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A Nonstimulant That Helps Hyperactivity?

By: Nicholas Lopez (Diagnosed ADHDer at 8)

Date: 10/14/2006

 

 

Table of Contents

1)      What is Strattera

2)      WHAT IS THIS SUPPOSED TO BE TREATING AGAIN?

3)      What Works!

4)      Why a nonstimulant?

5)      Does it work or am I paying for pretty sugar pills?

6)      SO IT WORKS, DOES IT WORK BETTER

 

 

 

 

 

 

 

 

What is Strattera

 

Strattera is the latest thing to hit the market, to scoop up the unlucky 7-10% of humans that are afflicted with Attention Deficit Hyperactive Disorder.  Strattera’s big sell is that it the first nonstimulant drug that works to able the everyday ADHDer. 

 

      Chemical Compound of atomoxetine HC1

It’s active in ingredient atomoxetine HCl is a selective norepinephrine reuptake inhibitor.  Atomoxetine HCl is the R(-) isomer as determined by x-ray diffraction.  The chemical designation is (-)-N-Methyl-3-phenyl-3-(o-tolyloxy)-propylamine hydrochloride.  The molecular formula is C17H21NO·HCl, which corresponds to a molecular weight of 291.82.  http://www.rxlist.com/cgi/generic3/strattera.htm

 

 

More specifically Strattera (atomoxetine HCl) like all SNRI’s doesn't make you produce more norepinephrine, rather it makes your neurons soak for a longer period of time in the norepinephrine you already produce.  Norepinephrine is released from the adrenal glands as a hormone into the blood, but it is also a neurotransmitter in the nervous system where it is released from noradrenergic neurons during synaptic transmission. It is one of the 'stress hormones' and affects parts of the human brain where attention and impulsivity are controlled. Along with epinephrine this compound effects the fight-or-flight response, activating the sympathetic nervous system to directly increase heart rate, release energy from fat, and increase muscle readiness. (http://en.wikipedia.org/wiki/Norepinephrine)

Being that Strattera influences the hormone that controls directly what seems to be the problem in people with ADHD it has seemed to be a healthy choice to get away from all the stimulant medications that have previously been used to treat ADHD.

 

WHAT IS THIS SUPPOSED TO BE TREATING AGAIN?

Attention-Deficit Hyperactive Disorder or commonly referred to as ADHD is a psychological disorder that effects people of all ages and becomes a large influencing factor in the day to day of all of it’s afflicted.  ADHD has 3 main types of symptoms: inattention, hyperactivity, and impulsiveness.  Symptoms of inattention include not paying attention, making careless mistakes, not listening, not finishing tasks, not following directions, and being easily distracted.  Symptoms of hyperactivity and impulsiveness include fidgeting, talking excessively, running around at inappropriate times, and interrupting others. Some patients have more symptoms of hyperactivity and impulsiveness while others have more symptoms of inattentiveness. Some patients have all 3 types of symptoms.

 

Symptoms of ADHD in adults may include a lack of organization, problems starting tasks, impulsive actions, daydreaming, daytime drowsiness, slow processing of information, difficulty learning new things, irritability, lack of motivation, sensitivity to criticism, forgetfulness, low self-esteem, and excessive effort to maintain some organization.  The symptoms shown by adults who primarily have attention problems but not hyperactivity have been commonly described as Attention-Deficit Disorder (ADD).

 

Many people have symptoms like these from time to time, but patients with ADHD have these symptoms more than others their age.  Symptoms must be present for at least 6 months to be certain of the diagnosis. (http://pi.lilly.com/us/strattera-ppi.pdf)

 

DSM-IVMore information on the diagnosis and

general symptoms of ADHD can be found in

your latest issue of the DSM IV.

 

 

 

 

 

 

What Works!

 

Through personal testing proven ADHD drug therapy includes Ritalin, Dexedrine, Concerta, and Adderall.  All four drugs are stimulant medications that have been used for nearly three decades to cope with the effects of ADHD.  Outside of drug therapy, there have been other proven techniques tied with drug therapy that have led people to be able to cope with ADHD.  These drugs have worked on millions of young kids and from personal experience I realize the difference in it’s effects on my system.  Stimulant medication is the paradox of ADHD.  For a child who can’t pay attention, focus or sit still for more than five seconds, dumping 40 mg of stimulant into his or her system will slow them down faster than you would believe.  Thousands of clinical trials have been done to prove the efficacy of these stimulant drugs.

