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\title{SUSPECTED ADR MONITORING AND COMPARATIVE ASSESSMENT OF
ANTIDIABETIC DRUGS ON GLYCEMIC CONTROL IN TYPE 2 DIABETIC PATIENTS}



\author[1]{krishna chand}%
\author[1]{Mohammad Ahmad}%
\author[1]{Md Afroz Ahmad}%
\author[1]{MD Amir Siddiqui}%
\author[1]{MD farhan khan}%
\author[1]{ayasha.salim}%
\affil[1]{Affiliation not available}%


\vspace{-1em}



  
  \date{May 08, 2026}


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\textbf{INTRODUCTION}

\textbf{DIABETES} \textbf{MELLITUS}

Diabetes mellitus (DM) commonly known as diabetes, is a group of
metabolic disorders characterized by a high blood sugar level over a
prolonged period. Diabetes mellitus is the most common endocrine
disorders affecting million people worldwide. It is a chronic condition,
characterized by hyper-glycemia, due to impaired insulin secretion. It
is a disease that affects the body ability to produce or use of insulin.
Insulin is a hormone. When the body turns the food you eat into energy
(sugar or glucose), insulin is released to help transport this energy to
the cells. Its chemical message tells the cell to open and receive
glucose. If the insulin produce is little or no production, leads too
much sugar remains in your blood (hyper glycaemia). Blood glucose levels
are higher than normal for individuals with diabetes. The chronic
hyperglycemia of diabetes is associated with long-term damage,
dysfunction and failure of various organs, especially the eyes, kidneys,
nerves, heart and blood vessels. {[}1{]}

\textbf{There are two types of diabetes: -}

Type 1(also know as insulin dependent diabetes mellitus) Type 2(also
known as non-insulin dependent diabetes mellitus)

\textbf{Type 1 diabetes: -} This type of diabetes mellitus is also known
as insulin dependent diabetes mellitus, in this condition, the pancreas
does not produce enough insulin according to the ones requirement. This
type of diabetes is also called ``juvenile onset diabetes mellitus'',
because it is often diagnosed in children or teenage between 12-18
years. {[}3{]}

\textbf{Type 2 diabetes: -} This type of diabetes mellitus is also known
as non-insulin dependent diabetes mellitus, this occurs when the body
does not produce enough insulin, or when the cells are unable to use
insulin properly, which is called insulin resistance. Type 2 diabetes is
commonly called ``adult onset diabetes mellitus'', since it is diagnosed
later in life, generally after the age of 45. 90-95\% of people are
suffering with this type of diabetes.{[}3{]}

\textbf{Other type's diabetes: -}

Gestational diabetes occurs during pregnancy and affects about 18
percent of all pregnancies, according to the American Diabetes
Association. Gestational diabetes usually goes away after pregnancy, but
once you've had gestational diabetes, your chances are higher that it
will happen in future pregnancies. In some women pregnancy uncovers Type
1 or Type 2 diabetes and these women will need to continue diabetes
treatment after pregnancy.

According to international diabetes federation (IDF), the number of
people with diabetes in the world in 2013 was 382 million, which is
going to increase to almost 592 million by 2035. India has the dubious
distinction of being home to a large number of people suffering from
diabetes. According to IDF, 65.1 million of adults in India suffered
from diabetes in the year 2013{[}2{]}. It has been predicted that the
prevalence of diabetes in the adult population in India will be 6\% by
the year 2025{[}3{]}.

\textbf{Diagnosis: -}

Diabetes mellitus is characterized by recurrent or persistent high blood
sugar, and is diagnosed by demonstrating any one of the following: -

Fasting plasma glucose level [?] (126 mg/dl)

Plasma glucose [?] (200 mg/dl) two hours after a 75-gram oral glucose load
as in a glucose tolerance test (OGTT)

Symptoms of high blood sugar and casual plasma glucose [?] (200 mg/dl)

\textbf{What causes diabetes?}

The cause of diabetes is unknown. Genetics, diet, obesity and lack of
exercise may play a role in developing diabetes, especially Type 2
diabetes.

