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.
Now, ACCORD results WERE stunning, no question. Many experts I read, many on the diaTribe advisory board, expected the trial would show that greater focus on earlier, more aggressive therapy, and getting to a low A1c, would show cardiovascular benefit. It hasn't. The stunning thing is that actually a greater focus on getting to an A1c of 6 actually, at least in this trial, prompted MORE cardiovascular deaths.
So speculation began flying about why this was true in a high-risk population. I think we don't have enough information, which is never a very interesting thing to say, but true in this case. The researchers said it wasn't due to hypoglcyemia, and that seems very clear - although we all know some hypos we report, some we don't ... and some could have come in the "sudden death" reports but we will never know.
They also said it didn't seem to be linked to any drug in particular. This one is harder to assess - so we think that means that when you add up all the deaths, it isn't statistically significant that people were on one drug than another. Does this mean that the different drug combinations and the different drug doses were all studied? No one knows. Usually announcements like this come with publishing of data, but not in this case ... so there's a lot of questions. By mentioning doses, we're not coming down on Avandia, or insulin, or SFUs, or any drugs in particular - just noting that, for example, 8 mg of Avandia is more than 4 mg and just want to make sure all the combos are studied to try to see if anything looked odd.
I digress! The rest of the New York Times piece was equally disturbing because .. well, mainly because there's no reference to the "very high risk" population that the trial focuses on. The ACCORD trial is important, but it has nothing to do with type 1 diabetes, for example. It's important, but newly diagnosed type 2 patients are on their own when figuring out how to interpret it. Those with diabetes under control are not the focus of the trial. The focus of the trial is very out of control type 2 patients. We think the NYT just as a public service should've mentioned this! They could also write about how everyone with diabetes could improve control since that would also be a good public service.
Here's the next part we saw as irresponsible: "And there are troubling questions about what the study means for people who are younger and who do not have cardiovascular disease. Should they forgo the low blood sugar targets? No one knows."
Um, well, actually, we do know. DCCT and UKPDS both show less blindness, kidney disease, and nerve disease based on lower glcyemic levels. The ACCORD trial had ZERO to do with "younger people who do not have cardiovascular disease" - so nothing has changed for anyone else, except those at big-time risk for cardiovascular disease. Everyone else - tight glycemic control matters.
Now granted, here's the twist. How do we know how to define "patient at high risk of cardiovascular disease"? Is this a patient who had the entry criteria? Is this a person the average criteria at time of death? Unfortunately, researchers wouldn't say the average A1c at the time of death or give any details on that. So we predict there will be a lot of questions flying around for the next little while. NIH confidently advised patients today to "check with their doctor" before changing anything about their treatment - on one hand, of COURSE ... on the other hand, do they think all the doctors in the country have thought it all through and know how to advise patients? Not with a trial this complex.
The one very interesting part of the article was speculation by Dr. Irl Hirsch of University of Washington who has studied people with diabetes for years and is one of the most highly thought of researchers around: " ...Or it may be that participants reduced their blood sugar too fast, Dr. Hirsch said. Years ago, researchers discovered that lowering blood sugar very quickly in diabetes could actually worsen blood vessel disease in the eyes, he said. But reducing levels more slowly protected those blood vessels." So basically he is saying maybe the speed of the drop resulted in trauma - he was referencing a similar study about retinopathy that showed this, though .. this is actually quite different from blood glucose control being bad for you.
Signing out now. Hoping to see better articles in the am. In the meantime, if you are type 1, you can read this piece with interest, but know that ACCORD has zero to do with you. If you are type 2 and newly diagnosed, keep moving on your plan - ACCORD has zero to do with you. If you have had type 2 for awhile but don't fall into the "high risk" profile, keep your goals intact. If you have type 2 and have heart disease or are at major risk of heart disease, I would read what the NIH website says, and then look out for broader information to emerge (should be very soon) - then you can look at it with your healthcare team and you can be very involved in all the decisions. And remember - no one is saying the typical goals of 6.5 - 7.0 aren't the right goals.
Although stopping the intensive arm of this trial is viewed as a reasonable thing to have done, it's not uniformly seen as the only thing to have done and many experts seem to feel it is prudent to wait and find out more before making any major changes.
And IF you know you fall into a high risk category for diabetes, definitely DO research this study - you can print it out and the FAQ at http://www.nih.gov/news/health/feb2008/nhlbi-06.htm. Please ask your doctor or educator what your A1c target should be in light of all the hubbub - you might suggest (okay, ask) if 7 is appropriate, if below 7 is right, if 6 should be avoided. This isn't that controversial to ask - it's your right - keeping in mind that your healthcare team doesn't have all the data either and that really, we're operating in a bit of a vacuum in terms of what patients at high risk of CVD should do until some details about the study come out - you can commiserate with your healthcare team for now that we don't yet have all the information.
In the meantime, if you have the time and inclination, whip out a quick letter to the mainstream media complaining about their implications that good diabetes management is questionable for people with diabetes - that's the biggest load of bollocks I've heard of in forever! Very wrong for them to perpetuate the myth ... all just to sell some papers.