Tara
05-25-03, 05:58 PM
APA: Long-Term Atomoxetine Safe in Children and Adolescents with Attention Deficit Hyperactivity Disorder
By Bruce Sylvester
PHILADELPHIA, PA -- May 23, 2002 -- The investigative drug atomoxetine is well-tolerated and safe for long-term treatment of children and adolescents with attention-deficit/hyperactivity disorder (ADHD), researchers reported here on May 22 at the annual meeting of the American Psychiatric Association (APA).
"Drugs for ADHD have traditionally been studied in acute studies, typically for two to six weeks," said David Michelson, MD, clinical researcher at Eli Lilly Research Laboratories, Indianapolis, Indiana. "So most of the data we have about efficacy and safety is from short studies. But, in fact, most of the drugs for ADHD are used over longer periods of time. If a child responds to a drug, he or she is likely to stay on it for a long period of time."
In an open-label extension of previous trials, 258 children (7-11 years) and 67 adolescents (12-17 years) received at least one dose of atomoxetine. Of these, 112 children (43 percent) and 30 adolescents (45 percent) received atomoxetine for at least a year.
Subjects were required to meet Diagnostic and Statistical Manual IV (DSM-IV) criteria for ADHD to qualify for the study. They first completed a 10-week open-label, dose-titration trial to establish efficacy, followed by the one-year extension study.
Results show that atomoxetine was well tolerated, with nine children (3.5 percent) and two adolescents (3 percent) withdrawing from the study due to adverse events.
The researchers noted a slight increase in mean diastolic blood pressure (DBP) and heart rate (HR) for children (DDBP=3.64 mm Hg; DHR=4.28 beats/minute [bpm]) and adolescents (DDBP=3.43 mm Hg; DHR=2.58 bpm).
Mean weight and height increased in children (2.17 kg, 4.01 cm) and in adolescents (4.35 kg, 5.81 cm). Electrocardiogram (ECG) parameter changes were consistent with an increased heart rate for both subgroups. The researchers found no evidence of a drug related QTc prolongation.
"It’s important to begin to develop systematic information about the efficacy, safety, and tolerability of using these drugs over longer periods of time," Dr. Michelson said. "What we have seen here is that these young people tend to do well with this therapy over long periods of use."
http://www.pslgroup.com/dg/215796.htm
By Bruce Sylvester
PHILADELPHIA, PA -- May 23, 2002 -- The investigative drug atomoxetine is well-tolerated and safe for long-term treatment of children and adolescents with attention-deficit/hyperactivity disorder (ADHD), researchers reported here on May 22 at the annual meeting of the American Psychiatric Association (APA).
"Drugs for ADHD have traditionally been studied in acute studies, typically for two to six weeks," said David Michelson, MD, clinical researcher at Eli Lilly Research Laboratories, Indianapolis, Indiana. "So most of the data we have about efficacy and safety is from short studies. But, in fact, most of the drugs for ADHD are used over longer periods of time. If a child responds to a drug, he or she is likely to stay on it for a long period of time."
In an open-label extension of previous trials, 258 children (7-11 years) and 67 adolescents (12-17 years) received at least one dose of atomoxetine. Of these, 112 children (43 percent) and 30 adolescents (45 percent) received atomoxetine for at least a year.
Subjects were required to meet Diagnostic and Statistical Manual IV (DSM-IV) criteria for ADHD to qualify for the study. They first completed a 10-week open-label, dose-titration trial to establish efficacy, followed by the one-year extension study.
Results show that atomoxetine was well tolerated, with nine children (3.5 percent) and two adolescents (3 percent) withdrawing from the study due to adverse events.
The researchers noted a slight increase in mean diastolic blood pressure (DBP) and heart rate (HR) for children (DDBP=3.64 mm Hg; DHR=4.28 beats/minute [bpm]) and adolescents (DDBP=3.43 mm Hg; DHR=2.58 bpm).
Mean weight and height increased in children (2.17 kg, 4.01 cm) and in adolescents (4.35 kg, 5.81 cm). Electrocardiogram (ECG) parameter changes were consistent with an increased heart rate for both subgroups. The researchers found no evidence of a drug related QTc prolongation.
"It’s important to begin to develop systematic information about the efficacy, safety, and tolerability of using these drugs over longer periods of time," Dr. Michelson said. "What we have seen here is that these young people tend to do well with this therapy over long periods of use."
http://www.pslgroup.com/dg/215796.htm