An observational study amongst anti-diabetic patients related to the anti-diabetic drugs prescription at tertiary care centre of northern India

 

Seema Mishra1*, Syed S. Ahmad1, Nilam Nigam1, Pratap Shankar2, Shravan Kumar3, Vinay Kumar1, Shalini Gupta1

1Department of Pharmacology, Rama Medical College Hospital and Research Centre, Kanpur, U.P.

2Center for Advance Research, King George’s Medical University, Lucknow, U.P.

3Department of Medicine, Rama Medical College Hospital and Research Centre, Kanpur, U.P.

*Corresponding Author E-mail: drseemamdixit@gmail.com

 

ABSTRACT:

Being a chronic metabolic disorder, Diabetes mellitus (DM) affecting six percent of the world population. The WHO defines diabetes mellitus as “A metabolic disorder of multiple aetiology characterized by chronic hyperglycemia with disturbances of carbohydrate, fat and protein metabolism resulting from defects in the insulin secretion, insulin action, or both”. Oral antidiabetic drugs (OADs) are the first line treatment for type 2 diabetes mellitus in management of the disease. Rational use of oral antidiabetic drugs (OADs) and insulin are used for the prevention of diabetes mellitus complications. Prescription of rational use of the drugs is a complex issue to achieve the goal that patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements for an adequate period of time, and at the lowest cost to them and their community. Rational use of the drugs in populations can be effectively studied with drug utilization reviews. The aim is to study the drug prescribing pattern of anti-diabetic drugs in newly diagnosed type 2 DM patients.

 

KEYWORDS: Observational study, anti-diabetic patients, anti-diabetic drugs, drug prescription, tertiary care centre, India.

 

 


INTRODUCTION:

Diabetes mellitus (DM) is a chronic metabolic disorder and six percent of the world population is affected by it1-3. The WHO defines diabetes mellitus as “A metabolic disorder of multiple aetiology characterized by chronic hyperglycemia with disturbances of carbohydrate, fat and protein metabolism resulting from defects in the insulin secretion, insulin action, or both”2-8. Many studies on Indian population shows that 4% of the adults suffered from diabetes mellitus in the year 2000 and it is expected to rise to 6% by the year 20259. Oral antidiabetic drugs (OADs) are the first line treatment for type 2 diabetes mellitus in management of the disease5. Rational use of oral antidiabetic drugs (OADs) and insulin are used for the prevention of diabetes mellitus complications6,10,11.

 

Prescription of rational use of the drugs is a complex issue to achieve the goal that patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements for an adequate period of time, and at the lowest cost to them and their community7,12-15. Rational use of the drugs in populations can be effectively studied with drug utilization reviews. The aim is to study the drug prescribing pattern of anti-diabetic drugs in newly diagnosed type 2 DM patients.

 

MATERIAL AND METHOD:

It is a prospective observational study of prescription event and adverse drug reaction monitoring to drugs used for diabetes mellitus type-2 treatment. This study was carried out on the patients at Department of Medicine Rama Medical College, Kanpur. The duration of study was 6 months. The study started only after the approval of Institutional ethics committee.

 

The various study tools that will be used are the Suspected Adverse Drug Reaction Reporting Form issued by Central Drugs Standard Control Organization (CDSCO) under Pharmacovigilance Programme of India (PvPI) which will record all the information, such as name, age, sex, weight, other relevant history including pre-existing medical conditions, details of suspected adverse drug reactions and details of suspected medications that the patients might be taking.

 

Data will be aggregated according to disease profile and other relevant information required for the study. Causality assessment was done using Naranjo’s causality assessment scale8.

 

Inclusion criteria:

·       Newly diagnosed patients of diabetes mellitus type-2.

·       Patients with age more than 18 years.

·       Patients of either sex

·       Patients having base line (pre treatment) biochemical parameters other than blood sugar (i.e. liver function test, kidney function test) within normal range.

·       Patients having no associated comorbidities.

 

Exclusion criteria:

·       Patients who were unwilling to participate and did not give consent in the study

·       Patients who were unable to give interview.

·       Patients with incomplete medical records.

·       Patients with chronic liver disease such as cirrhosis, chronic hepatitis and acute viral hepatitis

·       Terminally ill patients

·       Patients with concurrent major psychiatric illness and/or concurrent major medical illnesses

 

Data Management and Analysis:

Statistical analysis:

Categorical variables were presented in number and percentage (%). Qualitative variables were compared using Chi-Square test /Fisher’s exact test as appropriate. A p value of <0.05 was considered statistically significant. Statistical analysis was performed using GraphPadQuickCalcs software available online at http://graphpad.com/quickcalcs/. The data was entered in MS EXCEL spreadsheet and analysis was done using Statistical Package for Social Sciences (SPSS) version 21.0.

 

RESULT:

Demographic and health characteristics:

A total of 120 patients were diagnosed with type II diabetes. The total number of males in the study was 68 (56.7%) while females were 52 (43.3%) (Tab. 1).

