Pharmacotherapy of ADHD Across the Lifecycle: Stimulants

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1 Pharmacotherapy of ADHD Across the Lifecycle: Stimulants Thomas J. Spencer, MD Massachusetts General Hospital Harvard Medical School

2 Percent Change (Bmax/Kd) DVR Images Obtained with [ 11 C]Raclopride After Placebo and After Methylphenidate Control ADHD * Controls ADHD Placebo Placebo Caudate Putamen Ratio Methylphenidate Methylphenidate Volkow, ND et al., Archives of General Psychiatry, 64(8): , 2007.

3 Mechanism of Action MPH: Insights from PET Imaging Studies (Volkow et al. J Att Dis. 2002;(suppl)1) Because DA enhances task-specific neuronal signaling and decreases noise, MPH-induced increases in DA could improve attention and decrease distractibility Since DA modulates motivation, the increases in DA would also enhance the saliency of the task facilitating the interest it elicits and thus improving performance

4 Methylphenidate Increases Dorsal ACC & DLPFC in Patients with ADHD MPH-OROS Higher than Placebo at 6 Weeks damcc damcc DLPFC Parietal Bush et al. Archives of General Psychiatry. in press

5 Average Score MTA: Treatment Effects on Inattention Scores (SNAP) Average Score [MTA Group, Arch General Psychiatry, 1999] CC Beh MedMgt Comb 3 Parent 3 Teacher Assessment Point (Days)

6 Average Score Teacher SSRS Social Skills CC Beh MedMgt Comb Assessment Point (Days)

7 Methylphenidate (MPH) in ADHD: Optimizing Dosing Medication Starting Dose Maximum Dose* Usual Dosing Duration Ritalin IR 5 mg QD/BID 2 mg/kg/day 4 hr /BID Focalin 2.5 mg QD/BID 1 mg/kg/day 4 5 hr / BID TID Focalin XR 5 mg QD 1 mg/kg/day hr QD Daytrana 10 mg 6 16 hr Concerta 18 mg QD 2 mg/kg/day 12 hr / once Metadate CD 20 mg QD 8 hr / once Ritalin LA 20 mg QD 8 hr /once Quillivant <10 mg QD 12 hr /once Quillichew <10 mg QD 8 hr /once Aptensio XR 10 mg QD 12 hr /once *May exceed FDA approved dose. Wilens TE, et al. Postgrad Med. 2010;122(5):

8 Long Acting MPH formulations

9 Conc (ng/ml) MPH ER Individual PK Plots Time (hrs)

10 Clinical Ratings of ADHD Symptoms (ADHD-RS) Week OROS-MPH mg/day Placebo mg/day P=0.04* P=0. 03 P=0.001 P<0.001 Biederman et al Biol psych 2006

11 Pharmacological Dissociation Between The Robust Effects Of Methylphenidate On ADHD Symptoms And Weaker Effects On Working Memory Biederman et al. Eur Neuropsychopharmacol 2011

12 Focalin (D-MPH)* An Isomeric Form of MPH H H H H 2 N N 2 Ph 2 COOCH 3 CH 3 OOC 2 Ph H H l (-) Methylphenidate D (+) Methylphenidate *FDA approved for ADHD. Courtesy of T. Wilens, MD.

13 SODAS d-mph: DAT Occupancy (PET) by Hour and Dose Spencer et al. In Press J Clin Psych 20 mg 30 mg 40 mg

14 Amphetamine (AMPH) in ADHD: Optimizing Medication Starting Dose Dosing Maximum Dose* Usual Dosing Duration Adderall mg QD 1.5 mg/kg/day 6 hr / BID Adderall XR mg QD 12 hr / QD Vyvanse 30 mg QD hr / QD Dexedrine Tablets mg BID 1.5 mg/kg/day 3 5 hr / BID QID Evekeo mg BID 3 5 hr / BID QID Dexedrine Spansule 5 mg QD 6 hr / QD BID Dyanavel XR (suspension) Adzenys XR (disintegrating tab) mg QD 1.5 mg/kg/day 12 hr / QD mg QD Not established 12 hr / QD *May exceed FDA approved dose (eg, > 20 to 30 mg/day). Wilens TE, et al. CNS News Wilens TE, et al. Postgrad Med. 2010;122(5):

15 Meta-analysis of Within-Subject Comparative Trials Evaluating Response to Stimulant Medications Spencer et al. Arch of Gen Psych studies N= % Best Response (Percent) % 23% 10 0 Dextroamphetamine Methylphenidate Equal response to either stimulant 16

16 Mean ADHD-RS Total Score Transition (n = 221) 18-Month Summary of Symptom Improvement With MAS XR 20, 40, and 60 mg/day Results of Short-term and 18 Months of Long-term Open-Label Extension Study Short-term Adult Study Long-term Adult Study * Subthreshold ADHD LOCF 0 Baseline Week Month *P<.05 by 1-sample t test of mean change from baseline of long-term study. Wilens T. Presented at: 157th Annual APA Meeting; May 1-6, 2004; New York, NY.

17 SHP465 Mixed Amphetamine Salts Wigal et al. 2018

18 Change in ADHD-RS Total Score ADHD-RS Total Score LDX in Adult ADHD: ADHD-RS Total Scores (ITT Population) Placebo mg/d LDX 50 mg/d LDX 70 mg/d LDX -16.2* -17.4* -18.6* Baseline Endpoint Change from baseline (LS mean ± SE) A more negative change in ADHD-RS total score indicates greater improvement. LS=least squares; SE=standard error of the mean. *P<.0001 (adjusted Dunnett s test compared with placebo following ANCOVA with baseline score as covariate).

19 Effect Size Stimulant Tx of Executive Function Lisdexamfetamine in Adult ADHD + GEC > 65 Adler et al. JCP

20 Score Controlled Trial of Lisdexamfetamine Collisions * TX Group Placebo Baseline 2nd Simulation

21 Adverse Effects of Stimulants Adverse effects (AEs) are similar for all stimulants Decreased appetite Insomnia Headache Stomachache Irritability/rebound phenomena Rates of these AEs may be high prior to any medical intervention; thus, baseline levels should always be obtained Wilens T, Spencer T. In: Child and Adolescent Psychiatric Clinics of North America. Philadelphia, Pa: Saunders Press; 2000:

22

23 Screening for Cardiac Risk: AHA Guidelines Medical history Personal congenital or acquired cardiac disease history Family history of cardiac disease (<50 years of age) Palpitations, chest pain, fainting, seizures, post-exercise symptoms Ask about other medications (including OTC) Routine medical exam Monitor BP and pulse at baseline and follow-up, especially in adults ECG is reasonable but not mandatory Routine check of Holter, ECHO is not necessary Gutgesell H, et al. Circulation. 1999:99: Schubiner H, et al. J Atten Disord. 2006;10:

24 Medication for ADHD and Criminality (Lichtenstein et al. NEJM 2012: 367: ) Women-41% reduction Men- 32% reduction Swedish national registers (N= 25,656 with ADHD-about 50% on medications) Ca. 40% of convictions related to drug offenses (Tx OR=0.6). No difference in type of ADHD medication (stimulants, nonstimulants) or level of crime.

25 FDA PK/PD Classroom Study PI: Thomas Spencer, MD Heidi Boland, at (617)

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