An epileptic seizure is a transient occurrence of signs and/or symptoms due to abnormal excessive or synchronous neuronal activity in the brain.1The definition of epilepsy requires at least one seizure and evidence of persistent changes in the brain, which increases the likelihood of seizures in the future. The prevalence of men is slightly higher than that of women. 1, 2The International League against Epilepsy (ILAE) Commission on Classification and Terminology, classify seizures into: Focal seizures that can be further described as having motor, sensory, autonomic, cognitive, or other features, Generalized seizures that can be subdivided into: Absence (Typical, Atypical), Tonic clonic, Clonic, Tonic, Atonic, Myoclonic, and Types that may be focal, generalized, or unclear (Epileptic spasms). 1In most surveys, approximately 60% of epilepsy will have no identifiable cause, the main Investigations of a patient with suspected epilepsy are: Electroencephalography (EEG) and neuroimaging (MRI, SPECT, and PET).2The management of patients with epilepsy is both challenging and rewarding, The main goal of AEDs therapy is to eliminate seizures without causing side effects.3Since 1960s and 1970s sodium valproate (valproate) and carbamazepine became the standard treatments for epilepsy, which they still are.4The introduction of new AEDs and the increased emphasis on maximizing the quality of life for patients with epilepsy have led to a new set of goals for the treatment of seizures. These goals have evolved from complete control of seizures, whether or not side effects occurred, to enabling patients with epilepsy to lead lifestyles consistent with their capabilities.3The choice of AEDs following a new diagnosis of epilepsy can be complex and is affected by age, co-morbidity, concomitant medication, possibility of pregnancy and the individual’s epilepsy classification.4Treatment usually starts with one drug at a low dose. The dose is then increased slowly. In most patients, epilepsy remits over a period of years and drug therapy may be withdrawn slowly.5The principal antiepileptic drugs used to treat patients with epilepsy are carbamazepine, ethosuximide, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, phenobarbital, phenytoin, primidone, tiagabine, topiramate, valproate, and zonisamide.6Current guidelines recommend valproate (VPA) as a treatment of first choice for patients with generalized onset seizures whilst carbamazepine (CBZ) is recommended as the first line treatment for patients with partial onset seizures.7-8 Several terms are used to describe health problems reported by patients taking AEDs, e.g. ‘‘adverse events,’’ ‘‘adverse effects,’’ ‘‘side effects’’ and ‘‘adverse drug reaction’’. These terms are often used interchangeably, but they are not.9 World Health Organization (WHO)’s definition of an adverse drug reaction, which has been in use for about 30 years, It is "a response to a harmful and unexpected drug, and it occurs at a dose that humans usually use to prevent, diagnose, or treat disease or change physiological functions." 10The terms “adverse reaction” and “adverse effect” are interchangeable, except that an adverse effect is seen from the point of view of the drug, whereas an adverse reaction is seen from the point of view of the patient. 11 -9There are several ways in which adverse effects have been classified. The classification “dose-related” or “idiosyncratic” is most commonly used. 12Adverse effects are a leading cause of treatment failure with antiepileptic drugs. Not only do they cause 25% of patients to stop treatment prematurely, they also prevent a fully effective dose from being reached and impair patient compliance with treatment. 13Furthermore, adverse effects of antiepileptic drugs are a major source of disability, morbidity, and mortality. 13The main reason for changing AEDs is lack of efficacy, but significant side effects are also an important reason for modifying treatment in those patients who reported higher levels of discomfort.14 With certain modification on the definition of the international conference on harmonization Guideline (ICH) E2A, we can define “cosmetic effect’’ as any negative (unfavorable) effects or positive (favorable) effects on the beauty, that is associated with the use of a medicinal product, Provided that a causal relationship between them is at least a reasonable possibility.A previous studies done showed the adverse effects of anti-epileptic drugs in the self-administered Adverse Event Profile tend to segregate into five classes. These include 1) Cognition/Coordination (unsteadiness, double or blurred vision, difficulty in concentrating, shaky hands, dizziness, and memory problems); 2) Mood/Emotion (feelings of aggression, nervousness or agitation, and depression); 3) Sleep (tiredness, restlessness, upset stomach, sleepiness, and disturbed sleep); 4) Weight/Cephalgia (weight gain and headache); and 5) Tegument/Mucosa (hair loss, problems with skin, and trouble with mouth or gums.15The two classes of Tegument/Mucosa and Weight/Cephalgia with exclusion of headache can be regarded as cosmetic effects. 16-1 7, 18 Weight gain and loss of hair commonly occur with sodium valproate while loss of weight occurred with levetiracetame.Gum hypertrophy,hirstism and acne are famous side effects of phenytoin. carbamazepine, phenytoin, phenobarbital, and lamotrogine can cause maculopapular rashes. 18
Objectives
General Objectives:
- To assess the cosmetic effects of AEDs among adult Sudanese patients with epilepsy.
Specific Objectives:
- To assess the impact of the cosmetic effects of AEDs on the quality of life.
- To assess the correlation between the cosmetic effects of AEDs and the compliance with the medications.