The American Association of Clinical Endocrinologists (AACE) proudly showcased their new "comprehensive algorithm" for diabetes treatment at their 22nd Annual Conference in Phoenix, AZ, at the beginning of May, replacing their previous algorithm that's been in place since 2009.
Wait, an algorithm? No, not the technology software kind. Rather, this "algorithm" is a set of complex guidelines for doctors that, according to the AACE, "considers the whole patient, the spectrum of risks and complications for the patient, and evidence-based approaches to treatment." It's a multi-page, multi-color flow sheet to show docs how they should treat diabetes, beyond just looking at glucose levels. It also addresses obesity management, cardiovascular disease, pre-diabetes and just about every anti-diabetes medication under the sun.
Here's what it looked like, presented at the conference:
But just maybe stuffing everything but the kitchen sink into a single set of guidelines isn't the best idea... and the one thing they seem to have left out altogether is the psychological state of the patient. Huh?
The full document was published online April 22 and in the March/April issue of Endocrine Practice. But if you're a non-member of AACE, you'll have to pay $30 to download a copy.
Of note, even though members of AACE generally treat more type 1s than type 2s, this treatment algorithm is designed specifically for type 2s. And the scope of this new version has expanded substantially. The algorithm goes beyond diabetes: At a press briefing, President of the AACE Dr. Alan Garber, who also served as the chair of the algorithm task force, told the less than half-dozen of us who were in attendance that the algorithm was a "comprehensive plan for management of obesity, pre-diabetes, diabetes, and cardiovascular health, so that nothing is lost in shipping." There's even a section with "guiding principles" on managing lifestyle modifications, the individualization of treatment targets, and the minimization of both hypoglycemia and weight gain.
Who's the Algorithm For?
I asked Garber if the algorithm was intended as a guide for the specialist, or for primary care docs. He told me it was for both, and that he viewed it as a "guide for the perplexed."
Alrighty then. Now, he was quoted in an AACE press release as saying, "With more than 100 million suffering from diabetes and pre-diabetes in the United States, there simply are not enough endocrinologists to care for all patients. Thus, this algorithm is essential to assist and educate clinicians who are charged with these patients' care."
I'm trying to picture to myself how much help this multi-page, multi-color chart with its lines, boxes, and arrows would be helpful to a harried primary care doc—even if he/she bought a copy.
Every Option on the Table
Quoting Garber, there's a "fully expanded spectrum of agents from which to choose." That's an understatement. The algorithm is a virtual medicine cabinet, listing—as far as I can tell—every single FDA-approved diabetes drug there is, even some very new meds with short track records (and a few that were still in clinical trials at the time the algorithm was being finalized!), along with meds for obesity, hypertension, and high cholesterol. Even the quasi-disgraced and controversial TZD class of meds remain on the AACE menu.
Almost any diabetes drug can be introduced at any point in the disease process, and one thing I personally thought was an excellent feature (shared with the previous algorithm) is the fact that the treatment algorithm has three entry points, based on initial A1C levels. Someone with a very high A1C on diagnosis is started on more aggressive therapies and multiple agents from the get go; while someone who is diagnosed with a milder level of blood sugar is started off on a simpler therapy. It's a battle plan that makes sense to me.
Oddly, however, despite being arguably medicine-happy, and allegedly looking at the whole patient, the new algorithm does not address depression. This actually fits the AACE's overly clinical approach to diabetes.
You are a chart, not a person.
Too Cozy with Industry?
This extensive list of meds is not unexpected from the AACE, who have been widely criticized for being too chummy with big pharma in the past, a reputation that is not likely to change anytime soon. AACE even provides training for drug reps. Garber likes to call pharma "partners" of the AACE, and even gave an award to French insulin giant Sanofi during opening ceremonies this year.
AACE has around 6,000 members, of whom 1,400 traveled to Phoenix this year. Here to greet them were 672 "partners" from 80 pharma and device companies. That's an average staffing ratio of 1:2, each drug or device rep only needing to tend to the "needs" of two physician partners. Let's face it: there's a reason for the crackdown on aggressive pharma marketing to physicians. It muddies the waters.
But the new algorithm is more than a list of every diabetes drug known to man (even though it actually is, at least the FDA approved ones). The meds are broken into "when to use them" columns and stratified by AACE preference. "Good" choices are in green on the chart, and ones that require some caution are in yellow. Generally speaking, yellow warns of possible side effects. Additionally, the length of a bar in the chart is used as a visual for how much the AACE prefers one med over another.
All of the classes of drugs are also broken down in a separate color-coded table that looks at seven broad types of side effects ranging from heart attacks to weight gain. Each drug is rated as having few adverse events (or possible positive benefits) in green, being neutral in effect in pale blue, having moderate negative side effects in yellow, or having a "likelihood of adverse effects" in red. It reminded me of a bingo card. Endo Bingo. Lovely.
A Word on Weight
Instead of relying on BMI, the new guidelines go "beyond BMI" and use a "complications-centric" method of evaluating weight risk, that starts with taking physicians through the process of evaluating and "staging" a patient's weight, and then provides treatment options that range from writing a referral to a registered dietitian, to prescribing meds like orlistat or the brand-new Qsymia, to considering gastric bypass surgery.
This new approach to weight kicks in at the pre-diabetes level, as does the management of and cardiovascular risk factors such as high blood pressure and elevated cholesterol. The algorithm favors medicating cholesterol in persons with pre-diabetes, and in being as aggressive as necessary on blood pressure. The algorithm includes nine classes of anti-high blood pressure medications with instructions to use them in descending order, using all nine if needed, to get patient's blood pressure to goal. Whose goal? The AACE's of course, at 130/80.
Dissing the American Diabetes Association (ADA) Guidelines
Graber was vocal about the "regrettable tendency" to relax A1C goals, a not too subtle dig at the ADA, and maintained that it's "abundantly clear" that A1Cs of 6.5% or better limit microvascular damage. "Raising A1Cs is not the strategy to lower hypoglycemia risk," said Garber.
So I asked how he would characterize the AACE algorithm compared to the ADA treatment guideline? He started off diplomatically enough by saying the ADA guidelines were "perfectly fine," then spent the next ten minutes trashing them. He said the ADA's approach was nothing more than a glucose-control formula and didn't deal with other parts of the disease. Garber said it "pulls sugar" out of context, and "neglects" cardiovascular aspects of the disease.
At this point I lost my innocence about the possibility of the ADA and the AACE ever seeing eye-to-eye on anything in diabetes.
A panel discussion was scheduled to follow Garber's presentation on the algorithm, but that was cancelled. Garber didn't take any questions from his membership following his talk -- so I have no idea how the rank-and-file felt about it.
But Garber is convinced his pet algorithm will work, or would work if it weren't for those pesky PWDs. "There is no excuse for high blood glucose in the United States, given the vast array of agents to choose from," said Garber, who then followed up with, "What undermines our efforts is noncompliance on the part of patients."
Like the AACE in general, Garber's not what you would call warm and fuzzy when it comes to patients... Maybe it was the air conditioning, but it sure felt chilly in Pheonix that day.