A well-constructed, balanced story that was missing just one piece of information: cost. Had the article discussed the price tag of this approach, it would’ve aced our criteria.
In addition to summarizing the key points of the study, the article provides some important nuggets of context, describing how rosiglitazone is in the hot seat now, even mentioning that some feel clinical trials with it are unethical. Rosi is undergoing anFDA review in July, which may decide its fate, amid calls for it to be withdrawn from the market. And GSK just settled a court case alleging that the drug causes heart attacks and strokes. See this article at theheart.org for a more detailed description of the new study in light of more the surrounding controversy.
Costs and the cost-effectiveness of this strategy are not discussed. Any discussion of a preventive strategy should include comments on cost.
Avandia and metformin, at the doses used in the study, cost about $195 a month, according to drugstore.com.
We get absolute benefits, relative benefits, and the all-important number needed to treat (NNT). Very nice.
While harms weren’t quantified, the story provided a good amount of detail, context, and caveat about the safety of this regimen.
We get many important details about the study: the number of patients, the enrollment criteria, randomization, placebo control, half doses, and the length of follow-up. It also describes some limitations of the study, such as its inability to detect rare adverse events due to its size. It’s an important caveat, particularly with a cardiovascular cloud hanging over rosiglitazone. The author also points to the editorial’s observation that the approach didn’t affect the problems in the pancreas that underly diabetes and which must be addressed by such a strategy.
The author is very specific about the thresholds for the patient population, and who was considered at high risk to progress to diabetes. We note that it was judiciously limited in its use of the term "prevention."
Props to the author for citing the editorial written by two independent experts and published in the same issue of the Lancet. This article selects several of their many cogent comments. Ideally, another independent source outside the publication would’ve been consulted, too.
The story describes how GSK has a dog in this fight, funding the study and manufacturing Avandia. The story also provides the institutional affiliations of Zinman and the two editorialists. While it’s probably covered in the GSK funding source, we’ll point out that several investigators had other financial ties to GSK, too.
The article talks about the effectiveness of lifestyle changes and the challenge of implementing them. It also reviews the barriers to using full-dose rosi because of adverse events.
It’s clear Avandia and metformin are currently available.
We’re told of similar prior studies and the novelty of attempting a low-dose regimen to block progression.
We don’t see evidence that the article relied on any news releases.