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 Table of Contents  
ORIGINAL ARTICLE
Year : 2021  |  Volume : 12  |  Issue : 3  |  Page : 305-309

The extent of use of SGLT2 inhibitors in patients with type 2 diabetes in clinical practice: A study from India


1 AHC Diabetes Clinic, Ahmedabad, India
2 Dia-Care Diabetes & Hormone Clinic, Sabarmati, Ahmedabad, India
3 Dia-Care Diabetes & Hormone Clinic, Nehrunagar, Ahmedabad, India
4 Adhya Diabetes and Medical Care Centre, Ahmedabad, India
5 Glucowell, Diabetes Centre, Baroda, India
6 Sun Valley Diabetes & Multispecialty Hospital, Guwahati, India
7 RIMS Healthcare, Ahmedabad, India
8 Vijayratna Diabetes Centre, Ahmedabad, India
9 New DiaCare Centre & Polyclinic, Mysore, India
10 SMS Hospital, Jaipur, India
11 Jothydev Diabetes and Research Center, Thiruvanantpuram, India
12 Niyanta Diabetes Clinic, Ahmedabad, India
13 Chapadia Hospital, Junagadh, India
14 Samrpan Hospital Diabetes, Ahmedabad, India

Date of Submission28-Aug-2020
Date of Acceptance12-Dec-2020
Date of Web Publication30-Sep-2021

Correspondence Address:
Dr. Rutul Gokalani
AHC Diabetes Clinic, Opposite Kalasagar Mall, Sattadhar Cross Roads, Ghatlodiya, Ahmedabad 380061, Gujarat
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/JOD.JOD_81_20

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  Abstract 

Background and Aim: The cost of diabetes complication management is always much higher than the cost of diabetes treatment, even with novel and expensive molecules available. Thus, it is better to halt complications in the initial phase of the disease, rather than just treating hyperglycemia. Sodium-glucose co-transporter-2 inhibitor (SGLT-2i) is marking a new era in the management of type 2 diabetes mellitus (T2DM), showing significant benefits for mortality, hospitalization due to heart failure, and renal complications. The usage of SGLT2 inhibitors in clinical practice is still low. The aim of our study to know the prevalence and reasons for not prescribing SGLT-2i among Indian diabetologists. Materials and Methods: A cross-sectional survey was conducted in 10 states of India from 15 March to 31 July 2019. The primary question was asked to a doctor for the next 20 new patients at the clinic, “Was the patient initiated with SGLT-2i treatment?” If it was “Yes” the patient was excluded and if the marked option was “No” then the reason was selected for not prescribing the drug. Results: Out of 1132 patients, 687 (60.69%) patients were not prescribed SGLT2 inhibitors. Among them, the main reason for not prescribing SGLT-2i was cost (41.45%), followed by catabolic state (19.62%). Conclusion: It was found that cost is the major reason for not prescribing SGLT2 inhibitors. In spite of promising glycemic and extra glycemic benefits, it is the need of an hour to increase awareness and abetting physicians to prescribe SGLT-2 inhibitors in all appropriate patients at early stage of the disease to prevent the complications and its higher expenditure at the later stage of the disease.

Keywords: Barriers to prescribe SGLT-2i, complications of diabetes, drug usage study, prevention of diabetes complication, SGLT2 inhibitors


How to cite this article:
Gokalani R, Panchal D, Saboo B, Zinzuwadia P, Patel D, Chaudhury R, Chavda V, Phatak S, Prasad R, Dariya S S, Shnakar A, Prajapati A, Chudasama D, Patel N. The extent of use of SGLT2 inhibitors in patients with type 2 diabetes in clinical practice: A study from India. J Diabetol 2021;12:305-9

How to cite this URL:
Gokalani R, Panchal D, Saboo B, Zinzuwadia P, Patel D, Chaudhury R, Chavda V, Phatak S, Prasad R, Dariya S S, Shnakar A, Prajapati A, Chudasama D, Patel N. The extent of use of SGLT2 inhibitors in patients with type 2 diabetes in clinical practice: A study from India. J Diabetol [serial online] 2021 [cited 2021 Nov 30];12:305-9. Available from: https://www.journalofdiabetology.org/text.asp?2021/12/3/305/327317




  Key Message: Top


The low usage of novel antidiabetic molecules such as SGLT-2 related to cost is reflected in our study. Cost-effective analysis between conventional treatment modalities and newer molecules with evident benefits and high price tags is the need of the hour.


