Wednesday, February 6, 2008

My Take on ACCORD

I've heard from quite a few people today asking me what I think of the news that the ACCORD study seems to have found a connection between lowering the A1c below 7% and having cardiac patients die more frequently.

Deaths Partially Halt Diabetes Study

I'd like to see a more detailed report on the actual findings than what is currently appearing in the press,There is very little information here about what were the actual protocols used in this study. Follow up releases include claims supplied by the maker of Avandia that the study did not connect the excess deaths with the use of Avandia or "any drug."

But the little I could find about how this study was designed suggests that it may be impossible to tease out what really caused the excess deaths, because the study participants were given not only a wide variety of blood sugar lowering drugs, but also an aggressive blood pressure lowering drug regimen, and they were put on the aggressive combination of fibrates with statins to lower their LDL.

Here's the NIH description of the study:NIH Study Will Test Best Ways to Lower Risk of Heart Disease and Stroke in Adults with Type 2 Diabetes.

Clearly the participants in this study were ALL taking a large number drugs which were interacting like crazy with each other in a large number of possible combinations, any one of which might be causing the excess deaths.

For example, we recently learned that lowering LDL by combining a statin with another LDL lowering agent may thicken plaque, as that is what happened when Zetia was added to a statin. We also know that for people with compromised liver function the Beta Blockers used to lower blood sugar can actually be toxic (that information is in the prescribing information) and that both statins and TZDs can each affect liver function. What happens to the liver when both kinds of drugs are prescribed at once along with fibrates may never have been studied before.

The glaring omission in this study is this: There was no control group which lowered their A1c without the use of drugs. All the participants were taking drugs, lots of them. So we have no true way of knowing if it was the lowered blood sugar or the drugs causing the excess mortality. This really is a shame as many of you reading this are people diagnosed with diabetes who have lowered your blood sugars below 7% using carb restriction and exercise alone. So there is no reason that such a control group could not have been included.

But this study only involved people taking drugs, so we can be pretty sure that the people with lower blood sugars in this study took MORE drugs than those with higher blood sugars and that it is likely that it is some effect of the interactions of these drugs to blame if, as is claimed in the GlaxoSmithKline press release the data could not point to a clear connection between ONE drug and the excess deaths.

If we ever get access to more data I'll be sure to let you know what it tells us. We all have learned by now that what the headlines tell us a study shows is often NOT what the study actually shows, and that will probably be the case here.

My own experience after almost ten years of keeping my A1c in the 5% range is that despite doctors spending an unholy amount of their time and my money trying to prove that I must have heart disease since I have diabetes and eat a low carb/high fat diet, I've come up clean on the scans, treadmill tests, monitoring, and everything else they could throw at me.

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