In The News

SGLT2 Inhibitors and Diabetic Ketoacidosis: Data From the FDA Adverse Event Reporting System

Regulatory agencies have reported a potential link between sodium-glucose cotransporter-2 (SGLT-2) inhibitor use and diabetic ketoacidosis (DKA). To examine this, investigators conducted a detailed analysis of DKA events observed in patients using SGLT-2 inhibitors, as reported to the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). FAERS data covered the first quarter of 2014 through the third quarter of 2016; data were evaluated using proportional reporting ratios (PRRs) and safety signals.

Metrics Beyond Hemoglobin A1C in Diabetes Management: Time in Range, Hypoglycemia, and Other Parameters

May 1, 2017. There is a need to incorporate new, more targeted metrics beyond A1C and self-monitoring of blood glucose (SMBG) to assess glycemia in patients with diabetes. This article (full text available through link above) reviews clinical instances in which A1C should not be used and reflects on the use of other glucose metrics that can be applied in substitution for or in combination with A1C and SMBG to tailor an individualized approach that will result in better patient outcomes.

FDA Advisors Support Adding New Cardiovascular Data to Liraglutide Label

June 20, 2017. The U.S. Food and Drug Administration’s (FDA) Endocrinologic and Metabolic Drugs Advisory Committee has reviewed a supplemental new drug application for liraglutide. Specifically, the manufacturer of liraglutide requested to update liraglutide’s labeling based on data from LEADER, a pivotal cardiovascular outcomes trial that evaluated >9,300 patients with type 2 diabetes at high risk of major cardiovascular events.

Shifting Paradigms in the Medical Management of Type 2 Diabetes: Reflections on Recent Cardiovascular Outcome Trials

June 26, 2017. Several novel type 2 diabetes (T2D) medications have recently shown promise in preventing cardiovascular (CV) disease. This review discusses the results of 4 recent randomized controlled trials of empagliflozin, pioglitazone, liraglutide, and semaglutide in preventing CV outcomes in patients with or at risk of T2D and with established CV disease. On the basis of these trials, the authors propose a paradigm shift in T2D management, particularly for patients with prior macrovascular disease.

DEVOTE Study: Efficacy and Safety of Degludec Versus Glargine in Type 2 Diabetes

June 12, 2017. This randomized, double-blind, treat-to-target cardiovascular (CV) outcomes trial was undertaken to evaluate the CV safety of insulin degludec compared with insulin glargine. Patients with type 2 diabetes (N=7,637) were randomly assigned to receive insulin degludec or glargine U100 once daily between dinner and bedtime. The primary composite outcome was death from CV causes, nonfatal myocardial infarction, or nonfatal stroke, with a prespecified noninferiority margin of 1.3. The secondary outcome was severe hypoglycemia.

Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes: CANVAS Program Collaborative Group

June 12, 2017. This study reports on the cardiovascular, renal, and safety outcomes of canagliflozin treatment in patients with type 2 diabetes (T2D) and high cardiovascular (CV) risk. Data were analyzed from 2 trials (N=10,142) in which patients were assigned to receive canagliflozin or placebo and followed for a mean of 188.2 weeks. Mean participant age was 63.3 years, and 65.6% had a history of CV disease. The mean duration of diabetes was 13.5 years. The primary outcome was a composite of death from CV causes, nonfatal myocardial infarction, or nonfatal stroke.

Severe Hypoglycemia Among Patients With Type 2 Diabetes Requiring Emergency Hospital Admission: The HIPOS-ER Study

June 5, 2017. This cross-sectional, observational, multicenter study analyzed the prevalence of severe hypoglycemia in patients with type 2 diabetes taking antihyperglycemic agents and requiring emergency room (ER) assistance. Over the study period, data from 425,706 ER admissions were evaluated, and 238 (0.074%) patients met the study criteria. Median patient age was 77.5 years, and patients had a mean duration of diabetes of 19 years; 55% were on insulin therapy and 31.5% were receiving oral secretagogues.

Lower Risk of Heart Failure and Death in Patients Initiated on SGLT-2 Inhibitors Versus Other Glucose-Lowering Drugs: The CVD-REAL Study

May 18, 2017. This retrospective, matched, multinational claims analysis (N=309,056) was conducted to determine whether real-world data confirmed clinical trial findings of decreased rates of cardiovascular (CV) death and hospitalization for heart failure (HHF) in patients using sodium glucose co-transporter-2 (SGLT-2) inhibitor drugs. All patients had type 2 diabetes and atherosclerotic CV disease; propensity matching was used to compare patients using SGLT-2 inhibitors vs other glucose-lowering agents.

FDA Consumer Update: How to Safely Use Glucose Meters and Test Strips for Diabetes

May 16, 2017. The US Food and Drug Administration (FDA) has released a consumer update regarding the purchase and use of previously owned test strips for glucose meter testing. Some sellers are now marketing pre-owned or secondhand test strips, which may be sold at lower prices compared with new strips. Although this practice is technically legal, the FDA does not recommend that patients buy pre-owned test strips or resell unused strips because pre-owned strips can give incorrect results and may not be safe to use with specific devices.

Bydureon EXSCEL Trial Meets Primary Safety Objective in Type 2 Diabetes Patients at Wide Range of Cardiovascular Risk

May 23, 2017. Top-line results from the Phase IIIb/IV EXenatide Study of Cardiovascular Event Lowering (EXSCEL) trial have been announced by the drug’s manufacturer. The trial compared once-weekly injectable extended-release exenatide (Bydureon) vs placebo in adults with type 2 diabetes (T2D) and a wide range of cardiovascular (CV) risk profiles. More than 14,000 patients from 35 countries participated. The primary outcome was a composite of major adverse cardiac events (MACE): CV death, nonfatal myocardial infarction, or nonfatal stroke.

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