 

Tab. 1: Gender wise distribution

Gender

N (%)

Male

68(56.7%)

Female

52(43.3%)

Total

120(100%)

Age wise distribution of patients showed 6(5%) were aged between 21 – 30 yr, 13(10.8%) between 31 – 40 yr, 35(29.2%) between 41-50 yr, 45(37.5%) between 51-60 yr, 18(15%) between 61-70 yr and 3(2.5%) in >70 yr [Tab. 2].

 

Table 2: Age wise distribution

Age (Yrs)

N (%)

21 - 30

6(5)

31 - 40

13(10.8)

41 – 50

35(29.2)

51 – 60

45(37.5)

61 – 70

18(15)

>70

3(2.5)

Total

120(100)

Duration of diabetes was between 16 and 20 yr in 12(10%) patients, 11-15 yr in 21(17.5%) patients, 6-10 yr in 36 (30%) patients and ≤5 yr in 51 (42.5%) patients [Tab. 3].

 

Tab. 3: Duration of Diabetes Distribution

Duration of diabetes (Yr)

N(%)

16 - 20

12(10%)

11 - 15

21(17.5%)

6 - 10

36(30%)

< = 5

51(42.5%)

 

Drug Prescription Pattern of oral antidiabetics:

Drug Prescription Pattern of oral antidiabetics it was observed out of 120 patients monotherapy was prescribed to 55 patients (Metformin was to 40 patients, Glimipride/Gliclazide to 15 patients that accounted for 33.3% and 12.5% of total respectively), combination therapy was prescribed to 65 patients (Metformin plus Glimipride/Gliclazide to 36 patients, Metformin plus Glimipride/Gliclazide plus Glitazone to 10 patients and Metformin plus Dipeptidyltransferase IV inhibitor to 19 patients that accounted for 30%, 8.3%, and 10.5% of total respectively) [Tab. 4].

 

Table 4: Drug Prescription Pattern of Oral Antidiabetic

Oral Antidiabetic Drug

Monotherapy

N(%)

Metformin

40(33.3%)

Glimipride/Gliclazide

15(12.5%)

Combination Therapy

Metformin plus Glimipride/Gliclazide

36(30%)

Metformin  plus Glimipride/Gliclazide plus Glitazone

10(8.3%)

Metformin plus Dipeptidyltransferase IV inhibitor

19(10.5%)

 

DISCUSSION:

The total number of males in the study was 68 (56.7%) while females were 52 (43.3%). This is in agreement with previous reports as shown in study by Singh et al9,16 who included 55% of males while 45% were females, similarly study by Saravanan et al10 included 60% males rest 40% of females, another study included 51% males while 49% were females.

 

Age wise distribution of patients showed 6(5%) were aged between 21 – 30 yr, 13(10.8%) between 31 – 40 yr, 35(29.2%) between 41-50 yr, 45(37.5%) between 51-60 yr, 18(15%) between 61-70 yr and 3(2.5%) in >70 yr.It was observed from age wise distribution that maximum no. of patients with diabetes 37.5% were aged between 51 – 60 yr  and then 29.2%  between 41 – 50 yr. This was found in agreement with study done that showed almost similar observations, maximum no. of patients with diabetes 37% were between 51 – 60 yr and 26% were between 41 – 50 yr17,18.

 

Duration of diabetes was between 16 and 20 yr in 12(10%) patients, 11-15 yr in 21(17.5%) patients, 6-10 yr in 36 (30%) patients and ≤5 yr in 51 (42.5%) patients. It was found that maximum no. of patients 42.5% had ≤5 yr duration of diabetes. Similar pattern was seen in study done by Singh et al9 where 43.6% of patients had ≤5 yr duration of diabetes. In contrast study by Bhattacharjee et al10,19.20 showed 29.5% of patients had ≤5 yr duration of diabetes where as maximum no. of patients 36.5% were in the timeframe of 5–10 yr duration of diabetes.

 

Drug Prescription Pattern:

In Drug Prescription Pattern of oral antidiabetics, out of 120 patients monotherapy was prescribed to 55 patients (Metformin was to 40 patients, Glimipride/Gliclazide to 15 patients that accounted for 33.3% and 12.5% of total respectively), combination therapy was prescribed to 65 patients (Metformin plus Glimipride/Gliclazide to 36 patients, Metformin  plus Glimipride/Gliclazide plus Glitazone to 10 patients and Metformin plus Dipeptidyltransferase IV inhibitor to 19 patients that accounted for 30%, 8.3%, and 10.5% of total respectively).It was observed that Metformin was the maximum prescribed drug in monotherapy as well as maximum prescribed drug of all oral antidiabetics too.

 

CONCLUSION:

Out of total 120 patients male constituted more as compared to women. Age wise distribution showed maximum patients belong to age group between 41-50 yr, which appeared to be the most vulnerable group. Duration of diabetes was ≤5 yr seen in maximum patients.

 

Drug Prescription Pattern of oral antidiabetics showed that metformin was the most commonly prescribed drug followed by combination therapy of metformin plus glimipride/gliclazide.

