Post Marketing Trails
Community based practice
Seizure freedome rates across clinical settings
- Keppra demonstrated
seizure freedom in up to 9% of highly refractory patients in clinical
trials
- Seizure freedom rates were higher in two post-marketing trials:
- 20% in a 16-week community-based trial
- 40% in patients ≥65 years of age
- 26% in a separate 1-year follow-up study
Adapted from Ben-Menachem, 2003; Betts, 2003; Boon,
2002; Cereghino, 2000; Morrell, 2003; Privitera,2002
Keeper trial
- The purpose of this study was to gather additional safety and efficacy data on levetiracetam in the real-world setting of community-based practice
- A phase IV prospective, open-label, multi-center, community-based
trial
- A total of 1030 patients at least 16 years old with inadequately
controlled partial-onset seizures enrolled by 300 investigators
- All patients received 500mg levetiracetam bid as add-on, with max
dose of 1500mg bid
Responder rates for patients who completed the KEEPERTM study
Safety
- Overall 38.3% of patients (395/1030) reported at least one drug-related
adverse event. The four most commonly reported adverse events (5%
or more of patients) were somnolence, dizziness, asthenia, and headache; these events were predominantly mild-to-moderate in nature.
- Keppra was weight-neutral
- Behaioral adverse events occurred at low rate
Adverse events experienced by 5% or more of patients
(N=1030) |
|||||
| Event | Incidence, N(%) |
Severity*, N(%) |
Discontinued, N(%) |
||
Mild |
Moderate |
Severe |
|||
| somnolence | 132
(12.8) |
64 (6.2) |
47 (4.6) |
16 (1.6) |
24 (2.3) |
| dizziness | 86 (8.3) |
51 (5.0) |
30 (2.9) |
4 (0.4) |
13 (1.3) |
| asthenia | 74 (7.2) |
53 (5.1) |
13 (1.3) |
6 (0.6) |
11 (1.1) |
| headache | 61 (5.9) |
24 (2.3) |
25 (2.4) |
9 (0.9) |
14 (1.4) |
| * Some adverse events were unknown severity | |||||
KEEPER™ Trail elderly subgroup: analysis of patients ≥65
years -
a retrospective analysis in 78 patients
- Median percent reduction in seizure frequency was 80%
- ≥50% reduction in partial seizures—77% of patients
- Of the total number of subjects in Phase III studies
of levetiracetam, 347 were aged 65 years and over. No overall differences
in safety were observed between these subjects and younger subjects
- There were insufficient numbers of elderly subjects in controlled
trials of epilepsy to adequately assess the effectiveness of Keppra in
these patients
- Keppra is
substantially excreted by the kidneys; dosing must be individualized
according to the patient's renal function status
Seizures-freedom and ≥50% responder rates in elderly
patients
Levetiracetam in patients with refractory epilepsy: results of the SKATE trial in Austria, Germany and Switzerland.