 

Why a nonstimulant?

 

Other than to take advantange of a booming market, strattera does answer some problems.  Because it is a non stimulant drug it cannot be abused the came way methamphetamines can because it’s not related to crack cocaine.  It also rids people of the taboo feeling about pumping there already uncontrollable children full of more stimulant.  It banks less on it efficacy and more on it’s settling the fears of the global community.  A laundry list of its supposed benefits rest at the home page http://www.strattera.com

 

The fact that stimulants are controlled substances continues to fuel concerns in patients, families, and

prescribers. These concerns further limit stimulant use. These concerns persist, fueled by adversarial groups,

about the abuse potential of stimulant drugs by the patient, family member, or his or her peers; the possibility

of diversion; and safety concerns regarding the use of a controlled substance by patients who are impulsive

and may be susceptible to antisocial tendencies (Goldman et al. 1998).”

 

 

Does it work or am I paying for pretty sugar pills?

 

This is where the numbers get hazy.  Strattera was approved by the FDA in 2002 and has been clinically tried over and over again. Eli Lilly (the distributing company) claims 6 clinical trials of over 4000 patients were done to prove the effectiveness of Strattera against a placebo and trial data can be found at Strattera.com - Clinical Trials.  Unfortunately, Eli Lilly does not distribute the actual percentage and efficacy levels of patients that were effected.

 

Countering that argument a Q&A board for ADHD patients states that Strattera was not only non effective but nearly useless in it’s bouts with ADHD.  Complaints range from outrage to just plain confusion, but given the response it is wondered how useable it is.  The website also mentioned that psychiatrist have often recommended coupling Strattera with stimulant medications thus negating any point of using Strattera what so ever.

1)      ADHD Information -Strattera vs. Rittalin

2)      Strattera (atomoxetine) - The Good and the Bad

 

Actual clinical trials get far more interesting

1)      A Study done by Spencer & Biederman (2001) out of 22 tested children, 75% showed a 25% decrease in ADHD symptoms when given atomoxetine.  This trial led to larger trials based on the success rate of the children.  The trial was a 11 week test, that was given to these 22 children who aged from 7-14.  The study relied on questionnaire based assessments to rate the efficacy level of the 10-20mg daily dosages.  The results did prove to have some decent results but it was the very beginning of real large scale and long-term effect testing.

2)      An investigative clinical study performed by Bohnstedt et al (2005) tried to get a handle on the efficacy of atomoxetine by using a teacher and parent based rating systems.  The clinical trials consisted of 16 subjects, 10 give atomoxetine and 6 placebos.  The Subject ranged in age from 6-11 and were given up to a maximum of 120mg a day.  At least 7 visits were conducted during the length of the trial.  The results came in as effective over the placebo, but with a range of problems with the data, such as the rating scale was biased by the parents, and the sample size was much to small to be applicable.  The study did show that there was some efficacy in the drugs use.

 

No clinical trials were found that could prove that Strattera had absolutely no effect on reducing ADHD symptoms in any of the subject tested with the drug.

 

SO IT WORKS, DOES IT WORK BETTER

 

 


 

 

 

 

 

Clinical trials, public outcry, and personal stories say “it ain’t my stimulant.”

 

The American Psychiatric Association put forward this abstract at there last meeting in deciphering the debate Strattera vs. Adderall:


