In The News

FDA Approves Empagliflozin/Linagliptin Combination for Adults With Type 2 Diabetes

The U.S. Food and Drug Administration (FDA) has approved combined empagliflozin/linagliptin tablets (Glyxambi®) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who are good candidates for both drugs. The once-daily tablet combines a sodium-glucose cotransporter 2 (SGLT2) inhibitor (empagliflozin, 10 or 25 mg) with a dipeptidyl peptidase-4 (DPP-4) inhibitor (linagliptin, 5 mg).

Incretin-Based Drugs and the Risk of Congestive Heart Failure

This retrospective analysis was conducted to determine whether the use of incretin-based drugs (dipeptidyl-peptidase-4 inhibitors, glucagon-like receptor-1 analogs) was associated with an increased risk of congestive heart failure (CHF) among patients with type 2 diabetes. Data were obtained from the UK Clinical Practice Research Datalink, and patients with no prior CHF history and newly prescribed to antidiabetic drug regimens between January 1, 2007, and March 31, 2012, were evaluated. The cohort comprised 57,737 patients, with a mean 2.4 years’ follow-up.

Initial Combination Treatment With Empagliflozin and Linagliptin in Patients With Type 2 Diabetes

January 29, 2015. This study randomized antihyperglycemic drug-naïve patients (N=677) with type 2 diabetes to 52 weeks of treatment with 1 of 5 regimens: empagliflozin (EMP) 25 mg + linagliptin (LIN) 5 mg; EMP 10 mg + LIN 5 mg; EMP 25 mg; EMP 10 mg; or LIN 5 mg.  The primary endpoint was change in A1C from baseline to week 24; patients’ mean baseline A1C levels were 7.99% to 8.05%.

Incretin-Based Therapy and Risk of Acute Pancreatitis: A Nationwide Population-Based Case-Control Study

January 29, 2015. This case control study evaluated whether the use of incretin-based drug therapy (glucagon-like peptide-1 agonists and dipeptidyl peptidase-4 inhibitors) in type 2 diabetes was associated with an elevated risk of acute pancreatitis. Data were obtained from a nationwide population-based Danish medical database (12,868 patients with a first-time hospitalization for acute pancreatitis between 2005 and 2012, and 128,680 matched controls).

FDA Allows Marketing of First CGM Mobile Medical Apps

The US Food and Drug Administration (FDA) has approved marketing of the first set of mobile medical apps that allow diabetes patients to automatically and securely share data from a continuous glucose monitor (CGM) in real time using an Apple mobile device such as an iPhone. The Dexcom Share Direct Secondary Displays system’s data sharing enables caregivers to monitor patient blood glucose levels via mobile devices. You can follow this link to read the full FDA press release.

Endocrine Society Releases New Obesity Drug Treatment Guidelines

The Endocrine Society has published a guideline for the pharmacologic management of obesity in patients not achieving success with diet and exercise alone. These guidelines were developed to help providers identify patients who might benefit from pharmacotherapy for obesity and provide relevant evidence and background on available pharmacologic agents. The guidelines provide recommendations on medication use and dosage, including recommendations for patients with obesity-related comorbidities such as type 2 diabetes and cardiovascular disease.