\textbf{What are the symptoms of diabetes?}

\begin{itemize}
\tightlist
\item
  Extreme thirst
\item
  Frequent urination
\item
  Blurry vision
\item
  Extreme hunger
\item
  Increased tiredness
\item
  Unusual weight loss
\end{itemize}

\textbf{DRUG UTILIZATION REVIEW}

Drug utilization review (DUR) is defined as an authorized, structured,
ongoing review of prescribing, dispensing and use of medication. It
involves a comprehensive review of patients' prescription and medication
data before, during and after dispensing to ensure appropriate
medication decision-making and positive patient outcomes. As a quality
assurance measure, DUR programs provide corrective action, prescriber
feedback and further evaluations {[}5{]}. . 5 DUR is classified in three
categories:

\textbf{Prospective} - evaluation of a patient's drug therapy before
medication is dispensed

\textbf{Concurrent} - ongoing monitoring of drug therapy during the
course of treatment

\textbf{Retrospective} - review of drug therapy after the patient has
received the medication

Drug utilization evaluation is a discipline which aims to understand how
and why drug are used as they are, so that drugs use and healthy
outcomes can be improved.

\textbf{Types of Drug utilization review {[}DUR{]}:-}

Drug utilization studies have also been categorized in to two groups:

Quantitative studies involve the collection, organization and display of
estimates or measurements of drug use.

Qualitative studies are multidisciplinary operation, which collect,
organize, analyse and report information on actual drug use.

\textbf{ADR MONITORING/ PHARMACOVIGILANCE}

Science and activities relating to the detection, assessment,
understanding and prevention of adverse drug reactions (ADRs) or any
other medicines related problems.

``ADR is any response to a drug which is noxious and unintended and
occurs at doses normally used in man for prophylaxis, diagnosis or
therapy of disease or the modification of physiological
function''.{[}6{]}

\textbf{AIM AND OBJECTIVE}

\textbf{Primary Objective:} To monitor the suspected adverse drug
reactions and comparative assessement of Anti-diabetic drugs in diabetic
patients at integral institute of medical science and research.

\textbf{Secondary Objective:} Drug utilization pattern of Anti-diabetic
drugs prescribed in diabetic patient at integral institute of medical
science and research.

\textbf{STUDY DESIGN}

\textbf{Study design-} A prospective observational study.

\textbf{Study site}

Study was carried out in the IPD and OPD of (male and female medicine
ward IPD) Integral University Hospital; a 500 bedded teaching hospital
situated in the premises of Integral University, Lucknow.

\textbf{Study duration}

The Study was carried out for 6 months.

\textbf{Study population}

Study was conducted on all patients during study period at Integral
University Hospital, who had participated; subjects were enrolled on the
basis of inclusion and exclusion criteria.

\textbf{Sources of data}

Physician prescribing record

Patient medication profile

\textbf{Selection of patient}

\textbf{Inclusion Criteria}

All the patients were included irrespective of age and sex.

Pregnant and lactating patients were also included.

\textbf{Exclusion Criteria}

\begin{itemize}
\tightlist
\item
  Mentally retarded and unconscious patients.
\item
  Patients who are not treated with drugs.
\item
  Patients unable to comply.
\item
  Drug addicts.
\end{itemize}

\textbf{METHODOLOGY}

\textbf{Method and Materials used}

Medication Utilization and Adverse Drug Reaction Monitoring (MUADRM)
form and CDSCO Suspected ADR Reporting Form. The data was collected in a
predesigned format from the medical case sheets, drug charts, and
laboratory investigations of 100 patients. The enrolled patients were
observed from admission till discharge. Descriptive statistics was
applied to the collected data and analyzed using Microsoft Excel
software.

