Trobalt r (retigabina) of GSK shows its potential to keep epilepsy patients free of crisis in the long term.

More than six million people in Europe suffer from epilepsy and about 30% still experiencing crisis despite getting treatment with the antiepileptic drugs available (2). In addition, crises are associated to an increase in physical problems, including fractures and bruises, and higher rates of prevalence of diseases or psychosocial problems, so their reduction is an important milestone in the management of this disease (3).

Tabled data from three studies long-term: study 212 (extension of the 205 study of dose range) and 303/304 studies (extensions of trials registration for retigabina, 1 and 2 RESTORE pivotal *), which included 222, 181 and 375 patients, respectively. In all three studies, patients were treated with retigabina for a minimum of six (n = 612), 12 (n = 450) or 24 (n = 183) months. During the transition to open extensions, adjusted the dose of retigabina, or remained, 900 mg/day (studies 212 and 304) or 1,200 mg/day (study 303). Thereafter, doses of retigabina (study 303 and 304: 360 – 1200mg/day and study 212: 900 – 1200mg/day) and of the antiepileptic drugs already receiving patients could change according to individual efficacy/tolerability of each patient (1).

The results show that patients treated with retigabina for at least 12 months, 12.4% (n = 56) were free of crisis during a continuous period of six months. In those treaties for at least 24 months, 11.5% (n = 21) it was for a year, showing retigabina (1)’s long-term effectiveness.

Professor Martin j. Brodie, studies presented at the Congress, noted, be free of crisis with minimum side effects or without them, is the best result we could expect in antiepileptic drugs refers. We had already previously obtained these results in short-term with retigabina treatments and it is now very positive knowledge that these results are also maintained long term ”.

In the trials pivotal, the most frequent adverse events with the use of this medication in combination with other antiepileptic drugs (occurred in at least 5% of patients and with twice as often than in the treated with placebo) were dizziness (23%), fatigue (15%), confusion (9%), dizziness (8%), tremor (8%), abnormal coordination (7%), double vision (7%), alteration of care (6%), memory loss (6%), and blurred vision (5%). In addition, the drowsiness occurred in 22% of patients treated with retigabina in comparison with 12 per cent of patients who received placebo.

Retigabina

Retigabina, developed by Valeant Pharmaceuticals International and GSK, received approval from the European Medicines Agency in March 2011 (7) for the adjunctive treatment of partial seizures with or without secondary generalization in adults with epilepsy (when the crisis occurs only in a part of the brain) (8). GSK and Valeant signed a global agreement exclusively for retigabina in 2008.

In controlled trials with retigabina, urinary retention occurred in 0.9% of patients who were treated with the medication compared to 0.5% of patients who received placebo. Throughout phase II/III there were four (0.3%) serious cases of urinary retention, three of which led to the withdrawal of treatment. Therefore, the EU recommended that retigabina be used with caution in patients at risk for urinary retention (7).

Retigabina also led to a prolongation of the QT (the heart’s electrical activity) interval when studied in its highest dose in healthy volunteers, in a specific study to do so. As precautionary measure, the EU also recommends holding an electrocardiogram before his administration in patients who have or may have congestive heart failure, ventricular hypertrophy, hypokalemia or hypomagnesemia, and in patients who begin treatment they have over 65 years of age (8).

GlaxoSmithKline

GlaxoSmithKIine (GSK), one of the companies leading global research-based pharmaceutical and health care, aims to improve the quality of life of people, making it possible that people have more vitality, feel better and live longer.

GSK has extensive experience in research in the area of Neurology and a considerable variety of drugs in research in the field of neuroscience, remains committed to improving the quality of life of people with neurological disorders.

References

(*) Retigabine Efficacy and Safety Trials for Partial Onset Epilepsy

(1). Brodie MJ, et to the. Seizure-free rates in patients receiving ≥6, ≥12 and ≥24 months of open-label Retigabine (Ezogabine). Abstract accepted for presentation at the 15th Congress of the European Federation of Neurological Societies (EFNS), Budapest, Hungary, 10-13 September 2011

(2). World Health Organization. Epilepsy in the WHO European region. Fostering epilepsy care in Europe. August 2010

(3). World Health Organization. Epilepsy facts & figures.

(4). Brodie MJ et to the. Efficacy and safety of adjunctive ezogabine (retigabine) in refractory partial epilepsy. Neurology. 2010; 16; 75 (20): 1817

(5). GSK dates on file

(6). Porter et to the. Randomized, multicenter, dose-ranging trial of retigabine for partial-onset seizures. Neurology. 2007; 68: 1197

(7). EPAR Retigabina

(8). Retigabina data sheet technical