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ORIGINAL ARTICLE
Year : 2022  |  Volume : 66  |  Issue : 5  |  Page : 41-44  

Impact of empagliflozin add-on therapy on quality of life in patients of type 2 diabetes mellitus with hypertension: A prospective study


1 PhD Scholar, Department of Pharmacology, Lovely Professional University, Jalandhar, Punjab, India
2 Professor, Department of Endocrinology, SKIMS Deemed University, Srinagar, Jammu and Kashmir, India
3 Associate Professor, Department of Clinical Pharmacology, SKIMS Deemed University, Srinagar, Jammu and Kashmir, India
4 Senior Resident, Department of Endocrinology, SKIMS Deemed University; Lecturer, Department of Medicine, Government Medical College, Srinagar, Jammu and Kashmir, India
5 Lecturer, Department of Technical Education and Industrial Training, Punjab, India
6 Professor, Department of Pharmacology, Lovely Professional University, Jalandhar, Punjab, India

Date of Submission09-Aug-2022
Date of Decision10-Aug-2022
Date of Acceptance17-Aug-2022
Date of Web Publication11-Nov-2022

Correspondence Address:
Sazal Patyar
Department of Pharmacology, Lovely Professional University, Jalandhar, Punjab
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijph.ijph_1070_22

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   Abstract 


Background: Diabetes has a negative impact on patient's quality of life (QoL). Comorbidities and polypharmacy further worsen their QoL. Thus, in addition to glycemic control, assessment of QoL is also gaining importance. Objective: The objective of this study was to evaluate QoL in patients of type 2 diabetes mellitus (T2DM) with hypertension after add-on empagliflozin to triple drug therapy (metformin, teneligliptin, and glimepiride). Materials and Methods: A prospective research was done on T2DM patients with hypertension, who visited a tertiary care referral institute's endocrine outpatient clinic. For 3 months, empagliflozin, 25 mg once daily, was administered as an add-on treatment with metformin, teneligliptin, and glimepiride. In addition to clinical assessment, an Urdu-translated QoL instrument for Indian diabetes patients was used to conduct QoL study. The QoL outcomes prior to empagliflozin add-on were compared with those obtained at the conclusion of the 3 months of treatment. Results: Empagliflozin as an add-on therapy significantly improved various aspects of QoL like role limitation due to physical health, physical endurance, general health, symptom botherness, financial worries, emotional/mental health, and diet satisfaction (P < 0.001). It also improved glycemic and blood pressure parameters significantly. Conclusion: QoL is an essential measure with respect to patient-centered treatment approach. Empagliflozin, as an add-on medication, improved QoL, glycemic parameters and blood pressure in T2DM patients with hypertension. It can be recommended as an add-on, but more research with a larger sample size is required.

Keywords: Empagliflozin, hypertension, quality of life instrument in diabetes, type 2 diabetes


How to cite this article:
Najar IA, Masoodi SR, Mir SA, Bhat MH, Patyar RR, Patyar S. Impact of empagliflozin add-on therapy on quality of life in patients of type 2 diabetes mellitus with hypertension: A prospective study. Indian J Public Health 2022;66, Suppl S1:41-4

How to cite this URL:
Najar IA, Masoodi SR, Mir SA, Bhat MH, Patyar RR, Patyar S. Impact of empagliflozin add-on therapy on quality of life in patients of type 2 diabetes mellitus with hypertension: A prospective study. Indian J Public Health [serial online] 2022 [cited 2022 Nov 29];66, Suppl S1:41-4. Available from: https://www.ijph.in/text.asp?2022/66/5/41/360641




