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Anti diabetic drugs in patients with diabetes
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_________________________________
* Corresponding author: Sriram.S
E-mail address: visitram@yahoo.com
Available online at www.ijrpp.com
Print ISSN: 2278 – 2648
Online ISSN: 2278 - 2656 IJRPP | Volume 2 | Issue 2 | 2013 Research article
Study on Rational Use of Anti-Diabetic Drugs in Patients with Diabetes and
Other Co-Morbidities
*1
Sriram.S, 2
Senthilvel.N, 3
Merin.P, 4
Vidhya.D
*1
Prof & Head, Dept. of Pharmacy Practice, College of Pharmacy, Sri Ramakrishna Institute of
Paramedical Sciences, Siddhapudur, Coimbatore, Tamil Nadu, India.
2
Senior Consultant-Physician, Department of General Medicine, Sri Ramakrishna Hospital,
Coimbatore
3
Lecturer, Sri Krishna College, Trivandrum, India.
4
Lecturer, College of Pharmacy, SRIPMS, Coimbatore,Tamil Nadu, India.
ABSTRACT
India presently has the largest number of diabetic patients in world and has been infamously dubbed as the ‘Diabetic
capital of the world’. The study was undertaken to know the prevalence of Diabetic population and to evaluate the
prescriptions for rational use of Antidiabetic medications and the management of existing co-morbidities. A
prospective-observational study was carried out in General Medicine Department of a private corporate hospital, for
a period of eight months. Evaluation of prescriptions was done for rational use of antidiabetic drugs in diabetic
patients with other co-morbidities. Patient Information Leaflet, Diabetic food Chart & Diabetic Diary were prepared
and given to patients. Therapeutic guidelines was prepared and given to the relevant department. A total 93 diabetic
patients were enrolled in the study. In 48% of the diabetic population Hypertension was the major co-morbidity. The
major microvascular complications observed include diabetic nephropathy in 12 (12.93%) patients. The major
category of antidiabetic drugs prescribed were insulin (64.4%), sulphonyl urea (40.0%) and biguanides (28.9%), α-
glucosidase inhibitor prescribed was acarbose (17.8%).Thirty diabetic patients (32.26%) had two co-morbidities
followed by 21 patients (22.58%) with one co-morbidity and 16 (17.2%) patients had three co-morbid condition. In
patients with diabetes all drugs should be used with both potential risks and benefits in mind. Conversely, the drugs
that lower blood sugars by inducing weight loss and lessening insulin resistance, thereby improving glycemic
control and the patient’s quality of life need to be prescribed. Pharmacists play a major role in helping the patient
maintain control of their disease.
KEYWORDS: Diabetes Mellitus, Co-morbidities, Antidiabetic drugs
INTRODUCTION
During the last 20 years, the prevalence of diabetes
has increased dramatically. The International
Diabetes Federation states that 246 million adults
across the world have Diabetes mellitus. Diabetes
accounts around six percentage of total mortality
around the world, and 50% of diabetes- associated
deaths being attributed to cardiovascular disease.
Yearly on average 6, 25,000 newer diabetes cases are
diagnosed and more than 180,000 deaths due to the
disease and related complications. India presently has
the largest number of diabetic patients in world and
has been infamously dubbed as the ‘Diabetic capital
of the world’. According to the International Diabetes
International Journal of Research in
Pharmacology & Pharmacotherapeutics
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Federation (IDF), Diabetes Atlas (2006) was released
at 19th
World Diabetes Congress, there were an
estimated 40.9 million persons with diabetes in India
and the number may rise up to 70 million people by
2030. The countries having the largest number of
diabetic people will be India, USA and China and in
2025.
It has been found that diabetes mellitus is the main
cause of more than 11% of all new cases of
blindness, more than one third of renal diseases, and
half of non traumatic lower – extremity amputations.
