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…
Low-Carb And Low-Fat Diets Battle To A Draw
February 20, 2018 by 7 Comments
A new study comparing a low-carbohydrate diet with a low-fat diet found no important differences in weight loss or other important outcomes between the two diets. Some experts believe the result shows that the debate over the relative worth of these different diets has been overblown and confirms the view that calories count. Others say…
How Statins Make Some People Crazy
July 30, 2017 by 21 Comments
–Intelligent discussion about statins is threatened by zealous partisans. What is it about statins that causes so many people to go crazy? I’m not talking about any pharmacological effect of the drugs. Instead my focus here is on the zealous partisans— both against and in support of statins— who go off the deep end. Unfortunately…
The Unintended Consequences Of Bicycle Helmets
June 5, 2017 by 11 Comments
(UPDATED) –We should encourage people to cycle, not scare them away. From personal experience I can attest that it is almost impossible, in the US at least, to have an intelligent conversation about bicycle helmets. The universal view is that you have to be crazy not to wear a helmet. Since I almost never wear…
Top Cardiologist Blasts Nutrition Guidelines
February 27, 2017 by 15 Comments
–Salim Yusuf says new evidence fails to support many major diet recommendations. One of the world’s top cardiologists says that many of the major nutrition guidelines have no good basis in science. “I’m not a nutrition scientist and that may be an advantage because every week in the newspaper we read something is good for…
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…
More Shots Fired in ‘Sugar War’
December 19, 2016 by 1 Comment
–Industry-sponsored study questions current guidelines on dietary sugar. Dietary guidelines relating to sugar— all of which recommend significant reductions in sugar intake— are based on weak evidence and are not trustworthy, according to a systematic review published in Annals of Internal Medicine. But an accompanying editorial points out that the systematic review is itself not…
Genetic Studies Offer Hint Of Clinical Benefits-And Risks- of PCSK9 Inhibitors
November 30, 2016 by 2 Comments
–Both cardiovascular benefits and increase in diabetes seem likely. There is no more eagerly awaited question in cardiovascular medicine than the clinical role of the PCSK9 inhibitors. The first reports from a series of outcomes trials are not due until next year. But two large genetic studies published this week deliver strong indirect evidence that…
LDL-Lowering Genetic Variants Linked to Diabetes Risk
October 6, 2016 by 1 Comment
–What can genetics tell us about diabetes incidence with cholesterol drugs? Editor’s note: The following guest post was contributed by Marilyn Mann, a well-known advocate for patients with familial hypercholesterolemia and a patient advisor to Circulation: Cardiovascular Quality and Outcomes. In a study published in the Journal of the American Medical Association, several LDL-lowering genetic…
NIH Funds Second Round Of Controversial Chelation Tria
September 27, 2016 by Leave a Comment
–TACT2 will test chelation in heart attack patients with diabetes. The NIH has agreed to fund a second round of a highly controversial study testing the possible benefits of chelation therapy in heart attack patients with diabetes. The second Trial to Assess Chelation Therapy (TACT2), now recruiting patients at more than 100 clinical sites, is…
Experts Disagree About Cholesterol Screening In Kids
August 10, 2016 by 3 Comments
(Updated) –Lack of evidence leads to major disagreement over guidelines. Once again the US Preventive Services Task Force (USPSTF) has performed an invaluable— and almost certainly thankless— service. In a series of papers published in JAMA and Annals of Internal Medicine the USPSTF states unequivocally that there is no good high quality evidence to evaluate…
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,…
Time For Cardiologists To Start Prescribing Diabetes Drugs?
June 22, 2016 by 2 Comments
There’s an emerging consensus that now may be the time for cardiologists to start thinking seriously about prescribing diabetes drugs. Until now most cardiologists have not considered this to be part of their job description. But now new data from large cardiovascular outcome trials (CVOTs) shows that these drugs may one day become, like statins and…
Clinical Trial Expert’s Deep Dive Into The Important New Liraglutide Trial
June 13, 2016 by Leave a Comment
–Sanjay Kaul plunges into the LEADER data pool There will be a lot of discussion in the near future about the LEADER trial, the large new trial assessing cardiovascular outcomes with liraglutide (Victoza, Novo Nordisk). The trial is the latest in a series of large CVOTs with new diabetes drugs showing benefit— or at least…
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…
FDA Expands Metformin Label
April 10, 2016 by Leave a Comment
— The diabetes drug can now be used in more patients with reduced kidney function The FDA on Friday greatly expanded the indication for the type 2 diabetes drug metformin. Until now use of metformin in patients with reduced kidney function had not been recommended. The new label states that metformin “can be used safely…
FDA Adds Heart Failure Warning To Saxagliptin and Alogliptin Labels
April 6, 2016 by Leave a Comment
The FDA said on Tuesday that it was adding new warning to the labels of diabetes drugs containing the saxagliptin and alogliptin. The FDA said the drugs “may increase the risk of heart failure, particularly in patients who already have heart or kidney disease.” The announcement comes two years after an FDA panel recommended that…
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 –…
Study Finds No Improvement In Quality Of Life With ESAs
February 15, 2016 by Leave a Comment
Erythropoietin-stimulating agents (ESAs) continue to be widely prescribed despite the absence of evidence demonstrating benefit. TREAT– the first and only large trial to test clinical outcomes with the drugs–showed that ESAs did not reduce clinical events, though it did raise concerns that the drugs might increase the risk of stroke. Critics say that the drugs…
Lancet Sprints To The Front With A Blood Pressure Meta-Analysis
November 6, 2015 by 1 Comment
A new meta-analysis published in the Lancet on Friday lends fresh support to calls for more intensive blood pressure treatments. The publication comes only days before the highly anticipated presentation of the NIH’s SPRINT trial at the American Heart Association, which is also expected to offer support for stricter blood pressure control. Blood pressure goals were relaxed after the ACCORD…
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…
A Coke, A Smile, And 120 Million Dollars
September 24, 2015 by Leave a Comment
As I’ve reported in the past Coca-Cola has a long history of giving money to medical organizations and researchers. Now we know just how much. In response to a New York Times story this summer, Coke has disclosed details of its financial support to a great number and broad variety of health organizations and initiatives. Over the past five years, it…
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…
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