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Sglt2 Inhibitors Acidosis

Cardiovascular Safety, Longterm Noncardiovascular Safety, And Efficacy Of Sodiumglucose Cotransporter 2 Inhibitors In Patients With Type 2 Diabetes Mellitus: A Systemic Review And Metaanalysis With Trial Sequential Analysis

Cardiovascular Safety, Longterm Noncardiovascular Safety, And Efficacy Of Sodiumglucose Cotransporter 2 Inhibitors In Patients With Type 2 Diabetes Mellitus: A Systemic Review And Metaanalysis With Trial Sequential Analysis

Journal of the American Heart Association Journal of the American Heart Association Cardiovascular Safety, LongTerm Noncardiovascular Safety, and Efficacy of SodiumGlucose Cotransporter 2 Inhibitors in Patients With Type 2 Diabetes Mellitus: A Systemic Review and MetaAnalysis With Trial Sequential Analysis XinLin Zhang, QingQing Zhu, YuHan Chen, XueLing Li, Fu Chen, JianAn Huang, Biao Xu Journal of the American Heart Association. 2018;7:e007165 Background The cardiovascular and longterm noncardiovascular safety and efficacy of SGLT2 (sodiumglucose cotransporter 2) inhibitors have not been well documented. Methods and Results For cardiovascular outcomes, we performed a metaanalysis with trial sequential analysis of randomized controlled trials and adjusted observational studies, each with a minimum of 26weeks and 2000patientyears of followup. For longterm noncardiovascular safety and efficacy outcome analyses, we included only randomized controlled trials with at least 2years and 1000patientyears of followup. Five studies with 351476 patients were included in cardiovascular outcomes analysis. Metaanalyses showed that SGLT2 inhibitors significantly reduced the risks of major adverse cardiac events (hazard ratio [HR]: 0.80; 95% confidence interval [CI], 0.690.92; P=0.002), allcause mortality (HR: 0.67; 95% CI, 0.540.84; P<0.001), cardiovascular mortality (HR: 0.77; 95% CI, 0.600.98; P=0.03), nonfatal myocardial infarction (HR: 0.86; 95% CI, 0.760.98; P=0.02), hospitalization for heart failure (HR: 0.62; 95% CI, 0.550.69; P<0.001), and progression of albuminuria (HR: 0.68; 95% CI, 0.580.81; P<0.001). No significant difference in nonfatal stroke was found. Analyses limited to randomized controlled trials showed similar findings. Trial sequential analysis provided firm evide Continue reading >>

Sodiumglucose Cotransporter 2 Inhibitors And Euglycemic Diabetic Ketoacidosis: Metabolic Acidosis With A Twist

Sodiumglucose Cotransporter 2 Inhibitors And Euglycemic Diabetic Ketoacidosis: Metabolic Acidosis With A Twist

SodiumGlucose Cotransporter 2 Inhibitors and Euglycemic Diabetic Ketoacidosis: Metabolic Acidosis With a Twist We are experimenting with display styles that make it easier to read articles in PMC. The ePub format uses eBook readers, which have several "ease of reading" features already built in. The ePub format is best viewed in the iBooks reader. You may notice problems with the display of certain parts of an article in other eReaders. Generating an ePub file may take a long time, please be patient. SodiumGlucose Cotransporter 2 Inhibitors and Euglycemic Diabetic Ketoacidosis: Metabolic Acidosis With a Twist Aala Jaberi, Bhavna Seth, [...], and Steven C. Borkan A 47-year-old woman with a self-reported 11-year history of diabetes mellitus presented with 2 days of nausea, vomiting, decreased oral intake, and back pain radiating to the neck. Her review of systems was remarkable for a throbbing headache of 1 days duration. Her medications included levothyroxine, subcutaneous long-acting insulin (glargine), topiramate, and canagliflozin, a selective sodiumglucose cotransporter 2 (SGLT2) inhibitor of the gloflozin class, which had been initiated 2 weeks earlier. Her medical history was remarkable for post-thyroidectomy Graves disease, cholecystectomy for multiple cholelithiasis, depression, fibromyalgia, and hyperlipidemia. She also had a history of spinal fusion surgery. In the emergency department, she appeared volume depleted. Her vital signs were temperature 98.9 F, blood pressure 118/76 mmHg, and a regular heart rate of 91 bpm. Her BMI was 27.45 kg/m2. Physical examination was remarkable for dry mucosal membranes, the absence of axillary sweat, and mild epigastric tenderness. Blood chemistry tests revealed a glucose of 152 mg/dL, sodium 138 mEq/L, potassium 4.4 mEq/L, Continue reading >>

