PMID- 21561392
OWN - NLM
STAT- MEDLINE
DCOM- 20111101
LR  - 20191210
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 27
IP  - 7
DP  - 2011 Jul
TI  - Pregabalin or placebo used adjunctively with levetiracetam in refractory 
      partial-onset epilepsy: a post hoc efficacy and safety analysis in combined 
      clinical trials.
PG  - 1285-93
LID - 10.1185/03007995.2011.573778 [doi]
AB  - OBJECTIVE: Some patients with epilepsy require treatment with >1 adjunctive 
      antiepileptic drug (AED) to achieve adequate seizure remission. The purpose of 
      this analysis was to evaluate the efficacy and safety of adding adjunctive 
      pregabalin to an AED regimen that included levetiracetam in patients with 
      refractory partial-onset epilepsy. RESEARCH DESIGN AND METHODS: Data from the 
      pregabalin and placebo arms of two placebo-controlled, double-blind, randomized 
      studies of pregabalin in patients who received adjunctive treatment with 
      levetiracetam in addition to >/=1 other AEDs were pooled for this post hoc 
      analysis. Patients (aged >/=18 years) had >/=4 partial-onset seizures and no 28-day 
      period free of seizures during baseline. Efficacy outcomes included Response 
      Ratio (RRatio), change from baseline in seizure frequency, proportion of patients 
      with >/=50% reduction in seizure frequency, and 28-day seizure-freedom rate. Safety 
      was evaluated using adverse events (AEs). RESULTS: In total, 138 patients were 
      included in the analysis (placebo, n = 47; pregabalin, n = 91). Pregabalin was 
      significantly better than placebo for difference in least squares mean of the 
      RRatio (-16.4; 95% confidence interval [CI]: -28.5, -4.5; p = 0.0085), median of 
      the difference in percentage change from baseline in seizure frequency (-22.3; 
      95% CI: -40.1, -7.2; p = 0.0095), and proportion of 50% responders (36.3 vs. 
      17.0; odds ratio, 3.2; 95% CI: 1.3, 8.3; p = 0.018), but not 28-day 
      seizure-freedom rate (7 [7.7%] vs. 2 [4.3%]; p = 0.353). The most common AEs when 
      adding pregabalin were dizziness/vertigo, fatigue, somnolence, blurred vision, 
      and increased weight that were not proportional to the number of concomitant 
      AEDs. CONCLUSIONS: In this population of patients with refractory partial-onset 
      seizures, adding pregabalin to an AED regimen with levetiracetam produced further 
      seizure reductions. The safety profile of pregabalin in patients receiving 
      levetiracetam and >/=1 other AEDs did not appear to be compromised by the number of 
      concomitant AEDs.
FAU - Uthman, Basim M
AU  - Uthman BM
AD  - Weill Cornell Medical College in Qatar, Qatar Foundation Education City, Doha, 
      Qatar. bmu2001@qatar-med.cornell.edu
FAU - Almas, Mary
AU  - Almas M
FAU - Emir, Birol
AU  - Emir B
FAU - Giordano, Suzanne
AU  - Giordano S
FAU - Leon, Teresa
AU  - Leon T
LA  - eng
PT  - Evaluation Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20110512
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Anticonvulsants)
RN  - 0 (Placebos)
RN  - 44YRR34555 (Levetiracetam)
RN  - 55JG375S6M (Pregabalin)
RN  - 56-12-2 (gamma-Aminobutyric Acid)
RN  - ZH516LNZ10 (Piracetam)
SB  - IM
MH  - Adult
MH  - Anticonvulsants/*administration & dosage/adverse effects
MH  - Double-Blind Method
MH  - Drug Resistance/drug effects
MH  - Drug Therapy, Combination/adverse effects
MH  - Epilepsies, Partial/*drug therapy
MH  - Female
MH  - Humans
MH  - Levetiracetam
MH  - Male
MH  - Middle Aged
MH  - Piracetam/administration & dosage/adverse effects/*analogs & derivatives
MH  - Placebos
MH  - Pregabalin
MH  - Randomized Controlled Trials as Topic
MH  - Retrospective Studies
MH  - Treatment Failure
MH  - Treatment Outcome
MH  - gamma-Aminobutyric Acid/administration & dosage/adverse effects/*analogs & 
      derivatives
EDAT- 2011/05/13 06:00
MHDA- 2011/11/02 06:00
CRDT- 2011/05/13 06:00
PHST- 2011/05/13 06:00 [entrez]
PHST- 2011/05/13 06:00 [pubmed]
PHST- 2011/11/02 06:00 [medline]
AID - 10.1185/03007995.2011.573778 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2011 Jul;27(7):1285-93. doi: 10.1185/03007995.2011.573778. 
      Epub 2011 May 12.