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\begin{document}

\title{ADVERSE DRUG REACTION IN PEOPLE WITH EPILPSY}



\author[1]{Luqman Ogunjimi}%
\author[1]{Akinyinka Alabi}%
\author[1]{Aderonke Aderinola}%
\author[1]{Mojisola Bello}%
\author[1]{Yusuf Oladunjoye}%
\author[1]{Adeola Kasali}%
\author[1]{Emmanuel Kasumu}%
\author[1]{Ibironke Oyenuga}%
\author[1]{Akinbodu Shittabey}%
\author[1]{Modupeoluwa Onipede}%
\author[1]{Oludolapo Dele}%
\author[1]{Bamidele Osalusi}%
\affil[1]{Olabisi Onabanjo University Obafemi Awolowo College of Health Sciences}%


\vspace{-1em}



  
  \date{May 19, 2024}


\begingroup
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\selectlanguage{english}
\begin{abstract}
OBJECTIVES: There is a need for early identification and intervention of
Adverse Drug Reaction (ADR) to alleviate unacceptably growing burden,
morbidity and mortality associated in People With Epilepsy (PWE). This
study is aimed at identifying factors associated with ADR and medication
adherence among patients in PWE. METHODS: It is a cross-sectional
questionnaire-based study consisting of 940 consenting participants aged
16 years and above attending epilepsy clinics for period of 5years with
diagnosis confirmed by International League against Epilepsy (ILAE)
criteria and supported by Electroencephalography (EEG). 21-item
Liverpool Adverse Effect Profile (LEAP) and 8-item. Morinsky Medication
Adherence Scale (MMAS) were used to assess ADR and adherence
respectively. RESULTS: The highest reported ADR in PWE were nervousness
(34.3\%), aggression (33.6\%) and weight gain (32.3\%). Specifically,
(20.1\%) of the participant complained of memory problem, while the
lowest were hair loss (7.2\%), trouble with mouth (8.9\%) and problem
with skin (9.3\%). Using the MMAS, 545(90.2\%), 28(4.6\%) and 31(5.1\%)
of PWE in this study were classified as having high, medium, and low
adherence, respectively. Duration of AEDs use and duration of epilepsy
were the major determinant of ADR in PWE on regression model.
CONCLUSION: Duration of AEDs use and duration of epilepsy are the major
determinant of ADR in PWE. Effective strategies to identify and reduce
ADR should be incorporated to management of PWE by Health Care Providers
to improve their quality of life. Furthermore, physician should aim
towards reducing the duration of AED use and the epilepsy.%
\end{abstract}%



\sloppy


\textbf{ADVERSE DRUG REACTION IN PEOPLE WITH EPILPSY}

\textbf{Ogunjimi Luqman\textsuperscript{1}, Alabi
Akinyinka\textsuperscript{1}, Aderinola Aderonke\textsuperscript{1},
Olusola-Bello Mojisola\textsuperscript{3}, Oladunjoye
Yususf\textsuperscript{1}, Kasali Adeola\textsuperscript{1}, Kasumu
Emmanuel\textsuperscript{1}, Oyenuga Ibironke\textsuperscript{1},
Akinbodu Shittabey\textsuperscript{4}, Onipede
Modupeoluwa\textsuperscript{1}, Dele Oludolapo\textsuperscript{1},
Osalusi Bamidele\textsuperscript{2}.}

\textbf{1. Department of Pharmacology and Therapeutics, Obafemi Awolowo
College of Health Sciences, Olabisi Onabanjo University, Remo Campus,
Sagamu Ogun state, Nigeria.}

\textbf{2. Department of Medicine, Obafemi Awolowo College of Health
Sciences, Olabisi Onabanjo University, Remo Campus, Sagamu Ogun state,
Nigeria.}

\textbf{3. Radiology Department, Obafemi Awolowo College of Health
Sciences, Olabisi Onabanjo University, Remo Campus, Sagamu Ogun state,
Nigeria.}

\textbf{4. Department of Physiology, Obafemi Awolowo College of Health
Sciences, Olabisi Onabanjo University, Remo Campus, Sagamu Ogun state,
Nigeria.}

\textbf{Corresponding Author:} Ogunjimi Luqman Opeoluwa. \textbf{Msc
(Ib), MBChB (Ogun), FWACP (Neuro) FMCP (Neuro)}

Department of Pharmacology and Therapeutics, Obafemi Awolowo College of
Health Sciences, Olabisi Onabanjo University, Remo Campus, Sagamu, Ogun
State.

email: luqmanogunjimi@yahoo.com Telephone: +234-703-268-3222

ORCID iD. https://orcid.org/0000-0001-9185-9774.

