Levetiracetam observational studies

Observational studies Phenobarbital has been compared with levetiracetam and lamotrigine in patients with seizures and Alzheimer s disease in a prospective, randomized, three-arm parallel-group, case-control study (see above under Lamotrigine). 

Up to a few years ago, the association between the risk of suicidal ideation and behavior and the use of antiepileptic drugs had been explored in very few studies. In an observational study of 517 consecutive patients taking levetiracetam, four (0.7%) reported suicidal ideation [Id ]. The incidence of suicidal ideation and behavior resulting from antiepileptic drug exposure in clinical trials is unknown, because most published data group all psychiatric adverse events together rather than reporting suicidality by itself [15, 16, 17 ]. 

Observational studies Levetiracetam monotherapy has been investigated in 35 patients with late-onset post-stroke seizures in a prospective open study [178 ]. At a mean follow-up period of 18 months, 27 patients had achieved seizure freedom. Four of 35 patients stopped taking levetiracetam because of severe adverse events drowsiness with gait disturbance and aggressive behavior in two cases, and severe psychomotor agitation with aggressive behavior in the other two patients. 

Observational studies A phase 111 study evaluated the safety and efficacy of levetiracetam in 217 children and adults with primary generalized seizures. The most common adverse effects reported by >10% participants were headache and nasopharyngitis. The most frequent treatment-associated adverse effects were headache (4.6%), dizziness and depression (both 4.1%). Serious adverse effects related to treatment with levetiracetam 4.6% of patients experienced convulsion, atrial fibrillation, epilepsy, depression, psychosis, schizophrenia, suicidal ideation, erythematous rash, and status epilepticus. One patient each discontinued due to the following adverse effects arrhythmia, convulsions, tremor, aggression, depression, psychosis, and exanthem. One patient with worsening of comorbid schizophrenia committed suicide it had been 43 days since he had last taken levetiracetam at the time [87 -]. 

An observational study following 66 adults and children treated with levetiracetam after traumatic brain injury found that the most common adverse events were fatigue, headache, and somnolence [90 ]. Mood scores and number of infections did not differ between the treatment and observation groups. Two of the 66 patients stopped treatment due to somnolence. 

An observational study of 103 pafienfs was performed to assess cognition and behavior in children taking levetiracetam. Ninety-four patients reported adverse events, of which 47 were drug-relafed and included headache (8.7%), irritability (7.8%), aggression (6.8%), fatigue (4.9%), convulsion (3.9%), and abnormal behavior (3.9%) [91 ]. Nineteen (18.5%) patients experienced behavioral problems such as irritability, aggression, or abnormal behavior, which were attributed to levetiracetam. 

The safety of levetiracetam has been assessed in 24 children with uncontrolled partial-onset seizures in an open study (16). The most commonly reported adverse events were headache (33%), infection (33%), anorexia (25%), and somnolence (25%). The adverse events profile of levetiracetam was similar to that seen in adults. Owing to a dispensing error, one patient received an accidental overdose of 71 mg/kg/day, rather than 40 mg/kg/day, during the last 4 weeks of the evaluable phase of the study. No iU effects were reported or observed on examination or laboratory testing, and the patient completed the trial. 

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