DRUG UTILIZATION STUDY ON ORAL HYPOGLYCEMIC AGENTS IN TYPE 2 DIABETIC PATIENTS OF TERTIARY CARE HOSPITAL

Abstract

Objective: The main objective of the study is to determine the patient demographic characteristics, inspect prescription patterns of oral hypoglycemic agents, distribution of comorbid conditions in the outpatient department (OPD) of Visakha Institute of Medical Sciences (VIMS), Visakhapatnam. Method: A prospective observational study was conducted in patients with established type 2 diabetes mellitus (n=185) visiting OPD which were interviewed using a structured questionnaire during the period September– December 2019. Results: Majority of the type 2 diabetic patients in VIMS were treated with double drug therapy. The most commonly prescribed class of oral hypoglycemic agents were biguanides (metformin) followed by sulfonylureas (glimepiride), thiazolidinediones (pioglitazone), alpha-glucosidase inhibitor (voglibose), and dipeptidyl peptidase-4 inhibitor (vildagliptin).

Full text

Vol 13, Issue 5, 2020
Online - 2455-3891
Print - 0974-2441
DRUG UTILIZATION STUDY ON ORAL HYPOGLYCEMIC AGENTS IN TYPE 2 DIABETIC
PATIENTS OF TERTIARY CARE HOSPITAL
SARAGADAM BHUVANESWARI*
Department of Pharm D, Vignan Institute of Pharmaceutical Technology, Duvvada, Visakhapatnam, Andhra Pradesh, India.
Email: saragadambhuvana29@gmail.com
Received: 23 January 2020, Revised and Accepted: 02 April 2020
ABSTRACT
Objective: The main objective of the study is to determine the patient demographic characteristics, inspect prescription patterns of oral hypoglycemic
agents, and distribution of comorbid conditions in the outpatient department (OPD) of Visakha Institute of Medical Sciences (VIMS), Visakhapatnam.
Methods: A prospective observational study was conducted in patients with established type 2 diabetes mellitus (n=185) visiting OPD who were interviewed
using a structured questionnaire during the period September–December 2019. Statistical analysis used is Chi-square test, mean±standard deviation.
Results: The majority of type 2 diabetic patients in VIMS were treated with double-drug therapy. The most commonly prescribed class of oral
hypoglycemic agents were biguanides (metformin) followed by sulfonylureas (glimepiride), thiazolidinediones (pioglitazone), alpha-glucosidase
inhibitor (voglibose), and dipeptidyl peptidase-4 inhibitor (vildagliptin).
Conclusion: Our study concluded that diabetes mellitus is more prevalent in females than in males, mostly seen in the age group of 50–59 years(y)
old patients. Glycemic levels are under control in patients who show good adherence to treatment and with lifestyle modifications. Due to lack of
awareness, many patients are with uncontrolled glycemic levels so proper patient educated should be provided.
Keywords: Diabetes mellitus, Hyperglycemia, Oral hypoglycemic agents, Questionnaire, Prospective study, Insulin resistance, International Diabetes
Foundation, Indian Heart Association, Coexisting illness, Drug therapy regimen.
INTRODUCTION
Diabetes mellitus (DM) is a group of metabolic disorders characterized
by hyperglycemia and abnormalities in carbohydrate, fat, and protein
metabolism [1,2] resulting from defects in insulin secretion, insulin
action, or both [3,4].
Chronic condition of diabetes is associated with long-term damage and
dysfunction, failure of various organs, especially blood vessels, eyes,
kidneys, nerves, and heart. To prevent the risk of long-term complications,
there is a need for appropriate medical care and patient self-management
education [4]. Until recently, India had more diabetics than any other
country in the world, according to the International Diabetes Foundation
diabetes currently affects more than 63 million Indians, which is more than
7.4% of the adult population, nearly 1 million Indians die due to diabetes
every year. Indian Heart Association shows that India is estimated to be
hoe to 110 million individuals with diabetes by 2035 [5].
The high incidence is attributed to a combination of genetic susceptibility
and adoption of high calorie, low activity. Because of the following reasons,
Indians have a low-risk threshold for diabetes: Overweight, higher insulin
resistance, lifestyle, higher central obesity for a given BMI, a higher fat
mass, lower age of onset, and an occurrence at lower body mass index
(BMI > 23). Oral hypoglycemic drugs are used in the treatment of diabetes,
which is a disorder involving resistance to insulin secretion [3-6].
At present, among many classes of OHA, sulfonylureas and biguanides class
of drugs are most commonly prescribing and for monotherapy, metformin
is prescribing mostly followed by glimepiride, pioglitazone, and vildagliptin.
Drug utilization is defined as the distribution, marketing, prescription,
and use of drugs in the society, resulting in medical and social
consequences. This type of study will create a sound sociomedical and
sound economic basis for health-care decision-making (Table 1).
The main aim of this drug utilization study is to assess patient
adherence to therapy, the outcome of the drug therapy regimen, how
the OHA is prescribing, OHA is prescribing properly or not, and whether
drug therapy is rational or not.
METHODS
The study was carried out at the Department of Endocrinology in Visakha
Institute of Medical Sciences (VIMS), Visakhapatnam, to determine
patient demographic characteristics, analyze prescription patterns of
oral hypoglycemic agents, and distribution of comorbid conditions in
the outpatient department. All patients with established type 2 diabetes
attending the endocrinology department in the hospital were included
in the study during the period September–December 2019.
Information on age, gender, weight, family history, blood sugar levels,
glycosylated hemoglobin (HBA1c) levels, and oral hypoglycemic agents
was documented. The patient counseling was conducted using a
structured questionnaire (open question method):
• Doyouforgettotakeyourmedicine?
• Areyoucarelessabouttakingyourmedicine?
• Whenyoufeelgood,doyousometimesstoptakingmedicine?
• Sometimesifyoufeelworsewhiletakingmedicine,doyoustoptakingit?
A higher score on the scale of 0–4 indicates better adherence to
treatment (yes=0; no=1) [6,7].
The study data were analyzed using the Chi-square test that was used
for categorical data to test for the association.
Ethical approval
This study was approved by the ethical committee of the hospital VIMS.
RESULTS
Gender distribution of patients
Gender distribution of patients: It is found that diabetes is most
commonly occurring in females than males (Fig. 1).
© 2020 The Authors. Published by Innovare Academic Sciences Pvt Ltd. This is an open access article under the CC BY license (http://creativecommons.
org/licenses/by/4. 0/) DOI: http://dx.doi.org/10.22159/ajpcr.2020.v13i5.36919
Research Article

