"Hundreds Dead" in Failed Diabetes Drug Trial
 

"Hundreds Dead" in Failed Diabetes Drug Trial
by David Gutierrez, staff writer

(NaturalNews) The National Institutes of Health's (NIH) National Heart, Lung and Blood Institute has announced the early cancellation of one part of a major diabetes and cardiovascular disease study after discovering that patients undergoing that treatment were more likely to die from heart attacks and strokes.

The Action to Control Cardiovascular Risk in Diabetes (ACCORD) study included 10,251 adults with Type 2 diabetes who were considered to be at especially high risk of heart attacks and strokes. One of the treatments in the study involved using combinations of FDA-approved diabetes drugs to aggressively lower participants' blood sugar to levels as close to normal as possible.

"Of these, 257 in the intensive treatment group have died, compared with 203 within the standard treatment group," the NIH announced. At the time of the experiment's cancellation, patients had been undergoing treatment for an average of four years.

The NIH said that it does not know what caused the increased risk of death among patients undergoing intensive treatment, but it does not believe that the risk came from any individual drug or combination of drugs. Rather, there appears to be some negative effect on the body from so aggressively lowering blood sugar levels.

"This presents a real dilemma to patients and their physicians," said Richard Kahn, chief scientific and medical officer for the American Diabetes Association. "How intensive should treatment be? We just don't know."

Previously, health experts have believed that the closer to normal a diabetic's blood sugar can be lowered, the better. The NIH findings have offered a major challenge to that conventional wisdom.

Approximately 21 million people in the United States suffer from Type 2 diabetes, and the numbers increase every year. The elevated blood sugar that is characteristic of the disease is well-established to lead to a host of other health problems, including an elevated risk of cardiovascular disease, heart attack and stroke.
http://www.naturalnews.com/025080.html

Well, now I am thoroughly confused. I AM IN THE ACCORD PROGRAM. Have been or 4 years.

I'm in the Standard Blood Sugar group and the Intensive Blood Pressure group.

Four years ago, I went in with an a1c level of 9.5. It's now 6. I started with 46 units of Lantus and 2000 of Metformin. Went off the Metformin in 4 to 6 months. So for the most part of my participation in this protocol, I am just taking the shot of Lantus in the a.m. I'm now down to 16. They've changed my blood pressure meds from time to time. Sometimes they add a water pill to the meds. But I didn't like the light headedness so now I'm just on 20 mgs of the zestril.

My blood pressure is just fine. Of course I completely changed my eating habits and started walking. Lost a lot of weight.

When I got that letter in the mail saying what happened in the ACCORD program (got this letter last year), the letter said they moved ALL THE PEOPLE IN THE INTENSIVE BLOOD SUGAR PART OF THE STUDY into the STANDARD BLOOD SUGAR STUDY.

There was to be no more INTENSIVE BLOOD SUGAR STUDY.

When I went back to my next appointment, I remember asking the ACCORD people at Cornell, "What does this letter mean as far as I am concerned"?. They said "don't worry, this does not apply to you, you are doing just great , BETTER THAN EXPECTED". I seem to have gotten better readings than I was expected to get.

Now perhaps the 203 who died and who were in the same Standard group I was in, maybe they started out with blood sugars of 600 or so and got them down to normal, and maybe that was a strain on their heart?? I have no idea what blood pressure meds those people were on.

All I know is that this program saved MY life. I have a chance of going off insulin for good and at my age (61), that's a gift.

I do know that many of the people (most of them, that I saw there), were obese. Maybe they didn't change their eating habits?? But they took the meds, hoping that this would be enough?

I wish I had more information. All I can say is what happened to me. Out of all the people in the protocol, I was extremely lucky to achieve what I did. I put everything I learned, well I put it to my best advantage. I listened. I learned and I applied.

So far my ticker is ticking pretty good. Let's just hope it keeps ticking. My participation in the ACCORD program is over in April. They will continue to monitor me from time to time after that.

Melody

"hundreds dead"
 

When this huge study was begun, and I mean it is a huge study, there were guidelines put in place that the researchers
felt were acceptable.

Statistically a certain number of deaths would be allowed, based on information about diabetics that we already have.

The aggressive arm of the ACCORD study exceeded the limits
of the study, and hence was closed. The number of deaths in the other arm appear to be acceptable at this time or it would have closed also.

When the study is finalized and the results released, we will know more.

The HERS study on hormone replacement, had the same results. Deaths in that study of women taking hormones exceeded guidelines and it was terminated early.

"Statistically a certain number of deaths would be allowed, based on information about diabetics that we already have."


I know this is logical, but the concept of this statement scares me to death. (no pun intended).

I read a report that was intended for physicians eyes only. One of my neighbors is a physician and I sometimes get their mail. I happened to see the words ACCORD program on one of the pages in that report (or magazine, or whatever it was).

Because it was intended for physicians, the wording was considerably over my head. BUT NOT ALL OF IT.

I understood a bit of what I was reading.

There was an article and all it talked about was mortality rates. Mortality rates for diabetics in the study. Mortality rates for people over the age of 60 who were in the study. Mortality rates for people who sufferered myocardian infarctions (heart attacks).

The whole article was about MORTALITY RATES. And it gave percentages. Now because I'm not a physician, I couldn't translate all I read into my brain because most of it was OVER MY HEAD.

But I do know that THAT particular article was all about mortality rates. I remember saying out loud "oh my god, all I am is a MORTALITY RATE TO THESE PEOPLE??"

Never forgot that.

Melody