It hasn’t received a lot of media attention but on Tuesday the FDA approved an expansion of the canagliflozin (Invokana, Janssen) label to include a reduction in the risk of heart attack, stroke, or CV death in adults with type 2 diabetes and established CV disease. Canagliflozin, an oral SGLT2 inhibitor, thus becomes the third…
Screen-And-Treat to Prevent Diabetes Doomed to Fail
January 4, 2017 by 7 Comments
Screening must be supplemented by broader public health approaches. Screen and treat strategies to prevent type 2 diabetes are doomed to failure, according to a large new systematic review and meta-analysis published in The BMJ. Instead, the authors said and outside experts agreed, any effort to combat the already enormous and still growing problem of type 2…
Prominent Cardiologists Decry Tepid Support For Empagliflozin By Endocrinologists
July 5, 2016 by 1 Comment
At the FDA advisory panel empagliflozin enjoyed strong support from the cardiologists and statisticians but not from the endocrinologists. An FDA advisory panel last week turned out to be a much more contentious and divided than many had expected. Based on the FDA’s own analysis of last year’s Empa-Reg Outcome trial I had predicted that the…
Empagliflozin May Be Poised To Gain CV Indication
June 24, 2016 by Leave a Comment
–FDA reviewers have raised no major questions ahead of Tuesday’s advisory panel meeting. The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will likely lend its support to an important new expanded indication for empagliflozin (Jardiance, Boehringer Ingelheim). The new indication is to reduce the risk of all-cause mortality by reducing the incidence of cardiovascular death,…
Companies Plan To Study Diabetes Drug In Heart Failure Population
April 21, 2016 by 1 Comment
–New attention paid to the intersection of heart failure and diabetes Boehringer Ingelheim and Eli Lilly announced on Wednesday that they were planning two separate outcomes trials to test the effect of the diabetes drug empagliflozin (Jardiance) in patients with chronic heart failure. The trials herald a remarkable shift in emphasis, since there have been…
Top Line Results Favor Victoza In Large Cardiovascular Outcomes Trial
March 4, 2016 by Leave a Comment
Novo Nordisk today announced top-line positive results of the LEADERS trial, the cardiovascular outcomes trial testing its diabetes drug Victoza (liraglutide). Liraglutide is a GLP-1 inhibitor used to help achieve glucose control in patients with type 2 diabetes. 9,340 people with type 2 diabetes were randomized to liraglutide or placebo in LEADERS for 3.5 –…
Second Trial Of Controversial Chelation Therapy Gains Crucial Early Support
September 28, 2015 by 3 Comments
The National Institutes of Health is giving money to support the planning of a second trial to test the potential role of chelation therapy in treating patients with myocardial infarction. The first Trial to Assess Chelation Therapy (TACT) was extremely controversial. It was funded by the NIH more than a dozen ago as part of an initiative to…
Sanjay Kaul On The Empa-Reg Outcome Study
September 17, 2015 by 1 Comment
The really big medical news today is the publication of the highly anticipated Empa-Reg Outcome study in the New England Journal of Medicine. It is the first large clinical trial with a diabetes drug (empagliflozin, Jardiance) to demonstrate a significant reduction in cardiovascular outcomes. The trial even resulted in a surprising, statistically significant reduction in mortality. I asked Sanjay Kaul for…
No Increase In Diabetes Found With Ezetimibe In IMPROVE-IT
September 1, 2015 by Leave a Comment
A new analysis of the IMPROVE-IT trial found no significant increase in the rate of new onset diabetes in patients taking ezetimibe. Michael Blazing of Duke University presented the results of the IMPROVE-IT substudy on Tuesday afternoon at the European Society of Cardiology meeting in London. The analysis was prompted by previous findings from very…
IMPROVE-IT Substudy: Ezetimibe Benefit Restricted To Diabetics
August 31, 2015 by 1 Comment
The beneficial effects of ezetimibe are found almost exclusively in patients with diabetes, according to an update of the influential IMPROVE-IT trial presented on Sunday at the European Society of Cardiology meeting in London. The new finding may lead to questions about the widely accepted interpretation of the main finding of the trial, which is that it provided strong support for…
Wow! Maybe– Finally– A Positive Diabetes Drug Outcomes Trial
August 20, 2015 by 1 Comment
Until now the best thing anyone could say for sure about all the new diabetes drugs was that at least they didn’t kill people. That’s because although these drugs have been shown to be highly effective in reducing glucose levels, a series of large cardiovascular outcomes trials failed to provide any evidence of significant clinical…
More Evidence Linking Sugared Drinks To Diabetes
April 30, 2015 by 1 Comment
A new study uncovers some potentially important new details about the association between sugared drinks and diabetes. In a paper published in Diabetologia [pdf], researchers in the UK report on a study of more than 25,000 adults. Over the course of more than 10 years of followup 847 participants went on to develop diabetes. Instead of relying on a food…
Diabetes Drugs Get Neither Restrictions Nor Endorsements From FDA Committee
April 14, 2015 by Leave a Comment
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 with the drugs be added to the drugs’ labels….
