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Ritalin ® & AD/HD just calming the troublemaker ???. Dr.med.Sven Schellberg Global Communications & Brand Manager Psychiatry NOVARTIS Pharma AG, Basel, Switzerland. Don‘t worry, potentially a new Ritalin ® customer. What do these gentlemen have in common ?. ICD-10 versus DSM IV.

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ritalin ad hd just calming the troublemaker

Ritalin® & AD/HD just calming the troublemaker ???

Dr.med.Sven Schellberg

Global Communications & Brand Manager Psychiatry

NOVARTIS Pharma AG, Basel, Switzerland

icd 10 versus dsm iv
ICD-10 versus DSM IV

inattentive Type

314.00

Inattentiveness

Impulsivity

Disturbed activity

(Hyperactivity)

hyperkinetic

Syndrome

F90

combined

Type

314.01

hyperactive

impulsive Type

314.01

slide8

School

Delinquency

ADHD

Occupational status

Social/financial status

Drug abuse

Peer relationships

Traffic accidents

Marital status

statistics
Statistics
  • 2 - 6 % of pupils (age 6 – 16) show symptoms of AD/HD
  • Hyperactivity is more common in boys
  • in 70 % of the patients, symtomatology calms in adolescence
  • 30 % keep symptoms which need therapy in adulthood
ad hd
AD/HD

Etiology

etiology13
Etiology
  • Attention, evaluation of situations, learning and activity are functions which are located in dopaminergic areas of the brain
  • In animal experiments a depression of dopaminergic function leds to hyperactivity, aggression and worsening of learning procedures
etiology15
Etiology

Krause et al.

etiology16
Etiology

Bush et al.

etiology17
Etiology

Family and Interactions

Education

Environmental Effects

Food

stroop
Stroop

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blackredgreenyellowblueredblackgreenyellow

blackredgreenyellowblueredblackgreenyellow

ad hd19
AD/HD

Diagnosis

diagnosis
Diagnosis
  • History and anamnesis including interviews with patient, parents, teachers
  • Symptomatology (differing criterias between DSM IV (AAP) and ICD-10)
  • Rating Scales (CRS, CBCL etc.)
  • Exclusion of other medical disorders (e.g. epilepsy, brain damage, schizophrenia, hyperthyreosis)
  • physical examination including EEG, lab, intelligence testing
ad hd22
AD/HD

Treatment

slide23

Treatment of AD/HD always has to combine educational, psychotherapeutical and psychopharmacological methods

stimulants
Stimulants
  • The use of stimulants started in the 1930‘s when their stimulative effects on the dopamingergic system and their psychotropic effects were discovered
  • First Amphetamine and Metamphetamine were used
  • First descriptions of an use of Methylphenidate in „MCD“ in the 1960‘s
  • Detailed descriptions in the 1980‘s by Wender et al.
slide25

Methylphenidate (Ritalin®)

Dr.Leando Panizzon &

Marguerite („Rita“) Panizzon

stimulants chemistry
Stimulants - Chemistry

Amphetamine

Mescaline

Methylphenidate

Dopamine

MDMA „Extasy“

mode of action
Mode of action

Krause et al.

ad hd28
AD/HD

Because of time one example of efficacy only

substance abuse
Substance Abuse

relative risk

ritalin la
Ritalin® LA

Product backgrounder and competitors

facts and problems
Facts and Problems
  • Onset of action after 20 – 40 minutes
  • Duration of action 2-4 hours
  • Repeated dosing – often over school-time - mandatory
  • Acute tolerance requires peaked doses with raising plasma levels over the day and drug free interval at night
  • Stable plasma levels show poor clinical efficacy, sharp increase in plasma levels in the morning required
ritalin la objectives
Ritalin® LA - Objectives
  • Fast onset of action in the morning, with a high morning dose
  • Double peak pharmacokinetic with raising plasma levels over the day
  • Duration of action about 8 – 10 h to cover schoolday, but not to interfer with sleep at night
  • Easy to swallow, no food interaction
  • Easy switch from standard medication
  • Individualized dosing
ritalin la35
Ritalin® LA

Ritalin® LA 20 mg (n=19)

Markowitz J, et al. Clin Pharmacokinet. In press.

