Long-term tolerability of lamotrigine: data from a 6-year continuation study (original) (raw)
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Lamotrigine as monotherapy in clinical practice: efficacy of various dosages in epilepsy
Brain and behavior, 2016
The study was designed to evaluate the optimal dosage of lamotrigine, as monotherapy, in the treatment of adults suffering from complex partial seizures with or without secondary generalization in everyday clinical practice. The ones used in this study was the collection of the data of all adult patients treated with lamotrigine, retrospectively. The dosage and efficacy of treatment were evaluated along with side effects and retention rate. They showed that, out of 188 patients, 77% continued lamotrigine treatment; the mean effective dose was 250 mg or higher of lamotrigine, and the results more pronounced in older patients (age above 30 years) and those with a longer disease duration (5 years and more). It may be appropriate to reach a daily lamotrigine dose above 250 mg in adult patients suffering from epilepsy for more than 5 years using lamotrigine as monotherapy.
Epilepsy & Seizure, 2014
Purpose: To evaluate the efficacy and safety of lamotrigine monotherapy in patients with newly diagnosed partial seizures including secondarily generalized seizures or generalized tonic-clonic seizures, and those with recurrent seizures in Japan and South Korea. Methods: The study was a multi-center, open-label, evaluation of lamotrigine monotherapy in patients with newly diagnosed epilepsy or epilepsy with recurrent seizures. The primary endpoint was the seizure-free rate in the maintenance phase. Results: A total of 67 patients were enrolled; 52 patients completed 6 weeks of treatment (the escalation phase) and 42 patients completed 30 weeks of treatment (the escalation phase and the maintenance phase). The seizure-free rate in the maintenance phase for all seizure types was 43.1%. Adverse events (AEs) were reported in 82% (53/65) of patients. The most common AEs were headache (14/65, 22%), nasopharyngitis (12/65, 18%) and rash (7/65, 11%). Conclusion: The seizure-free rate with lamotrigine monotherapy in the maintenance phase was 43.1% for all seizure types. Lamotrigine monotherapy appears to be effective in patients with newly diagnosed epilepsy and those with recurrent seizures in Japan and South Korea. The safety profile of lamotrigine in this monotherapy study was similar to that observed in patients with adult bipolar disorder treated with lamotrigine monotherapy.
The efficacy and long-term tolerability of lamotrigine in the treatment of severe epilepsy
Epilepsy Research, 1990
We report the effects of the addition of lamotrigine, a novel antiepileptic drug, to the therapy of 125 patients with severe refractory epilepsy. Forty-five patients (36%) reported adverse experiences and in 19 (15%), the drug was withdrawn. The commonest adverse experiences were diplopia, headache, ataxia, drowsiness, skin rash and deterioration in seizure control. Two patients were withdrawn for other reasons, The remaining 104 patients were followed for a mean of 11 moaths (range 3-27): 26 (25%) of these showed a marked improvement in seizure frequency (a 50% or more reduction when compared with the pre-trial period), but no patient was rendered seizure-free. Tolerance to the effects of the drug was not seen.
Epilepsy Research, 1990
The efficacy of lamotrigine (LTG), a new antiepilel~ic drug (AED) chemically unrelated to drugs in current use, was evaluated in 21 in-patients (18 males, 3 females; mean age 34.6; range 23-42 years) with severe refractory epilepsy. An add-on double-blind placebo-controlled crossover design was used, with 12 week treatment periods, and a 6 week washout period. Subjects were allocated to 1 of 2 dosing schedules according to their concomitant AEDs. Doses were increased according to clinical response. Although there was no significant reduction in total seizure count during the lamotrigine treatment period compared to placebo, there appears to be a drug effect as there was a marked reduction in generalized ~onic-clonic seizures in favour of lamotrigine in the last 4 weeks of the treatment period. There was no significant difference in volunteered adverse experiences during active and placebo treatment. Concomitant serum AED concentrations, biochemical and haematoE~gical parameters were unaffected by lamotrigine treatment.
Epilepsy & Seizure
To investigate the efficacy and safety of long-term lamotrigine monotherapy, 22 Japanese patients (19 with newly diagnosed epilepsy and 3 with recurrent epilepsy) were enrolled in the extension phase of the study after completion of 30 weeks of lamotrigine treatment. More than 80% of patients remaining at each time point achieved seizure-free status at all time points up to week 120 in the extension phase. No unexpected adverse events were reported. Our findings suggest that long-term lamotrigine monotherapy appears to be effective and generally well tolerated in adult Japanese patients with partial seizures and generalized tonic-clonic seizures.
