Título / Title

OPHTHALMOLOGICAL EVALUATION OF THE EFFECT OF THERAPIES WITH DAPAGLIFLOZIN OR GLIBENCLAMIDE IN PATIENTS WITH TYPE 2 DIABETES: RANDOMIZED AND CONTROLLED CLINICAL TRIAL

Introdução / Purpose

Background Despite technological advances, Diabetic Retinopathy (DR) continues to have a strong impact at the individual and population level, with projections of an increase in the coming decades. The pharmacological potential in retinal cells is still a field to be explored. Data in the literature show the potential benefit of sodium-glucose cotransporter-2 (SGLT2/iSGLT2) inhibitors in patients with diabetic eye disease, especially in the early stages. However, large safety studies that studied the systemic effects of such medications did not systemically assess the retina. Spectral Domain Optical Coherence Tomography (SD-OCT) allows the in vivo segmentation of retinal layers. In patients with type 2 diabetes mellitus (T2DM), a progressive thinning in the central retinal thickness (CRT) is primarily related to neuroretinal degeneration and occurs before visual acuity decline or changes detected by clinical examination. Aim We investigated the change in CRT measured by SD-OCT in T2DM patients after 12 weeks of treatment with dapagliflozin versus glibenclamide.

Material e Método / Methods

Methods Ninety-seven patients (57 ± 7 years) with T2DM and clinical or subclinical atherosclerosis were randomized 1:1 to dapagliflozin (10 mg/day) or glibenclamide (5 mg/day) in addition to metformin XR 1.5 g/day. SD-OCT images were obtained in all patients included in the study, both at the time of randomization and at the end of the study.

Resultados / Results

Results Baseline and posttreatment values for fasting glucose and glycated hemoglobin were equivalent in both arms. There was no difference regarding diabetic retinopathy status after therapy. Central subfield thickness changed by +2 (6) μm in the dapagliflozin group and by -1 (7) μm in the glibenclamide group (P = 0.001).

Discussão e Conclusões / Conclusion

Conclusion It is concluded, therefore, that a short-term treatment with dapagliflozin can increase CRT compared to the glycemic equivalent, which may support future studies and contribute to the control of DR in earlier stages.

Palavras Chave

Key words: Diabetic retinopathy; Optical coherence tomography; SGLT2i; Type 2 diabetes mellitus

Area

CLINICAL RETINA

Institutions

Universidade Estadual de Campinas - UNICAMP - Campinas - São Paulo - Brasil

Authors

VICENTE HIDALGO RODRIGUES FERNANDES, FERNANDO R. P. CHAVES, ALEXANDRE A. S. SOARES, JOAQUIM BARRETO, IKARO BREDER, LUIZ SERGIO F. CARVALHO, CARLOS EDUARDO LEITE ARIETA, ANDREI CARVALHO SPOSITO