The Good, The Bad, and the Ugly Part I: Why I’m not a Fan of the ADA/EASD’s 2012 Position StatementPosted May 30, 2012 by John L. Leahy, MD
The highly awaited ADA/EASD statement on management of type 2 diabetes was published online April 19th, 2012.1 I feel like a curmudgeon,but as a general statement, I’m not a fan. In fact, I’m worried that at best it will have little impact, and at worst could be harmful.
My biggest surprise and disappointment is that the intent of the original ADA/EASD consensus statement to help providers be more effective clinicians through specific recommendations is hugely deemphasized. Instead, the document is now more of a general review, laying down principles with few specifics. In this, the first of two blogs, I’ll explain why, starting with a trip down memory lane.
First ADA/EASD Consensus Statement
The first ADA/EASD document on treating type 2 diabetes jointly appeared in the August 2006 issues of Diabetes Care and Diabetologia.2 It was historical, in that there had been significant tension between the organizations for years over issues such as the target A1c goal (6.5% in Europe and 7.0% in the U.S.) and different cultural approaches to health care. Magically, with this first consensus statement, the disagreement melted away.
The impact was immediate and significant. The document was well written and informative, with the right balance of background information and clinical pearls for the target audience. However, few read it. Instead, the treatment algorithm figure was shown at meeting after meeting and served as the only information about the paper and its recommendations for most providers. It was unwieldy and not visually pleasing. No one took full ownership to advocate and disseminate the recommendations, and the document rapidly became out-of-date as more diabetes medications came to market.
Second ADA/EASD Consensus Statement
An update appeared in January 2009,3 mostly by the same authors, with a similar writing style and intent. Unfortunately, although this was again a well-written document, it still featured a visually much less appealing algorithm figure. And, as before, the figure appeared at umpteen meetings and served as the only part of the document seen by most providers.
This time around the revised recommendations were not terribly well accepted by the diabetes specialty community, and at times there was open hostility. One issue was its failure to vary starting therapy for different levels of A1c—it was metformin for everyone—that flew in the face of the general belief that higher A1c patients needed multiple agents as initial therapy. In addition, focusing only on A1c goals challenged the belief of a particularly vocal group that postmeal hyperglycemia or glucose variability was most cardiotoxic.
Most attacked was the treatment algorithm itself, and consequently the algorithm figure, that divided second line therapy (i.e., after metformin) into validation tiers. Simply put, many had trouble believing that metformin followed by insulin or a sulfonylurea (50- to 90-year-old therapies) were the best we had, and should stand alone in the first tier. And the second tier was only pioglitazone or exenatide. What about DPP-4 inhibitors?
To be fair, the recommendations were often misrepresented. In actuality, the tiers were based on validation—how much information about efficacy and long-term safety was available for the different agents, an approach favoring drugs that had been used for decades, and excluding new drugs. However, it was rarely presented in that fashion. Instead the tiers were usually misdescribed as the most preferred versus less preferred therapy choices.
So the second version of the consensus statement was a harder sell, and felt inaccurate and dated as soon as it appeared. Compounding this were guidelines from other organizations (such as the AACE roadmap 4 and country-specific guidelines that appeared soon after) that were better accepted and felt more up-to-date.
2012 ADA/EASD Position Statement
Rumors started a year ago that the ADA and EASD were working on an updated position statement they would take full ownership for. It’s now here, and, indeed, it opens with strong statements (frankly the strongest statements of the document) in support of a patient-centered approach. OK. But a well-known tough issue for healthcare providers regarding effective diabetes care is starting patients on injectables, not something they want to do. It often requires a strong and sometimes uncomfortable push from the healthcare provider to turn the patients into believers. This has been a major focus of fighting treatment inertia for nearly a decade—and it doesn’t come through in this document.
This opening is followed by superficial overviews of the goals of therapy, epidemiology and pathogenesis, and basic characteristics of the available therapies. Fine, but nothing surprising or terribly informative. I’m naïve enough to think most providers know enough of this already, so there’s little within these starting pages that will turn on many mental light bulbs.
I’m also a little turned off by the repeated statements about inability to make specific recommendations because of lack of adequate head-to-head long-term data for all of the available therapies. I know that’s true, but why write a position statement if you cannot make many recommendations? For instance, what to do after failing metformin? They say “With a distinct paucity of long-term comparative-effectiveness trials available, uniform recommendations on the best agent to be combined with metformin cannot be made.” So they say you can do anything: add a sulfonylurea, pioglitazone, DPP-4 inhibitor, GLP-1 receptor agonist, or insulin, with the various drug characteristics, side effects, cost, and patient preference determining the choice. Accurate, but how does that really help? Who doesn’t know that? Plus the lack of specifics throughout the document steps back from the intent of the prior consensus statements to help general providers be more effective and is a major disappointment for me.
Regarding my feelings about specific statements and recommendations within the document, I will be publishing a companion blog next week, in which I pay homage to the Clint Eastwood's American Classic The Good, the Bad, and the Ugly. In the meantime, here is a link to the 2012 Position Statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) on Management of Hyperglycemia in Type 2 Diabetes.
1 Inzucchi S, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2012, published online April 19, 2012.
2 Nathan DM, Buse JB, Davidson MB, et al. Management of hyperglycemia in type 2 diabetes: A consensus algorithm for the initiation and adjustment of therapy: a consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2006;29:1963-1972.
3 Nathan DM, Buse JB, Davidson MB, et al. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2009;32:193-203.