Close Concerns Weblog

ACCORDing to Dr. Shamoon and Jill Crandall - Breath of Fresh Air

What's a patient to do?!

"When it comes to controlling blood sugar for people with diabetes, low is good, but lower may not always be better. That is the message from a major government-sponsored study intended to find the best strategy for preventing people with Type 2 diabetes from having heart attacks and strokes or dying of cardiovascular disease." - Wall Street Journal, February 7, 2008

"For decades, researchers believed that if people with diabetes lowered their blood sugar to normal levels, they would no longer be at high risk of dying from heart disease. But a major federal study of more than 10,000 middle-aged and older people with Type 2 diabetes has found that lowering blood sugar actually increased their risk of death, researchers reported Wednesday." - New York Times, February 7, 2008

These were the opening paragraphs last week of the WSJ and NYT stories on ACCORD ~ although later in the story, advice wasn't so controversial, we felt these opening paragraphs were leading, at the very least!

One question we've heard come up a lot from patients is: "They say this is a small group - patients who have had diabetes for ten years with at least two risk factors of cardiovascular disease - how do I know if I fall into that group?" Patients also say their doctors point out that the study data hasn't been released, so the fail-safe "Don't do anything without your doctor" applies, but your doctor may not have a clear opinion about ACCORD yet. Now one thing - in the WSJ story, it says that the "at risk" group to whom the "extremely tight control might be dangerous" might apply was pegged at about 10%. When we talked to the author of the story, he said that the source of this figure was Dr. John Buse, the head of the ADA. So that's good - 10% is lower than 100% and we know Dr. Buse is a quite leading figure in diabetes. For people at high risk, of course (which for now means people with type 2 with cardiovascular disease or with two risk factors - obesity, high blood pressure, high cholesterol, or smoker), we urge you to make sure you're seeing an endocrinologist and diabetes educator and to stay close to them as more information comes out about ACCORD.

We saw a very insightful letter in this morning's NYT from Dr. Harry Shamoon and Jill Crandall, very respected doctors at the Albert Einstein College of Medicine in New York, urging patients not to forget tight control. Read on ... and thank you, thank you for what seems like most sensible advice.

We hope to see ACCORD data soon, in the meantime, so that many other questions can begin to be answered.

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Re “Study Undercuts Diabetes Theory” (front page, Feb. 7):

While the interim results of the Accord trial may be disappointing to patients with Type 2 diabetes, it is important to remember that there is incontrovertible evidence from the 20-year Diabetes Control and Complications Trial that controlling high blood glucose levels does indeed prevent vascular complications.

The most recent data from this trial even demonstrated a benefit of intensive treatment of blood glucose on cardiovascular disease, an effect that persisted many years after the formal study ended.

Of course, patients with Type 2 diabetes have many other risk factors for heart disease in addition to high blood glucose, including older age, overweight or obesity, high blood pressure and abnormal lipids. The interplay between all these risk factors and glucose is likely the reason that people with diabetes are at such high risk for heart attacks.

Finally, it is clear that people with Type 2 diabetes are at the same risk for developing eye, kidney and nerve problems from high blood glucose levels as patients with Type 1 and therefore will benefit from proper control of blood glucose.

Also, since the level of blood glucose control being tested in the Accord trial was significantly lower than that ordinarily achieved in medical practice, their results should not be taken as evidence that current standards should be abandoned. For all these reasons, most diabetes experts will continue to tell their patients to keep their blood glucose levels as near to normal as feasible.

Jill P. Crandall
Harry Shamoon
Bronx, Feb. 7, 2008

Januvia May Have Some Company in the DPP-4 Inhibitor Arena in the US (it already does in the EU!)

For people with type 2 diabetes, choosing the right treatment option can be very difficult given the sheer number of diabetes drugs that are available. But patients in the US who want to try using a relatively new class of drug called a DPP-4 inhibitor have two options today: Januvia or Janumet (Januvia combined in one pill with metformin), both manufactured by Merck. This may change as other companies move their own DPP-4 inhibitors forward. [For a more in depth discussion about incretins and the DPP-4 inhibitor class, see Learning Curve in the latest issue of DiaTribe.]

ACCORD - Take a deep breath

We're trying ourselves to take some deep breaths after seeing some of the coverage of the ACCORD trial results, out this morning. We take specific exception to the New York Times, which opened its story with:

"For decades, researchers believed that if people with diabetes lowered their blood sugar to normal levels, they would no longer be at high risk of dying from heart disease."

First of all, it's untrue. The trial EDIC, published in 2005, has proven conclusively that better glycemic control results in less cardiovascular risk for those with type 1 diabetes  - that came out with GREAT acclaim and it's never been disputed. The DCCT was published in 1993 and UKPDS in 2000 ... those trials proved conclusively that tighter glycemic control would lead to lower microvascular risk - so, risk of eye disease, kidney disease, nerve disease.

But not cardiovascular disease. The EDIC was the DCCT follow up - that data was widely awaited and hugely celebrated. UKPDS - there hasn't been follow up and that trial showed microvascular benefits, not cardiovascular benefit. (Not because there aren't any - it may just be too early to know.)

So, the writer is wrong in saying "it's been thought for decades". But that's not the half of what is wrong with this piece, what is so irresponsible.

Why does that opening make me so mad? It implies that patients who are in good control should consider changing their minds on tight glycemic control, on good diabetes management. That's wrong - that is not what ACCORD shows.

Where are the candidates on diabetes and obesity?

i've been really kind of depressed about healthcare lately. Like many of you, i want a president who is going to make diabetes a national priority and i just don't see signs that it will happen. our newsletter diaTribe wrote to all the campaigns in mid-January to ask them a couple of very straightforward questions about diabetes and obesity and their views and levels of support and we haven't heard from ANY of the campaigns. we want to publish the story in our next issue and so far we are nowhere.

i know they get a lot of mail. I know diaTribe is small. but 20 percent (twenty percent!) of people over 60 have diabetes. new numbers from the ADA put the national diagnosed figure at 17.5 million. that's seven percent of us. AND the latest economic figures say ONE of five healthcare dollars (one of FIVE!) now goes to diabetes.

and their staffs can't tell us how they feel about diabetes and overweight and obesity and what should be done? these aren't hard questions and americans need to hear from them.

personally, we haven't hidden our bias. we want it to be cheaper to feel better. we want help figuring out how to eat well and exercise, we want better access to good food and we want it for everyone. we get it that there isn't that much money but they should explore how to get this done with the help of industry and foundations if they are spending too much on Iraq so there's no money left over.

maybe 17.5 million people aren't enough? what about 50 million more with pre-diabetes?

sigh. if anyone has any thoughts about how to raise their attention, please let me know. so far, our story for our next issue of diaTribe is basically just about how not a single presidential candidate or a single staff member (not even Gov Huckabee's office!) has written back to us. If you and your families or friends would be wiling to sign a statement just saying we're wondering where they stand we would really appreciate it. Our link is at http://www.surveymonkey.com/s.aspx?sm=TppsqeCewszwot24R_2bJKNA_3d_3d.