concerta oros
Concerta® - OROS™

Concerta® is a trademark of Janssen Cilag, / J&J

ritalin la vs concerta
Ritalin® LA vs. Concerta®

Concerta® 18 mg (n=19)

MPH concentration (ng/mL)

Time (h)

Ritalin® LA 20 mg (n=19)

Markowitz J, et al. Clin Pharmacokinet (2003) 42(4) 1-9

important differences
Concerta®

Dose strenghts 18, (27), 36, (54) mg

Initial dose 22 %

Sustained dose 78 %

Duration of action up to 12 h

Capsule must not be opened

Ritalin® LA

Dose strenghts 20, 30, 40 mg

Initial dose 50 %

Sustained dose 50 %

Duration of action up to

8 h

Capsule may be opened and sprinkled on soft food

Important differences

Concerta® is a trademark of Janssen Cilag, / J&J

how to switch
How to switch ?
  • Switching can be done from day to day
  • Switching sometimes needs new dose adjustment
  • Always remind initial 50 % of dose (10 mg, 15 mg, 20 mg)
  • Starting with too high doses may lead to initial side effects and bad compliance !
pharmacodynamics

Pharmacodynamics

Or what does this mean in daily practice ?

school day efficacy of ritalin la vs concerta
School Day Efficacy of Ritalin® LA vs. Concerta®
  • Randomized, rater blind, placebo controlled clinical trial
  • 36 children, 6-12 years, 29 boys, 7 girls
  • All stabilized on 20 mg MPH/die ahead of trial
  • 4 way crossover design
  • Study medication on days 7, 14, 21, 28, standard medication in-between
  • Swanson, Kotkin, Alger M-Flynn, Pelham (SKAMP) Attention/Deportment Scale
  • Age/intelligence-appropriate, 400-question, 10-minute written math test
slide42

Worsening

Improvement

Ritalin® LA vs. Concerta®SKAMP Attention over first 4 hours

Change from Baseline (Predose) 0-4 Hours N=36

Ritalin® LA 20 mg

-2.481

*†

Concerta®18 mg

-1.362

Concerta®36 mg

-1.55

1.24

Placebo

*P=0.015 for Ritalin® LA 20 mg vs Concerta® 18 mg.

†P=0.043 for Ritalin® LA 20 mg vs Concerta® 36 mg.

‡P<0.001 vs all active treatment groups.

slide43

Ritalin® LA vs. Concerta®SKAMP Attention over schoolday

Worsening

Improvement

Change from Baseline (Predose) 0-8 HoursN=36

Ritalin® LA 20 mg

-4.481

*†

Concerta®18 mg

-2.719

Concerta®36 mg

-3.244

3.786

Placebo

*P=0.074 for Ritalin® LA 20 mg vs Concerta® 18 mg.

†P=0.208 for Ritalin® LA 20 mg vs Concerta® 36 mg.

‡P<0.001 vs all active treatment groups.

slide44

Placebo

Ritalin® LA 20 mg

Ritalin® LA vs. Concerta®SKAMP Combined

Concerta® 36 mg

N=36

Concerta® 18 mg

*†

*†

*†

*

Mean change from predose in SKAMP-combined

0.5

1.0

2.0

3.0

4.0

6.0

8.0

0

Time (h)

*P<0.05 for Ritalin® LA 20 mg vs Concerta® 36 mg.

†P<0.05 for Ritalin® LA 20 mg vs Concerta® 18 mg.

strattera atomoxetine eli lilly
Strattera® (Atomoxetine, Eli Lilly)
  • Atomoxetine is a norepinephrine-reuptake inhibitor, orginally developed as antidepressant (Pharmacia)
  • Atomoxetine has no dopaminergic activity
  • Atomoxetine is the first non-stimulant approved for treatment of AD/HD
  • Atomoxetine is the first pharmacologic treatment, approved for the use of adult AD/HD
  • Onset of action as with other antidepressants is delayed (4 – 6 weeks at minimum)
strattera atomoxetine eli lilly46
Strattera® (Atomoxetine, Eli Lilly)
  • Efficacy of Atomoxetine seems to be lower than that of stimulants
  • Common side effects are nervousness, sleeplesness, loss of appetite, decreased body weight, sexual dysfunction, especially in boys
  • In US Atomoxetine gained 15 % market share in AD/HD market within 6 months after launch
  • Approval and launch in EU has been delayed several times – expected currently for H2/2004