In The News

FDA Drug Safety Communication: Interim Results Find Increased Risk of Leg/Foot Amputations With Canagliflozin

March 18, 2016. The US Food and Drug Administration (FDA) has issued a public alert regarding interim safety results for the sodium-glucose cotransporter 2 (SGLT2) inhibitor canagliflozin, obtained from an ongoing clinical trial of the drug. Specifically, an increased prevalence in leg and foot amputations has been observed, mostly affecting the toes, in patients treated with canagliflozin. The FDA is investigating this issue and will update the public when they have more information. You can read the full article here.

Diabetes Medications as Monotherapy or Metformin-Based Combination Therapy for Type 2 Diabetes

April 19, 2016. This systematic review and meta-analysis was conducted to evaluate the comparative effectiveness of various monotherapies and selected metformin-based combinations available to treat type 2 diabetes (T2D). The study evaluated thiazolidinediones, metformin, sulfonylureas, dipeptidyl peptidase-4 inhibitors, sodium-glucose cotransporter 2 inhibitors, and glucagon-like peptide-1 receptor agonists, along with selected metformin-based combinations. A total of 179 head-to-head studies and 25 observational studies were evaluated.

Hypoglycemia Risk With Addition of Dipeptidyl Peptidase-4 Inhibitors to Sulfonylureas

May 3, 2016. This systematic review and meta-analysis quantified hypoglycemia risk associated with the use of dipeptidyl-peptidase-4 (DPP-4) inhibitors and sulfonylureas versus placebo and sulfonlyureas. Ten studies, representing 6546 patients, were selected for analysis. The sulfonylureas evaluated were glimepiride and glyburide, with some studies not specifying drug names. The risk ratio for hypoglycemia with DPP-4 inhibitors was 1.52 (95% confidence interval 1.29 to 1.80) compared with placebo.

FDA Issues Drug Safety Communication Related to Ongoing Safety Review of Insulin Glargine and Possible Cancer Risk

May 4, 2016. The US Food and Drug Administration (FDA) has released an update regarding its ongoing investigation of insulin glargine (Lantus) use and possible cancer risk. In this announcement, the FDA outlines the key literature it has reviewed since this investigation was started in 2009. At this time, the FDA has not concluded that Lantus increases cancer risk. This review is ongoing, and the FDA will update the public when it has additional information. Follow this link to read the FDA Safety Announcement.

American Association of Clinical Endocrinologists and American College of Endocrinology Issue Position Statement on the Association of SGLT-2 Inhibitors and Diabetic Ketoacidosis

May 2016. Recent reports of diabetic ketoacidosis (DKA) occurring in conjunction with sodium glucose-cotransporter 2 (SGLT-2) inhibitor therapy have raised concerns that these agents may increase the risk of DKA, especially among insulin-using patients. To address these concerns, the American Association of Clinical Endocrinologists (AACE) and the American College of Endocrinology (ACE) convened a public conference in which experts from Europe and the United States evaluated relevant cases and clinical data.

Lipid-Lowering Efficacy of the PCSK9 Inhibitor Evolocumab (AMG 145) in Patients With Type 2 Diabetes

May 2016. This random-effects meta-analysis evaluated data from randomized controlled trials to assess the efficacy of the PCSK9 inhibitor evolocumab, compared with placebo and ezetimibe, in improving lipid profiles in patients with and without type 2 diabetes (T2D). Three trials were suitable for evaluation; they included 413 patients with T2D and 2119 patients without T2D. In patients with T2D, evolocumab was associated with mean low-density lipoprotein cholesterol (LDL-C) reductions of 60% vs placebo and 39% vs ezetimibe.

FDA Adds Warnings About Heart Failure Risk to Labels of Drugs Containing Saxagliptin and Alogliptin

April 5, 2016. A US Food and Drug Administration (FDA) safety review has found that saxagliptin and alogliptin, 2 dipeptidyl peptidase-4 inhibitor medications used to treat type 2 diabetes, may increase heart failure risk, particularly in patients with existing cardiovascular or kidney disease. Therefore, the FDA is adding warnings to these drug’s labels regarding the potential for increased heart failure. The FDA recommends that health care professionals consider discontinuing these medications in patients who develop heart failure.

FDA Revises Warnings Regarding Use of Metformin in Certain Patients With Reduced Kidney Function

April 8, 2016. The US Food and Drug Administration (FDA) is requiring labeling changes for metformin-containing medicines for diabetes, expanding the drug’s use in certain patients with impaired renal function. The current metformin labeling strongly recommends against use in patients with impaired kidney function. However, following a review of numerous medical studies, the FDA has concluded that metformin can be used safely in patients with mild renal impairment and in some patients with moderate renal impairment.

Impact of CMS Competitive Bidding Program on Medicare Beneficiary Safety and Access to Diabetes Testing Supplies

March 18, 2016. This retrospective, longitudinal analysis evaluated US Centers for Medicare & Medicaid Services (CMS) claims data (2009-2012) to confirm a 2012 CMS report indicating no acquisition disruptions or changes in health outcomes due to the rollout of the CMS Competitive Bidding Program (CBP) for diabetes supplies. The study population comprised 43,939 beneficiaries in the 9 test markets originally targeted by the CBP (TEST group) and 485,688 beneficiaries in non-test markets (NONTEST group); all patients were insulin users.

Glucose Variability: Timing, Risk Analysis, and Relationship to Hypoglycemia in Diabetes

April 2016. This “Perspective” article from Diabetes Care discusses the close relationship between glucose control, glucose variability (GV), and hypoglycemia. The authors emphasize that diabetes control requires optimization and balance between 2 key markers: hypoglycemia frequency and A1C levels (reflecting average blood glucose, primarily driven by the extent of hyperglycemia). They stress the need to standardize GV measurement to improve patient assessment. Follow this link to read the study abstract.