Levetiracetam Appears Safe, Effective for Treatment of

[Guest guest]

Now this is bizarre!

Levetiracetam Appears Safe, Effective for Treatment of

Aggressive Disorders

Jill

Oct. 8, 2004 (Atlanta) — Levetiracetam (Keppra)

shows promise as a first-line approach to the

treatment of aggressive disorders, according to

a study presented here at the American

Psychiatric Association 56th Institute on

Psychiatric Services.

According to investigator A. Deutschman,

MD, chief of psychiatry at Southwest General

Health Center in Cleveland, Ohio,

anticonvulsants are commonly used in the

treatment of aggressive disorders, particularly

aggression seen in adolescents and young

adults. However, many of the anticonvulsants

currently used have serious adverse effects,

requiring the practitioner to monitor for problems

associated with the liver, bone marrow, sodium

levels, or for significant weight gain.

" We got interested in this molecule because it is an anticonvulsant,

and it has a wonderful side effect

profile, " Dr. Deutschman told Medscape. " And we thought if it worked,

it would really be an advance. "

To investigate, Dr. Deutschman and colleagues performed an

open-label, naturalistic trial in 54 patients,

39 men and 15 women, with a median age of 13 years. Patients had

diagnoses of oppositional defiant

disorder (ODD, 62%), conduct disorder (CD, 11%), and intermittent

explosive disorder (IED, 27%) and

were treated in an outpatient setting. On average, patients had two

comorbidities and were treated with

two concurrent agents.

Patients received an average of 1,835 mg of levetiracetam a day (dose

range, 125 - 5,000 mg/day) for an

average of 52 days (range, 14 days - one year). Information was

collected with respect to patient age,

sex, ethnicity, primary diagnosis, dose and duration on

levetiracetam, symptoms and severities at

baseline and at final visit, comorbidities, concurrent medications,

and adverse effects. Analyses were

performed in SAS and Systat, and symptom improvement was tested using

t tests (overall change) and

McNemar's test (individual symptoms).

The researchers found that symptom severity improved significantly

overall (t = 3.14; P = .003) as well as

common individual symptoms (P < .05). Furthermore, compliance was

high, with 11% discontinuing the

medication due to lack of effectiveness and 12% discontinuing due to

adverse effects. The adverse-effect

burden was low, with 9% experiencing sedation. Dr. Deutschman

reported that lack of randomization

and blind evaluation limited the study, but he added that the study

drew strength from the fact that it

included complex and diverse " real world " patients.

" What's interesting to me about this is that the FDA studies look at

things with one diagnosis, and almost

all patients that a psychiatrist sees has more than one problem, " he

told Medscape.

According to Dr. Deutschman, due to variability of the drug's

effectiveness among individual patients, the

option of levetiracetam is less attractive in patients who need

immediate help. However, it appears to be

an attractive option for those who can use the drug on a trial basis.

The study was funded in part by UCB Pharmaceuticals, the maker of

Keppra. Dr. Deutschman has been

a speaker for UCB Pharmaceuticals.

56th APA-IPS: Poster 8. Presented Oct. 7, 2004.

Reviewed by D. Vogin, MD