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NHLBI Study: What’s Next?

Last week The National Heart, Lung, and Blood Institute (NHLBI) halted a treatment regimen that was part of a large trial assessing treatment goals for those with both type 2 diabetes and very high risk of cardiovascular disease. Patients had been divided into two groups with different blood sugar goals: one with a conventional treatment goal and another with a more rigorous, lower target. Researchers cancelled the intensive target after a larger number of patients in that group died and will continue the study using the conventional target for all patients.

The ACCORD (Action to Control Cardiovascular Risk in Diabetes) study enrolled 10,251 participants. Of these, 257 in the intensive treatment group have died, compared with 203 within the standard treatment group. This is a difference of 54 deaths, or 3 per 1,000 participants each year, over an average of almost four years of treatment. The death rates in both groups were lower than seen in similar populations in other studies. …The intensive treatment group had a target blood sugar goal, measured by hemoglobin A1C, of less than 6 percent. This is similar to blood sugar levels in adults without diabetes. The standard treatment group aimed for a target similar to what is achieved, on average, by those with diabetes in the United States (A1C of 7 to 7.9 percent) and lower than at study entry.

via Science Daily [1]

Approximately, 50% of the deaths were related to cardiovascular events, and the other half were from “other causes” such as cancer. The institute [2] has commented that “differences” in the causes of death between the two groups exist, but the comment doesn’t provide detail about the nature of those discrepancies.

The full report won’t be out for a few weeks, but the news of the study alteration has everyone stirring. We’re anxious to see more about the study and what the institute’s analysis finds. (And, of course, we’ll be sure to follow up.) In the meantime, we thought we’d introduce the story and share a few questions that are on our minds. We talk a lot about the health threat of diabetes and the importance of a healthy lifestyle to prevent or respond to the diagnosis.

First off, it’s clear there’s a lot to sift through. It’s important to note that the mortality rate, although unanticipated by researchers, was “lower than seen in similar populations in other studies.” We aren’t trying to blow the news out of proportion or jump the gun. Nonetheless, we’ve been scratching our heads about a few things.

We first wondered about the nature of the “intensive” therapy. The institute’s public comments don’t reveal much. The New York Times reported [3] that the intensive therapy approach incorporated “multiple drugs and insulin shots” in addition to stringent dietary regimens and “regular” meetings with doctors and counselors. But the combination and content of the therapy approach was different for each patient, as determined by the doctor (and, of course, the blood sugar target of the assigned group).

So, what are “regular” meetings? What was the ceiling on insulin shots? What was known (if anything) about the combinations of “multiple” drugs, especially given that each patient was also given blood pressure medication or a combination of cholesterol lowering drugs? (Extra large pill box, please.) So far, the institute has found “no connection” between drug or drug combinations and the deaths.

What kind of support did the counselors provide? The New York Times’ reports concern about the “stress” imposed by the rigorous process in the intensive therapy group. Was stress management incorporated into the program?

And what about the strict diet? We assume they are based on the same recommended models that encourage a diet “rich” in carbohydrates (albeit “whole grains”). Was there a standard exercise program assigned to both groups?

As we said, we’re eager to get our hands on the upcoming reports and comments from the institute, and we wonder how many of these questions will be answered then. The study will, admittedly, still be ongoing at that point. We’ll prudently hold off on prolonged commentary until we hear more. However, we wonder about the nature of treatment “therapy” in a study like this. And when it comes to the seeming definition of “intensive,” it’s clear some things remain pretty conventional.

betsymartian [4] Flickr Photo (CC)

Further Reading:

Lap Bands and Type 2 Diabetes [5]

The Definitive Guide to Type 2 Diabetes [6]

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