  Introduction Top


Globally, around 463 million people are suffering from diabetes mellitus (DM). The greatest rise in the prevalence of DM is reported from low- and middle-income countries. India stands second after China, having 77 million people with type 2 diabetes.[1] T2DM is significantly associated with cardiovascular disease (CVD) and is a risk factor for heart failure (HF)[2],[3] Patients are hospitalized for HF approximately four times more frequently than patients without diabetes. Diabetes is one of the most common risk factors for chronic kidney disease (CKD) and end-stage renal disease (ESRD).[4] Further, T2DM medications often have deleterious side effects. Thiazolidinediones are linked to edema, hospitalization for heat failure (HHF), and CV death in certain patient subsets.[4] Dipeptidyl peptidase-4(DPP-4) inhibitors are a comparatively newer class of diabetes medicines with an overall safer profile, but their drugs such as saxagliptin and alogliptin have shown an increasing trend of hospitalization for heart failure in their respective cardiovascular outcome trials.[5] Drugs such as sulfonylureas (SUs) are prone to hypoglycemia, weight gain, increasing CV risk, and mortality.[6],[7] On the contrary, the SGLT-2 inhibitors have not only shown safety but also come up with positive results for heart failure and MI outcomes and mortality; glucagon-like peptide 1 receptor agonists (GLP-1RA) have proven to be beneficial for CV mortality but no advantage for heart failure has been noted and available as an injectable option till date in India. Thus, on comparing the newer classes of drugs, SGLT2 inhibitors, GLP1RA and DPP4 inhibitors for all-cause and cardiovascular mortality, SGLT-2 inhibitors are most likely to rank best, GLP-1RA agonists second best, and DPP-4 inhibitors the last among these three newer classes of drugs.[8] Other benefits of SGLT2 inhibitors are weight reduction, lesser hypoglycemia risk, renal protection, potential BP reduction, uricosuric effect, and liver fat reduction. All these extra-glycemic benefits have put SGLT2 inhibitors in the first line with or without metformin in patients with atherosclerotic cardiovascular disease (ASCVD), in patients with a high risk of ASCVD, HF, and CKD.[9],[10],[11],[12] The same is endorsed by most of the guidelines. In spite of so many benefits with SGLT2 inhibitors, the usage of SGLT2 inhibitors still remains very low in India.

Objective

To find out the frequency for prescribing and reasons for low usage of SGLT2 inhibitors among patients of T2DM in our country.


  Materials and Methods Top


A cross-sectional survey was undertaken from 15 March to 31 July 2019, initially by the diabetologists in Ahmedabad and later the members of the D-GENius group (group of young diabetologists under Diabetes India) joined [Table 1]. All the doctors involved in the study are practicing diabetologists from different parts of India with more than two years of clinical experience in treating diabetes. A total of 63 doctors with 44 sites from 10 states of India, namely Uttar Pradesh, Rajasthan, Haryana, Madhya Pradesh, Assam, West Bengal, Karnataka, Kerala, Maharashtra, and Gujarat, were a part of this study. The study included patients with type 2 diabetes visiting the clinic/ hospital for the first time, aged 18 to 80 years. The patients who were already on SGLT2 inhibitor treatment, who were being treated for type 1 DM, Latent Autoimmune Diabetes in Adults (LADA), and Gestational Diabetes Mellitus (GDM) were excluded. The total sample size was 1132.
Table 1: Participating states and number of sites

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The primary question was asked to a doctor for the next 20 new patients coming to the clinic (newly diagnosed or new to their clinic), “Was the patient initiated with SGLT-2i treatment?” and it was required to mark the answer as “Yes” or “No” in the given questionnaire form. If the answer was “No,” then a further mark had to be made, stating one reason from the given reasons in the form for not prescribing SGLT-2i.

A common excel sheet was followed at each site. That included age, gender, and duration of diabetes of patients, and it enlisted the reasons for not prescribing SGLT2 inhibitors.

The reasons for “not prescribing SGLT-2i” were extracted from the literature review and continuous medical education (CME) discussions.

  1. Cost


  2. Reduced estimated glomerular filtration rate (eGFR) <45


  3. Acute illness and hospitalization


  4. Recurrent genital or urinary tract infection (GTI or UTI)


  5. Age (doctor’s own perspective for advanced age)


  6. Suspected Type 1/LADA (suspected insulin deficiency)


  7. Catabolic state


  8. Other [e.g., risk of amputation, suspecting peripheral artery disease (PAD), risk of fracture, or any other]


Statistical analysis

Descriptive statistics was done in Microsoft excel to study the proportion of patients prescribed with, not prescribed with SGLT2 and to rule out the percentage of their respective reasons.