\textbf{Data collection}

The following data was collected based on the questionnaire.

\begin{itemize}
\tightlist
\item
  Patient profile (age, sex, weight, patient address, marital status).
\item
  Drugs prescribed (generic/brand name)
\item
  Drugs dose and frequency
\item
  Demographics, current diagnosis, medical history
\end{itemize}

\textbf{Evaluation of parameters}

The following parameters were evaluated:

Types of antidiabetic prescribed

\begin{itemize}
\tightlist
\item
  Average number of antidiabetic per prescription
\item
  Average age range of patients utilizing antidiabetic
\item
  Comparison of antidiabetic prescribed in monotherapy vs. fixed dose
  combination therapy
\item
  Comparison of antidiabetic prescribing by generic vs. brand name
\item
  Compliance or adherence (using Weekly Diary Cards).
\item
  A criterion for non-compliance is \textless{} 80\% of recommended
  intake of prescribed drugs.
\item
  Mode of administration of drugs
\item
  Concomitant diseased conditions
\item
  Most commonly used agents of a particular class
\item
  Most common diagnosis
\item
  Average cost of drug per prescription
\end{itemize}

\textbf{RESULTS}

\textbf{1. Gender distribution among diabetic patients}

Among the 100 diabetic patients, 44 patients were male and 56 patients
were female (Figure1)\selectlanguage{english}
\begin{longtable}[]{@{}lll@{}}
\toprule
\textbf{Gender} & \textbf{No. of Patients} & \textbf{Patients (\%
age)}\tabularnewline
Male & 44 & 44\%\tabularnewline
Female & 56 & 56\%\tabularnewline
Total & 100 & 100\%\tabularnewline
\bottomrule
\end{longtable}

\textbf{Figure 1 : Gender distribution of diabetic patients}

\textbf{2. Age distribution of the study subjects}

The lowest numbers of patients were from the age group less than 30
years and the highest percentages were in geriatric patients to 50-60
years (Figure2).\selectlanguage{english}
\begin{longtable}[]{@{}llll@{}}
\toprule
\textbf{Age (years)} & \textbf{Male} & \textbf{Female} & \textbf{Total
no. of patients}\tabularnewline
\textbf{Less than 30} & \textbf{2} & \textbf{3} &
\textbf{5}\tabularnewline
\textbf{30-40} & \textbf{5} & \textbf{8} & \textbf{13}\tabularnewline
\textbf{40-50} & \textbf{11} & \textbf{12} & \textbf{23}\tabularnewline
\textbf{50-60} & \textbf{11} & \textbf{20} & \textbf{31}\tabularnewline
\textbf{60-70} & \textbf{9} & \textbf{12} & \textbf{21}\tabularnewline
\textbf{70-80} & \textbf{6} & \textbf{1} & \textbf{7}\tabularnewline
\textbf{Total} & \textbf{44} & \textbf{56} & \textbf{100}\tabularnewline
\bottomrule
\end{longtable}

\textbf{Table 2: Age distribution amongst diabetic patients}

\textbf{3. Smokers VS non-smokers amongst diabetic patients}

38 patients were smokers, in which 24 were males and 14 were females. 62
patients were non smokers including 20 males and 42 females. (Figure3).\selectlanguage{english}
\begin{longtable}[]{@{}llll@{}}
\toprule
\textbf{Smoking Status} & \textbf{No. of Male} & \textbf{No. of Female}
& \textbf{Total}\tabularnewline
\textbf{Smokers} & \textbf{24} & \textbf{14} &
\textbf{38}\tabularnewline
\textbf{Non Smokers} & \textbf{20} & \textbf{42} &
\textbf{62}\tabularnewline
\textbf{Total} & \textbf{44} & \textbf{56} & \textbf{100}\tabularnewline
\bottomrule
\end{longtable}

\textbf{Table 3 : Smokers vs. non-smokers amongst diabetic patients}

\textbf{4. Alcoholics Vs non-alcoholics amongst diabetic patients}

It was observed that 2 males and 0 females were alcoholics. Remaining 98
were non-alcoholics including 42 males and 56 were females (Figure 4).\selectlanguage{english}
\begin{longtable}[]{@{}lll@{}}
\toprule
\textbf{Gender} & \textbf{Alcoholic} &
\textbf{Non-alcoholic}\tabularnewline
Male & 02 & 42\tabularnewline
Female & 00 & 56\tabularnewline
Total & 02 & 98\tabularnewline
\bottomrule
\end{longtable}