\textbf{Declarations}

\textbf{Ethical approval:} This was obtained from joint review board of
Olabisi Onabanjo University Teaching Hospital with assigned number of
OOUTH/HREC/294/2019AP.

\textbf{Consent to participate:} Participants for this study were fully
informed on the research protocol detailing the purpose, method, risks,
and benefits of the research. Each of the participant then voluntarily
gave a written and well understood informed consent. The consent was
translated to the local language for those who did not understand
English language and the services of interpreters were employed.
Participants were free to decline participation or withdraw from the
study at any time without reprisal or loss of benefit. There were
sections for the person giving the consent, person obtaining the consent
and witnesses in the informed consent.

\textbf{Consent for publication} : All the authors gave consent for
publication of this manuscript. The corresponding author shall be Dr
Ogunjimi Luqman of the department of Pharmacology and Therapeutics,
Obafemi Awolowo College of Health Sciences, Olabisi Onabanjo University,
Ogun state, Nigeria.

\textbf{Material and data availability statement} : The data will be
made available upon reasonable request, the principal investigator, will
make the data available.

\textbf{Conflict of interest:} We declare that there are no conflict of
interest

\textbf{Source of funding:} None

\textbf{Author's contribution:} Luqman, Yusuf and Oludolapo conceived
the idea of the study. Ibironke, and Adeola were involved with
statistical analysis. EEG interpretation was done by Luqman and
Bamidele. Luqman, Akinyinka, Shittabey, Bamidele, Ibironke, Aderonke,
Modupeoluwa and Adeola were involved in the study design, interpretation
and also made significant intellectual contribution to the manuscript
development. Mojisola and Luqman performed neuroimaging, recruited
patients, and made significant intellectual contributions to the
development of manuscripts. Luqman, Oludolapo, Aderonke, Emmanuel and
Akinyinka provided the laboratory expertise and also contributed
significantly in the manuscript development.



\textbf{ABSTRACT}

\textbf{OBJECTIVES:} There is a need for early identification and
intervention of Adverse Drug Reaction (ADR) to alleviate unacceptably
growing burden, morbidity and mortality associated in People With
Epilepsy (PWE). This study is aimed at identifying factors associated
with ADR and medication adherence among patients in PWE.

\textbf{METHODS:} It is a cross-sectional questionnaire-based study
consisting of 940 consenting participants aged 16 years and above
attending epilepsy clinics for period of 5years with diagnosis confirmed
by International League against Epilepsy (ILAE) criteria and supported
by Electroencephalography (EEG). 21-item Liverpool Adverse Effect
Profile (LEAP) and 8-item. Morinsky Medication Adherence Scale (MMAS)
were used to assess ADR and adherence respectively.

\textbf{RESULTS:} The highest reported ADR in PWE were nervousness
(34.3\%), aggression (33.6\%) and weight gain (32.3\%). Specifically,
(20.1\%) of the participant complained of memory problem, while the
lowest were hair loss (7.2\%), trouble with mouth (8.9\%) and problem
with skin (9.3\%). Using the MMAS, 545(90.2\%), 28(4.6\%) and 31(5.1\%)
of PWE in this study were classified as having high, medium, and low
adherence, respectively. Duration of AEDs use and duration of epilepsy
were the major determinant of ADR in PWE on regression model.

\textbf{CONCLUSION:} Duration of AEDs use and duration of epilepsy are
the major determinant of ADR in PWE. Effective strategies to identify
and reduce ADR should be incorporated to management of PWE by Health
Care Providers to improve their quality of life. Furthermore, physician
should aim towards reducing the duration of AED use and the epilepsy.



