Table 3.
Summary of studies on more than one antiepileptic drug (n=7).
| Authors | Type of study | N | Population | AED studied | Type of therapy | Dose (per day) | Comparison | Significative PSG results (mean ± SD) |
|---|---|---|---|---|---|---|---|---|
| Wolf et al (1984)51 | Prospective, non-blind, non- randomised (class III) |
Focal epilepsy (n=15) PB (n=34) | PHB monotherapy. 4 cycles and crossover | Phenobarbitone (n=34) and phenytoin (n=34) | Placebo | Daily dose. Steady state serum level PB=26.8pg/ml (10-46) | Phenobarbitone (n=34) and phenytoin (n=34) | 1st Cycle: •fREM (min): in PB (126.4+44.9) vs. baseline (95.3±39.7)* •fREM latency (min): in PB (112.9+40.6) vs. baseline (81.7+33.8)* •fStage N4 (min): in PB (45.1+30.1) vs. baseline (25.4+13.5)* |
| 2nd
Cycle: Time awake (min): in PB (1.7+2.0) vs. baseline (4.6+8.6)* •fREM (min): in PB (117.1+21.9) vs. baseline (108.1+25.6)** •fREM latency (min): in PB (220.8+50.2) vs. baseline (175.5+50.6)** •fStage N2 (min): in PB (58.5+25.3) vs. baseline (38.7+15.7)* •fStage N3 (min): in PB (32.0+19.1) vs. baseline (22.5+14.4)** •fStage N4 (min): in PB (13.3+7.4) vs. baseline (21.2+16.6)** | ||||||||
| 3rd Cycle: Time awake (min): in PB (1.8+2.6) vs. baseline (3.8+3.0)** •FStage N4 (min): in PB (3.5+7.4) vs. baseline (8.0+10.3)** •fREM latency (min): in PB (281.8+48.2) vs. baseline (321.9+52.1)** •FStage N1 (min): in PHE (4.0+3.9) vs. baseline (8.7+6.8)* •FStage N2 (min): in PHE (41.9+17.3) vs. baseline (54.9+17.4)** •fStage N3 (min): in PHE (14.4+10.3) vs. baseline (9.9+10.6)** •fStage N4 (min): in PHE (17.7+15.3) vs. baseline (8.0+10.3)* | ||||||||
| 4th Cycle: Time awake (min): in PB (1.3+0.8) vs. baseline (3.2+4.0)* •fREM latency (min): in PB (403.1+50.7) vs. baseline (366.1+47.9)** •fStage N2 (min): in PB (51.5+17.3) vs. baseline (41.8+14.1)* •fStage N3 (min): in PB (36.9+18.3) vs. baseline (26.4+12.8)** •fStage N4 (min): in PB (1.6+3.6) vs. baseline (6.2+10.6)** •fStage N3 (min): in PHE (11.5+8.3) vs. baseline (7.8+10.1)* | ||||||||
| Wolf et al. (1984)47 | Observational, nonrandomized (class III) | 229 | Absence seizures | ETH (n=143) VPA (n=187) | Monotherapy | NA | NA |
No values available: •fStage N1 (%): in ETH vs. baseline* SWS (%): in ETH vs. baseline* •fREM duration (min): in ETH vs. baseline in third REM cycle * >V REM duration (min): in ETH vs. baseline in fourth REM cycle * •fStage N1 (%): in VPA vs. baseline* |
| Drake et al. (1990)44 | Observational (class III) | 17 | Focal or generalized epilepsy | PHE (n=5), CBZ (n=5), VPA (n=5), CNZ (n=2) |
Chronic monotherapy | NA | NA | PHE (n=5), CBZ (n=5), VPA (n=5), CNZ (n=2) SWS and REM: in both groups compared to published norms but none values were presented. |
| Manni et al. (1993)52 | Observational (Class III) | 30 | Generalized epilepsy treated with PB; Focal epilepsy treated with VPA. |
PB (n=10) VPA (n=10) | Chronic monotherapy | PB (mean serum = 19.3±1.7pg/ml) VPA (mean serum = 85.7±4.7g/ml) |
Healthy controls (n=10) | MSLT: Daytime sleep propensity: in PB vs. controls and vs. CBZ No significative differences in PSG recordings among the 3 groups. |
| Bonanni et al. (1997)40 | Prospective, non- randomized (Class III) | 26 | Focal epilepsy | CBZ = 26 CBZ+VGB= 14 |
Chronic CBZ monotherapy (n=26) CBZ + VGB (n=14) |
CBZ: 600-1,600mg VBB: 2-3g/day |
Healthy controls (n=12) | No significative differences were found. |
| Legros et al. (2003)38 | Observational, uncontrolled (class III) | 39 | Focal epilepsy with at least 24-h seizure-free | Monotherapy | Each drug with different dose | Patients with no AED as controls (n=13) |
PHE (n=7): •fStage N1 (%): in PHE (13.2+7.3) v. controls (7.7±4.8)**; SWS (%): in PHE (7.9±4.2) v. controls (11.3+4.4)*; REM (%): in PHE (13.9+6.2) v. controls (18.8+5.1)*; VPA (n=2): •fStage N1 (%): in VPA (16.8+9.8) v. controls (7.7±4.8)**; |
|
| No significative differences were found in CBZ (n=10), PB (n=1), GBP (n=3), LTG (n=4), PRI (n=1), FBM (n=1), ZNS (n=1), TGB (n=1). | ||||||||
| Cho et al. (2011)37 | Longitudinal randomized trial (class II) | 31 | Newly diagnosed focal epilepsy | LEV (n=16) CBZ-CR (n=15) | Monotherapy | LEV (1,000mg/day) CBZ-CR (400mg/day) |
NA |
LEV group (n=16) Sleep efficiency (min): on LEV (90.62±4.77) vs. baseline (84.32±13.65)* WASO (min): on LEV (31.72±38.88) vs. baseline (55.61±56.06)* CBZ-CR group (n=15) “TStage N3 (%): on CBZ-CR (26.78±9.47) vs. baseline (21.29±9.76)* |
Abbreviations: PB = Phenobarbitone; PHE = Phenytoin; ETH = Ethosuximide; VPA = Valproic acid; CNZ = Clonazepam; CBZ = Carbamazepine; GBP = Gabapentin; LTG = Lamotrigine; FBM = Felbamate; ZNS = Zonisamide; TGB = Tiagabin; CBZ-CR = Carbamazepine-controlled release.
*
p<0,05;
**
p>0,01;
***
p<0,001.