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A multicentric cross-sectional observational survey was conducted to understand the patient, physician, nurse, caregiver, and diabetes counselor/educator-related factors that define the "glycemic happiness" of persons with type 2 diabetes mellitus (T2DM). Five sets of questionnaires based on a five-point Likert scale were used. A total of 167 persons with T2DM, 167 caregivers, and 34 each of physicians, nurses, and diabetes counselors/educators participated. For persons with T2DM, an adequate understanding of diabetes (mean score ± standard deviation: 4.2 ± 0.9), happiness and satisfaction with life (4.1 ± 0.8), flexibility (4.2 ± 0.8) and convenience (4.2 ± 0.7) of treatment, and confidence to handle hypo/hyperglycemic episodes (4.0 ± 0.9) were the factors positively associated with glycemic happiness. Caregivers' factors included information from physicians on patient care (4.5 ± 0.6), constructive conversations with persons with T2DM (4.2 ± 0.8), helping them with regular glucose monitoring (4.2 ± 0.9), and caregivers' life satisfaction (4.2 ± 0.8). Factors for physicians, nurses, and diabetes counselors/educators were belief in their ability to make a difference in the life of persons with T2DM (4.8 ± 0.4, 4.4 ± 0.5, and 4.5 ± 0.5), satisfaction from being able to help them (4.9 ± 0.3, 4.6 ± 0.5, and 4.6 ± 0.5), and professional satisfaction (4.9 ± 0.4, 4.4 ± 0.6, and 4.7 ± 0.4). Our survey identified the key factors pertaining to different stakeholders in diabetes care, which cumulatively define the glycemic happiness of persons with T2DM.
RESUMO
INTRODUCTION: This Delphi study aims to provide evidence-based expert opinion on the usage and current position of gliclazide in type 2 diabetes mellitus (T2DM) management in India. METHODS: The single interaction modified Delphi-based methodology was used to collect opinions on gliclazide usage and its position in diabetes management from 338 endocrinologists/diabetologists who have had clinical experience with gliclazide. Participants, using a 9-point scale, were asked to rate eight statements comprising a total of 52 items on the related topics. RESULTS: The Delphi consensus suggests that in drug-naïve patients with T2DM, intolerant to metformin or in whom metformin is contraindicated, dual therapy of gliclazide/gliclazide-modified release (MR) should be considered along with a dipeptidyl peptidase 4 (DPP4) inhibitor if glycated hemoglobin A1c level is greater than 7.5% and with insulin if the A1c level is greater than 9%. If the patients are inadequately controlled with metformin (A1c greater than 6.5% after 3 months of therapy), gliclazide/gliclazide-MR shall be added on to the treatment regimen to achieve greater and sustained reductions in A1c levels. However, it was not preferred over other antidiabetic classes in such clinical settings except alpha-glucosidase inhibitors (AGI). Early addition of gliclazide/gliclazide-MR shall be preferred over the up-titration of metformin beyond half-maximal dose for effective management of T2DM. Gliclazide/gliclazide-MR can be used safely in patients with diabetes and cardiovascular and chronic kidney disease. It can be used in older patients with T2DM as it does not have active metabolites and has a low risk of hypoglycemia. CONCLUSION: The expert panel proposed consideration of monotherapy or dual therapy of gliclazide as an ideal choice in patients with T2DM because of its efficacy, long-term glycemic control, favorable renal outcomes, cardiovascular safety, and an optimal safety profile.
RESUMO
BACKGROUND: The efficacy of gliclazide has been reported in clinical trials in India. However, real-world data on the effectiveness of gliclazide in India is unavailable. OBJECTIVE: To provide real-world evidence regarding the effectiveness of gliclazide or gliclazide + metformin fixed-dose combination or separate medications, used either as monotherapy or as the latest add-on to other antihyperglycemic agents in reducing glycated hemoglobin (HbA1c) levels in Indian patients with type 2 diabetes mellitus (T2DM). METHODS: Electronic medical record data of adult patients who were diagnosed with T2DM who were newly initiated on or had been prescribed gliclazide or gliclazide + metformin combination for < 30 days as monotherapy or as add-on therapy to other antihyperglycemic agents, and had HbA1c ≥ 6.5% were retrospectively analyzed. Mean change in HbA1c from baseline was the primary endpoint. Secondary endpoints were assessment of dosages and formulations of gliclazide or gliclazide + metformin prescribed in the HbA1c spectrum and antihyperglycemic agents to which gliclazide or gliclazide + metformin was added as an adjunct. Readings were obtained before initiating gliclazide or gliclazide + metformin and after at least 90 days of treatment with gliclazide or gliclazide + metformin. RESULTS: Included patients (n = 498) were categorized into gliclazide only (n = 66), gliclazide + metformin only (n = 179), gliclazide add-on (n = 169), and gliclazide + metformin add-on (n = 84) groups. Mean (95% confidence interval [CI]) change in HbA1c among patients with baseline HbA1c > 7% was - 0.8% (- 1.26, - 0.34) in gliclazide only group; - 1.6% (- 1.89, - 1.31; p < 0.001) in gliclazide + metformin group; - 1.2% (- 1.50, - 0.90; p < 0.001) in add-on gliclazide group; and - 1.4% (- 1.75, - 1.05; p < 0.001) in add-on gliclazide + metformin group. Gliclazide once daily was the most prescribed regimen in the gliclazide only group (72.7%), with 60 mg being the most prescribed modified-release dose (62.5%). Gliclazide + metformin twice daily was the most prescribed regimen in the gliclazide + metformin group (69.3%) with 80 mg + 500 mg being the most prescribed immediate-release dose (62.9%). Gliclazide and gliclazide + metformin were most added as an adjunct to existing prescriptions of biguanides (83.4%) or insulin (64.3%), respectively. CONCLUSION: Gliclazide or gliclazide + metformin prescribed as mono- or add-on therapy during routine clinical practice effectively reduced HbA1c in Indian patients with T2DM, thus validating the use of gliclazide and gliclazide + metformin for managing T2DM in India.
