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Long-Term Safety Of Atomoxetine In The Treatment Of Attention Deficit Hyperactivity Disorder: Presented at WCP

By Bruce Sylvester
Special to DG News

YOKOHAMA, JAPAN -- August 29, 2002 -- Long-term use of atomoxetine in pediatric attention deficit hyperactivity disorder (ADHD) is safe and well-tolerated, researchers report.

The results of an open-label extension study led by M.Y. Hill of Eli Lilly and Company, Indianapolis, Indiana, United States, were presented at the 12^th World Conference of Psychiatry in Yokohama, Japan.

Researchers enrolled 325 subjects, 266 males, 59 females, aged from seven to 17 years old. Only patients from previous atomoxetine trials were allowed to enroll in this long-term study. All met DSM-IV criteria for ADHD from their previous atomoxetine trial.

The ADHD subtype profile was: hyperactive/impulsive (4 or 1.2 percent), inattentive (62 or 19.1 percent) and combined (259 or 79.7 percent)

"The subjects had no serious medical illness, comorbid psychosis or bipolar disorder, history of seizure disorder, or ongoing use of psychoactive medications other than the study drug," the authors wrote.

The mean number of days on open-label, continuation therapy was 313. One hundred and forty two subjects completed one year.

The researchers assessed tolerability and safety of long-term treatment using data on discontinuations, adverse events, ECG data, weight, height, and vital signs.

A slight increase was noted from baseline to endpoint in mean diastolic blood pressure (3.6 mm Hg) and pulse (3.9 bpm). Mean weight increased (2.6 kg) from baseline to endpoint, as did mean height (4.4 cm).

The most commonly observed adverse events (headache, rhinitis, abdominal pain, pharyngitis and vomiting) and those associated with atomoxetine therapy (decreased appetite and weight loss) decreased over time. Twelve of the subjects (3.7 percent) left the trial due to an adverse event.

"A clinically nonsignificant decrease of 4.8msec in mean Fridericia corrected QT interval from baseline-to-endpoint was observed," the investigators reported.

The authors concluded that, "Overall, atomoxetine was well tolerated in this long-term clinical trial. In contrast to acute studies, this study revealed that during long-term therapy mean weight increased. Effects on ECG parameters were consistent with increased heart rate. No evidence for a drug related QTc prolongation was observed."

The research was funded by Lilly Research Laboratories.

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