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For
parents who have a child taking medication to help manage ADHD symptoms, a
frequent source of difficulty is the need for multiple doses each day. Among
children who take Ritalin (the generic is methylphenidate), a second dose
while at school and a third dose in the late afternoon is often necessary to
provide good control of symptoms over the course of the day.
Administration during the school day can be associated with complications,
and is often a source of concern or embarrassment for the child. As children
move into adolescence, this can frequently lead to a refusal on the part of
the teen to continue on meds, even though medication may still be necessary
to help manage the child's symptoms and help with behavior and academic
performance.
Although sustained release forms of Ritalin last longer and can help somewhat
with this problem, the additional duration of benefit provided by a single
dose varies substantially across children. Adderall, a more recently approved
stimulant medication for treating ADHD, also has a therapeutic effect that
lasts longer than Ritalin, and many children on Adderall can get by with a
single dose during the school day. Even with Adderall, however, a
second dose in the afternoon is often required.
Recently, a new medication called Concerta was approved by the FDA for the
treatment of ADHD and is expected to be widely available very shortly.
Concerta is simply methylphenidate in which a unique and patented system is
used to maintain a smooth and optimal level of medication in a child's system
throughout the entire day. In fact, the benefits of Concerta are
reported to persist throughout the school day and into the evening. This would make the administration of
medication to children with ADHD much more convenient, and should help to
eliminate many of the problems associated with multiple daily doses.
Results of a study on the effectiveness of Concerta was presented at the May
meeting of the American
Academy of
Pediatrics. This study was supervised by Dr. James Swanson from the
University of California
at Irvine, a
leading researcher in the field of ADHD. His work has included
studies of both medication and behavioral treatment so I believe he has a
broad perspective on the treatment of ADHD.
Participants in this study were 64 6-to-12 year old children with a confirmed
diagnosis of ADHD, all of whom were being treated currently with
methylphenidate. During the study each child received 3 different
treatments: methylphenidate on their regular dose 3 times per day, Concerta
once per day, and a placebo. Each treatment was received for 7
consecutive days and neither parents, teachers, nor children were aware of what
treatment the child was receiving each week. At the end of each week,
standardized behavior rating forms were completed by parents and teachers, as
were ratings of possible adverse side effects. (To be sure that
participants would not know when the child was on the Concerta, one
"real" dose and 2 placebo pills were given each day. This
way, 3 "doses" each day were required during every week of the
trial.)
Results indicated that both Concerta and the 3 daily doses of methylphenidate
resulted in significantly lower symptom ratings compared to placebo from both
parents and teachers. The two medications, in contrast, did not differ
from one another. This means, of course, than a single daily dose of
Concerta was as effective as 3 doses of regular methylphenidate in managing
the symptoms of ADHD. Side effects were reported to be mild and were
quite similar to regular methylphenidate. Only 3 side effects were
reported to occur in over 2% of the children – abdominal pain, headaches, and
fever - and these all occurred in less than 5% of the participants.
Overall, parents reported preferring Concerta to the methylphenidate used
during the study and to the treatment their child had been receiving prior to
the study. Remember, this preference for Concerta was reported even
though during the study, all children received 3 doses per day. (During the
time they were receiving Concerta, it was just the first dose each day that
was real medication. The second two "doses" were actually
placebos.) The most likely reason for this, I think, is that with
Concerta, the smoother release of medication throughout the day may have
resulted in more consistent management of symptoms than regular
methylphenidate.
A Second Study Of Concerta
I also recently saw a press release describing a second study involving
Concerta. A larger number of participants – 407 children with a
confirmed diagnosis of ADHD - were included and these children week followed
over the course of an entire school year. Children in the study ranged
in age from 6 to 13 and had previously completed a short-term controlled
study that included regular methylphenidate, Concerta, and placebo
conditions. In this second study, children were assigned to one of three
dosing levels - 18, 36, or 54 mg. - based on the dose level administered in
the short-term study. Data on the results of this study are not yet
published in a peer reviewed journal, but were presented at a recent meeting
of the American Psychiatric Association.
During the course of the year, children were evaluated with varying frequency
using standardized ratings of behavior and attention. Results indicated
sustained improvement in behavior and attention over the course of the
year. In a global assessment of treatment effectiveness obtained at the
end of the study, over 60% of teachers and 84% of parents rated treatment as
good or excellent. Thus, it appears from these results that the once
per day treatment with Concerta provide effective symptom management over the
course of the entire year. Side effects reported were similar to those
that have been reported before for regular methylphenidate.
Note: I was previously advised by a subscriber to note when studies reporting
effective medication treatment have been funded by the pharmaceutical company
who manufactures the drug. I believe this is the case here. While
some would argue that this means the results are suspect, I do not personally
feel this to be correct.
Such medication studies are typically conducted by independent academicians,
and I have several colleagues who are routinely involved in pharmaceutical
trials. The clinic where they work is paid by the drug company to
conduct the study, but this does not influence -in my opinion - the integrity
with which the data is collected and reported. It is also important to be
aware that there is not really an alternative to the drug company paying for
such studies. These studies are necessary to obtain FDA approval and no
one else is going to fund studies of a medication that has not yet been approved
by the FDA.
Should you make the switch to Concerta for your child?
The answer to this question is not necessarily straightforward. If your child is currently taking another
medication that is working well, and having to take multiple doses each day
is not a problem, there may be no good reason to switch. Basically, why
tinker around if everything is going fine?
If you and your child's physician do elect to try Concerta, you should be
aware that because Concerta is methylphenidate that is being delivered in a
way that maintains a steady dose over the entire day, children doing well
on regular methylphenidate should do well on Concerta. If your
child has been on another type of medication such as Adderall or Dexedrine,
however, one could not necessarily assume that Concerta would be equally
effective in managing ADHD symptoms. It is possible, for example, that your
own child's symptoms would not be managed as well if the switch were made.
If your child's current medication seems to be working well, but he/she
requires multiple doses each day which is resulting in compliance problems,
than discussing a switch to Concerta with your child's physician should be
considered. As noted above, the need for only once-a-day dosing may be
especially helpful with teens who often balk at needing to take medication
during the school day.
If your child is not currently taking medication to manage ADHD symptoms, but
this is something you are considering, it may be worth asking your doctor
about starting out with Concerta. So far, it appears to be as effective as
regular methylphenidate in managing ADHD symptoms, and to produce no
additional side effects. The caution to keep in mind, however, is that
it has not yet been studied as extensively as regular methylphenidate or even
Adderall, and there can be no guarantee that these initially encouraging
results will hold up to further study. There is no compelling reason,
however, to think that they will not. My own personal expectation is
that they will.
One other issue that I think is important in the decision to use Concerta is
whether a child really needs medication throughout the entire day, which is
what Concerta provides. For example, some children require
medication primarily to assist with academic functioning during the school
day, and really do not need it except for these times. For these
children, a single morning dose of methylphenidate or Adderall may be
all they require. In such instances, it seems like a legitimate
question to ask is whether Concerta would really be preferable.
In summary, although Concerta appears like it will be an extremely helpful
and valuable new medication for many children with ADHD, it is not
necessarily going to be the best choice for everyone. As always,
carefully evaluating what is required by each individual child is still
required to make the best decisions about medication.
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