\textbf{1.0 INTRODUCTION}

Epilepsy is a major public health with serious physical, social and
psychological consequences that relies heavily on antiepileptic drugs
(AEDs), adherence to medication to achieve to seizure remission and
improve quality of life while avoiding unwanted
side-effects.(Abou-Khalil, 2016; Fadare et al., 2018; George et al.,
2015; Lyseng-Williamson, 2011; Olusanya et al., 2017)In a systematic
review among developing countries to determine magnitude, causes, and
possible intervention strategies, the overall estimated Treatment Gap
(TG) was 56/100. (Nwani et al., 2013) Inadequate skilled manpower, cost
of treatment, cultural beliefs, unavailability of AEDs were some of the
identified reason for the relatively high TG.(Nwani et al.,
2013)Furthermore, Adverse Drug Reaction(ADR) contributes significantly
to the TG and negatively impact on outcome, and quality of care, social
and economic burden in People With Epilepsy (PWE).(Adedapo et al., 2021;
Coleman \& Pontefract, 2016; Habib et al., 2013)In a recent cohort study
among adults admitted to medical wards in southwestern Nigeria, aimed at
determining prevalence, incidence, risk factors and fatality of ADR,
anticonvulsant therapy accounted for 2.9\% with Carbamazepine (CAP) and
phenytoin being the major culprit.(Adedapo et al., 2021)Cognitive
dysfunction, somnolence, irritability, behavioral issues, drowsiness,
gingival hyperplasia, depression, gastrointestinal disturbance, and
fatigue are some of the common ADR in PWE.(Du et al., 2019; Fadare et
al., 2018; Kaushik et al., 2019; Silvennoinen et al., 2019)ADR has been
established as a key factor of non-adherence, poor treatment outcome,
poor seizure control and increased hospitalizations and poor quality of
Life.(Adedapo et al., 2021; Yang et al., 2014)Gender, sex, genetic
influence, background chronic illness, polytherapy, inappropriate dose,
idiosyncratic reactions, seizure type, duration of use and type of AEDs,
idiosyncratic and dose dependent reaction are factors associated with
ADR (Abou-Khalil, 2016; Du et al., 2019; Meador et al., 2009; St. Louis,
2009). Liverpool Adverse Effect Profile (LAEP) is a reliable instrument
which has been tested as a good measure of ADR in PWE on AEDs across the
globe and has been correlated with medication adherence, depression
status and suicidal tendency, cognitive dysfunction, and level of
education.(Du et al., 2019; Fadare et al., 2018; Lee et al., 2014;
Olusanya et al., 2017; Yang et al., 2014) Morinsky Medication Adherence
Scale (MMAS) is an 8-item scale which has been previously validated and
extensively used severally in conditions like diabetes mellitus,
psychiatric disorders and hypertension among Nigeria cohorts with
description of good internal consistency and reliability. There is an
increasing need to develop appropriate strategy for effective early
identification and intervention to alleviate unacceptably growing
burden, morbidity and mortality associated with ADR in PWE. This study
is aimed at identifying factors associated with ADR and medication
adherence among patients in PWE.



\textbf{METHOD}

A multicenter observational and descriptive study carried out in
southwestern part of Nigeria among adults PWE after due ethical
clearance has been obtained. The estimation of sample size was done by
using the single population proportional formulation by taking 5\%
margin of error, 95\% confidence level and proportion of reported
adverse events as 0.5\%. Using convenient sampling method, we included
940 consenting participants aged 16 years and above attending epilepsy
clinics for period of 5years with diagnosis confirmed by International
League against Epilepsy(ILAE) criteria and supported by
Electroencephalography(EEG).(Brodie et al., 2018; Fisher, 2017; Hirsch
et al., 2013; Scheffer et al., 2017) The case records of all patients
attending/that attended neurology clinics in the last 5 years with
diagnosis of epilepsy in the selected hospitals was reviewed with the
use of a semi structured questionnaire, to extract information about
clinical and socio demographic characteristics. These include age, age
of onset, seizure characteristics, type, and duration of AEDs.

LEAP, a previously validated instrument was used to assess ADR. It is a
21- item self-reported questionnaire, designed to measure AEDs side
effect which covers both Central Nervous System (CNS) and Non-CNS
related adverse effects. The total score of LAEP ranges from 19 to 76,
with higher score indicating more adverse effects burden. Scores [?]45
indicates mild to moderate adverse effects and reaches the toxic level
if the total score exceeds 45.(Fadare et al., 2018). (Fadare et al.,
2018; Sakuma et al., 2014; Yang et al., 2014). MMAS a previously
validated and extensively used adherence instrument was used to measure
medication adherence. There are five expected responses in MMAS namely;
never, rarely, sometimes, often and always respectively which are scored
as 0, 1, 2, 3, 4 respectively and subsequently subdivided into 0 (high
adherence), 1-2 (medium adherence) and \textgreater{}2 (poor adherence).
These instruments were administered by Neurologist and trainees who are
qualified Doctors at participating Centers. Data were cleaned, coded,
and analyzed using the IBM Statistical Package of Social Sciences
Version 23. Socio-demographic and clinical characteristics of patients
were presented as frequency (percentage). Using Pearson chi square test.
Independent T-test was used to examine the possible association between
ADR with gender, AED therapy (monotherapy and polytherapy) and
medication adherence. One-way ANOVA test was used to assess the
association between type of seizure, duration of epilepsy and
epileptiform pattern. The significance level of statistical measures was
set at p\textless{}0.05.