Understanding Sglt2 Inhibitors' Diabetic Ketoacidosis Risk

Understanding Sglt2 Inhibitors' Diabetic Ketoacidosis Risk

Deepali Dixit, PharmD, BCPS, is a Clinical Assistant Professor at Ernest Mario School of Pharmacy and a Clinical Critical Care Pharmacist in the Medical Intensive Care Unit at Robert Wood Johnson University Hospital. Dr. Dixit has been involved in multiple committees and in leadership positions in regional and national pharmacy and organizations. Dr. Dixit's research interests include sedation and delirium in the critically ill, infectious disease, alcohol withdrawal syndrome, chronic obstructive pulmonary disease, and patient safety. This article was collaboratively written with Shannon Anthony, PharmD Candidate. In May 2015, the FDA issued a warning about the risk of developing diabetic ketoacidosis while using SGLT2 inhibitors. That December, the FDA updated the drugs’ labels to include warnings about developing ketoacidosis even with near-normal blood glucose levels.1 SGLT2 inhibitors lower blood glucose levels by decreasing renal glucose reabsorption, which increases urinary glucose excretion.2 Three drugs in this class are currently available in the United States: canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance).1 These medications are approved for managing type 2 diabetes, although they’re increasingly used off-label to treat type 1 diabetes (T1D), and trials are currently being conducted to evaluate their efficacy for this potential indication.3 Diabetic ketoacidosis (DKA) develops most frequently in T1D patients secondary to omission or decreased dosage of insulin, acute illness, or a recent surgical procedure.4 The typical clinical presentation includes hyperglycemia (>250mg/dL), anion-gap acidosis, and elevated plasma and urine ketones.3 Early diagnosis and management of ketoacidosis is vital. The cornerstone DKA treatment Continue reading >>

Sodium-glucose Cotransporter-2 Inhibition And Acidosis In Patients With Type 2 Diabetes: A Review Of Us Fda Data And Possible Conclusions.

Sodium-glucose Cotransporter-2 Inhibition And Acidosis In Patients With Type 2 Diabetes: A Review Of Us Fda Data And Possible Conclusions.

Sodium-glucose cotransporter-2 inhibition and acidosis in patients with type 2 diabetes: a review of US FDA data and possible conclusions. D'Elia JA, et al. Int J Nephrol Renovasc Dis. 2017. Kidney and Hypertension Section, Joslin Diabetes Center, Harvard Medical School. Department of Pharmacy Practice, MCPHS University, Boston, MA. Division of Kidney Diseases and Hypertension, Rhode Island Hospital, Alpert Medical School, Brown University, Providence, RI, USA. Int J Nephrol Renovasc Dis. 2017 Jun 15;10:153-158. doi: 10.2147/IJNRD.S135899. eCollection 2017. OBJECTIVE: To evaluate whether adverse event reports to the US Food and Drug Administration on incidents of ketoacidosis from use of sodium glucose cotransport inhibitors (SGLT2 inhibitors) provide insight into ways this new class of drugs is being prescribed with other antihyperglycemic agents; to examine possible mechanisms to explain ketoacidosis. DESIGN AND METHODS: Reports of adverse events concerned to SGLT2 inhibitors, namely, empagliflozin, dapagliflozin, and canagliflozin were obtained under the Freedom of Information Act for 5 years ending in August 31, 2015. The data were evaluated for incidents of ketoacidosis by looking for keywords such as diabetic ketoacidosis, ketoacidosis, lactic acidosis, acidosis, and metabolic acidosis. Results were tabulated individually for empagliflozin (n=260 adverse event reports), dapagliflozin (n=520), and canagliflozin (n=2159). Adverse events were categorized according to age, gender, and insulin use. RESULTS: There were 46, 144, and 450 reports of ketoacidosis concerned with the use of empagliflozin, dapagliflozin, and canagliflozin, respectively. The use of SGLT2 inhibitors was not strictly limited to patients with type 2 diabetes but was cut across categories of insul Continue reading >>

Sglt2 Inhibition And Ketoacidosis Should We Be Concerned? | Panicker Rajeev | British Journal Of Diabetes

Sglt2 Inhibition And Ketoacidosis Should We Be Concerned? | Panicker Rajeev | British Journal Of Diabetes