   Introduction Top


As the worldwide burden of diabetes and its complications is rising, it is being referred to as a “quiet pandemic.” India is the world's second-most diabetes-affected country. Diabetes was anticipated to impact 77 million individuals in India in 2019; with this figure expected to rise more than 134 million by 2045.[1] Type 2 diabetes mellitus (T2DM) and hypertension have a bidirectional link and typically coexist. The coexistence of T2DM and hypertension adversely affects the treatment outcomes, increases the risk of cardiovascular diseases, reduces quality of life (QoL), and may result in mortality. As a result, it is critical to establish therapeutic regimens that have the potential to enhance clinical results as well as QoL.[2] Diabetes affects QoL in general, while there may be differences depending on ethnicity, environment, gender, socioeconomic status, culture, occupation, or dietary habits. When problems or comorbidities appear, a diabetes patient's QoL deteriorates further.[3]

Empagliflozin is a sodium-glucose co-transporter-2 inhibitor that reduces renal glucose reabsorption in T2DM patients. It controls blood sugar levels without the need for insulin.[4] Furthermore, empagliflozin has been shown to reduce blood pressure in T2DM and hypertension patients. It has been shown to be useful in T2DM diabetes that has not been properly managed with metformin, glimepiride, or dipeptidyl peptidase-4 inhibitors.[5] However, there is currently a dearth of data on its influence on QoL in T2DM patients with hypertension that are on triple drug therapy (glimepiride, metformin, and teneligliptin). As a result, this study used an Urdu-translated QoL instrument for Indian diabetic (QOLID) patients to study the influence of the aforementioned treatment regimen on QoL in Indian patients before and after therapy.


   Materials and Methods Top


Study design and setting

The 1-year prospective, open-label research was carried out in a north Indian tertiary care institution (Deemed University). Patients with T2DM and hypertension who visited the hospital were evaluated and recruited based on inclusion and exclusion criteria. The patients (200 in all) were recruited in October 2020, and the trial was completed in October 2021.

Ethics

The study procedure was approved by the Institutional Ethics Committee (IEC/2020-591) in accordance with the Indian Council of Medical Research's ICH-GCP ethical guidelines. In this investigation, good clinical practice standards and a revised version of the Helsinki Declaration were followed. Participants in the research provided written informed permission before the study. Each and every participant was guaranteed confidentiality and the anonymity of their identity.

Data collection procedure

Patients with T2DM who had hypertension were given empagliflozin (25 mg/day) as an add-on medication in addition to the triple therapy of metformin (2 g/day), teneligliptin (20 mg/day), and glimepiride (8 mg/day). Patients with poorly managed hypertension (systolic blood pressure [SBP] of 130 mmHg or higher and/or diastolic blood pressure [DBP] of 80 mmHg or higher) (hemoglobin A1C [HbA1c] 6.5% or higher) and blood glucose (fasting 126 mg/dl or higher and postprandial of 200 mg/dl or higher) were included in the study. The current study excluded participants with severe comorbidities that had a significant impact on blood glucose levels.

Procedure and tool for data collection

A manually designed case report form was used to collect sociodemographic information in addition to clinical data. QOLID was used to compare the quality of health outcomes before and after therapy. [Figure 1] depicts a collection of 34 questions encompassing eight categories (including the role of limitation to physical health, physical endurance (PE), general health (GH), treatment satisfaction (TS), symptom botherness (SB), financial concerns, mental health, and food satisfaction).[6] Patient responses were gathered through face-to-face interviews at baseline and follow-up, and scores were recorded in the case report form. To assess the internal consistency of the QOLID instrument in the Urdu version, Cronbach's alpha was calculated using baseline QOLID score data. Cronbach's alpha was 0.89.
Figure 1: This comprises a group of 34 items covering eight domains of QOLID. QOLID: QoL Instrument for Indian diabetic

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Analysis of statistical data

For all statistical studies, GraphPad Prism 6 was utilized. The data were given as mean and standard deviation (SD). To examine the change in QoL scores, the Wilcoxon matched-pairs signed–rank test was utilized. P < 0.05 level of significance was considered statistically significant.


