April 15th, 2015
Diabetes Drugs Get Neither Restrictions Nor Endorsements from FDA Committee
Larry Husten, PHD
Two diabetes drugs survived a meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Tuesday. Rejecting recommendations from critics that the drugs should either be withdrawn or get new restrictions on use, the committee voted against any harsh measures, recommending only that information from two neutral clinical trials be added to the drugs’ labels. The two trials were […]
September 15th, 2014
New Observations on Saxagliptin
Benjamin Scirica, MD MPH
Benjamin Scirica discusses his study group’s new analysis of data from the SAVOR-TIMI 53 randomized, placebo-controlled trial of saxagliptin in patients with type 2 diabetes.
July 3rd, 2014
Sitagliptin Associated with Increase in Heart Failure Hospitalizations
Larry Husten, PHD
The cardiovascular effects of drugs used for glucose control in patients with diabetes have been a subject of controversy for many years now. More recently, attention has started to focus specifically on the risk for heart failure (HF). Now, an observational study will likely raise new questions about the dipeptidyl peptidase (DPP)-4 inhibitor sitagliptin (Januvia, Merck). In […]
September 26th, 2013
Increase In Deaths Linked To First-Line Treatment With Sulfonylureas
Larry Husten, PHD
First-line treatment with sulfonylureas instead of metformin in people with type 2 diabetes is associated with a significantly elevated risk of death, according to results from an observational study presented at the European Association for the Study of Diabetes (EASD) meeting in Barcelona. Although guidelines do not recommend the use of sulfonylureas for first-line treatment, the drugs are still […]
June 19th, 2013
Top-Line Results: No Cardiovascular Benefits Found For Saxagliptin
Larry Husten, PHD
Top-line results of a large phase 4 study with saxagliptin (Onglyza, Bristol-Myers Squibb and AstraZeneca) demonstrate that the drug is safe but has no cardiovascular benefits. AstraZeneca and Bristol-Myers Squibb today announced the top-line results for the SAVOR-TIMI-53 Cardiovascular Outcomes Trial of Onglyza®. The full results are scheduled to presented at the annual meeting of the European Society of Cardiology in Amsterdam on September 2 […]
May 2nd, 2011
FDA Approves New Drug for Type 2 Diabetes
Larry Husten, PHD
The FDA announced today that it has approved linagliptin, a new drug for type 2 diabetes. The DPP-4 inhibitor was developed by Eli Lilly and Boehringer Ingelheim and will be sold under the brand name of Tradjenta. Linagliptin was studied in 3,800 patients with type 2 diabetes, the FDA said, and was better than placebo in […]