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FDA approves Strattera for ADHD (I thought it was approved)

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Nachum

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1.

FDA approves Strattera for ADHD (I thought it was
approved)

Posted by: "Nachum"
bergosfamily@...

bergosfamily

Thu May 15, 2008 7:47 pm (PDT)

Please note, the following article is from a
conventional site.
http://www.news-medical.net/?id=38203

First my outraged comments.

Even I am taken aback by this one.
They are proud of these
results? That from 69% of children that respond well
to this drug,
87% who have taken it for three months can stop without
relapsing and
that is called a success? That means that less than 10% of the

children that are receiving this drug are being helped by it. And
these
are the children a chosen population who responded well at
first! That 63% of
long term users can stop and not relapse? If I
had an herb that was cheap and
harmless that showed results like
this, I would not bother with it and I would
look for something else.
This is even after a multicentered study, that
entails a lot of
statistical numbers cooking. They climb on the rooftops and
scream
hurray, a 12% vs. a 2.5% relapse rate?
That after it has been in
use for six years they can say, "In the
past, our understanding of ADHD
treatment was limited to
clinical data on short-term use, meaning a few weeks
or a couple of
months," and then get such shoddy long term results and be
proud of
it.
And the FDA likes this? That just tells us to what extent
the FDA
is in you-know-whose pocket.
I also beg to differ with the last
paragraph of the following article.
Nachum Bergos

FDA approves
Strattera for ADHD in children and adolescents
8-May-2008

Eli
Lilly and Company announced today that the United States Food and
Drug
Administration (FDA) has approved Strattera (atomoxetine HCI)
for maintenance
treatment of Attention-Deficit/Hyperactivity Disorder
(ADHD) in
children and adolescents. Strattera, a selective
norepinephrine reuptake
inhibitor, is the first FDA-approved non-
stimulant to treat ADHD in children,
adolescents and adults.
"The approval provides physicians and their
patients with the first
treatment option that is indicated for maintenance of
ADHD" said
Thomas J. Spencer, M.D., Associate Professor of Psychiatry,
Harvard
Medical School. "This is critical as ADHD may be a life-long
disease
and effective long-term control of symptoms may mean improved
outcomes in children and adolescents."

The safety and
efficacy of Strattera in the maintenance of ADHD was
demonstrated in one of
the largest relapse prevention studies ever
conducted in ADHD, which is one of
the most common mental health
disorders in children and adolescents.

The 18-month trial of about 600 children and adolescents aged six to
15
years, who met DSM-IV (Diagnostic and Statistical Manual of Mental
Disorders)
criteria for ADHD, showed Strattera was superior to
placebo in maintaining
continuous efficacy in patients, as measured
by the ADHD Rating Scale
(ADHD-RS). Additionally, at the end of the
trial, patients taking Strattera
had lower relapse rates (2.5
percent) as compared to patients taking placebo
(12.2 percent).

Strattera provides uninterrupted relief from ADHD
symptoms throughout
the day into the evening. This is important since the
symptoms of
ADHD go beyond the work and school day. ADHD patients can
experience
frustration, low self-esteem, difficulty with relationships and
increased lifestyle risks.

"In the past, our understanding of
ADHD treatment was limited to
clinical data on short-term use, meaning a few
weeks or a couple of
months," said A.J. Allen, M.D., Ph.D., Strattera
global medical
director for Eli Lilly and Company. "For the first time,
clinicians
have guidance that Strattera is effective for up to a year in
patients who respond well to initial treatment."

The long-term,
international, multi-center study, which was reviewed
by the FDA as part of
its decision to grant this approval, employed a
treatment discontinuation
design (3 months of acute open-label
treatment followed by up to 15 months of
placebo controlled
maintenance treatment) that enabled investigators to test
the
efficacy of Strattera as maintenance therapy. In the study, 604
patients initially received acute open label treatment with
Strattera. After
10-weeks, 69% of patients qualified as responders
and were re-randomized to
double-blind treatment with either
Strattera or placebo for nine months. A
second six-month
randomization occurred after approximately one year of
treatment with
81 patients taking Strattera and 82 patients in the placebo
group.

Results of both randomization phases showed that patients treated

with Strattera had significantly greater continuous response rates
versus patients taking placebo. For child and adolescent ADHD
patients with
a good initial response to Strattera and who continued
to respond well for 1
year, 97.5% maintained response on Strattera
vs. 87.8% on placebo (relapse
rates 2.5% for Strattera vs. 12.2% for
placebo). Additionally, relapse rates
for those discontinuing
treatment after one year were lower than the relapse
rates for
patients who discontinued treatment during the 6 months following
the
open label treatment phase (Strattera, 61/292 [20.9%]; placebo,
46/124 [37.1%]).

Strattera was generally well-tolerated. The most
common side effects
reported in the study were headache and the common cold

(nasopharyngitis). In the study, the mean final dose of Strattera
was
approximately 1.54 mg/kg/day after 12 months and 18 months treatment.
There were no significant differences in standardized height change
between
groups during the post-randomization period.

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