This Reuters story summarizes new findings about Jardiance (empaglifozin), a diabetes drug developed by Eli Lilly and Boehringer Ingelheim and approved by the FDA last year. Following a recently published study, Jardiance is now being positioned as an add-on to standard care and a preventative therapy that reduces the risk of cardiovascular death, as well as risk of death from any cause, in patients with type 2 diabetes. The story capably lays out the basics of the study, but its reliance on relative risk figures (which may tend to inflate the magnitude of the effect), as well as the lack of any comment on potential harms, were considered significant drawbacks by our reviewers.
Editor’s note: We learned that Reuters made updates to the initial version of this story, including the headline, after our review was complete. Although we applaud such efforts to provide more information and context to readers, such efforts do miss readers like us who only saw the original version of the story.
People with type 2 diabetes are two to four times more likely to develop cardiovascular disease than people without diabetes, according to the World Heart Association. Cardiovascular disease is also a leading cause of death among people with diabetes.
An add-on therapy that can help prevent serious heart disease and fatal complications could have a significant impact on the lives of millions of people with type 2 diabetes.The CDC estimates that more than 9% of the U.S. population — or 29 million people — have type 2 diabetes.
The initial version of the story that we reviewed did not address cost.
An update to the story, posted after our review, noted the drug costs more than $4,000 annually.
The story relies entirely on relative risks to convey the benefits found in the study — most notably in the headline. We think that estimates based on relative risk can be misleading in isolation, and so we always prefer for stories to include a measure of absolute risk reduction as well. For example, the abstract of the study explains that the “slashing” of deaths mentioned in the headline means that the death rate was 5.7% in the Jardiance group compared with 8.3% in the placebo group.
The article didn’t mention any harms associated with Jardiance, a type of SGLT2 inhibitor. Some mention of potential adverse effects is always appropriate in stories about new drugs.
A close call on this one. The story makes it clear that this was a trial comparing empagliflozin to placebo in patients with type 2 diabetes who were at high risk of cardiovascular disease. And it lays out the main outcomes. But beyond that, it doesn’t tell us much. And it allows the lead study author to speculate — prematurely perhaps — that the study “would prompt medical societies to recommend in their treatment guidelines that Jardiance be used for type 2 diabetics that have a history of heart disease or are at risk of cardiovascular events.” While that’s possible, we don’t really know what these societies will recommend until they actually synthesize this evidence together with other available data — and so the story could have pushed back on that point.
We’ll give the benefit of the doubt here.
There’s no evidence of disease mongering in the story.
The initial version of this story includes only comments from Dr. Bernard Zinman, the lead investigator. The updated version of the story includes additional perspectives on the research, but neither version of the story makes it clear the the study was funded by Boehringer Ingelheim and Eli Lilly, or that Dr Zinman and other co-authors disclosed financial relationships with Boehringer Ingelheim related to the study and outside of the study.
This is a novel preventative therapy and designated as an add-on, not a replacement, to standard therapy which include statins to lower cholesterol, and blood pressure drugs. The story mentions Invokana, another drug in the same class as empagliflozin, and it talks about cholesterol-lowering drugs and blood pressure medication.
The story notes that Jardiance was approved for use in the United States last fall, so it’s clear that the drug is available.
The drug is newsworthy because it is the first drug to have shown a significant reduction in cardiovascular events in people with type 2 diabetes — and the story makes this clear.
The story includes quotes from interview with Dr. Zinman, so we know that it went beyond the news release issued for the study.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
Comments (1)
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marry
September 21, 2015 at 8:26 pmI also hope lots of people don’t use drug to help fight your diabetes. Try good diet and exercise.
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