scholarly journals Sodium-Glucose Co-Transporter-2 (SGLT2) Inhibitors: Comparing Trial and Real World Use (Study Protocol)

2017 ◽  
Vol 8 (2) ◽  
pp. 355-363 ◽  
Author(s):  
Andrew McGovern ◽  
Michael Feher ◽  
Neil Munro ◽  
Simon de Lusignan
Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 2350-PUB
Author(s):  
TAKAHIRO TOSAKI ◽  
SHIORI TOGA SATO ◽  
MASAKI KONDO ◽  
YUICHIRO YAMADA ◽  
AKEMI INAGAKI ◽  
...  

2018 ◽  
Vol 132 (18) ◽  
pp. 2003-2012 ◽  
Author(s):  
Giulia Ferrannini ◽  
Lars Rydén

Cardiovascular (CV) disease (CVD) is the main cause of morbidity and mortality in patients with type 2 diabetes mellitus (T2DM). Despite optimal glycaemic control, standard antihyperglycaemic therapy failed to impact CV events in intervention trials; therefore, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) issued a guidance to the pharmaceutical industry to specifically assess the CV outcomes and safety of new glucose-lowering drugs. Amongst them, sodium-glucose transporter 2 (SGLT2) inhibitors proved to not only provide good tolerance, few adverse effects, and good glycometabolic control, but also striking reduction in the risk of CV events. In this review, data from the main randomised controlled trials are presented, including post-hoc analyses looking into several aspects of CV protection. Moreover, the main findings from observational real-world studies to date are described, overall reassuring as regards to CV safety and efficacy of SGLT2 inhibitors. Finally, several mechanisms which might contribute to the cardioprotective effect of SGLT2 inhibition are depicted, including findings from recent mechanistic studies.


BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e049592
Author(s):  
Hiroyuki Seki ◽  
Norifumi Kuratani ◽  
Toshiya Shiga ◽  
Yudai Iwasaki ◽  
Kanae Karita ◽  
...  

IntroductionSodium-glucose cotransporter 2 (SGLT2) inhibitors are a new class of antihyperglycaemic agents that promote urinary glucose excretion in the renal proximal tubule and have cardio-protective and renal-protective properties. However, there are several safety concerns related to increased risks of hypoglycaemic, urinary tract infections and ketoacidosis. Ketoacidosis is a potentially fatal complication that often presents as euglycaemic ketoacidosis during SGLT2 inhibitor treatment. Furthermore, invasive treatment and related surgical stress may increase the risk of ketogenesis. Therefore, this study aims to clarify the incidence of SGLT2 inhibitor-associated postoperative ketoacidosis (SAPKA) among patients who are receiving SGLT2 inhibitors and undergoing surgery under general anaesthesia.Methods and analysisThis multicentre, prospective, observational study will recruit 750 adult Japanese patients with diabetes who are receiving SGLT2 inhibitors and undergoing surgery under general anaesthesia. Urine samples will be collected on postoperative days 0, 1, 2 and 3. Blood gas analysis will be performed when urine ketone positivity is detected. The incidence of postoperative ketoacidosis will be identified based on urine ketone positivity and a blood pH of ≤7.3. The study will also collect data to identify risk factors for SAPKA.Ethics and disseminationThe study protocol has been approved by the ethics committee of Kyorin University (approval number: 785, 26 October 2020) and local ethical approval will be required at each participating centre. Study findings will be submitted to peer-reviewed journals and abstracts will be submitted to relevant national and international meetings.Trial registration numberUMIN000042795


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