Dapagliflozin increases retinal thickness in type 2 diabetic patients as compared with glibenclamide: A randomized controlled trial.

AIM: In patients with type 2 diabetes mellitus (T2DM) a progressive thinning in the central retinal thickness (CRT) is mainly related to neuroretinal degeneration and occurs before the decline in visual acuity or capillary density. We investigated the change in CRT by optical coherence tomography (OCT) in T2DM patients after 12 weeks of treatment with dapagliflozin or glibenclamide. 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) on top of metformin XR 1.5 g/day. OCT was obtained in all patients enrolled in the study, both at the time of randomization and at the end of the study. RESULTS: Baseline and post-treatment values of fasting glucose and glycated hemoglobin were equivalent in the two arms. There was no difference in change in diabetic retinopathy status after therapy. The center subfield thickness changed by +2(6)µm in the dapagliflozin group and by -1(7) µm in the glibenclamide group (P = 0.001). CONCLUSION: A short-term treatment with dapagliflozin may increase CRT as compared with equivalent glycemic control with glibenclamide.

Assessment of dapagliflozin effect on diabetic endothelial dysfunction of brachial artery (ADDENDA-BHS2 trial): rationale, design, and baseline characteristics of a randomized controlled trial.

BACKGROUND: Endothelial dysfunction (ED) is a hallmark in type 2 diabetes mellitus (T2DM) that favor both atherogenesis and ischemia and reperfusion injury (IRI). Sodium-glucose-2 co-transporter inhibitors (SGLT2i) may hypothetically improve microvascular and macrovascular functions via a broad spectrum of mechanisms, being superior to traditional antidiabetic therapy such as sulfonylurea, even in subjects under equivalent glycemic control. Hence, the present clinical trial was designed to compare the effect of these two treatments on markers of arterial wall function and inflammation in T2DM patients as well as on the potential mediating parameters. METHOD AND RESULTS: ADDENDA-BHS2 is a prospective, single-center, active-controlled, open, randomized trial. Ninety-eight participants (40-70 years old) with HbA1c 7-9% were randomized (1:1, stratified by gender, BMI and HbA1c levels) to either dapagliflozin 10 mg/day or glibenclamide 5 mg/day on top of metformin. The primary endpoint was the change of flow-mediated dilation (FMD) after a 12-week period of treatment evaluated at rest and after IRI between dapagliflozin and glibenclamide arms. Secondary outcomes were defined as the difference between treatments regarding: plasma nitric oxide (NO) change after FMD, plasma isoprostane, plasma levels of vascular inflammatory markers and systemic inflammatory markers, plasma levels of adipokines, anthropometric measures, glucose control parameters, office and ambulatory BP control. Safety endpoints were defined as systolic and diastolic function assessed by echocardiography and retinopathy change. Serious adverse events were recorded. The study protocol was approved by the Independent Scientific Advisory Committee. CONCLUSION: The ADDENDA-BHS2 trial is an investigator-initiated clinical trial comparing the effect of dapagliflozin versus glibenclamide on several aspects of vascular function in high cardiovascular risk T2DM patients. Besides, a large clinical and biochemical phenotype assessment will be obtained for exploring potential mediations and associations.Trial registration Clinical trial registration: NCT02919345 (September, 2016).

Perception of difficulties with vision-related activities of daily living among patients undergoing unilateral posterior capsulotomy.

OBJECTIVES: To assess the influence of Nd:YAG (neodymium: yttrium-aluminum- garnet) laser unilateral posterior capsulotomy on visual acuity and patients' perception of difficulties with vision-related activities of daily life. METHODS: We conducted an interventional survey that included 48 patients between 40 and 80 years of age with uni- or bilateral pseudophakia, posterior capsule opacification, and visual acuity

Perception of difficulties with vision-related activities of daily living among patients undergoing unilateral posterior capsulotomy

