Subject: A
retrospective, cross-sectional, observational survey study to
analyse the role of Lacosamide as a first add-on in the
treatment of partial onset seizures
Epilepsy
is a chronic noncommunicable disease of the brain, characterized by
recurrent seizures, which are brief episodes of involuntary movement
that may involve a part of the body (partial) or the entire body
(generalized) and are sometimes accompanied by loss of consciousness
and control of bowel or bladder function.1
Epilepsy
is the most common chronic brain disease and affects people of all
ages. More than 50 million people worldwide have epilepsy; nearly
80% of them live in low- and middle-income countries.2
As per the
study published in 2019, in 2016, there were 45•9 million (95% UI
39•9–54•6) patients with all-active epilepsy (both idiopathic and
secondary epilepsy globally; age-standardized prevalence 621•5 per
100 000 population). As per the 2019 study, the prevalence of
epilepsy in India as per year 2016 was 3,934,737. The prevalence of
epilepsy in India has been mentioned as crude prevalence of
5.35/1,000, while as another study observed age-adjusted prevalence
rate as 4.71 per 1000.4,5,6
People
with epilepsy and their families frequently suffer from stigma and
discrimination. In many parts of the world the true nature of
epilepsy has also long been distorted by myths, fear and mistaken
notions about the disorder.2
ASDs,
previously also termed antiepileptic or anticonvulsant drugs, are
the main form of symptomatic treatment of people with epilepsy.
About 30 ASDs are currently used, of which most were approved over
the last 30 years.7
Lacosamide
is an antiepileptic drug (AED) approved for adjunctive treatment for
partial-onset seizures in patients ≥ 17 years of age. Lacosamide
(LCM) exerts its therapeutic activity by causing slow inactivation
of neuronal sodium channels, a mechanism distinct from fast sodium
channel activating AEDs like carbamazepine and lamotrigine.
Lacosamide demonstrates linear kinetics, nearly 100%
bioavailability, with a half-life of approximately 13 hours, and no
major pharmacokinetic drug–drug interactions. The tolerability and
efficacy of lacosamide was established in patients with medically
resistant partial-onset seizures in three randomized,
placebo-controlled trials. In VITTOBA, a prospective real-world
study demonstrated that lacosamide added as first add on, was
effective at improving seizure control and was well tolerated in
patients treated in routine clinical practice.9
Clinical
studies have shown fast onset of anticonvulsant effects and a
significant reduction of partial-onset seizures. LCM was well
tolerated with the most common adverse event being dizziness,
followed by headache, nausea and diplopia. LCM was substantially
less associated with sedation, cognitive dysfunction, rash and mood
disorders when compared with many other existing anti-epileptic
drugs.10
Lacosamide
(Lacoset) is marketed by Sun Pharmaceutical Industries Ltd. Although
every product is marketed only after regulatory approval, it is
important to know how it performs in day-to-day practice of
individual medical practitioners. For this purpose, we have planned
to conduct a retrospective, cross-sectional, observational survey to
assess the role of Lacosamide in patients with epilepsy
We invite
you to participate in this data collection activity. All you need to
do is to report on a standard form your experience with Lacosamide
in the normal course of your practice. If you agree to participate,
you will need to fill data collection forms (which we call DCF).
We trust
you and we are partners in promoting safe and effective drug
therapy. In that spirit we hope you will consent to participate in
this study. If you do, please sign and return the enclosed reply
along with your visiting card for accuracy of records.
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