Clonidine for Attention-Deficit/Hyperactivity Disorder: II. ECG Changes and Adverse Events Analysis - 01/11/17
THE CAT STUDY TEAM
ABSTRACT |
Objective: |
To examine the safety and tolerability of clonidine used alone or with methylphenidate in children with attention-deficit/hyperactivity disorder (ADHD).
Method: |
In a 16-week multicenter, double-blind trial, 122 children with ADHD were randomly assigned to clonidine (n = 31), methylphenidate (n = 29), clonidine and methylphenidate (n = 32), or placebo (n = 30). Doses were flexibly titrated up to 0.6 mg/day for clonidine and 60 mg/day for methylphenidate (both with divided dosing). Groups were compared regarding adverse events and changes from baseline to week 16 in electrocardiograms and vital signs.
Results: |
There were more incidents of bradycardia in subjects treated with clonidine compared with those not treated with clonidine (17.5% versus 3.4%; p =.02), but no other significant group differences regarding electrocardiogram and other cardiovascular outcomes. There were no suggestions of interactions between clonidine and methylphenidate regarding cardiovascular outcomes. Moderate or severe adverse events were more common in subjects on clonidine (79.4% versus 49.2%; p =.0006) but not associated with higher rates of early study withdrawal. Drowsiness was common on clonidine, but generally resolved by 6 to 8 weeks.
Conclusions: |
Clonidine, used alone or with methylphenidate, appears safe and well tolerated in childhood ADHD. Physicians prescribing clonidine should monitor for bradycardia and advise patients about the high likelihood of initial drowsiness.
Le texte complet de cet article est disponible en PDF.Key Words: : clonidine, electrocardiogram, tolerability, methylphenidate
Plan
| Editorship of Mina K. Dulcan, M.D. This project was supported by NINDS grant 5R01 NS039087 (Dr. Sallee). Additional NIH support came from K23 MH065375 (Dr. Daviss) and K24 AA000301 (Dr. Bukstein). Members of the CAT Study Team are listed at the end of the article. Clinical trial registration information-URL:www.clinicaltrials.gov. Unique identifier: NCT00031395. Disclosure: Dr. Daviss is on the speakers’ bureau of Shire Pharmaceuticals. Dr. Patel is on the speakers’ bureau of Pfizer, Shire, and Eli Lilly and serves as a consultant to Shire and Lilly. Dr. Robb receives research support from Abbott, Eli Lilly, Forrest, Janssen, McNeil, Organon, Otsuka, and Pfizer and is on the advisory board of Eli Lilly and the speakers’ bureaus of Abbott, McNeil, and Pfizer. Dr. Bukstein is on the speakers’ bureaus of McNeil Consumer and Specialty Pharmaceuticals, Shire, and Novartis; is a consultant to Shire, Cephalon, and Forest Research Institute; and receives funding support from Shire, Eli Lilly, and Sanofi Aventis. Dr. Palumbo is on the ADHD Advisory Board, the speakers’ bureau of McNeil Consumer and Specialty Pharmaceuticals, and is a consultant to/principal investigator for Pfizer; is a site investigator for Shire, Noven, Eli Lilly, Organon, and Cephalon; and has received educational grant support from Novartis, McNeil, and Celltech/UCB. Dr. Sallee is a consultant to Shire and Otsuka. The other authors report no conflicts of interest. |
Vol 47 - N° 2
P. 189-198 - février 2008 Retour au numéro
Article précédent
- Clonidine for Attention-Deficit/Hyperactivity Disorder: I. Efficacy and Tolerability Outcomes
- DONNA R. PALUMBO, FLOYD R. SALLEE, WILLIAM E. PELHAM, OSCAR G. BUKSTEIN, W. BURLESON DAVISS, MICHAEL P. McDERMOTT, THE CAT STUDY TEAM
- Dexmethylphenidate ExtendeD-Release Capsules in Children With Attention-Deficit/Hyperactivity Disorder
- RAUL R. SILVA, RAFAEL MUNIZ, LINDA PESTREICH, MATTHEW BRAMS, ALICE R. MAO, ANN CHILDRESS, JAMES WANG
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