   Results Top


Clinical and sociodemographic characteristics of patients

A total of 200 individuals with T2DM and hypertension were recruited, with a mean age of 49.83 (SD ± 9.36) years. The study population had 37.5% of men and 62.5% of women. Most of them (96.5%) were married and lived in rural areas (60.5%). 64% of patients came from low-income families, whereas 36% came from middle-income families. The majority of people, 59.5%, had diabetes for <5 years, 24% had a family history of diabetes, 32% were smokers, and only 36% exercised. The study found a significant reduction of P < 0.05 in mean change in SBP (6.47 ± 4.40), DBP (1.56 ± 2.32), fasting blood glucose (42.38 ± 42.40), postprandial glucose (73.00 ± 44.70), and HbA1C (0.62 ± 0.34) during follow-up when compared to baseline [Table 1].
Table 1: Efficacy parameters at baseline and follow-up

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Changes from baseline to follow-up (after 3 months) in quality of life

[Table 2] shows the QoL scores at baseline and follow-up. It shows that all eight QOLID parameters show a significant difference of P < 0.05 after the end of the study.
Table 2: Quality of life scores in baseline and follow-up during treatment

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Comparison of independent variables with quality of life instrument for Indian diabetic parameters at the end of the study

The following statistically significant differences were observed at the end of the study:

  • Smoking history versus role limitation due to physical health (RL) (P = 0.0038), (PE) (P = 0.0057), GH (P = 0.0030), TS (P = 0.0095), emotional/mental health (EH) (P = 0.0095), and diet satisfaction (DS) (P = 0.0464)
  • Exercise versus RL (P = 0.0038), PE (P < 0.0001), GH (P < 0.0001), TS (P < 0.0001), SB (P < 0.0001), financial worries (FW) (P = 0.0016), EH (P < 0.0001), and DS (P < 0.0001)
  • Monthly income versus RL (P < 0.0001), PE (P < 0.0001), GH (P < 0.0001), TS (P < 0.0001), SB (P < 0.0001), FW (P = 0.0022), EH (P < 0.0001), and DS (P < 0.0001)
  • Age versus RL (P = 0.0038), PE (P < 0.0001), GH (P < 0.0001), TS (P < 0.0001), SB (P < 0.0001), EH (P < 0.0001), and DS (P < 0.0001). Body mass index (BMI) versus FW (P = 0.0068)
  • Educational status versus RL (P = 0.0038), PE (P < 0.0001), GH (P < 0.0001), TS (P < 0.0001), SB (P < 0.0001), EH (p < 0.0001), and DS (P < 0.0001)
  • Duration of diabetes versus RL (P < 0.0001), PE (P < 0.0001), GH (P = 0.0001), TS (P < 0.0001), SB (P = 0.0031), FW (P = 0.0424), EH (P < 0.0001), and DS (P = 0.0001).



   Discussion Top


Previous research has shown that the severity of T2DM has a negative impact on QoL. According to the American Diabetes Association's new guidelines, T2DM treatment must be “patient-centered,” with an emphasis on increasing patients' QoL and glucose levels. As a result, QoL is becoming increasingly important.[7] This study discovered a link between glycemic markers and QoL. There was a substantial improvement in QoL in T2DM patients with hypertension who received empagliflozin as an add-on medicine to the triple therapy (metformin + teneligliptin + glimepiride). Furthermore, an improvement in QoL is proportional to improvement in glycemic indices was seen, as previously reported by Somappa et al.[8] With the exception of the food satisfaction category, lifestyle factors (e.g., smoking) were found to be the major predictors of QoL in diabetic-hypertensive patients.[9] With the exception of financial concerns and DS, which have been reported in the previous studies,[10] the study found a substantial association with QOLID characteristics. Overweight (BMI = 23–27.5 kg/m2) and underweight (BMI = 18.5 kg/m2) individuals exhibited significantly lower QoL than normal patients. Anthropometric evaluation of patients revealed a strong connection with financial concerns (P < 0.0068). Complications associated with increasing BMI worsen physical well-being and add to increased financial concerns. Increased BMI has a negative impact on patients' QoL.[11] Our study shows that longer diabetes durations were also linked to worse QoL.[12] In this study, no significant variations in gender, marital status, residential status, or family history were detected across all eight QOLID domains.