\textbf{3.0 RESULT}

\textbf{3.1. Relationship between socio-demographic level/ clinical
profiles and adherence level in PWE}

The mean age (SD) among the participant was 39.19(18.80). The mean (SD)
of the female among participant was 38.07(18.35) compare to the mean
(SD) value of 40.44(19.24) among male participant. The total number of
male participants was 445(47.3\%) while that of female participant was
495(52.7\%). The number of participants that were never married,
currently married, separated, widow/widower, cohabiting, divorce
respectively was 383(40.7\%), 539(57.3\%), 2(0.2\%), 11(1.2\%),
2(0.2\%), 3(0.3\%) respectively. The number of participants that had
none, primary, secondary, tertiary, postgraduate level of formal
education respectively was 45(4.8\%), 37(3.9\%), 350(37.2\%),
414(44.0\%), 94(10.0\%) respectively. The level of adherence (high,
medium, low) in PWE were comparable with regards to gender, age, marital
status, formal education, seizure remission, and seizure type. Using the
MMAS, 545(90.2\%), 28(4.6\%) and 31(5.1\%) of PWE in this study were
classified as having high, medium, and low adherence, respectively. (see
Table 1)

\textbf{4.2: Comparison between the mean LAEP scores and social
demographic/clinical profiles}

There was significant association between drug adherence, duration,
duration of AEDs, and epileptiform pattern with mean LEAP score of
45.25(9.36), 44.24(10.40), 40.98(9.30) respectively ranging from high
adherence to low adherence respectively, 41.43(9.74), 41.05(9.70),
42.84(10.12), 46.10(9.98), 46.98(10.40) respectively in the duration of
\textless{}1 Month, 1-5 months, 6 months -1year, 2-5year,
\textgreater{}5 years respectively, 41.33(9.49), 47.21(10.59)
respectively ranging from \textless{}2Years, \textgreater{}2Years
respectively, 43.54(9.92), 41.51(10.52), 46.08(9.25), 42.47(10.10)
respectively, for generalized, focal, focal to secondary generalized,
none respectively. (see Table 2)

\textbf{4.3: Frequency and prescription pattern of AEDs among
participants}

The frequency of participants on medication were 604(64.2\%) with those
on monotherapy and polytherapy respectively been 498(52.9\%) and
106(11.2\%) respectively. The frequency of participants that were on
CAP, LVC, Gabapentin, Valproate, Phenytoin, Clonazepam,
Phenobarbiturate, CAP+LVC respectively were 414(68.5\%), 56(9.2\%),
1(0.1\%), 11(1.8\%), 11(1.8\%), 1(0.1\%), 4(0.6\%), 55(9.1\%)
respectively. The mean (SD) of the participant on medication,
monotherapy, polytherapy, CAP, LVC, Gabapentin, Valproate, Phenytoin,
Clonazepam, Phenobarbiturate, CAP+LVC respectively were 44.43(10.48),
44.08(10.65), 46.10(9.52), 44.26(10.59), 44.63(10.58), 65, 37.91(13.40),
38.91(9.44), 36, 45.50(3.00), 47.44(8.61) respectively. (See Table 3)

\textbf{4.4} \textbf{Frequency of reported adverse effects of PWE.}

The highest reported ADR in PWE were nervousness (34.3\%), aggression
(33.6\%) and weight gain (32.3\%). Specifically, (20.1\%) of the
participant complained of memory problem, while the lowest were hair
loss (7.2\%), trouble with mouth or gum (8.9\%) and problem with skin
(9.3\%). (see Table 4)

\textbf{4.5 Determinant of ADR in PWE}

There was significant association between medication adherences
(p0.000), duration of epilepsy (p0.000), duration of AED (p0.000),
epileptiform pattern (p0.019) with mean LEAP score. (See Table 3)
However on regression model, only duration of AEDs used and duration of
epilepsy, were the major determinant of ADR in PWE. (see Table 5)