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Bhuvaneswari
Family history of diabetes mellitus
An analysis of the questionnaire revealed that among 185 diabetic
patients, 104 (56.2%) patients had a family history of diabetes. The
percentage of patients with no family history of diabetes was found to
be 81 (43.8%).
Age distribution of patients
Diabetic patients who visited the endocrinology department were in
the age group ranging from 30 to 80 years old (Fig. 2).
Social history
Among 59 (32%) male diabetic patients, 51% of patients were smokers
and 30% of patients were alcoholics.
Patients who are chronic alcoholic their blood sugar levels were found
to be >270 mg/dl even though patients are on multiple drug therapy [8].
These patients are counseled to reduce the intake of alcohol and smoking
by showing their blood sugar levels and also risk behind abruptly stop
smoking and alcohol which will cause withdrawal symptoms such as
nausea, anorexia, confusion, palpitations, and seizures.
Distribution of coexisting illnesses
Distribution of coexisting illnesses: among (n=185) diabetic patients
57% had associated hypertension, 40% had associated dyslipidemia,
and overweight. It is observed that overweight is the main cause of
diabetes mellitus in most patients. Many patients are also suffering
from other comorbid conditions like thyroid, cardiovascular diseases,
stroke, etc. (Fig. 3).
Distribution of drug therapy regimen
The most commonly prescribed drug for monotherapy is metformin
OD or BD or insulin and commonly prescribed double-drug therapy is
metformin+glimepiride or insulin commonly prescribed triple-drug
therapy regimens are metformin+glimepiride+pioglitazone or with insulin
or voglibose, but generally for triple- and multiple-drug therapy insulin will
not be prescribed. If patient blood sugar levels are high, drug dose should
be increased or other classes of the drug should be added. If blood sugar
levels low, reduce drug dose or omit a drug [9,10] (Figs. 3 and 4).
Distribution of oral hypoglycemics
The most commonly prescribed and available OHA in VIMS are
metformin, glimepiride, pioglitazone, voglibose, and vildagliptin
(Fig. 5).
Adherence to treatment
An analysis of the questionnaire revealed [10] (Fig. 6):
Optimal glycemic control
Among n=185, type-2 diabetic patients who are receiving OHA
111 (60%) had controlled optimal glycemic levels and 74 (59%) had
inadequately controlled glycemic levels [11] (Figs. 7 and 8).
Association between optimal glycemic levels was statistically significant
in diabetic patients on antidiabetic therapy with lifestyle modifications
(p=0.014); however, this association with therapy type and other data
was not significant statistically (p>0.05) (Table 2, Figs. 9 and 10).
DISCUSSION
This study showed that the majority of diabetic patients ranged between 50
and60yearsoldwithameanageof44.5±24.2.WhileMoradiet al. [12] also
concluded that diabetes was more frequent in the age group of 50–60 years
which is similar to our study, these reports showed that diabetes starts in
lower ages in our society that shows the need for screening for diabetes from
an early age (>45 years), especially patients who have a family history [13]
of diabetes mellitus and cardiovascular diseases.
Our results showed that diabetes is more prevalent in females than in
males which were not agreed with the results of other studies [14]. The
risk of type 2 diabetes is 1.76% greater in females compared to males in
our country [15]. This may be related to the fact that obesity, hypertension,
and cardiovascular diseases because they normally less physical activity
compared to men, so weight control programs and following lifestyle
modifications are strongly recommended in this population.
Table 1: List of oral hypoglycemic agents and their classes [3,4]
Class Mechanism Agents Advantages Disadvantages
Biguanides Decrease hepatic
gluconeogenesis
Metformin No hypoglycemia, weight normal,
easily available
GI disturbance, lactic
acidosis
Sulfonylureas Stimulate insulin
secretion
Glimepiride, gliclazide,
glibenclamide, glipizide,
tolbutamide
Cost effective, easily available Hypoglycemia, weight gain
Thiazolidinediones Improve insulin
resistance
Pioglitazone Lower insulin requirements Edema, CHF, weight gain,
fracture, macula edema
Alpha-glucosidase
inhibitors
Decrease insulin
absorption
Acarbose, voglibose Reduce postprandial blood glucose
levels
GI flatulence
DPP 4 inhibitors Prolong GLP-1 action Vildagliptin, saxagliptin, sitagliptin No hypoglycemia Not available
Meglitinides Stimulate insulin
secretion
Repaglinide, nateglinide The short onset of action, low
postprandial blood glucose levels
Hypoglycemia
Fig. 1: Gender distribution among type-2 diabetic patients [7].
One hundred and eighty-five diabetic patients were evaluated
during the study period September–December, of whom 59 (32%)
patients were male and 126 (68%) patients were female
Fig. 2: Age distribution among type-2 diabetic patients [7].
Among 185 diabetic patients, the age group of 30–39 years
included 10 (5%) patients. The age group of 40–49 years included
57 (31%) patients. The age group of 50–59 years included
65 (35%) patients. The age group of 60 years and above included
46 (29%) patients. Most of the diabetic patient is seen in the age
group of 50–59 years old with the mean age of 44.5±24.2