Many evidences points that diabetes patients are
having two to four times more chances to die from
heart diseases and stroke. Due to progressive nature
of type 2 diabetes mellitus (T2DM), many
individuals require insulin to optimize glycemic
control over time as oral hypoglycemic agents fail to
achieve targets. Data from the UK Prospective
Diabetes study suggest that 53% of patients will
require insulin after 6 years following diagnosis and
75% of patients will need multiple treatments after 9
years. Even though insulin treatment is very effective
in achieving glycemic control, use of insulin is
associated with weight gain due to increased body fat
mass, especially abdominal obesity. Obesity accounts
greatly to insulin resistance, even in the absence of
diabetes. In fact, weight loss is a corner stone of
therapy for obese type 2 diabetic patients. [1]
Two major types of heart and blood vessel disease,
also called cardiovascular disease, are common in
people with diabetes: coronary artery disease (CAD)
and cerebral vascular disease. People with diabetes
are also at risk for heart failure. Narrowing or
blockage of the blood vessels in the legs, a condition
called peripheral arterial disease, can also occur in
people with diabetes. Diabetes is the most common
cause of kidney failure, accounting for nearly 44
percent of new cases. Even when diabetes is
controlled, the disease can lead to Chronic Kidney
Diseases (CKD) and kidney failure. Over several
years, people who are developing kidney disease will
have small amounts of the blood protein albumin
beginning to leak into their urine. This first stage of
CKD is called microalbuminuria. The kidney’s
filtration function usually remains normal during this
period. As the disease progresses, more albumin
leaks into the urine. This stage may be called
microalbuminuria or proteinuria. As the amount of
albumin in the urine increases, the kidneys’ filtering
function usually begins to drop. The body retains
various wastes as filtration falls. As kidney damage
develops, blood pressure often rises as well. Overall,
kidney damage rarely occurs in the first 10 years of
diabetes, and usually 15 to 25 years will pass before
kidney failure occurs. [2]
The pharmacist can play an important role in diabetes
care by screening patients at high risk for diabetes,
assessing patient health status and adherence to
standards of care, educating patients to empower
them to care for themselves, referring patients to
other health care professionals as appropriate, and
monitoring outcome. Pharmacists play a major role in
helping the patient maintain control of their disease.
The pharmacist can monitor the patient's blood
glucose levels and keep a track of it. [3]
METHODOLOGY
This prospective-observational study was conducted
in the General Medicine Department of a 700 bedded
multi- specialty private corporate hospital. The
reason for selection of this department was that, a
pilot study done revealed more prevalence of diabetic
cases in the department of General Medicine that has
got lot of potential to use many classes of antidiabetic
drugs. The study was carried out for a period of eight
months. Approval provided by the hospital authority
to use the hospital facilities was obtained. All the
patients getting admitted to General Medicine
Department with T1DM and T2DM along with other
co morbid disease conditions were included in the
study. Patients in the outpatient department and
patients with incomplete case sheets were excluded
from the study.
Specially designed data entry format has been used to
note down the cases from study site which included
the details of patient’s demographics, past medical
history, laboratory investigations done, diagnosis and
the drugs prescribed. All prescriptions for diabetes
(with other co-morbid diseases) were evaluated for
patient details like sex, age, obesity, laboratory
investigations, self care assessment, co-morbid
disease states, drugs prescribed, rationality of the
prescriptions, complication associated and its
management, drug interactions etc. Systemic
hypertension was found to be the major co-morbidity
(45%) associated with diabetes. Special study was
3. Sriram.S et al / Int. J. of Res
done on rationality and appropriateness of diabetic
hypertensive study population.
Patient information leaflet (Figure 1) on management
of diabetes and diabetic diary (Figure 2) were
provided to all the patients who were enrolled in the
of Res. in Pharmacology and Pharmacotherapeutics Vol-2(2) 2013 [344-352
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done on rationality and appropriateness of diabetic-
Patient information leaflet (Figure 1) on management
of diabetes and diabetic diary (Figure 2) were
provided to all the patients who were enrolled in the
study. Diabetic diet chart which was prepared in
consultation with the dietician of the study hospital
was given to the patients with explanations for their
easy reference.
