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"effects of Dapagliflozin a SGLT2 inhibitor on blood pressure, cardiovascular remodeling and obesity profile in resistant hypertension subjects´" "

Grant number: 15/23969-2
Support type:Scholarships in Brazil - Doctorate
Effective date (Start): January 01, 2016
Effective date (End): January 31, 2018
Field of knowledge:Biological Sciences - Pharmacology
Principal Investigator:Heitor Moreno Junior
Grantee:Nathália Batista Corrêa
Home Institution: Faculdade de Ciências Médicas (FCM). Universidade Estadual de Campinas (UNICAMP). Campinas , SP, Brazil
Associated research grant:13/07607-8 - OCRC - Obesity and Comorbidities Research Center, AP.CEPID

Abstract

Resistant hypertension (RH) is a multifactorial disease associated with other clinical conditions such as type 2 diabetes (DM2), obesity and dyslipidemia, as well as target-organ damage, which increases the risk of cardiovascular events. Therefore, new therapeutic strategies in an attempt to achieve blood pressure control and reduce cardiovascular risk of these patients have been studied. There are currently available on the market SGLT2 cotransporter inhibitors for the treatment of type 2 diabetes, which act by inhibiting sodium and glucose reabsorption in the kidney. Clinical studies have shown promising results with the use of this medication in reducing BP, weight and cardiovascular outcomes. This study aimed to assess whether intervention with the SGLT2 inhibitor reduces PA levels, lesions in target organs, fat profile and change the adipokines levels in patients with resistant hypertension with DM2. This crossover clinical study, randomized, double-blind will include 18 patients with resistant hypertension and type 2 diabetes, followed in Ambulatory of Resistant Hypertension HC-UNICAMP. They will be randomly assigned in two groups (1) initially treated with dapagliflozin in combination with their usual antihypertensive therapy and metformin, at 12 weeks (n = 9) or group (2) Control initially treated with glibenclamide at a dose of 5mg daily in combination with antihypertensive therapy usual and metformin, at 12 weeks (n = 9). Office ambulatory and home BP measurements will be performed; anthropometric measurements, determination of vascular stiffness by the speed of the pulse wave, echocardiogram, bioelectrical impedance, enzyme immunoassays for the determination of adipokines, and lab tests to evaluate biochemical parameters pre- and after using the treatments. Will be realized 2 intermediate visits for evaluation of adherence of study medication by pill counts, and verification of adverse reactions through the use of questionnaires. Verification of BP reduction, target-organ damage, weight and change of adipokines levels with the use of SGLT2 inhibitors in these patients will provide new opportunities for treatment of patients with resistant hypertension.