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Fig. 5: Percentage of oral hypoglycemic agents. Among total oral
hypoglycemics, metformin accounted for 95% followed by glimepiride
76%, pioglitazone 40%, vildagliptin 35%, and voglibose 18%
Fig. 6: Percentage of patient’s adherence to treatment [10]. Among 185
of diabetic patients, only 75 (40.6%) patients showed good adherence
to treatment and the remaining 110 (59.40%) showed non-adherence
to the treatment with a mean standard deviation of 92.5±22.7
Fig. 7: Among 126 female patients and 59 male patients,
78 female patients and 26 male patients are under glycemic
control which is not significant statistically (p=0.897)
Fig. 8: Patients of the age group of 30–39 years are mostly under
glycemic control, some patients of age group of 40–49 years, 50–
59 years, and 60 and above years old are under optimal glycemic
control, and some are not under optimal controlled levels, the
association is statistically not significant (p=0.896)
Fig. 3: Percentage of comorbidities among type-2 diabetic patients
[8]. Among 185 patients, 107 (57.8%) patients had associated
hypertension, 74 (40%) patients had associated dyslipidemia,
44 (23.7%) patients had associated cardiovascular disease,
54 (29%) patients had associated thyroid problems, 48 (26%)
patients had obesity, 26 (14%) patients had associated stroke,
15 (8%) patients had associated asthma, and 9 (5%) patients had
associated filariasis with the mean standard deviation of 38.5±23
Fig. 4: Drug therapy regimen [8]. The majority (67%) of patients
were on double-drug therapy, 23% were prescribed with triple-
drug therapy, and 10% were prescribed monodrug therapy with
the mean standard deviation 61.1±55.4
Fig. 9: Patients under double-drug therapy regimen are showing
good glycemic control (92 patients) than triple-drug therapy.
Patients under monotherapy are not showing a proper glycemic
control and the association is not statistically significant (p=0.696)
Fig. 10: Patients with lifestyle modifications are showing good
glycemic control (76 patients) and patients without lifestyle
modifications are not under glycemic control (109 patients). This
shows that many patients need to adopt good lifestyle modifications
and this association is statistically significant (p=0.014)
This study shows that biguanides were the most commonly prescribed
class followed by sulfonylureas were the most commonly prescribed class
of drugs which was similar to a previous study [16-18]. This reflects that
biguanides and sulfonylureas are the choices of most physicians in the
treatment of type 2 diabetes mellitus. Metformin (biguanide) 95% was the
most common oral hypoglycemic agent to be prescribed which is similar
to several studies [6,18-21] followed by glimepiride (sulfonylureas)
76%. The study documented low prescribing frequency of newer oral
hypoglycemic agents such as pioglitazone and vildagliptin, they were
used in a combination with sulfonylureas or biguanides to achieve better
glycemic control which was similar to the previous studies [6,16].
In this study, drugs were prescribed by generic name which is a most
commonly advisable method for easy understanding and to avoid patient
and pharmacist-related errors. In this study, drugs were prescribed from
the national essential drug list which shows the awareness and selection
of drugs from an essential drug list for rational use of drugs.
About 60% of patients on antidiabetic therapy had controlled optimal
glycemic levels, while 40% had inadequate/uncontrolled glycemic levels.
Many studies have documented from 52% to 88% which were higher than
our studies [22-26], these variations are may be due to differences in methods

