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FDA approves Strattera for ADHD (I thought it was approved)   Message List  
Reply | Forward Message #1844 of 2081 |
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.




Fri May 16, 2008 2:46 am

bergosfamily
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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...
Nachum
bergosfamily
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May 16, 2008
2:47 am
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