SGLT2 inhibition and ketoacidosis should we be concerned? Obesity and Endocrinology Research Group, Institute of Ageing and Chronic Disease, University of Liverpool Address for correspondence: Professor John PH Wilding Obesity and Endocrinology Research Group, University of Liverpool, Clinical Sciences Centre, Aintree University Hospital NHS Foundation Trust, SGLT2 inhibitors represent a novel class of oral glucose- lowering treatment that addresses some important unmet clinical needs in the treatment of type 2 diabetes, specifically weight reduction and a low propensity to cause hypoglycaemia. SGLT2 inhibition lowers the renal threshold for glucose excretion, resulting in renal glycosuria, a shift in substrate utilisation from carbohydrate to fat oxidation and hyperglucagonaemia; this poses a theoretical risk for ketoacidosis (including euglycaemic ketoacidosis) in the presence of other precipitating factors, especially reduction in insulin doses or low carbohydrate intake. There have been reports of several cases of ketoacidosis, mostly euglycaemic, and in people with type 1 or type 2 diabetes. Subsequent to this there were warnings from regulatory bodies (FDA and EMEA). In this article, we examine the reports of ketoacidosis associated with SGLT2 inhibition and try to explain the intrinsic pathophysiological mechanisms associated with this class of drugs which might contribute to ketoacidosis. The implications of these for clinical practice are summarised with key messages to health care providers. Key words: SGLT2 inhibitors, ketoacidosis, type 2 diabetes, mechanisms, clinical practice SGLT2 inhibitors are a new class of drugs for the treatment of type 2 diabetes that act by inhibiting renal glucose reabsorption. They have been adopted rapidly into clinical practic Continue reading >>

Fda Warns That Sglt2 Inhibitors May Lead To Ketoacidosis

Fda Warns That Sglt2 Inhibitors May Lead To Ketoacidosis

FDA Warns That SGLT2 Inhibitors May Lead to Ketoacidosis Twenty cases of acidosis were reported in about 14 months The FDA is warning that the type-2 diabetes medicines canagliflozin, dapagliflozin, and empagliflozin may lead to ketoacidosis, a serious condition in which the body produces high levels of blood acids called ketones that may require hospitalization. The agency is investigating to determine whether changes are needed in the prescribing information for this class of drugs, called sodium-glucose cotransporter-2 (SGLT2) inhibitors. The FDA advised health care professionals to evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing the signs or symptoms: difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. Providers should discontinue SGLT2 inhibitors if acidosis is confirmed and take appropriate measures to correct the acidosis and monitor sugar levels. SGLT2 inhibitors are FDA-approved for use with diet and exercise to lower blood sugar in adults with type-2 diabetes. They lower blood sugar by causing the kidneys to remove sugar from the body through the urine. These medicines are available as single-ingredient products and also in combination with other diabetes medicines such as metformin. The safety and efficacy of SGLT2 inhibitors have not been established in patients with type-1 diabetes, and FDA has not approved them for use in these patients. A search of the FDA Adverse Event Reporting System (FAERS) database identified 20 cases of acidosis reported as diabetic ketoacidosis (DKA), ketoacidosis, or ketosis in patients treated with SGLT2 inhibitors from March 2013 to June 6, 2014. All patients required emergency department visits or hospitalization to treat the ketoacidosis Continue reading >>

Fda Warns Of Ketoacidosis With Sglt2 Inhibitors

Fda Warns Of Ketoacidosis With Sglt2 Inhibitors

FDA Warns of Ketoacidosis with SGLT2 Inhibitors With increasing use of the newer non-insulin based oral glucose lowering agents, more side effects are now beginning to emerge. On May 15, 2015 the Food and Drug Administration (FDA) issued a formal communication warning about the risk of acidosis with the use of SGLT2 inhibitors. SGLT2 inhibitors, which work by blocking glucose reabsorption in the renal tubule, are rarely used as monotherapy. Instead they are more commonly prescribed as combination therapy with other oral glucose lowering agents, such as the DPP-4 inhibitors. They have been approved for use in type 2 diabetes (T2DM) but their safety and efficacy is not yet established in type 1 diabetes. Post-marketing surveillance of the FDA Adverse Event Reporting System (FAERS) has identified 20 cases of acidosis (either diabetic ketoacidosis (DKA), ketosis or ketoacidosis) between March 2013 and June 2014 in individuals who were taking SGLT2 inhibitors. The unusual observation that most of these individuals had T2DM (knowing that DKA is more commonly associated with type 1 diabetes and low insulin levels) raised some concern that this may be a serious adverse effect associated with the SGLT2 inhibitor itself. There were many unusual features that concerned the FDA. First, the onset of the acidosis occurred after a median of 2 weeks (range 1 to 175 days), suggesting a likely cause and effect relationship with the drug. Second, the DKA was very unusual in that glucose levels were only mildly elevated at <200mg/dL, whereas DKA is traditionally characterized by glucose levels that are extremely elevated.Third, although some patients had other possible explanations for development of the anion gap metabolic acidosis (i.e., alcohol, renal failure, etc.) and others had obvi Continue reading >>