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Table 2: Characteristics of diabetic patients based on glycemic
control
Patient
characteristics
Glycemic level Total
(n=185)
p value
Controlled Uncontrolled
Gender
Male 33 26 59 0.897
Female 78 48 126
Age (years)
30–39 7 2 9 0.896
40–49 35 22 57
50–59 41 24 65
60 above 40 14 54
Therapy type
Monotherapy 16 2 18 0.696
Double-drug
therapy
92 32 124
Triple-drug
therapy
36 7000 43
Antidiabetic
therapy
Withlifestyle
modifications
44 32 76 0.014
Without
lifestyle
modifications
37 72 109
of data collection, measurement of blood glucose levels such as pre-prandial
and post-prandial levels, and the difference in the population surveyed.
The most prevalent antidiabetic therapy was double-drug therapy, the most
commonly prescribed double-drug therapy is metformin+glimepiride
or insulin or pioglitazone or vildagliptin. However, the study by Willey
et al. has shown good glycemic control on monotherapy [24]. This study
shows glycemic control with monotherapy and combination therapy was
not significant statistically p>0.05 (0.696) and we found a statistically
significant (p<0.05) association between glycemic control and antidiabetic
therapy with lifestyle modifications. Thus, from the above results, it shows
that lifestyle modifications with antidiabetic therapy have the potential to
improve glycemic control in patients with type 2 diabetes mellitus [27-29].
CONCLUSION
From this study, it is concluded that double-drug therapy was more used
than monotherapy, in this, metformin and glimepiride combination drugs
were commonly used followed by metformin and pioglitazone, mostly
prescribing in an oral dosage form. Patients with lifestyle modifications
showed controlled blood sugar levels than patients without lifestyle
modifications. Polypharmacy is a big problem, especially for elderly
patients, due to illiteracy, lack of awareness, and negligence, many patients
show non-adherence to the treatment. This study mainly focused on the
need for patient education or counseling on diabetes mellitus disease, the
use of antidiabetic and concomitant drugs, monitoring of blood glucose
and HBA1c levels, diet control, physical activity, and complications of
diabetes mellitus, by providing the above information can reduce the
chance of medication errors and can improve adherence to treatment.
ACKNOWLEDGMENT/FUNDING
I would like to thank VIMS Hospital, Endocrinology Department doctor
and other staff members for granting the permission.
AUTHORS’ CONTRIBUTIONS
Data collection, literature search, design, analysis, interpretation of
data, and proofreading done by Saragadam Buvaneswari.
CONFLICTS OF INTEREST
No conflicts of interest.
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