Get Rid of Sugar, Not Salt, Say Authors
December 10, 2014 by Leave a Comment
Too much negative attention has been focused on salt and not enough on sugar, write two authors in Open Heart. Reviewing the extensive literature on salt and sugar, they write that the adverse effects of salt are less than the adverse effects of sugar. The evidence supporting efforts to reduce salt in the diet is not convincing…
Study Suggests Vitamin D Can’t Prevent Diabetes
October 1, 2014 by Leave a Comment
A vitamin D pill can’t substitute for a healthy diet and sunshine, a new genetic study published in The Lancet Diabetes & Endocrinology suggests. In recent years many people have been seduced by observational studies that found low levels of vitamin D in people who developed type 2 diabetes. The new study instead suggests that the association is not…
FDA Approves Lilly’s Once-Weekly Shot For Diabetes
September 18, 2014 by Leave a Comment
The FDA said today that it had approved dulaglutide, Lilly’s once-weekly injection to control blood sugar in adults with type 2 diabetes. The drug will be marketed under the brand name of Trulicity. … Click here to read the full post on Forbes. …
Statins And Diabetes: A Clearer Picture Emerges
September 9, 2014 by 1 Comment
In recent years, the medical community has become increasingly aware that taking statins can result in slightly higher glucose levels, and this can lead to a diagnosis of diabetes in a small but statistically significant number of people. But it has been unclear whether the diagnosis of diabetes in people taking statins also places them…
Januvia Linked To Increase in Heart Failure Hospitalizations
July 2, 2014 by Leave a Comment
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. Now, an observational study will likely raise new questions about the dipeptidyl peptidase (DPP)-4 inhibitor sitagliptin (Januvia, Merck). In a…
Major Medical Organizations Establish Ambitious Diabetes Registry
June 10, 2014 by Leave a Comment
Our knowledge of diabetes today is a bit like the way blind men understand an elephant. With a myriad of isolated perspectives it’s nearly impossible to gain a broad overview. Now, a new initiative from a group of major medical organization will seek to provide the tools to better see a full picture of the elephantine…
Intensive Insulin Therapy Saves Lives– But Is The Finding Still Relevant?
May 12, 2014 by 1 Comment
A trial that started back in 1990 continues to demonstrate a significant mortality advantage for intensive insulin therapy in heart attack (MI) patients. But experts say the trial design is so outdated that the findings should have no influence on clinical practice today. During the years 1990 through 1993 the Swedish DIGAMI I (Diabetes Mellitus…
Glucose Measurements Don’t Improve Cardiovascular Risk Assessment
March 25, 2014 by Leave a Comment
Although blood glucose and glycated hemoglobin (HbA1c) play a central role in diabetes, the value of these measurements to assess cardiovascular risk has been unclear. Now, in a paper published in JAMA, members of the Emerging Risk Factors Collaboration analyze data from nearly 300,000 people without known diabetes or cardiovascular disease who were enrolled in…
Heart Failure: The Missing 800 Pound Gorilla In Diabetes Trials
March 12, 2014 by Leave a Comment
Is heart failure the missing 800 pound gorilla in diabetes trials? That’s the argument proposed by a group of prominent cardiovascular and diabetes researchers. It was long believed that by virtue of their glucose-lowering properties diabetes drugs would confer substantial cardiovascular benefits. Now, however, that belief is no longer widely held and the FDA now…
FDA Investigating Heart Failure Risk Linked To Onglyza
February 11, 2014 by Leave a Comment
The FDA said today that it was conducting an investigation of a possible increased risk for heart failure associated with the diabetes drug saxagliptin. Saxagliptin is marketed by AstraZeneca as Onglyza and Kombiglyze XR. (AstraZeneca recently completed the purchase of all rights to the drug from its manufacturer, BristolMyers-Squibb.) The investigation stems from findings from the cardiovascular outcomes trial SAVOR-TIMI 53 trial in which more…
Mediterranean Diet Protects Against Diabetes, Regardless of Weight Loss
January 6, 2014 by Leave a Comment
Even if it doesn’t lead to weight loss, a Mediterranean diet could help prevent the onset of type 2 diabetes, according to a subanalysis of last year’s influential PREDIMED study. In the main trial, reported in the New England Journal of Medicine, nearly 7500 people at high risk for cardiovascular disease were randomized to a low-fat diet or…
Cardiology Goes Better With Coke
July 23, 2013 by 3 Comments
At the bottom of this post I’ve reprinted an email cardiologists are receiving from the American College of Cardiology. See the bottom of the message for the disclosure that Coca Cola is paying for this educational program. I don’t have much to say about this though I wonder what the faculty of this program will…
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