\textbf{Table 4 : Alcoholics Vs non-alcoholics amongst diabetic
patients}

\textbf{Type of anti-diabetic prescribed}

In this drug utilization study, 100 prescriptions were analyzed. A total
of 195 antidiabetic drugs prescribed, of which 37.90 \% were Biguanides,
22.60 \% sulphonylureas, 25.64 \% were insulin. DPP-4 Inhibitors were
7.20\% , 1.02\% were thiazolidinediones (PPAR\selectlanguage{greek}γ \selectlanguage{english}activator) and 5.64\%
were \selectlanguage{greek}α-\selectlanguage{english}Glucosidase inhibitors. Most of the anti- diabetic prescribed
were from the essential medicine list. During the study, it was observed
that most frequently prescribed anti-diabetic drug classes were
biguanides insulin and sulphonylureas and the most frequently prescribed
anti-diabetic as monotherapy among them is Biguanides.

\textbf{Type of anti-diabetic drug prescribed}\selectlanguage{english}
\begin{longtable}[]{@{}lll@{}}
\toprule
\textbf{Drug class} & \textbf{No. of drugs} & \textbf{Dug (\%
age)}\tabularnewline
\textbf{Insulin} & 50 & 25.64\%\tabularnewline
\textbf{Biguanides} & 70 & 35.90\%\tabularnewline
\textbf{Sulphonylurea} & 48 & 24.60\%\tabularnewline
\textbf{DPP-4 Inhibitors} & 14 & 7.20\%\tabularnewline
\selectlanguage{greek}\textbf{Thiazolidinediones(PPARγ activator)}\selectlanguage{english} & 02 &
1.02\%\tabularnewline
\selectlanguage{greek}\textbf{α-Glucosidase inhibitors}\selectlanguage{english} & 11 & 5.64\%\tabularnewline
\textbf{Total} & 195 & 100\%\tabularnewline
\bottomrule
\end{longtable}

\textbf{Type of adverse drug reactions}

Overall 9 ADRs were reported during the study (table ). hypoglycemia was
the most common adr observed in 04 patients (moderate intensity in 2
patients and mild in one patient). Whereas gastric irritation occurs in
02 patients and abdominal discomfort occurs in 03 patients.

\textbf{Type of ADRs reported}\selectlanguage{english}
\begin{longtable}[]{@{}lll@{}}
\toprule
\textbf{Type of ADRs} & \textbf{No. of Patients} & \textbf{Patients (\%
age)}\tabularnewline
Hypoglycemia & 04 & 8.00\%\tabularnewline
Gastric irritation & 02 & 4.00\%\tabularnewline
Abdominal discomfort & 03 & 6.00\%\tabularnewline
\bottomrule
\end{longtable}

\textbf{Type of gender distribution of ADRs}

Overall 9 ADRs were reported during the study, among which 6 patients
were males and 3 patients were found to be female. The percentages of
ADR distribution among genders were found to be 66.66\% in males and
33.33\% in females.

\textbf{DISCUSSION}

Little information exists about the perspective behaviour of physicians
and the misuse of anti- diabetic drug.

The clinical study i.e.; drug utilization of anti-diabetic drug used in
diabetes is carried out for the first time at inpatient and outpatient
department of INTEGRAL UNIVRSITY HOSPITAL, LUCKNOW.

In our study, it was observed that over 350 persons (suffering from
various diseases) visited the inpatient department of IU Hospital over a
period of 6 months. 100 patients, on the basis of inclusion and
exclusion criteria, were selected for the present study.

Demographic characteristics showed that percentage of males suffering
from diabetes was more than females. It was observed that among them
(male and female) 44\% were male and 56\% were females. Studies showed
that females are more persistent diabetic as compared to males; the
major reason might be due to the occupational reasons.

Further, it was found that a majority of the patients who were having a
diabetes were in the age group of 50-70 years and the lowest \% was in
less than 30 years of age groups.