TITLE: Comparative Efficacy of Amphetamine and Atomoxetine by Symptom Severity / Supported by Shire US, Inc. James J. McGough, M.D., University of California Los Angeles Neuropsychiatry Institute, 300 UCLA Medical Plaza, Los Angeles, CA 90095; Sharon B. Wigal, Ph.D., Joseph Biederman, M.D., Thomas J. Spencer, M.D., James T. McCracken, M.D., David A. Mays, Ph.D., Garrick Fiddler, M.D.
Educational Objectives: After reviewing this poster, the participant should be able to compare the response rates of school-aged children with attention- deficit/hyperactivity disorder (ADHD) to mixed amphetamine salts extended release (MAS XR) and atomoxetine. 199
Summary: Objective: To compare the efficacy of mixed amphetamine salts extended release (MAS XR; Adderall XR®) and a once-daily selective norepinephrine reuptake inhibitor (atomoxetine; Strattera®) in children with ADHD. Methods: Amulticenter, randomized, double-blind, forced-doseescalation classroom analog study. Subjects (N=215) were randomized in a 1:1 ratio to receive once-daily MAS XR or atomoxetine. Efficacy measures included the SKAMP Teacher Rating Scale. This is a post-hoc analysis of subjects with a baseline CGISeverity score that indicated marked or severe impairment who were ‘‘improved’’ or ‘‘not improved’’ on the SKAMP deportment and attention scores at endpoint. Results: The markedly or severely impaired ITT sample at endpoint included 71 subjects (MAS XR, n=33 and atomoxetine, n= 38). Of the 33 subjects receiving MAS XR, 82% demonstrated improvement from baseline on SKAMP deportment (P<0.0001) and attention (P=0.001) scores. In contrast, 34% of those receiving atomoxetine were noted to have improvement. Approximately 66% of those subjects who received atomoxetine did not demonstrate improvement in SKAMP deportment or attention scores at endpoint. Both agents were well tolerated, and most AEs were mild or moderate. Conclusion: These data suggest that in ADHD subjects with at least a marked impairment, more than twice as many may respond to MAS XR compared with atomoxetine.
References: 1. McCracken JT, Biederman J, Greenhill LL, et al: Analog classroom assessment of a once-daily mixed amphetamine formulation, SLI381 (Adderall XR), in children with ADHD. J Am Acad Child Adolesc Psychiatry 2003; 42:673-683. 2. Michelson D, Allen AJ, Busner J, et al: Once-daily atomoxetine treatment for children and adolescents with attention deficit hyperactivity disorder: a randomized, placebo-controlled study. AM J Psychiatry 2002; 159:1896-1901.

 

This abstract is worth showing in entirety because while some of the psychological jargon is difficult reading it gives and idea of the experimental process while also contributing to the fact that stimulants are more effective, more useful and more practically used then non stimulant medication for the treatment ADHD.  The entire document can be found at http://www.psych.org/edu/other_res/lib_archives/archives/meetings/2004nra.cfm?pf=y&

 

Personal stories of the ineffectiveness of Strattera’s ADHD treatment are shown in the personal stories above in section 5

 

L SIDE EFFECTS L

 

The side effects of both stimulants and non stimulants are long lists of things that all together don’t sound pleasant.  Yet when compared it seem that the side effects of a stimulant rather than Strattera are a little more manageable.

 

A warning was put out on Strattera by the FDA after they released it that they were finding severe liver damage in some cases of subjects, and that medication should be stopped immediately if one notices such side effects.  Look for Jaundice and other signs

  • In Children

o         decreased appetite

o         difficulty falling asleep

o         stomachache,

o         emotional ability

o         weight loss

  • In Adults

o         dry mouth

o         loss of appetite

o         difficulty falling asleep

o         headache

o         weight loss.

 
Side effects for Strattera include:                  Side effects for Stimulant treatment include: (Safety Information - ADDERALLXR.COM)

o         upset stomach

o         decreased appetite

o         nausea or vomiting

o         tiredness

o         dizziness

o         mood swings

o         Constipation

o         dry mouth

o         nausea

o         decreased appetite

o         dizziness

o         problems sleeping

o         sexual side effects

o         problems urinating

o         menstrual cramps. 

 

 

 

 

As shown, Strattera’s side effects are much less manageable.  The other problem with Strattera lies within the newness of the product; researches just do not know what real long term effects will appear, because they have not had the time to see it yet.  All and all Stimulant medication combined with non-drug therapy is the best away to achieve easier life for those with ADHD.

 

 

 

Bibliography

1) Thomas Spencer, MD, Joseph Biederman, MD, John Heiligenstein, MD, Timothy Wilens, MD, Douglas Faries, PhD, Jefferson Prince, MD, Stephen V. Faraone, PhD, Jackie Rea, BA, Jennifer Witcher, PhD, Stephanie Zervas, BA, An Open-Label, Dose-Ranging Study of Atomoxetine in Children with Attention Deficit Hyperactivity Disorder, Journal Of Child And Adolescent Psychopharmacology, Volume 11, Number 3, 200, Mary Ann Liebert, Inc. Pp. 251–265

 

2) Bradley N. Bohnstedt, William G. Kronenberger, David W. Dunn, Ann L. Giauque, Elisabeth A. Wood, Mary E. Rembusch, Deborah Lafata, Investigator Ratings of ADHD Symptoms During a Randomized, Placebo-Controlled Trial ofAtomoxetine: A Comparison of Parents and Teachers as Informants. Journal of Attention Disorders, Volume 8 Number 4, May 2005 153-159

 

 

 

 

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