Acidosis: What Drug Is At Fault?

Acidosis: What Drug Is At Fault?

The sodium/glucose cotransporter 2 (SGLT2) inhibitors are a relatively new class of drugs in the armamentarium for managing diabetes. In May 2015, the US Food and Drug Administration (FDA) sent out a warning to alert the healthcare community about the potential for euglycemic ketoacidosis in patients with type 2 diabetes who are using SGLT2 inhibitors (canagliflozin, dapagliflozin, and empagliflozin).[ 1 ] Patients with type 1 diabetes using this class of medication off-label may be at even higher risk for this complication. The warning resulted from identification of 20 cases of acidosis (diabetic ketoacidosis, ketoacidosis, or ketosis) reported to the FDA Adverse Event Reporting System database between March 2013 and June 6, 2014. The risk was particularly high in patients undergoing anesthesia for minor procedures. Subsequent to this FDA warning, the results of the EMPA-REG trial were presented at the European Association for the Study of Diabetes 2015 meeting and published simultaneously in the New England Journal of Medicine.[ 2 ] This trial enrolled approximately 7000 patients with type 2 diabetes and established cardiovascular (CV) disease who were randomly assigned on a 1:1:1 basis to receive empagliflozin 10 mg daily, empagliflozin 25 mg daily, or placebo. This was on top of standard care (including glucose-lowering therapy). The primary outcome was a composite CV endpoint that included death from CV causes and nonfatal myocardial infarction or stroke. The results from the two empagliflozin groups were pooled, and showed that the primary outcome occurred less frequently in this group compared with placebo recipients (10.5% vs 12.1%; hazard ratio, 0.86; P < .001 for noninferiority; P = .04 for superiority). Empagliflozin did not reduce the rate of nonfatal myoc Continue reading >>

Euglycemic Diabetic Ketoacidosis: A Predictable, Detectable, And Preventable Safety Concern With Sglt2 Inhibitors

Euglycemic Diabetic Ketoacidosis: A Predictable, Detectable, And Preventable Safety Concern With Sglt2 Inhibitors

The Case At Hand Recently, the U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication that warns of an increased risk of diabetic ketoacidosis (DKA) with uncharacteristically mild to moderate glucose elevations (euglycemic DKA [euDKA]) associated with the use of all the approved sodium–glucose cotransporter 2 (SGLT2) inhibitors (1). This Communication was based on 20 clinical cases requiring hospitalization captured between March 2013 and June 2014 in the FDA Adverse Event Reporting System database. The scarce clinical data provided suggested that most of the DKA cases were reported in patients with type 2 diabetes (T2D), for whom this class of agents is indicated; most likely, however, they were insulin-treated patients, some with type 1 diabetes (T1D). The FDA also identified potential triggering factors such as intercurrent illness, reduced food and fluid intake, reduced insulin doses, and history of alcohol intake. The following month, at the request of the European Commission, the European Medicines Agency (EMA) announced on 12 June 2015 that the Pharmacovigilance Risk Assessment Committee has started a review of all of the three approved SGLT2 inhibitors (canagliflozin, dapagliflozin, and empagliflozin) to evaluate the risk of DKA in T2D (2). The EMA announcement claimed that as of May 2015 a total of 101 cases of DKA have been reported worldwide in EudraVigilance in T2D patients treated with SGLT2 inhibitors, with an estimated exposure over 0.5 million patient-years. No clinical details were provided except for the mention that “all cases were serious and some required hospitalisation. Although [DKA] is usually accompanied by high blood sugar levels, in a number of these reports blood sugar levels were only moderately increased” (2). Wit Continue reading >>