This is the first study in the northern India. Empagliflozin can be recommended as an add-on therapy; however, more research with a larger sample size is required.


   Conclusion Top


As an add-on therapy, empagliflozin substantially improved several elements of QoL such as RL, PE, GH, SB, financial concerns, emotional/mental health, and DS. It also improved QoL and glycemic and blood pressure parameters in T2DM with hypertension patients.

Acknowledgment

We would like to thank the Department of Endocrinology and Clinical Pharmacology, SKIMS Deemed University, Srinagar, JK, India. Furthermore, we thank Dr. AMJ Newton, Lowrey research cancer center, UNSW, Sydney, Australia, for his valuable comments during the study. We also thank patients, DM scholars, PhD scholars, nurses, and dieticians.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
   References Top

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Pradeepa R, Mohan V. Epidemiology of type 2 diabetes in India. Indian J Ophthalmol 2021;69:2932-8.  Back to cited text no. 1
[PUBMED]  [Full text]  
2.
Sun D, Zhou T, Heianza Y, Li X, Fan M, Fonseca VA, et al. Type 2 diabetes and hypertension. Circ Res 2019;124:930-7.  Back to cited text no. 2
    
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Trikkalinou A, Papazafiropoulou AK, Melidonis A. Type 2 diabetes and quality of life. World J Diabetes 2017;8:120-9.  Back to cited text no. 3
    
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DeFronzo RA, Davidson JA, Del Prato S. The role of the kidneys in glucose homeostasis: A new path towards normalizing glycaemia. Diabetes Obes Metab 2012;14:5-14.  Back to cited text no. 4
    
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Pattanaik SR. Efficacy and safety of addition of empagliflozin in diabetic patients uncontrolled with glimepiride+metformin+teneligliptin. J Evid Based Med Health 2018;5:1226-30.  Back to cited text no. 5
    
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Nagpal J, Kumar A, Kakar S, Bhartia A. The development of 'quality of life instrument for Indian diabetes patients (QOLID): A validation and reliability study in middle and higher income groups. J Assoc Physicians India 2010;58:295-304.  Back to cited text no. 6
    
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American Diabetes Association. Standards of medical care in diabetes-2015 abridged for primary care providers. Clin Diabetes 2015;33:97-111.  Back to cited text no. 7
    
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Somappa HK, Venkatesha M, Prasad R. Quality of life assessment among type 2 diabetic patients in rural tertiary centre. Int J Med Sci Public Health 2014;3:415-7.  Back to cited text no. 8
    
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Hlatky MA, Chung SC, Escobedo J, Hillegass WB, Melsop K, Rogers W, et al. The effect of obesity on quality of life in patients with diabetes and coronary artery disease. Am Heart J 2010;159:292-300.  Back to cited text no. 9
    
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Jin X, Liu GG, Gerstein HC, Levine MA, Guan H, Li H, et al. Minimally important difference and predictors of change in quality of life in type 2 diabetes: A community-based survey in China. Diabetes Metab Res Rev 2018;34:e3053.  Back to cited text no. 10
    
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Akinci F, Yildirim A, Gözü H, Sargin H, Orbay E, Sargin M. Assessment of health-related quality of life (HRQoL) of patients with type 2 diabetes in Turkey. Diabetes Res Clin Pract 2008;79:117-23.  Back to cited text no. 11
    
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Abedini MR, Bijari B, Miri Z, Shakhs Emampour F, Abbasi A. The quality of life of the patients with diabetes type 2 using EQ-5D-5 L in Birjand. Health Qual Life Outcomes 2020;18:18.  Back to cited text no. 12
    


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