Figure1:Information Leaflet
Figure 2: Diabetic Diary
346
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study. Diabetic diet chart which was prepared in
consultation with the dietician of the study hospital
was given to the patients with explanations for their
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RESULTS
A total of ninety three diabetic patients were enrolled
in the study. The prevalence of Type II diabetes were
high i.e., 89 (97%) compared to Type I diabetic
population which constitutes only 4 patients during
the study. The age was 61.2±12.4 years (mean±
and the duration of diabetes was 6.4±6.3 years
(mean± S.D). Study results on major co
along with diabetes revealed that in 48 % of the
diabetic population Systemic Hypertension was the
major co-morbidity (Figure3). The major
microvascular complications observed include
diabetic nephropathy in 12 (12.93%) patients (Table
1). The major category of antidiabetic drugs
prescribed to these patients were insulin (64.4%)
(Table 2), sulphonyl urea (40.0) and biguanides
(28.9%), α-glucosidase inhibitor prescribed was
acarbose (17.8%) (Table3). Number of co
Table 1: Micro Vascular Complications
Category
Diabetic Neuropathy
Diabetic Nephropathy
Diabetic Retinopathy
Diabetic Foot
et al / Int. J. of Res. in Pharmacology and Pharmacotherapeutics Vol-2(2) 2013 [344-352
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A total of ninety three diabetic patients were enrolled
in the study. The prevalence of Type II diabetes were
high i.e., 89 (97%) compared to Type I diabetic
population which constitutes only 4 patients during
the study. The age was 61.2±12.4 years (mean± S.D)
and the duration of diabetes was 6.4±6.3 years
(mean± S.D). Study results on major co-morbidity
along with diabetes revealed that in 48 % of the
diabetic population Systemic Hypertension was the
morbidity (Figure3). The major
mplications observed include
diabetic nephropathy in 12 (12.93%) patients (Table
The major category of antidiabetic drugs
prescribed to these patients were insulin (64.4%)
, sulphonyl urea (40.0) and biguanides
prescribed was
(Table3). Number of co-morbidity
is 2.23±1.03 (mean± S.D) and the m
was found to be Systemic Hypertension in 45 patients
(Table 4). This compelled the physician to prescribe
more number of drugs which ultim
effect on the glycemic control of the patient. It was
observed that in 22 patients Insulin and
Fluroquinolone combination were seen which
requires close monitoring of glucose level and
adjustment in the dose of antidiabetic agents.
percentage of diabetic hypertensive patients who
could achieve target blood pressure of < 130/80 mm
of Hg was 46.7% (Table 5). Study on the rational use
of drugs revealed that there are drugs which were
prescribed with wrong frequency of administration.
Acarbose which should be prescribed thrice daily was
prescribed only once a day and frusemide which is to
be prescribed in twice daily dose was also prescribed
only once daily.
Figure 3: Major Co- Morbidities
Table 1: Micro Vascular Complications (n=93)
No: Of Patients (%)
Diabetic Neuropathy 6 (6.45)
Diabetic Nephropathy 12 (12.93)
Diabetic Retinopathy 1(1.07)
Diabetic Foot 6 (6.45)
352]
is 2.23±1.03 (mean± S.D) and the major co-morbidity
was found to be Systemic Hypertension in 45 patients
. This compelled the physician to prescribe
more number of drugs which ultimately may have
effect on the glycemic control of the patient. It was
observed that in 22 patients Insulin and
Fluroquinolone combination were seen which
requires close monitoring of glucose level and
adjustment in the dose of antidiabetic agents. The
ntage of diabetic hypertensive patients who
could achieve target blood pressure of < 130/80 mm
of Hg was 46.7% (Table 5). Study on the rational use
of drugs revealed that there are drugs which were
prescribed with wrong frequency of administration.
e which should be prescribed thrice daily was
prescribed only once a day and frusemide which is to
be prescribed in twice daily dose was also prescribed
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Table 2: Categorization of Antidiabetic Drugs Prescribed (n=93)
Antidiabetic drug No of Patients (%)
Insulin Therapy 54 (58.06)
Insulin + Single OHA 9 (9.67)
Single OHA Therapy 9 (9.67)
Combined OHA Therapy 12 (12.90)
Insulin+ Combined OHA Therapy 4 (4.30)
Table 3: OHA Prescribed (n=93)
Table 4: Major Co-morbidity (Systemic Hypertension)
Baseline Characteristics (n=45)
S.NO CHARACTER AVERAGE
1 Age 60.04 yrs
2 Years of HT 5.98 yrs
3 SBP 139.64mmHg
4 DBP 86.50mmHg
5 Years of DM 8.16 yrs
6 FBS 139 mg/dl
7 RBS 206.31 mg/dl
Table 5: Blood Pressure of Diabetic Hypertensive Patients According To Type of Therapy Received (n = 45)
PATIENTS ON NO: PATIENTS WITH SBP
(MM OF HG)
NO: PATIENTS WITH DBP
(MM OF HG)
<130 % >130 % <80 % >80 %
Mono therapy
(n = 31)
12 39 19 61 10 32 21 68
Multiple therapy
(n = 14)
9 64 05 36 06 43 08 57
OHA NO: OF PATIENTS (%)
Acarbose 3(3.22)
Metformin 15(16.12)
Glimepride 6(6.45)
Glipizide 2(2.15)
Glibenclamide 2(2.15)
Metformin + Glimepride 7(7.52)
Pioglitazone + Glimepride 1(1.07)
Glipizide + Metformin 1(1.07)
Glibenclamide + Metformin 1(1.07)
Glimepride+Pioglitazone
+Metformin
1(1.07)
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DISCUSSION
A total of ninety three diabetic patients were enrolled
in the study of which 65 (70%) were male and 28 (30
%) were female population. Similar study conducted
by Venmans M.A.J [4] also showed more male
population (55%) compared to female (45%). By
calculating the Body Mass Index using the height and
weight of the patient, they were categorized as Obese
or Non – Obese. Of the 93 patients screened 21
(22.58%) were in obese category with body mass
index more than 30 and the remaining 72 were in
non-obese category. The social status details from the
standard data entry format revealed that around 41%
of the patients screened were smokers and 21% were
alcoholics. (Table 6)
The prevalence of Type II diabetes were high i.e., 89
(97%) compared to Type I diabetic population which
constitutes only 4 patients during the study. The age
categorization study revealed that between the age of
51-65, the late adulthood age patients were more
(48%) followed by adulthood (17%),This is
comparable with other study done by Vijay [6]which
shows that more number of diabetic patients were in
50-60 age frequency. Out of four Types I cases in
two patients there were early onset of diabetes and
was during adolescent age.