\textbf{4.0 DISCUSSION}

We reported a significant association between medication adherence,
duration of epilepsy, duration of AED use, Epileptiform pattern with
mean LAEP score. Furthermore, the mean LAEP from this study was higher
compared to values previous studies. The mean age of our participant is
39.19\selectlanguage{ngerman}±8.80, with higher values in male compared to female participants.
The female preponderance among participants was like findings from
previous studies among PWE. Furthermore, the mean (SD) between ages
13-20, 21-35, 36-50, \textgreater{}50 respectively is 175(18.6),
298(31.7), 201±21.4, and 266(28.3), respectively. Paul et al found that
the prevalence of active epilepsy was very similar for 0-39 age group
but higher among women in the age group of 40-50 years. When the
prevalence trend of lifetime epilepsy was analyzed by sex, the peak in
the 20-39 age group is higher for men, but the second peak in the 50-59
age group is seen only in women.(Paul et al., 2012)The mean LAEP score
among cohorts from this study is higher than reported values from
previous studies conducted in Nigeria, Italy, and India.(Du et al.,
2019; Fadare et al., 2018; Lee et al., 2014) This difference might be
due to pharmacogenomics, drug interaction, inter and intra racial
disparity, under reporting of ADR, varied doses of AEDs, different
number of participants and duration of treatment but more importantly
different methodological approach. For instance, Fadare and his
colleagues in a Nigeria study aimed at determining medication adherence
and adverse effect profile of AEDs among Nigerian cohorts, reported a
lower mean LAEP score with highest value of those on
phenobarbital.(Fadare et al., 2018)This finding which is similar to that
of this study, is not unexpected as Phenobarbitone has been associated
with several significant adverse effect profile ranging cognitive
dysfunction, enzyme inductions, drowsiness, headache, dizziness and
psychomotor disturbance.(Abou-Khalil, 2016; Goodman et al., 2015; Roy et
al., 2016)In a study to access the extent of ADR of CBZ and its
potential associated factors, memory, headache, restlessness, tiredness
and depression were most frequently reported ADR and identified female
gender, lower level of formal education has factors associated with
ADR.(Olusanya et al., 2017) Nasopharyngitis, agitation, hyperkinetic
muscle activity, outburst of anger, agitation has been associated with
ADR of LVC.(Bates et al., 1995; Belcastro et al., 2008; Joshi et al.,
2017)In a review recently published by Cochrane evaluated the
effectiveness of LVC, six most common ADR in a decreasing order:
somnolence, headache, asthenia, accidental injury, dizziness and
infection were reported. Only somnolence and infection were
significantly associated with LVC.(Kaushik et al., 2019) Routine
evaluation for known ADR that is specific for AEDs should be
incorporated to management of PWE by physician and Health Care Providers
(HCP) to improve their quality of life. In previous studies, age,
gender, multiple drugs, disease state, allergy, genetic factors, and
large doses of drugs were identified as determinants of ADR in PWE. In
this study, adherence, duration of epilepsy, duration AEDs use, presence
of Epileptiform pattern, drug adherence and duration of seizures were
identified as significant factors associated with high mean LEAP which
increase the possibility of the occurrence of high ADRs in PWE.
In-tandem with previous studies,(Du et al., 2019; Fadare et al., 2018;
Kaushik et al., 2019)the present study reported higher mean LAEP score
for patients on polytherapy compared to those on monotherapy, though not
statistically significant. This is not unexpected as polypharmacy or use
of more than one medication for epilepsy has been linked to increase
ADR.(Adedapo et al., 2021; St. Louis, 2009)This is the reason why PWE,
therapy should be started with a single AEDs and then titrate as
appropriate after due consideration of other factors that govern choice
of AEDs. Combination therapy should be considered only when monotherapy
fails.(Assadeck et al., 2019; Joshi et al., 2017; Stephen \& Brodie,
2012)It is recommended that AED can be gradually withdrawn after 2 years
of seizure freedom, and this must be carried out under the guidance of a
physician.(Assadeck et al., 2019; Brodie \& Sills, 2011; St. Louis,
2009)

