my personal edition > psychiatry other > news


  E-Mail this DGDispatch to a colleague

DGDispatch

Atomoxetine Helps Treat Pediatric Nocturnal Enuresis: Presented at APA

By Paula Moyer

SAN FRANCISCO, CA -- May 26, 2003 -- Children who have nocturnal enuresis may gain some additional dry nights per week when treated with atomoxetine (Strattera), regardless of whether or not they have attention deficit/hyperactivity disorder (ADHD).

The findings were presented here on May 21^st at the 2003 Annual Meeting of the American Psychiatric Association.

"During our clinical trials to get atomoxetine approved for ADHD, several parents reported that their children were having more dry nights," said Calvin Sumner, MD, a senior clinical research physician at Eli Lilly and Company. "Therefore, we decided to see if we could replicate this finding in a study specifically on atomoxetine as a potential treatment for enuresis."

The investigators pointed to the fact that tricyclic antidepressants such as imipramine are often used to treat enuresis. They theorized that a noradrenergic agonist like atomoxetine may work due to noradrenergic effects on the bladder.

For their outpatient, multicenter, randomized, double-blind, parallel, placebo-controlled study, they recruited 87 children aged 6 to 18 years who had nocturnal enuresis. In the amoxetine group, the average age was 10.2 years and 10 subjects had ADHD, versus an average age of 9.1 years and 17 ADHD cases in the placebo group.

At baseline, the treatment group had an average of 1.51 dry nights per week and the placebo group had an average of 1.01 nights per week.

The initial dosage of amoxetine was 0.5 mg/kg/day for 3 days, titrated to 1.0 mg/kg/day for the next 3 days. The dose was then increased to 1.5 mg/kg/day for the rest of the 12-week study. Doses were given twice daily, once in the morning and again in the late afternoon or evening.

The investigators determined treatment efficacy by measuring the mean number of dry nights per week. They used an intent-to-treat analysis of the primary outcome measure, which consisted of a daily parent diary called the Dry Night Log-Parent Report (DNL-PR).

Dr. Sumner and colleagues were able to gather baseline and end point DNL-PR data for 42 of the 44 atomoxetine-treated subjects and 41 of the 43 placebo-treated subjects.

Subjects who were treated with atomoxetine had an average of 1.47 more dry nights per week over baseline, compared with an increase of.60 dry nights per week for the placebo group (P=0.02). Among the atomoxetine-treated subjects, 35.7% had an increase of at least 2 dry nights per week compared with 14.6% of the placebo-treated subjects (P=0.042).

The investigators observed similar rates of adverse events in the two groups, primarily headache, nausea, gastroenteritis, elevated heart rate, and insomnia.

Atomoxetine for nocturnal enuresis is "not a cure, but it's an improvement," Dr. Sumner said. "This drug seems to make a difference in enuresis, and it's worth being excited about." He added that atomoxetine might be an effective adjunct to behavioral interventions, such as the enuresis alarm.

The study was funded by Eli Lilly and Company.


[Study title: Atomoxetine Versus Placebo For Treating Pediatric Nocturnal Enuresis. Abstract NR704]

E-Mail this DGDispatch to a colleague

To print, use this version