 

REFERENCES:

1.      Acharya KG, Shah KN, Solanki ND, Rana DA. Evaluation of antidiabetic prescriptions, cost and adherence to treatment guidelines: A prospective, cross-sectional study at a tertiary care teaching hospital. J Basic Clin Pharma 2013; 4:82-87.

2.      Kannan, Arshad, Senthil K. A study on drug utilization of oral hypoglycemic agents in Type-2 diabetic patients. Asian J Pharm Clin Res 2011; 5:60-4.

3.      About Diabetes. Available from: http://www.who.int/diabetes/ action_online/basics/en/index.html

4.      Day C (2001) The rising tide of type 2 diabetes. Br J Diabetes Vasc Dis 1:37.

5.      Chaudhari VP, Ganguly B (2013) Changing pattern of prescribing antidiabetic agents in patients suffering from diabetes mellitus. Int J Basic Clin Pharmacol 2:47-50.

6.      Hermansen K, Mortensen LS, Hermansen ML (2008) Combining insulins with oral antidiabetic agents: Effect on hyperglycemic control, markers of cardiovascular risk and disease. Vasc Health Risk Manag 4:561-74.

7.      Sivasankari V, Manivannan E, Priyadarsini SP (2013) Drug utilization pattern of anti-diabetic drugs in a rural area of Tamilnadu, South India – A prospective, observational study. Int J Pharm Biol Sci 4:514-9.

8.      Syed Ahmed Zaki (2011) Adverse drug reaction and causality assessment scales. Lung India 28(2).

9.      Singh Siddharth, Singh Preet Paul, Singh Abha Goyal, Murad Mohammad Hassan, Sanchez William (2013) Anti-diabetic medications and the risk of hepatocellular cancer: a systematic review and meta-analysis. Am J Gastroenterol 108(6):881-91.

10.   Saravanan K, Manna PK, Mohanta GP, Manavalan R (2011) A study of adverse drug reaction on drugs used in the management of type 2 diabetic mellitus. Journal of Pharmacy Research 4(10):3394-3395.

11.   Anita Rani Kansal, Rajinder Mahal, D. Behera, Rohit Sarin. A study to assess learning need, knowledge and attitude of nurses regarding tuberculosis care under RNTCP in two tertiary care tuberculosis institutions of Delhi, India. Asian J. Nur. Edu. & Research 4(1): Jan.-March 2014; Page 30-34.

12.   Bharat Pareek, Kiran Batra, Raman Kalia. Development of Professionalism Assessment Scale for Nurse Educator. Asian J. Nur. Edu. and Research.2016; 6(4): 506-510.

13.   Dhara Vashi, Suresh Kumar. Impurity Identification and Characterization of some Anti-Diabetic Drugs using various Analytical Methods. Asian J. Pharm. Res. 2019; 9(4):243-248.

14.   Merry Raphael, Vijayanarayana K, GirishThunga, Karthik Rao N, Sreedharan N. Utilization Pattern of Anti-Diabetic Drugs in Type 2 Diabetes Mellitus in Tertiary Care Hospital. Research J. Pharm. and Tech. 2017; 10(7): 2063-2068.

15.   Geetha P, Shanmugasundaram P. A Prospective Observational Study on assessment of risk factor associated with diabetic retinopathy in patients diagnosed with type 2 Diabetes Mellitus in south Indian population. Research J. Pharm. and Tech 2019; 12(2):595-599.

16.   Harpreet Kaur. Effectiveness of structured teaching programme regarding selfcare management in relation to prevention of complications among diabetics. Asian J. Nur. Edu. & Research 4(3): July- Sept., 2014; Page 279-283.

17.   Pushpendra Kumar, Titi Xavier Mangalathil, Vikas Choudhary. An experimental Study to Assess the Effectiveness of Structured Teaching Programme on Knowledge Regarding the Management of Diabetes Mellitus among G.N.M. Students in selected Nursing School at Sikar, Rajasthan. Asian J. Nur. Edu. & Research 4(3): July- Sept., 2014; Page 304-306.

18.   Jeeva S., Molly Babu. Knowledge of Diabetic Clients Regarding Self-care Practices in Management of type II Diabetes Mellitus at selected Rural Community of Bangalore, Karnataka. Asian J. Nur. Edu. and Research.2017; 7(1): 86-94.

19.   Jyoti Bhardwaj, Rashmi Choudhary, Poonam Sharma. A comparative study on quality of life among type 1 and type 2 diabetes mellitus clients at selected hospitals of district Mohali, Punjab. Asian J. Nursing Education and Research. 2018; 8(1): 152-158.

20.   Sindhu L, Jaya Kumar B. Effectiveness of Educational Intervention on Body Mass Index (BMI) of Patients with Type 2 Diabetes Mellitus in South Indian Population. Asian J. Nursing Education and Research. 2018; 8(3):434-436.

 

 

 

Received on 20.12.2020            Modified on 10.02.2021

Accepted on 09.03.2021           © RJPT All right reserved

Research J. Pharm. and Tech 2021; 14(12):6555-6557.

DOI: 10.52711/0974-360X.2021.01134