Lamotrigine add-on for drug-resistant partial epilepsy
Reviews, 1996
The study purpose was to perform an open, prospective study on various aspects of Lamotrigine (LTG) effectiveness in Bulgarian patients with drug-resistant epilepsy. The study was performed with the participation of patients with epilepsy who attended the Clinic of Neurology at the University Hospital in Plovdiv, Bulgaria. The patients completed diaries about seizure frequency, severity, and adverse events. There were regular documented visits at 3 or 6 months during the first year of treatment with LTG and at 6 months afterwards, with dynamic assessment of seizure frequency, severity, adverse events, and EEG recordings. LTG was applied as add-on treatment in 73 patients (47 males, mean age 36 years). There was a relatively mild and stable dynamic improvement of seizure severity, a satisfactory seizure frequency reduction in 39.7% of participants, a stable mean seizure frequency reduction (43-59%) from the 6 th to the 36 th month of treatment and a stable responder rate (55.7-59.4%) during the same period. There were adverse events (dizziness/vertigo, generalized edema, irritability, aggressiveness, speech disturbances, visual hallucinations, sleepiness, insomnia, headache, diplopia, nystagmus, impaired balance, muscle cramps, gastrointestinal discomfort, generalized rash, fatigue, nausea) in 12.3% of patients. In conclusion, LTG treatment is associated with: a low and stable improvement of seizure severity, a good and stable improvement of seizure frequency, a possible worsening of seizure control, a good safety and tolerability.
Lamotrigine in Multihandicapped Therapy-Resistant Epileptic Patients
Clinical Drug Investigation, 1998
Objectives: This study evaluated the effects of lamotrigine in routine therapy in the highly selected clientele of the Residential Department of the Bethel Epilepsy Centre. Patients and Methods: In an open, observational, add-on study design, 125 resident patients with severe therapy-resistant epilepsy and multiple additional handicaps were treated with lamotrigine in titrated doses. Seizure types, monthly seizure frequency, seizure severity, and psychological status were recorded during a 3-month baseline and a 3-month lamotrigine treatment period prior to the key date of this analysis (31 March 1996). Results: At the time of analysis, the mean lamotrigine dosage was 391 mg/day (mean serum concentration 4.25 mg/L). 71.4% of the patients (after a mean observation time of 21.9 months) were still receiving lamotrigine. In the remaining 28.6%, the main reasons for withdrawal (after a mean of 10.5 months) were lack of effectiveness (19 patients, 15.2%), increase in seizure frequency (8 patients, 6.4%), and negative psychotropic effects (5 patients, 4.0%). On an intention-totreat basis, the responder rate (reduction in seizure frequency by 50% or more) was 28.8% (35.6% in focal epilepsy, 26.7% in generalised epilepsy, and 22.4% in epilepsy with focal and generalised seizures). Seizure reduction was similar for all seizure types. Lamotrigine was more effective when combined with valproic acid (p < 0.005) and less effective when combined with carbamazepine or phenytoin. Stepwise multivariate logistic regression revealed valproic acid (and not lamotrigine dose or concentration, co-medication, epileptic syndrome, or seizure type) as the only factor predicting seizure response. 28.0% of the patients had shorter and/or less severe seizures, and 8.8% had longer/more severe seizures. 25.6% experienced a positive and 8.0% a negative psychotropic effect (mostly aggression). In all, 53.6% of patients benefited according to the three efficacy criteria, and 8.8% deteriorated. The most frequent dose-dependent adverse effects were ataxia, dizziness and diplopia. Conclusions: Lamotrigine was an effective and well tolerated drug for this special patient group, especially when combined with valproic acid.
Long-term safety and efficacy of lamotrigine (Lamictal®) in paediatric patients with epilepsy
Seizure, 1997
This study was initiated to evaluate the long-term safety, tolerability and effect on seizure control of lamotrigine (Lamictal@) in paediatric patients with epilepsy. A total of 155 children (aged 2-19 years) with treatment-resistant epilepsy received add-on therapy or monotherapy lamotrigine for up to four years. Patients had already experienced benefit from lamotrigine treatment in an open one-year study before entering this open continuation study of up to three additional years of treatment. Overall, including both these studies, patients were treated with lamotrigine for 53-221 weeks, representing 417.9 patient-years of experience. The physician's global assessment of seizure control compared to the three-month period before lamotrigine treatment, indicated that seizure control was generally maintained during long-term lamotrigine treatment for up to four years. For 19 patients, the investigator recorded a subjective improvement in behaviour, alertness, seizure severity, quality of life and mobility with lamotrigine treatment, sometimes independent of seizure control. In total, 34 patients received lamotrigine monotherapy; 22 of these were maintained on lamotrigine monotherapy for at least one year. Lamotrigine was well tolerated. The majority of adverse experiences were classified by the'physician as being mild in intensity and only six patients (4%) withdrew from the study due to adverse experiences.