In this drug utilization study, 100 prescriptions were analyzed. A total
of 195 antidiabetic drugs prescribed, of which 37.90 \%
were\textbf{Biguanides} , 22.60 \% \textbf{sulphonylureas} , 25.64 \%
were\textbf{insulin} . \textbf{DPP-4 Inhibitors} were 7.20\%, 1.02\%
were\selectlanguage{greek}\textbf{thiazolidinediones (PPARγ activator)}\selectlanguage{english} and 5.64\%
were\selectlanguage{greek}\textbf{α-Glucosidase inhibitors.}\selectlanguage{english} Most of the anti- diabetic
prescribed were from the essential medicine list.

During the study, it was observed th at most frequently prescribed
anti\textbf{biguanides} \textbf{insulin} and
\textbf{sulphonylureas}diabetic drug classes were and the most
frequently prescribed anti monotherapy among them is \textbf{Biguanides}
.

Overall 9 ADRs were reported during the study (table 6.8). Hypoglycemia
was the most common ADR observed in 04 patients (moderate intensity in 2
patients and mild in one patient). Whereas gastric irritation occurs in
02 patients and abdominal discomfort occurs in 03 patients, among which
6 patients were males and 3 patients were found to be female. The
percentages of ADR distribution among genders were found to be 66.66\%
in males and 33.33\% in females. Among all 9 ADRs, 3 cases of mild
(33.33\%), 4 cases of moderate (44.44\%), and 2 cases of severe
(22.22\%) types of ADRs were detected.

\textbf{LIMITATION}

Our study have many limitations. The study was carried out over a 6
month period,and the seasonal variations in disease pattern and drug
utilization were not considered.

Furthermore, the no of patients was low and the study was restricted
only one hospital, hence the result cannot be considered representatives
of the whole country. However in spite of all these limitations, our
study highlighted some rational prescribing practices. Continuing
education on rational drug use and development of easy to use treatment
guidelines for common disease suggested. In our future endeavors, we
plan to study the effect of regulatory and educational interventions on
drug use patterns in the management of diabetes mellitus.

\textbf{CONCLUSION}

The present study was conducted to analyze the rational prescribing of
drugs in the medicine ward of a tertiary care hospital using WHO core
indicators. Fem{ales were more prone to diabetes mellitus.}

Metformin , insulin and sulphonylureas was the most commonly used drug.
The prescribing trend also appears to be moving towards combination
therapy particularly two drugs therapy. This study contributes to the
growing body of literature on drug utilization research. However, the
study has its own limitations since follow-up of the patients was not
possible and hence the effectiveness of the anti-diabetic agents could
not be assessed. In the future one can investigate the appropriateness
of prescriptions and adherence to evidence based recommendations.

\textbf{REFERENCES}

1. American Diabetes Association. Diagnosis and classification of
diabetes mellitus. Diabetes

Care 2012; 35 Suppl 1:64-71.

2. ''Diabetes Blue Circle Symbol''. International Diabetes Federation.
17 March 2006. Archived from the original on 5 August 2007.

3. IDF Diabetes Atlas. 6th ed. International Diabetes Federation, 2013.
Available from:

. {[}Last accessed on 2014 Nov 17{]}.

WHO. October 2013. Archived from the original on 26 August 2013.
Retrieved 25 March 2014.

4. King H, Aubert RE, Herman WH. Global burden of diabetes, 1995-2025:
prevalence,

numerical estimates, and projections. Diabetes Care 1998; 21(9):1414-31.

Definition and diagnosis of diabetes mellitus and intermediate
hyperglycemia: report of a

WHO/IDF consultation (PDF). Geneva: World Health Organization. 2006. p.
21. ISBN 978-924- 159493-6.

5.Vijan, S (March 2010). ''Type 2 diabetes''. Annals of Internal
Medicine. 152 (5): ITC31-15.

doi:10.7326/0003-4819-152-5-201003020-01003. PMID 20194231

6.Navarro, Robert. Chapter 8: Drug Utilization Review Strategies. In
Managed Care Pharmacys Practice, published 2008, pp. 215 -- 229.

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