Our Review Summary
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.
Why This Matters
Type 2 diabetes represents a significant public health problem that is now reaching epidemic proportions in many countries. Although lifestyle changes have been shown to be valuable in reducing the risk in prone patients, other prophylactic measures would be welcome. Single-drug treatments and standard-dose drugs taken in combination have been shown to reduce risk but with both a clinical and financial cost. This study is interesting and worthy of consideration because it reports on a low dose combination strategy for risk reduction. The story is an excellent summary of the study and places the results in context. However, it does miss out on an important consideration, that of cost. Ideally, preventing an illness in a population should cost less that the treatment of the illness. A bit more digging by the reporter would have been worth the effort to the reader. 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 an
FDA review in July, which may decide its fate, amid calls for it to be withdrawn from the market.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.
Criteria
Not Satisfactory
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.
Satisfactory
We get absolute benefits, relative benefits, and the all-important number needed to treat (NNT). Very nice.
Satisfactory
While harms weren’t quantified, the story provided a good amount of detail, context, and caveat about the safety of this regimen.
Satisfactory
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.
Satisfactory
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."
Satisfactory
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.
Satisfactory
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.
Satisfactory
It’s clear Avandia and metformin are currently available.
Satisfactory
We’re told of similar prior studies and the novelty of attempting a low-dose regimen to block progression.
Satisfactory
We don’t see evidence that the article relied on any news releases.
Total Score: 9 of 10 Satisfactory
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