Using the MMAS-8, 4(0.43\%), 571(61.7\%), and 351(37.9\%) respectively,
of the participants were identified as highly adherent, medium adherent
and no adherent to AEDs, respectively. This shows that, majority of PWE
in this study had reduced number of highly adherence patients compared
to findings in previous studies.(Du et al., 2019)This underscores the
importance of compliance for better seizure controls and extent of TG.
The use of alternatives to medicine such as healing homes, herbalists,
and other spiritual mission houses, have been ascribed for low adherence
in previous studies which account for the high rate of treatment gap in
observed low- and middle-income countries.(Assadeck et al., 2019; Nwani
et al., 2013; Owolabi et al., 2020) There is a dramatic global disparity
in the care for epilepsy between high- and low-income countries, and
between rural and urban settings. The reported size of the epilepsy
treatment gap in Sub Sahara African varies widely, ranging from 23\% in
Senegal to 100\% in Uganda, Tanzania, Gambia, and Togo.(Adeloye, 2014;
Ding et al., 2021; Owolabi et al., 2020) A similar study in eastern
Nigeria, reported overall treatment gap of 76\%, diagnosed gap in 38\%
(n=11/29) and those who were diagnosed but discontinued AED treatment of
their own volition accounting for a therapeutic gap of 38\%
(n=11/29).(Nwani et al., 2013) An online survey among 408 adults with
epilepsy and 175 neurologists who treat epilepsy revealed that 29\% of
patients self-reported non-adherent to medications in a one-month
period. Surprisingly from this study, there was no significant
association between medication adherence and age, gender, marital
status, level of education, seizure remission, seizures, and type of
seizure in this study. However, there was a significant association
between adherence and mean LAEP score. Nervousness, aggression, and
memory problems were the most common ADRs previously reported in PWE.
This finding is similar to findings from this study which revealed
nervousness, aggression, weight gain, unsteadiness, restlessness and
tiredness are the most common ADR. Furthermore, we reported that
Carbamazepine (68\%) was the most frequently prescribed monotherapy AEDs
used, followed by Levetiracetam (9\%) in this study, like other
published studies in India and Nigeria.

\textbf{CONCLUSION}

We reported a significant association between medication adherence,
duration of epilepsy, duration of AED use, Epileptiform pattern with
mean LAEP score. Furthermore, the mean LAEP from this study was higher
compared to values from previous studies. Duration of epilepsy and AEDs
usage are the major determinant of adverse drug reaction in PWE. Routine
evaluation for known ADR that is specific for AEDs should be
incorporated to management of PWE by physician and Health Care Providers
(HCP) to improve their quality of life. Overall goal of seizure
management should be aimed at achieving early seizure control and
remission with the aim of attaining a seizure free stage period of more
than 3-5years so that AEDs might not be needed.



