In the methylphenidate group, therapy was started at 18 mg once daily and was titrated upward as deemed necessary by the physician. Similarly, atomoxetine was initiated at 0.5 mg/kg daily and was titrated upward if the physician considered it necessary.
At the first visit, children in the methylphenidate group had a mean ADHD-RS score reduction of 11.50 compared with a reduction of 8.55 in the atomoxetine group (P < .0006), with a mean difference in scores of 2.95. At the second visit, the mean reduction in score for the methylphenidate arm was 16.17 compared with 12.49 for the atomoxetine group (P < .0001), with a mean difference of 3.58 in scores between the two groups. At the third and final visit, children in the methylphenidate group had a mean score reduction over baseline of 21.10 compared with 15.94 for the atomoxetine group (P < .0001, with a mean difference of 5.16 between the groups.
Based on the CGI-I scale, the investigators found that 71.7% of patients in the methylphenidate group responded to treatment compared with 56.1% of those in the atomoxetine group (P < .0001). They found that 20.1% of those in the methylphenidate group and 23.6% of those in the atomoxetine group experienced treatment-related adverse effects and concluded that the two groups had similar experiences with these effects.
“When a child with ADHD responds quickly to a medication, it gives everyone confidence,” David W. Goodman, MD, who was not involved in the study, told Medscape in a telephone interview. He is an assistant professor of psychiatry and behavioral sciences at Johns Hopkins University School of Medicine in Baltimore and the director of the Adult Attention Deficit Disorder Center of Maryland in Lutherville.
“This study is interesting because often the reluctance to start a medication is resolved when a benefit is seen within a few days of starting treatment,” Dr. Goodman said. “The physician can then recruit the patient’s and parent’s cooperation and adherence to treatment.”
APA 157th Annual Meeting: Abstract NR451. Presented May 4, 2004.
Reviewed by Gary D. Vogin, MD
http://www.medscape.com/viewarticle/475153?src=m (free registration required)
Re: New study comparing strattera to methylphenidate
Ooops. I should have read more closely. Indeed the study was done by the Concerta people. What a crock! As if we don’t have enough to cope with without bad science paid for by self-serving drug companies and performed by sell-out researchers.
Re: New study comparing strattera to methylphenidate
[quote=”Anonymous”]Hmmm. Hard to understand how a three week trial of Straterra could work, since it requires a few weeks of ramp-up followed by up to six weeks at full dosage to achieve complete effect. Sounds like this one was sponsored by the Concerta folk?[/quote]
I was asking myself that question. How can they compare when strattera needs a ramping up period and a 4 to 6 week on target dose for consistent result. Sounds like the results are skewed towards concerta.
They also don’t compare how long Concerta (10 hours) last and how long strattera (24 hours) lasts.
Re: New study comparing strattera to methylphenidate
I agree with other comments about needing a longer study to compare the two medications due to the time it takes for Strattera to become effective. One important point may be , however, that if a medication does not become effective quickly some parents may give up on it. Anecdotally, many docs are seeing better results with stimulants for most kids. The best Strattera responders seem to be those who have failed a trial of stimulants. Much more research is needed to confirm the validity of these observations however and Strattera is certainly a reasonable first choice. If it works, great! If not, try the stimulants. Another interesting point is the similarity in the rate of side effects experienced on the two medications studied. One argument for Strattera has been that it may present fewer side effects. I’d like to see further comparisons on that point. The bottom line is that for those choosing medication it is important to closely monitor side effects and symptom reduction and to titrate dosages carefully with lots of doctor/parent/patient contact. If one medication is not effective at any dose or has too many side effects in a particular child, then it is appropriate to consider trying a different medication rather than giving up altogether.
Hmmm. Hard to understand how a three week trial of Straterra could work, since it requires a few weeks of ramp-up followed by up to six weeks at full dosage to achieve complete effect. Sounds like this one was sponsored by the Concerta folk?