According to the present study results on major co-
morbidity along with diabetes revealed that in 48% of
the diabetic population Systemic Hypertension was
the major co-morbidity similar study conducted by
Robert Chilton et.al also reveals that 75% of the
diabetics study population had hypertension. [7] In
type 2 diabetes hypertension is likely to be present as
a part of the metabolic syndrome (i.e., obesity,
hyperglycaemia, dyslipidemia) that is followed by
high rates of CVD [8]. The other major co-
morbidities were respiratory tract infection in 18
patients (22.5%). Bronchial asthma in 15 patients (
16%) ,Ischemic heart disease in 11 patients (11.8 %)
and Urinary tract infection in 14 patients (15%).The
major microvascular complications include diabetic
nephropathy in 12 (12.93%) patients, followed by
diabetic neuropathy and diabetic foot, both in six
patients. The major macrovascular complications
were systemic hypertension in 45 patients (48.38%),
followed by Ischemic heart disease and congestive
heart failure in 18 patients (19.35%) and stroke in 7
(7.52%) patients. This is comparable with study
conducted by American Diabetes Association [8]
stating nephropathy and hypertension are the major
microvascular and macrovascular complications
respectively. It was found that 35 patients in the
study population had diabetes between one to four
years of duration and 23 (24.73%) had for a duration
between 5 to 10 years. Six patients had diabetes for
more than 20 years. 12 (12.9%) patients were
diagnosed as diabetics very recently i.e. within one
year and six were newly diagnosed.
The major lab investigations done included fasting
blood sugar ( 65%).Similar study conducted by
Sarwar et.al [9] shows that more number of lab
investigations were done for FBS and random blood
sugar levels (78%) followed by renal function test
in 61 (65%) , blood counts estimation in 56 patients
(60.21%) urine examination in 39% and electrolytes
in 27 % of population .
The study on the major category of Antidiabetic drug
prescribed includes Insulin therapy in 54 (58%).This
is comparable with study of Denis R [10] shows that
more number of the patients were on insulin therapy.
Exogenous insulin therapy is rationale to compensate
for secretory failure of beta cells in the presence of
marked insulin resistance. Hence insulin therapy may
be used as an alternative to oral drugs after its failure
or contraindication [11]. “Diabetes mellitus Insulin-
Glucose infusion in Acute Myocardial Infarction”
(DIGAMI) study documented a beneficial
cardiovascular effect of intensive insulin therapy in
the year following myocardial infarction. Combined
oral Hypoglycemic drugs were given in 12 patients.
Nine patients received single OHA therapy and
combination of insulin and OHA for 4 patients. Of all
OHA prescribed, the biguanides, Metformin was
prescribed in 15 (16.12%) patients. Metformin is a
peripheral sensitizer of insulin and has beneficial
effects on insulin resistance; an important factor in
the pathogenesis of type 2 diabetes [12]. Metformin
was followed by Glimepride in 6 patients (6.45%).
Similar study done by G Sultana et.al [12] shows that
metformin and glimepride were the mostly prescribed
OHA’s respectively. The other category of drugs
prescribed include Antibiotics in 68 (73.18%), Anti
hyperlipidemic drugs in 47 (50.53%), followed by
NSAIDS in 43(46.23%) and antihypertensives in 42
(45.16%) patients.
Thirty diabetic patients (32.26%) had two co-
morbidities followed by 21 patients (22.58%) with
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one co-morbidity and 16 (17.2%) of patients had
three co-morbid condition during the study period.
This compelled the physician to prescribe more
number of drugs which ultimately may have effect on
the glycemic control of the patient. It was observed
that in 22 patients Insulin and Fluroquinolone
combination were seen which requires close
monitoring of glucose level and adjustment in the
dose of antidiabetic agents.