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\end{enumerate}

\textbf{TABLE 1: Showing relationship between adherence level and
clinical profiles in PWE.}\selectlanguage{english}
\begin{longtable}[]{@{}llllllll@{}}
\toprule
\begin{minipage}[b]{0.12\columnwidth}\raggedright\strut
Variables\strut
\end{minipage} & \begin{minipage}[b]{0.12\columnwidth}\raggedright\strut
N (\%) Total=940\strut
\end{minipage} & \begin{minipage}[b]{0.12\columnwidth}\raggedright\strut
High adherence N=545\strut
\end{minipage} & \begin{minipage}[b]{0.12\columnwidth}\raggedright\strut
Medium adherence N=28\strut
\end{minipage} & \begin{minipage}[b]{0.12\columnwidth}\raggedright\strut
Poor adherence N=31\strut
\end{minipage} & \begin{minipage}[b]{0.12\columnwidth}\raggedright\strut
Total adherence N=604\strut
\end{minipage} & \begin{minipage}[b]{0.12\columnwidth}\raggedright\strut
x\textsuperscript{2} value\strut
\end{minipage} & \begin{minipage}[b]{0.12\columnwidth}\raggedright\strut
p value\strut
\end{minipage}\tabularnewline
\midrule
\endhead
\begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
Gender Male Mean (SD) Female Mean (SD)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
40.44(19.24) 38.07(18.35)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
259(47.5) 286(5.5)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
12(42.9) 16(57.1)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
12(38.7) 19(61.3)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
283(46.9) 321(53.1)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
1.103\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
0.5766\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
Age Mean (SD) 13-20 21-35 36-50 \textgreater{}50\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
39.19(18.80) 175(18.6) 298(31.7) 201(21.4) 266(28.3)\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
39.6(19.1) 102(18.7) 172(31.6) 108(19.8) 163(29.9)\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
38.1(19.3) 7(25.0) 9(32.1) 6(21.4) 6(21.4)\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
43(20.1) 5(16.1) 8(25.8) 5(16.1) 13(41.9)\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
39.7(19.1) 114(18.9)1(31189(31.3) 119(19.7) 182(30.0)\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
f=0.577 3.398\strut
\end{minipage} & \begin{minipage}[t]{0.10\columnwidth}\raggedright\strut
0.562 0.757\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
Marital Status Never married Currently married Separated Widow/widower
Cohabiting Divorce\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
383(40.7) 539(57.3) 2(0.2) 11(1.2) 2(0.2) 3(0.3)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
214(39.3) 318(58.3) 1(0.2) 9(1.7) 1(0.2) 2(0.4)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
11(39.3) 17(60.7) 0(0.0) 0(0.0) 0(0.0) 0(0.0)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
15(48.4) 15(48.4) 0(0.0) 0(0.0) 0(0.0) 1(3.2)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
240(39.7) 350(57.9) 1(0.2) 9(1.5) 1(0.2) 3(0.5)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
7.320\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
0.695\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
Formal Education None Primary Secondary Tertiary Postgraduate\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
45(4.8) 37(3.9) 350(37.2) 414(44.0) 94(10.0)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
27(5.0) 26(4.8) 210(50.0) 235(43.1) 47(8.6)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
1(3.6) 1(3.6) 9(32.1) 16(57.1) 1(3.6)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
0(0.0) 3(9.7) 15(48.4) 12(38.7) 1(3.2)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
28(4.6s) 30(5.0) 234(38.7) 263(43.5) 49(8.1)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
7.405\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
0.494\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
Seizure remission \textless{}1 month 1-5 months 6months-1 year 2-5 years
\textgreater{}5 years\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
146(15.5) 290(30.9) 266(28.3) 194(20.6) 44(4.7)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
86(15.8) 166(30.5) 162(29.7) 108(19.8) 23(4.2)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
2(7.1) 9(32.1) 12(42.99) 5(17.9) 0(0.0)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
6(19.4) 7(22.6) 8(25.8) 9(29.0) 1(3.2)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
94(15.6) 182(30.0) 182(30.0) 122(20.2) 24(4.0)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
6.502\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
0.591\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
Seizures types Focal onset Generalized onset Unknown onset\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
226(24.0) 686(73.0) 28(3.0)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
135(24.8) 394(72.3) 16(2.9)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
5(17.9) 23(82.1) 0(0.0)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
8(25.8) 22(71.0) 1(3.2)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
148(24.5) 439(72.7) 17(2.8)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
1.746\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
0.782\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
Epilepsy classification focal Generalized Combined Unknown\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
704(74.9) 216(23.0) 17(1.8) 3(0.3)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
58(10.6) 388(71.2) 76(13.9) 23(4.2)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
2(75.8) 23(82.1) 3(10.7) 0(0.0)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
5(16.1) 24(77.4) 1(3.2) 1(3.2)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
65(10.8) 435(72.0) 80(13.2) 24(4.0)\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
5.680\strut
\end{minipage} & \begin{minipage}[t]{0.12\columnwidth}\raggedright\strut
0.460\strut
\end{minipage}\tabularnewline
\bottomrule
\end{longtable}

\textbf{TABLE 2: Showing comparison of the mean LAEP scores and social
demographic/clinical profiles.}\selectlanguage{english}
\begin{longtable}[]{@{}llll@{}}
\toprule
\begin{minipage}[b]{0.22\columnwidth}\raggedright\strut
Variables\strut
\end{minipage} & \begin{minipage}[b]{0.22\columnwidth}\raggedright\strut
LAEP Mean (SD)\strut
\end{minipage} & \begin{minipage}[b]{0.22\columnwidth}\raggedright\strut
Statistical value\strut
\end{minipage} & \begin{minipage}[b]{0.22\columnwidth}\raggedright\strut
P value\strut
\end{minipage}\tabularnewline
\midrule
\endhead
\begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
Gender Male Female\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
42.74(10.35) 43.11(9.90)\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
T=0.564\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
0.573\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
Number of AEDs Monotherapy Polytherapy\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
44.08(10.65) 46.09(9.52)\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
T=-1.788\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
0.074\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
Drug adherence High adherence Medium adherence Low adherence\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
45.25(9.36) 44.24(10.40) 40.98(9.30)\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
F=11.563\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
\textbf{0.000*}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
Duration \textless{}1 Month 1-5 Months 6 months -1year 2-5year
\textgreater{}5years\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
41.43(9.74) 41.05(9.70) 42.84(10.12) 46.10(9.98) 46.98(10.40)\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
F=10.120\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
\textbf{0.000*}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
Duration of AED \textless{}2Years \textgreater{}2Years\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
41.33(9.49) 47.21(10.59)\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
T=-7.141\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
\textbf{0.000*}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
Epileptiform Pattern Generalized Focal Focal to Secondary generalized
None\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
43.54(9.92) 41.51(10.52) 46.08(9.25) 42.47(10.10)\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
F=3.342\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
\textbf{0.019*}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
Seizure type Focal onset Generalized Unknown\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
42.11(9.24) 43.33(10.33) 40.14(10.88)\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
F=2.330\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
0.098\strut
\end{minipage}\tabularnewline
\bottomrule
\end{longtable}

AEDs -- Anti-epileptic Drugs

*statistically significant.