OBJECTIVES: To assess the influence of Nd:YAG (neodymium: yttrium-aluminum- garnet) laser unilateral posterior capsulotomy on visual acuity and patients' perception of difficulties with vision-related activities of daily life. METHODS: We conducted an interventional survey that included 48 patients between 40 and 80 years of age with uni- or bilateral pseudophakia, posterior capsule opacification, and visual acuity <0.30 (logMAR) in one eye who were seen at a Brazilian university hospital. All patients underwent posterior capsulotomy using an Nd:YAG laser. Before and after the intervention, patients were asked to complete a questionnaire that was developed in an exploratory study. RESULTS: Before posterior capsulotomy, the median visual acuity (logMAR) of the included patients was 0.52 (range 0.30-1.60). After posterior capsulotomy, the median visual acuity of the included patients improved to 0.10 (range 0.0-0.52). According to the subjects' perceptions, their ability to perform most of their daily life activities improved after the intervention (p<0.05). CONCLUSIONS: After patients underwent posterior capsulotomy with an Nd:YAG laser, a significant improvement in the visual acuity of the treated eye was observed. Additionally, subjects felt that they experienced less difficulty performing most of their vision-dependent activities of daily living.

Are routine preoperative medical tests needed with cataract surgery? / ¿Es necesario hacer pruebas clínicas rutinarias antes de la cirugía de cataratas?

Objetivos. El objetivo de este estudio consistió en determinar si la realización rutinaria de pruebas clínicas antes de la cirugía de cataratas reduce la tasa de complicaciones perioperatorias en adultos. Métodos. El estudio se realizó en un centro médico universitario de Brasil entre el 10 de febrero de 2000 y el 10 de enero de 2001. Los pacientes con operaciones de cataratas programadas fueron asignados aleatoriamente a un grupo en el que las pruebas preoperatorias se realizaron de forma rutinaria (grupo R) o a un grupo en el que se realizaron de forma selectiva (grupo S). A los pacientes asignados al grupo S solo se les solicitaron pruebas preoperatorias en caso de que presentaran un problema médico nuevo o agravado que justificara su realización. En el grupo R se practicaron tres pruebas preoperatorias de forma rutinaria: un electrocardiograma de 12 derivaciones, un hemograma completo y una determinación de la glucemia. Resultados. De los 1 025 pacientes estudiados, 512 fueron asignados al grupo R y 513 al grupo S. La proporción de intervenciones canceladas y no programadas nuevamente fue similar en ambos grupos: 2% en cada uno. La tasa acumulada de complicaciones médicas también fue similar en ambos grupos: 9,6% en el grupo R y 9,7% en el S (P = 0,923). Lo mismo ocurrió con los tipos de complicaciones médicas observadas. Conclusiones. Los resultados de este estudio indican que la realización rutinaria de pruebas médicas antes de la cirugía de cataratas no reduce la tasa de complicaciones perioperatorias y que parece ser más eficiente no solicitar pruebas preoperatorias, a no ser que la historia clínica o la exploración física del paciente indiquen su realización

Objective. The objective of this study was to investigate whether routine medical testing before cataract surgery reduces the rate of complications during the perioperative period in adults. Methods. The study was carried out in an academic medical center in Brazil, between 10 February 2000 and 10 January 2001. The scheduled cataract operations were randomly assigned to one of two groups: 1) to be preceded by routine testing (the "routine-testing group") or 2) not to be preceded by routine medical testing (the "selective-testing group"). If the patient was assigned to the selective-testing group, it was requested that no preoperative testing be performed unless the patient presented with a new or worsening medical problem that would warrant medical evaluation with testing. In the case of patients assigned to the routinetesting group, three tests were requested: a 12-lead electrocardiogram, a complete blood count, and measurements of serum glucose. Results. The sample of 1 025 patients scheduled to undergo cataract surgery was comprised of 512 assigned to the routine-testing group and of 513 assigned to the selective-testing group. The two groups had similar proportions of operations canceled and not subsequently rescheduled, 2% in each group. The cumulative rate of medical events was similar in the two groups, 9.6% in the routine-testing group and 9.7% in the selective-testing group (P = 0.923). The types of medical events were also similar in both groups. Discussion. The results of this study suggest that routine medical testing before cataract surgery does not reduce the rate of complications during the perioperative period. The results also suggest it would be more efficient not to request routine preoperative tests unless indicated by patient history or physical examination