The article describes a new drug that may help improve blood sugar in people with diabetes more so than other drugs (e.g. metformin alone) or with reportedly fewer side effects. Overall, the story does address what type of evidence the claims are based on and what the reported benefits are, although context is lacking. Readers might think this is an important new medicine, when in fact, it is likely not any more effective than existing drugs currently on the market. Importantly, side effects or harms of treatment were minimized. Actual rates of low blood sugar episodes with the new drug were not reported, yet were noted to be a serious side effect of older drugs. Readers aren’t able to judge how much better the new drug may be at reducing the chance of this important side effect. The article also reports that there appear to be no serious side effects of the drug, which may be true for the moment, but caution should have been given to these findings, given that the only study was performed by the manufacturer and the study was short-term. Considering the immense health burden diabetes represents, lifestyle changes to improve blood sugar should have been mentioned as part of the treatment options.
The story does not mention projected costs for the new drug. The story could have provided some insight into the costs of available drugs to treat Type 2 diabetes. The likelihood of this new drug in combination with metformin being less exepnsive than available drugs is very low.
The story reports the benefit in terms of an intermediate outcome, A1C. The study tells how many participants achieved an A1C < 7% by taking the new drug plus metformin vs. metformin alone. However, the story could have pointed out that the study was short-term (6 months), so it's not clear what long-term outcomes might be. While the absolute benefits are provided, the story lacks context.
The story describes a serious side effect of low blood sugar and tells readers that the number of low blood sugar episodes with the new drug is lower than that for older drugs. Yet, this could be a serious complication and the actual rate of this complication is not reported. The story does describe actual rates of some side effects for the new drug when combined with an existing drug (metformin). These included diarrhea (10% of participants) and nausea (8% of participants). The story describes sore throat, headache, and runny nose as “less common,” with no quantification. Yet the story does not mention side effects for the new drug individually, so readers don’t know whether these side effects reported may be related to the existing drug metformin. The story also claims that there appear to be no big safety problems, which is probably a premature statement given the relatively long lag time often needed to see safety problems.
The story explains that participants received either the new drug or placebo, implying this is a randomized, controlled trial (although whether participants were randomized is not explicit). The study also measured a relevant, although intermediary, endpoint of A1C, which is a measure of average blood sugar over the past 2 to 3 months. The story discloses that this is a study done by the manufacturer, which is not without bias, but is common when studying new drugs in order to get FDA approval. Additional context could have been provided around this drug in comparison to existing, effective drugs. This drug is compared to placebo, which is okay and necessary for FDA approval, but a better comparison is to other, existing drugs to lower blood sugar.
The story provides a brief description of the nature of type 2 diabetes, namely that it is more common with age and among those who are overweight, which is true.
The story does not obtain independent comment on the study findings.
The story does mention some other medications to lower blood sugar, such as sufonylureas and insulin. However, lifestyle interventions are very important for controlling blood sugar (as well as blood pressure and cholesterol) and are not mentioned at all. This is an important treatment area that should not be overlooked in diabetes.
The story says “Merck is expecting the FDA to approve Januvia by mid-October. The company has also submitted an application for a single tablet combination of Januvia and metformin, known as MK-0431a. The FDA is expected to make a decision on that drug by the end of March 2007.” On the first statement, the story should not simply take the word of Merck on the date of – or the certainty of – expected FDA approval. And on the second statement, the story doesn’t say who expects the FDA approval of the second drug. Who said that? Who’s the source?
The story describes a study evaluating a new drug, which works differently than other drugs for lowering blood sugar. However, while it may work differently, its effects are not different and appears to offer no distinct advantages over what is currently available.
It is unclear where the author obtained the information. The reuslts have not been presented as yet and the authors were not quoted. It appears that the source was the drug company; no information was given from experts in the field to place this new agent in context. Nonetheless, because we can’t be sure the story relied solely or largely on a news release, we rate it N/A.
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
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