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

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. problem, for elderly patients, to illiteracy, lack of awareness, and patients show non-adherence to the treatment. on for on mellitus the use of antidiabetic and monitoring of blood and HBA1c diet control, physical activity, and complications of


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][4][5][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?
The study data were analyzed using the Chi-square test that was used for categorical data to test for the association.

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).
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.   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][17][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][19][20][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][23][24][25][26], these variations are may be due to differences in methods of data collection, measurement of blood glucose levels such as pre-prandial and post-prandial levels, and the difference in the population surveyed.

Bhuvaneswari
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][28][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.