Severe Ketoacidosis Associated With Canagliflozin (invokana): A Safety Concern

Severe Ketoacidosis Associated With Canagliflozin (invokana): A Safety Concern

Case Reports in Critical Care Volume 2016 (2016), Article ID 1656182, 3 pages 1Section of Pulmonary and Critical Care Medicine, Providence Hospital and Medical Center, 16001 W 9 Mile Road, Southfield, MI 48075, USA 2Department of Internal Medicine, Providence Hospital and Medical Center, 16001 W 9 Mile Road, Southfield, MI 48075, USA Academic Editor: Kurt Lenz Copyright © 2016 Alehegn Gelaye et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Abstract Canagliflozin (Invokana) is a selective sodium glucose cotransporter-2 (SGLT-2) inhibitor that was first introduced in 2013 for the treatment of type 2 diabetes mellitus (DM). Though not FDA approved yet, its use in type 1 DM has been justified by the fact that its mechanism of action is independent of insulin secretion or action. However, some serious side effects, including severe anion gap metabolic acidosis and euglycemic diabetic ketoacidosis (DKA), have been reported. Prompt identification of the causal association and initiation of appropriate therapy should be instituted for this life threatening condition. 1. Introduction More than 5 million patients are admitted annually to intensive care units (ICUs) in the United States. A number of life threatening medical conditions, including diabetic ketoacidosis, can be associated with metabolic acidosis. Metabolic acidosis may also arise from several drugs and toxins through a variety of mechanisms. Since approval of the first-in-class drug in 2013, data have emerged suggesting that Sodium Glucose Transporter-2 (SGLT-2) inhibitors, including canagliflozin, may lead to diabetic ketoacidosis [1]. We pre Continue reading >>

Get Unlimited Access On Medscape.

Get Unlimited Access On Medscape.

You’ve become the New York Times and the Wall Street Journal of medicine. A must-read every morning. ” Continue reading >>

Euglycemic Diabetic Ketoacidosis: The Clinical Concern Of Sglt2 Inhibitors

Euglycemic Diabetic Ketoacidosis: The Clinical Concern Of Sglt2 Inhibitors

Euglycemic diabetic ketoacidosis is a post market warning in patients with type 1 diabetes and type 2 diabetes treated with SGLT-2 inhibitors. We report a case of a 39-year-old obese female with presumed type 2 diabetes for seven years who presented to the emergency department with three days of nausea, vomiting, and abdominal pain. Due to previous total non-adherence with a prescribed insulin regimen, she was recently started on canagliflozin and liraglutide. The diagnosis of euDKA was missed in the initial evaluation as the blood glucose level was only 167 mg/dL. Further work up showed severe metabolic acidosis with an anion gap of 25 and positive ketones in the urine. She was treated successfully with dextrose water 5%/half normal saline and an insulin drip. As part of the work up, she tested positive for glutamic acid decarboxylase autoantibodies. Given the increasing utilization of SGLT-2 inhibitors and the fact that patients can present with near-normal glycemia, the diagnosis can be missed. Vigilance with the use of SGLT-2 inhibitors is necessary to decrease morbidity and potentially mortality particularly in patients with long-standing type 2 diabetes associated with marked β-cell insufficiency, type 1 diabetes mellitus, or latent autoimmune diabetes of adult onset. Continue reading >>

Three Diabetes Drugs Linked To Ketoacidosis, Fda Warns

Three Diabetes Drugs Linked To Ketoacidosis, Fda Warns

NASHVILLE -- Three type 2 diabetes drugs -- canagliflozin (Invokana), dapagliflozin (Farxiga), and empagliflozin (Jardiance) -- may lead to ketoacidosis, the FDA warned today. The sodium-glucose co-transporter-2 (SGLT2) inhibitors are designed to lower blood sugar in patients with diabetes, but the FDA is investigating a connection between the drugs and dangerously high acid levels in the blood. They are also looking at whether changes will need to be made to the prescribing information, they said in the warning, which is posted online. At least two studies presented here at the annual meeting of the American Association of Clinical Endocrinologists have found a connection between the SGLT2 inhibitors and diabetic ketoacidosis (DKA). "Healthcare professionals should evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing these signs or symptoms," the FDA said. "Discontinue SGLT2 inhibitors if acidosis is confirmed, and take appropriate measures to correct the acidosis and monitor sugar levels." The signs and symptoms listed included difficulty breathing, nausea, vomiting, abdominal pain, confusion, and unusual fatigue or sleepiness. The FDA is issuing the warning after they searched their database of adverse event complaints, they said in an announcement. From March 2013 to June 2014 there were 20 cases of DKA reported, most of them with type 2 diabetes as the indication. Hospitalization was required in all of the cases, and the median time to onset was 2 weeks after starting the drug. "I would encourage that these cases be studied so we can learn the scenarios behind them so they can be broadcast," said Farhad Zangeneh, MD, medical director of Endocrine, Diabetes and Osteoporosis Clinic, in an interview with MedPage Today. "The important Continue reading >>

