Gene/Protein Disease Symptom Drug Enzyme Compound
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Query: UMLS:C0015672 (fatigue)
 51,768 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

The Safety of Keppra as Adjunctive Therapy in Epilepsy (SKATE) study aimed to evaluate the safety and efficacy of levetiracetam (Keppra, LEV) as add-on therapy for refractory partial seizures in clinical practice. This Phase IV, 16-week, open-label study recruited patients > or =16-year old with treatment-resistant partial seizures. LEV (1000 mg/day) was added to a stable concomitant antiepileptic drug regimen. LEV dosage was adjusted based on seizure control and tolerability to a maximum of 3000 mg/day. 1541 patients (intent-to-treat population) were recruited including 1346 (87.3%) who completed the study and 77.0% who declared further continuing on LEV after the trial. Overall, 50.5% of patients reported at least one adverse event that was considered related to LEV treatment. The most frequently reported drug-related adverse events were mild-to-moderate somnolence, fatigue, dizziness and headache. Serious adverse events considered related to LEV occurred in 1.0% of patients. 7.5% of patients reported adverse events as the most important reason for study drug discontinuation. The median reduction from baseline in the frequency of all seizures was 50.2%; 15.8% of patients were seizure free; 50.1% had seizure frequency reduction of > or =50%. At the end of the study, 60.4% of patients were considered by the investigator to show marked or moderate improvement. There was a significant improvement in health-related quality of life as assessed with the QOLIE-10-P (total score increasing from 55.6 to 61.6; p<0.001). This community-based study suggests that LEV is well tolerated and effective as add-on therapy for refractory partial seizures in adults. These data provide supportive evidence for the safety and efficacy of LEV demonstrated in the pivotal Phase III placebo-controlled studies.
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PMID:The SKATE study: an open-label community-based study of levetiracetam as add-on therapy for adults with uncontrolled partial epilepsy. 1768 53

Poorly-controlled epilepsy can have a significant negative impact on quality of life, clinically important changes are seen in patients emotional well-being, cognitive functioning, social functioning and energy/fatigue levels. Poorly-controlled epilepsy places an undue economic burden on the patient and community. Increased costs are seen in both direct and indirect healthcare costs (e.g., inpatient care and loss of earnings associated with time lost from work). Therefore, long-term efficacy and tolerability are key considerations when designing the patient's treatment regimen. Therapy can be individualized using both classical drugs and newer antiepileptics such as levetiracetam (Keppra, UCB Pharma Inc.), which is currently recommended as add-on therapy for partial-onset seizures. Studies have revealed characteristics that suggest levetiracetam is the first of a new class of antiepileptic drugs, differentiated by its innovative mechanism of action. Its efficacy and tolerability have enabled many patients who were refractory to treatment with other antiepileptic drugs to achieve long-term seizure freedom. Levetiracetam has a high long-term retention rate, a powerful measure of adverse events and efficacy over time. Another equally important benefit is ease of use, levetiracetam is administered twice-daily and has a simple titration regimen. Pharmacoeconomic data show that the incremental cost of treating patients with levetiracetam is low when compared with the benefits of seizure freedom. Ongoing studies suggest that this antiepileptic drug has potential as first-line treatment for many types of epilepsy and in many different patient populations.
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PMID:Levetiracetam: an innovative and cost-effective add-on drug for refractory partial epilepsy. 1980 17