S Divya*, Devarakonda Sivakumar, D. Likhitha, K. Sravani, S. Priya

^*Department of Pharmacy Practice, Ratnam Institute of Pharmacy, Nellore, Andhra Pradesh

¹Pharm D, Ratnam Institute of Pharmacy, Nellore, Andhra Pradesh

Corresponding author: S Divya, Department of Pharmacy Practice, Ratnam Institute of Pharmacy, Nellore, Andhra Pradesh, Email: divyapharma94@gmail.com

Citation: S Divya, Devarakonda Sivakumar, D. Likhitha, K. Sravani, S. Priya (2021) Efficacy of Empagliflozin in reducing cardiovascular risk and glycemic control in long standing diabetic patients: An Observational Study. J Pharm Exper Med, 1(1); XX-XX.

Copyright: © 2021, S Divya, Devarakonda Sivakumar, D. Likhitha, K. Sravani, S. Priya. This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International License, which permits unrestricted use, distribution and reproduction in any medium, provided the original author and source are credited

ABSTRACT

Diabetes mellitus is a heterogeneous complex metabolic disorder characterized by elevated blood glucose concentrations. The chronic hyperglycemia of diabetes is associated with long-term damage, dysfunction and failure of various organs. This is a leading health disorder with rising prevalence day by day with irrespective of age and gender. The diabetes patients are prone to have cardiovascular risk such as dyslipidemia, hypertension, coronary artery disease, obesity. The management of diabetes mellitus includes insulin and oral anti-diabetic agents. Among them Sodium glucose co-transporter 2 inhibitors are effective in achieving glycemic control in long-standing diabetic patients as single or add-on therapy. A large number of studies had proven that empagliflozin which belongs to the class SGLT2 inhibitors had shown potent glycemic control and reduces the cardiovascular risk in long-standing diabetic patients.

KEYWORDS

Diabetes mellitus, SGLT2 inhibitors, Empagliflozin, Glycemic control, Cardiovascular risk

INTRODUCTION

Diabetes mellitus (DM) refers to a group of common and chronic metabolic disorder that shares the phenotype of hyperglycemia. Several distinct types of DM are caused by a complex interaction of a genetics and environmental factors. Coming to the history of type-2 diabetes, it is described as a metabolic syndrome firstly in 1988 [1]. Usually type 2 diabetes arises due to interaction between different factors such as environmental, social habits and genetic factors [2,3]. The metabolic dys-regulation associated with DM causes secondary pathophysiology changes in multiple organ system that imposed a tremendous burden on the individuals with diabetes and on the health care system. According to 2011 census, due to the cause of diabetes 4.6 million deaths were noted [4].

CLASSIFICATION

Diabetes is a heterogeneous, complex metabolic disorder characterized by elevated blood glucose concentrations secondary to either resistance to the action of insulin, insufficient insulin secretion or both. 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. A wide spread pathological change is thickening of capillary basement membrane, increase in vessel wall matrix and cellular proliferation resulting in vascular complications like lumen narrowing, early atherosclerosis, sclerosis of glomerular capillaries and peripheral vascular insufficiency. According to American Diabetes Association (ADA) 1997, the Diabetes classification includes: 1. Type 1 diabetes mellitus, 2. Type 2 diabetes mellitus, 3. Gestational diabetes and still it is most widely accepted classification [5].

STUDY DESIGN AND METHODOLOGY

3.1 Aim of the study

To conduct an observational study on efficacy of Empagliflozin [SGLT2 inhibitor] in reducing cardiovascular risk and achieving glycaemic control in long standing diabetes patients who are on more than two Anti-diabetic therapy.

3.2 Type of study: Observational study

3.4 Place of Study​: ACSR Government General Hospital Nellore

3.5 Period of the study: ​6 months [July 2019 to November 2019]

3.6 Study Population: 40 Patients

3.7. Patient Enrolment: Patients enrolled in the study based on the inclusion and exclusion criteria.

3.7.1 Inclusion criteria:

 ● Patient‘s with age between 35-85 years.

 ● Patient having history of T2DM

 ● Patient having co-morbidities of hypertension and other cardiovascular related ones.

 ● Patient’s who were willing to take the drug.

 ● Patient having stable background anti-hyperglycemic therapy.

 ● Patient’s who were on dual or triple therapy. (Metformin, sulfonylureas and gliptins)

3.7.2 Exclusion criteria:

● Patient’s who are not willing to take the drug.

● Patient using SGLT2: GLP-IRA/ saxagliptin.

● Patient having GFR <60 ml/min/1.73 m²

● Patient having LVEF<30%.

● Patient’s with NYHA class 4 or recent HHF.

● Pregnancy and lactation mothers were excluded. 

CLINICAL MANIFESTATIONS

The person with diabetes mellitus mainly present frequent urination, Dry mouth, repeated infections, blurred vision, fatigue, susceptibility to certain infections, slow wound healing, numbness in soles and palms, tingling, acanthosis nigricans (rarely), weight loss [6].

RESULTS AND DISCUSSION

Categorized based on age

Out of 40 patients 7 belong to 35-45 years; 17 belong to 46-55 years; 5 belong to 56-65 years; 4 belong to 66-75 years; 7 belong to 76-85 years.

Categorized based on gender

Among 70 patients 24 were males and 16 were females.

Categorized based on co-morbidities

Distribution based on co-morbidities, out of 40 members the patients with co-morbidities were 16 and the patients without co-morbidities were 24.

Categorized based on duration of type 2 DM

Among 40 patients 16 patients has 6-10 years of duration of type 2 diabetes mellitus; 18 patients has 11-15 years of duration of type 2 diabetes mellitus; 5 patients has 16-20 years of duration of type 2 diabetes mellitus; and 1 patient has >20 years of duration of type 2 diabetes mellitus.

Categorized based on Social habits

Among total subjects 10 were alcoholics; and 2 were smokers.

Patient’s data during Observational study

Patient’s data was tabulated in Table 2 with respective to their visits and glucose levels in order to support the glycemic control of Empagliflozin. Patient’s data was tabulated in Table 3 with respective to their ejection factor in order to support the cardiovascular protection of Empagliflozin.

CONCLUSION

Empagliflozin has a consistent cardio protective effect in patients with T2DM and CVD, regardless of the number of CV risk factors that are controlled. Empagliflozin can be taken along with the other oral anti-diabetes medications such as metformin, sulfonylureas, mono or poly therapy but strict monitoring, awareness regarding dietary modifications are needed during the continuous period of treatment along with the betterment of CV symptoms, empagliflozin was achieved the better glycemic control especially in patients with cardiovascular disease. It is a good alternative to the uncontrolled hyperglycemic patients who are already using triple therapy at maximum dose and not willing to take insulin despite of having minimal adverse effects, it is having very good proven cardiac safety, which makes diabetic management more potent.

CONFLICT OF INTEREST

None

ETHICAL CONCERN

We have obtained informed concern from every patient participated in the study.

SOURCE OF FUNDING

None

ACKNOWLEDGEMENTS

None

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