Most Recent Papers With The Keyword Acidosis Sglt2 | Read By Qxmd

Most Recent Papers With The Keyword Acidosis Sglt2 | Read By Qxmd

Retrospective review of SGLT2 inhibitor exposures reported to 13 poison centers. Scott E Schaeffer, Carol DesLauriers, Henry A Spiller, Alfred Aleguas, Salvador Baeza, Mark L Ryan BACKGROUND: SGLT2 inhibitors are a new class of oral antidiabetics prescribed in the United States since 2013. They act by inhibiting reabsorption of glucose in the proximal convoluted tubule of the kidney, allowing excess glucose to be excreted. Little has been reported regarding effects of non-therapeutic exposure to this class of medication. METHODS: Retrospective records from 13 poison centers were examined for human exposures to SGLT2 inhibitors between 1st January 2013 and 31st December 2016... Acid-base and electrolyte disorders associated with the use of antidiabetic drugs. Theodosios Filippatos, Eleftheria Tzavella, Christos Rizos, Moses Elisaf, George Liamis The use of antidiabetic drugs is expected to substantially increase since diabetes mellitus incidence rises. Currently used antidiabetic drugs have a positive safety profile, but they are associated with certain acid-base and electrolyte abnormalities. The aim of the review is to present the current data regarding the antidiabetic drugs-associated acid-base and electrolyte abnormalities. Areas covered: Sodium-glucose cotransporter 2 (SGLT2) inhibitors have been linked with the scarce, but serious, complication of euglycemic diabetic ketoacidosis, as well as with an increase in serum potassium, magnesium and phosphorus levels... Ketoacidosis associated with SGLT2 inhibitor treatment: Analysis of FAERS data. Jenny E Blau, Sri Harsha Tella, Simeon I Taylor, Kristina I Rother BACKGROUND: Regulatory agencies have concluded that sodium glucose cotransporter 2 (SGLT2) inhibitors lead to ketoacidosis, but published literature on this po Continue reading >>

Sodiumglucose Cotransporter-2 Inhibition And Acidosis In Patients With Type 2 Diabetes: A Review Of Us Fda Data And Possible Conclusions

Sodiumglucose Cotransporter-2 Inhibition And Acidosis In Patients With Type 2 Diabetes: A Review Of Us Fda Data And Possible Conclusions

Sodiumglucose cotransporter-2 inhibition and acidosis in patients with type 2 diabetes: a review of US FDA data and possible conclusions We are experimenting with display styles that make it easier to read articles in PMC. The ePub format uses eBook readers, which have several "ease of reading" features already built in. The ePub format is best viewed in the iBooks reader. You may notice problems with the display of certain parts of an article in other eReaders. Generating an ePub file may take a long time, please be patient. International Journal of Nephrology and Renovascular Disease Sodiumglucose cotransporter-2 inhibition and acidosis in patients with type 2 diabetes: a review of US FDA data and possible conclusions John A DElia, Alissa R Segal, [...], and Larry A Weinrauch To evaluate whether adverse event reports to the US Food and Drug Administration on incidents of ketoacidosis from use of sodium glucose cotransport inhibitors (SGLT2 inhibitors) provide insight into ways this new class of drugs is being prescribed with other antihyperglycemic agents; to examine possible mechanisms to explain ketoacidosis. Reports of adverse events concerned to SGLT2 inhibitors, namely, empagliflozin, dapagliflozin, and canagliflozin were obtained under the Freedom of Information Act for 5 years ending in August 31, 2015. The data were evaluated for incidents of ketoacidosis by looking for keywords such as diabetic ketoacidosis, ketoacidosis, lactic acidosis, acidosis, and metabolic acidosis. Results were tabulated individually for empagliflozin (n=260 adverse event reports), dapagliflozin (n=520), and canagliflozin (n=2159). Adverse events were categorized according to age, gender, and insulin use. There were 46, 144, and 450 reports of ketoacidosis concerned with the use of em Continue reading >>

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