There were 45 patients who met the inclusion criteria
for Diabetes Mellitus with Hypertension as co-
morbidity. The average age was 60.04 years old and
53% were male. The mean duration of hypertension
was 5.98 years and mean duration of diabetes was
8.16 years (Table 4).
The percentage of diabetic hypertensive patients who
could achieve target blood pressure of < 130/80 mm
of Hg was 46.7%. The blood pressure control of
patients receiving monotherapy & multiple drug
therapy were analyzed. Systolic blood pressure
control was 39% in patients on monotherapy, 64% in
patients receiving multi drug regimens. Diastolic
blood pressure control was 32% in patients on
monotherapy, 43% in patients receiving multiple
therapies. The major categories of antidiabetic drugs
prescribed to these patients were insulin (64.4%),
sulphonyl urea (40.0%), biguanides (28.9%), α-
glucosidase inhibitor (17.8%) and thiazolidinediones
(04.4%). Metformin (28.9%) was the only biguanides
prescribed. α-glucosidase inhibitor prescribed was
acarbose (17.8%). A total of 31 patients (68.9%)
received monotherapy and 14 (31.1%) received
combination therapy. Major monotherapy to treat
diabetes was insulin in 21(46.7%) patients.
The baseline characteristic studies done on 45
patients who are having hypertension as co-morbidity
revealed that the average fasting blood sugar value is
139mg/dl and the average random blood sugar level
is 206mg/dl. The major antihypertensive drug
prescribed in type 2 diabetes patients were
Telmisartan in 26 (57.8%) followed by
Hydrochlothiazide in 25 (55.5%) of patients. Study
on the rational use of drugs revealed that there are
drugs which were prescribed with wrong frequency
of administration. Acarbose which should be
prescribed thrice daily was prescribed only once a
day and frusemide which is to be prescribed in twice
daily dose was also prescribed only once daily.
Table 6: Patient Characteristics (n=93)
Characteristics Category Statistical analysis value
Gender Male
Female
69.89%
30.10%
Age Mean ± S.D 61.24±12.35
No. Of co-morbidity Mean ± S.D 2.23±1.03
Duration of diabetes Mean ± S.D 6.4±6.3
Alcohol Yes 20.43
Smokers Yes 40.86
GUIDELINES
Once the diagnosis of diabetes has been established,
the question of initiating therapy must be addressed.
At this initial stage, the physician or healthcare
professional who is seeing the patient should obtain a
detailed history and perform a complete examination
with appropriate laboratory testing. The future
progression of the patient's care will be affected by a
number of factors, including the physician's treatment
philosophy, the patient's healthcare beliefs and
competence at self-care, and the availability of a team
consisting of a dietician, diabetes educator, exercise
physiologist, and, when needed, social workers and
psychologists
The approach must consider the “whole person” with
diabetes, not just the levels of glycemic control to be
achieved or the therapy to be used to accomplish this
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(i.e., insulin or oral antidiabetic therapies). To this
end, a strong, integrated team approach is the one
most likely to succeed. Although, as noted above, the
complete team may not exist in most cases, the
physician and the patient can make considerable
progress together, with other components of the team,
especially the diabetes educator and dietician, coming
from the community. In diabetes care, lifestyle
modification can prevent complications or markedly
delay their appearance, as well as decreasing the need
for medication. Pharmacist provided interventions
help in the prevention of acute complications and
reduce the risk of long-term complications.
Table 7: General Information on OHA
CONCLUSION
This study shows the significance of including
dietary modifications, strict glycemic control,
cardiovascular prevention and treatment of
complications and co-morbidity. In patients with
diabetes all drugs should be used with both potential
risks and benefits in mind. Conversely, the drugs that
can lower blood sugars by inducing weight loss and
lessening insulin resistance, thereby improving
glycemic control and the patient’s quality of life need
to be prescribed. Many patients with type 2 diabetes
have concomitant hypertension, hyperlipidemia,
atherosclerosis, and coronary heart disease. Any drug
that could complicate these conditions should be used
cautiously under the direct supervision of a
physician. Hypertension affects about 60% of
patients with type 2 diabetes. More studies should be
carried out in this particular area as serious
cardiovascular events are more than twice as likely in
patients with diabetes and hypertension as either
disease alone.The benefits of tight blood pressure
(BP) control in patients with diabetes are to be kept
in mind while treating Diabetic patients. Measures
should be taken to improve patient adherence to the
prescribed studies. Drug interactions and cost
minimization during prescribing antidiabetic drugs
will enhance patient healthcare.
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