  Results Top


It was found that out of 1132 patients 445 (39.31%) patients were prescribed SGLT2 inhibitors and 687 (60.69%) were not prescribed SGLT2 inhibitors 60.69% were male and 39.31% were female [Table 2] and [Figure 1].
Table 2: Baseline characteristics

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Figure 1: Gender distribution of patients not prescribed SGLT2i

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Cost (41.45%) was the leading reason for not prescribing SGLT2 inhibitors, followed by catabolic state (19.63%), recurrent UTI (13.36%), acute illness (7.63%) [Figure 2], age (8.55%), reduced eGFR < 45 (4.45%), other (2.48%), and suspected type 1 diabetes/ LADA-suspected insulin deficiency (2.45%).
Figure 2: Result obtained on not prescribing SGLT2i (in percentage)

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  Discussion Top


In spite of this much of expenditure, approximately 4.0 (3.2–5.0) million people aged between 20 and 79 years were estimated to die from diabetes in 2017, which is equivalent to one death every eight seconds.[13] Premature death and disability due to diabetes are also associated with a negative economic impact for countries, often called the indirect costs of diabetes, which is never considered when managing diabetes.[14] Unsurprisingly, it has been seen that the more the drug costs the harder it becomes to afford for the patient; the future cost of not managing diabetes well leads to an indirect cost of complications later. In the current study, more than half of the patients were not prescribed SGLT2i, with cost being the barrier, as this can evidently be unconvincing to the patients or at times even to the treating physician. Of course, affordability should be kept in mind while prescribing, but at the same time certain factors are overlooked in giving key importance to affordability. The efforts are focused on the treatment of the disease and later on the complications of the disease, but with little effort geared toward primary and secondary prevention. Although we are familiar that affordability, as always, will be the Achilles’ heel, we also witness that the economic yields of preventing a heart failure-associated hospitalization or a transition to dialysis dependency can be quite profound. The disease is given lesser importance until it becomes serious. Once it becomes serious, cost does not remain a barrier anymore and any price will be paid to prolong the life of the patient. Each patient with type 2 diabetes should be considered vulnerable and, hence, should be treated vigilantly to avoid unpleasant future outcomes. In this regard, formal cost-effective analysis can be very instructive.[15],[16]

In the Indian scenario, diabetologists or endocrinologists are not the first choice of consultation for the patients with diabetes; rather, the primary care physicians take care of a big chunk of patients with diabetes for a certain period unless disease advances or complications take place. This study involved young diabetologists from bigger cities of the country. However, from this it can be assumed that the prescription percentage for SGLT-2i could be even less among primary care physicians and in smaller towns, where affordability could be quite a larger issue. Hence, it is essential that primary care physicians should be well versed with first-line therapies of this chronic illness. As recent CVD guidelines, SGLT2-I has been approved as a first-line anti-hyperglycemic therapy along with or without metformin.

Moreover, there is a paradigm shift in the guidelines and management of patients with T2DM. In the patients with established ASCVD, metformin is no longer a drug of choice as monotherapy, as guidelines suggest that SGLT-2i or GLP-1 can be considered in a certain subset of patients.[17] Drugs with evident benefits should be given importance, to improve the quality of life of the patients living with chronic illness and to prevent future unexpected medical expenses.

On top of the primary benefit of SGLT-2i as an anti-hyperglycemic drug, these drugs possess several pleiotropic effects. They have shown splendid results in reducing the progression of albuminuria and the regression of eGFR in recent renal outcome trials.[4] Various studies have shown the beneficial effects on CV risk factors by a reduction in BP, improvement in endothelial function and arterial stiffness, promoting weight loss, improving lipid profile, attenuating non-alcoholic steatohepatitis (NASH) and nonalcoholic fatty liver disease (NAFLD) etc.[18],[19],[20] There are a few clinical trials focusing on heart failure and renal outcome in patients with or without diabetes and showing dramatically positive results; several such studies are going on for the same.[21] However, the advocacy for such antidiabetic drugs in patients with diabetes must be strongly emphasized.

This study was conducted before the cost-effective option of remogliflozin was available in India, though a CV outcome trial is lacking for the drug.


  Conclusion Top


Acceptance and early usage of SGLT2 inhibitors in the clinical practice is very low. It is an undeniable fact that the cost of the drug is an impediment to prescribing costly drugs, especially when there is no universal health coverage system and health expenditure is out of pocket. More robust studies are required to understand the cost-effectiveness of drugs such as SGLT2 inhibitors.

Limitations

  • We did not rule out the reasons of not prescribing SGLT2i regionally


  • The study did not access the other comorbidities present in the patients with type 2 diabetes.


  • Author contribution

    Dr. Rutul Gokalani contributed toward the concepts, study design, definition of intellectual content, literature search, statistical analysis, article preparation, editing, and he was the guarantor. Dr. Dharmendra Panchal was involved in the study design, literature search, data analysis, and article review. Dr. Banshi Saboo provided guidance throughout the project and performed the article review. Dr. Padmanabh Zinzuwadia actively participated in preparing the article, and was involved in the data analysis and article review. All other contributors were mainly involved in data collection in their respective regions, with data analysis, data acquisition, the review process, and editing.

    Financial support and sponsorship

    Nil.

    Conflict of interest

    None.



     
      References Top

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        Figures

      [Figure 1], [Figure 2]
     
     
        Tables

      [Table 1], [Table 2]



     

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