\textbf{TABLE 3: Showing frequency and distribution pattern of AEDs
used.}\selectlanguage{english}
\begin{longtable}[]{@{}lll@{}}
\toprule
\textbf{Variables} & \textbf{N} & \selectlanguage{ngerman}\textbf{Mean±SD}\tabularnewline
\midrule
\endhead
Total number of patients on meds & 604 & 44.43(10.484)\tabularnewline
Monotherapy & 498 & 44.08(10.65)\tabularnewline
Polytherapy & 106 & 46.10(9.52)\tabularnewline
CAP & 414 & 44.26(10.59)\tabularnewline
LVC & 56 & 44.63(10.58)\tabularnewline
GBP & 1 & 65.00\tabularnewline
VLP & 11 & 37.91(13.40)\tabularnewline
PNT & 11 & 38.91(9.44)\tabularnewline
CNP & 1 & 36.00\tabularnewline
PNT & 4 & 45.50(3.00)\tabularnewline
CAP+LVC & 55 & 47.44(8.61)\tabularnewline
\bottomrule
\end{longtable}

\textbf{Carbamazepine (CAP), Levetiracetam (LVC), Gabapentin (GBP),
Valproate (VLP), Phenytoin (PNT), Clonazepam (CNP), Phenobarbiturate
(PB).}

\textbf{TABLE 4: Frequency of reported adverse effects of PWE.}\selectlanguage{english}
\begin{longtable}[]{@{}lll@{}}
\toprule
\textbf{Variables} & \textbf{Frequency} &
\textbf{Percentage}\tabularnewline
\midrule
\endhead
Unsteadiness & 251 & 26.7\tabularnewline
Tiredness & 213 & 22.7\tabularnewline
Restlessness & 216 & 23.0\tabularnewline
Feeling anger or aggression to others & 316 & 33.6\tabularnewline
Nervousness and or agitation & 322 & 34.3\tabularnewline
Headache & 123 & 13.1\tabularnewline
Hair loss & 68 & 7.2\tabularnewline
Problem with skin & 87 & 9.3\tabularnewline
Double or blurred vision & 117 & 12.4\tabularnewline
Upset stomach & 152 & 16.2\tabularnewline
Difficulty in concentrating & 178 & 18.9\tabularnewline
Trouble with mouth or gums & 84 & 8.9\tabularnewline
Shaky hands & 165 & 17.6\tabularnewline
Weight gain & 304 & 32.3\tabularnewline
Dizziness & 105 & 11.2\tabularnewline
Sleepiness & 116 & 12.3\tabularnewline
Depression & 187 & 19.9\tabularnewline
Memory problems & 189 & 20.1\tabularnewline
Disturbed sleep & 184 & 19.6\tabularnewline
\bottomrule
\end{longtable}

\textbf{TABLE 5: Determinant of ADR in PWE}\selectlanguage{english}
\begin{longtable}[]{@{}lllll@{}}
\toprule
\begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
\textbf{Variable}\strut
\end{minipage} & \begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
\textbf{B}\strut
\end{minipage} & \begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
\textbf{t-test}\strut
\end{minipage} & \begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
\textbf{p value}\strut
\end{minipage} & \begin{minipage}[b]{0.19\columnwidth}\raggedright\strut
\textbf{95\% CI} \textbf{Lower -- Upper}\strut
\end{minipage}\tabularnewline
\midrule
\endhead
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
DRUG ADHERENCE\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
2.199\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
1.310\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
0.199\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
-1.097 -- 5.494\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
DURATION OF EPILEPSY\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
1.269\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
3.231\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{0.001*}\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
0.498 -- 2.040\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
DURATION OF AED\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
5.119\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
5.972\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
\textbf{0.000*}\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
3.436 -- 6.802\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
EPILEPTIFORM PATTERN\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
0.036\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
0.105\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
0.917\strut
\end{minipage} & \begin{minipage}[t]{0.17\columnwidth}\raggedright\strut
-0.633 -- 0.705\strut
\end{minipage}\tabularnewline
\bottomrule
\end{longtable}

Anti-epileptic Drug (AED)

\selectlanguage{english}
\FloatBarrier
\end{document}

