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      Real-World Clinical Experience with SGLT2 Inhibitors: Use of Special Screening Tool for Type 2 Diabetes Patients to Avoid Serious Adverse Events: A Single-Centre Prospective Study

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          Abstract

          Background: Promising results of clinical trials involving SGLT2 inhibitors urge every clinician managing diabetes to use them. However, upcoming real-world data still show increased incidence of adverse events, but efficacy is comparable to clinical trials. Objectives: Genitourinary infection is the most commonly reported adverse effect with SGLT2 inhibitors. We evaluated effectiveness of patient screening protocol and advice of hygiene and hydration to avoid adverse effects of SGLT2 inhibitors in real-world setting. Method: This was a prospective observational longitudinal study which included consecutive subjects with uncontrolled T2DM recommended with SGLT2i after a simple screening protocol from December 2017 to November 2018. The adverse effects and metabolic parameters were evaluated at 1st, 3rd, 6th, and 12th months for each patient. Results: Of 413 patients recommended for SGLT2 inhibitors, 335 patients started the medication. At baseline, average age, glycosylated haemoglobin (HbA1c), and weight were 53 years, 9.5%, and 82 kg, respectively. Data of 332, 299, 270, and 231 patients were available at the 1st, 3rd, 6th, and 12th months for safety follow-up, respectively. Genitourinary tract infection was the most common adverse effect (8%) followed by ketosis (4%). Two patients needed to stop the drug permanently due to recurrent transient ischaemic attack and emphysematous pyelonephritis. Significant reduction in mean weight and HbA1c was observed at 6 months ( n = 270): 2.9 kg and 1.1%, respectively, and at 12 months ( n = 231): 3.8 kg and 1.6%, respectively. Conclusion: Simple screening protocol for patients considered for SGLT2i significantly reduced incidence of genitourinary adverse events.

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          Most cited references 14

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          Randomized, Double-Blind, Phase 3 Trial of Triple Therapy With Dapagliflozin Add-on to Saxagliptin Plus Metformin in Type 2 Diabetes.

          To compare the efficacy and safety of treatment with dapagliflozin versus that with placebo add-on to saxagliptin plus metformin in patients whose type 2 diabetes is inadequately controlled with saxagliptin plus metformin treatment.
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            Why Do SGLT2 Inhibitors Inhibit Only 30–50% of Renal Glucose Reabsorption in Humans?

            Sodium glucose cotransporter 2 (SGLT2) inhibition is a novel and promising treatment for diabetes under late-stage clinical development. It generally is accepted that SGLT2 mediates 90% of renal glucose reabsorption. However, SGLT2 inhibitors in clinical development inhibit only 30–50% of the filtered glucose load. Why are they unable to inhibit 90% of glucose reabsorption in humans? We will try to provide an explanation to this puzzle in this perspective analysis of the unique pharmacokinetic and pharmacodynamic profiles of SGLT2 inhibitors in clinical trials and examine possible mechanisms and molecular properties that may be responsible.
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              Empagliflozin as Add-on Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Linagliptin and Metformin: A 24-Week Randomized, Double-Blind, Parallel-Group Trial.

              To evaluate the efficacy and safety of empagliflozin versus placebo as add-on therapy in patients with type 2 diabetes and inadequate glycemic control with linagliptin and metformin.
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                Author and article information

                Journal
                DDE
                10.1159/issn.2673-1738
                International Journal of Diabetes and Metabolism
                S. Karger AG
                2673-1797
                2673-1738
                2020
                December 2020
                09 September 2020
                : 26
                : 1
                : 38-43
                Affiliations
                aDepartment of Medicine, BAPS Shastriji Maharaj Hospital, Vadodara, India
                bDepartment of Epidemiology, ICMR-National JALMA Institute of Leprosy and Other Mycobacterial Diseases, Agra, India
                Author notes
                *Vishwa B. Unadkat, Consultant Physician & Diabetologist, BAPS Shastriji Maharaj Hospital, Vadodara 390012 (India), vishw_u4u@yahoo.com
                Article
                510262 Dubai Diabetes Endocrinol J 2020;26:38–43
                10.1159/000510262
                © 2020 The Author(s) Published by S. Karger AG, Basel

                This article is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND). Usage and distribution for commercial purposes as well as any distribution of modified material requires written permission. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

                Page count
                Tables: 5, Pages: 6
                Categories
                Research Article

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