PMID- 19877974
OWN - NLM
STAT- MEDLINE
DCOM- 20100125
LR  - 20220330
IS  - 1557-8992 (Electronic)
IS  - 1044-5463 (Print)
IS  - 1044-5463 (Linking)
VI  - 19
IP  - 5
DP  - 2009 Oct
TI  - Safety and effectiveness of coadministration of guanfacine extended release and 
      psychostimulants in children and adolescents with attention-deficit/hyperactivity 
      disorder.
PG  - 501-10
LID - 10.1089/cap.2008.0152 [doi]
AB  - OBJECTIVE: The aim of this study was to evaluate the safety and effectiveness of 
      guanfacine extended release (GXR) administered concomitantly with 
      psychostimulants in children and adolescents with attention-deficit/hyperactivity 
      disorder (ADHD) and suboptimal response to a psychostimulant alone. DESIGN AND 
      METHODS: This was a multicenter, open-label, 9-week, dose-escalation study of 75 
      subjects with ADHD treated with methylphenidate (MPH) or amphetamine (AMP) alone 
      for at least 1 month, yet with suboptimal control of ADHD symptoms. Sixty-three 
      subjects (84.0%) completed the study. Patients received GXR in addition to their 
      psychostimulant. Starting with 1 mg/day, GXR was increased weekly to the highest 
      tolerated dose (1, 2, 3, or 4 mg/day), which was maintained through week 6. GXR 
      was then titrated downward in 1-mg weekly decrements from week 7 through week 9. 
      Psychostimulant treatment regimens were continued until at least week 7. MAIN 
      OUTCOME MEASURES: Safety assessments included adverse events (AEs), vital signs, 
      physical examination, clinical laboratory tests, the Pediatric Daytime Sleepiness 
      Scale, and the Pittsburgh Side Effects Rating Scale. Efficacy was assessed using 
      the ADHD Rating Scale IV (ADHD-RS-IV), the Conners' Parent Rating Scale-Revised 
      Short Form, Clinical Global Impressions, Parent Global Assessment, and Child 
      Health Questionnaire-Parent Form. RESULTS: The most common treatment-related AEs 
      were upper abdominal pain (25.3%), fatigue (24.0%), irritability (22.7%), 
      headache (20.0%), and somnolence (18.7%). Most AEs were mild to moderate in 
      severity. Investigator-rated AEs due to blood pressure decreases, heart rate, or 
      electrocardiogram findings were infrequent. Mean changes from baseline 
      (psychostimulant monotherapy just prior to receiving GXR) to end point in 
      ADHD-RS-IV total score were statistically significant overall: -16.1 (p < 
      0.0001). Significant improvement in both subscales of the ADHD-RS-IV was 
      observed. Improvement of symptoms was observed in a majority of subjects. 
      CONCLUSION: Coadministration of GXR and MPH or AMP was generally safe and 
      associated with statistically significant and clinically meaningful ADHD symptom 
      improvement in children and adolescents.
FAU - Spencer, Thomas J
AU  - Spencer TJ
AD  - Clinical and Research Program, Pediatric Psychopharmacology, Harvard Medical 
      School and Massachusetts General Hospital , Boston, Massachusetts, USA. 
      tspencer@partners.org
FAU - Greenbaum, Michael
AU  - Greenbaum M
FAU - Ginsberg, Lawrence D
AU  - Ginsberg LD
FAU - Murphy, William Rory
AU  - Murphy WR
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Child Adolesc Psychopharmacol
JT  - Journal of child and adolescent psychopharmacology
JID - 9105358
RN  - 0 (Adrenergic alpha-Agonists)
RN  - 0 (Central Nervous System Stimulants)
RN  - 0 (Delayed-Action Preparations)
RN  - 207ZZ9QZ49 (Methylphenidate)
RN  - 30OMY4G3MK (Guanfacine)
RN  - CK833KGX7E (Amphetamine)
SB  - IM
MH  - Adolescent
MH  - Adrenergic alpha-Agonists/administration & dosage/adverse effects/*therapeutic 
      use
MH  - Amphetamine/adverse effects/therapeutic use
MH  - Attention Deficit Disorder with Hyperactivity/*drug therapy
MH  - Central Nervous System Stimulants/adverse effects/*therapeutic use
MH  - Child
MH  - Delayed-Action Preparations
MH  - Dose-Response Relationship, Drug
MH  - Drug Therapy, Combination
MH  - Female
MH  - Guanfacine/administration & dosage/adverse effects/*therapeutic use
MH  - Humans
MH  - Male
MH  - Methylphenidate/adverse effects/therapeutic use
MH  - Psychiatric Status Rating Scales
MH  - Severity of Illness Index
PMC - PMC2861960
EDAT- 2009/11/03 06:00
MHDA- 2010/01/26 06:00
PMCR- 2010/10/01
CRDT- 2009/11/03 06:00
PHST- 2009/11/03 06:00 [entrez]
PHST- 2009/11/03 06:00 [pubmed]
PHST- 2010/01/26 06:00 [medline]
PHST- 2010/10/01 00:00 [pmc-release]
AID - 10.1089/cap.2008.0152 [pii]
AID - 10.1089/cap.2008.0152 [doi]
PST - ppublish
SO  - J Child Adolesc Psychopharmacol. 2009 Oct;19(5):501-10. doi: 
      10.1089/cap.2008.0152.