Deaths Halt Part of Large Diabetes Trial

[flashl]

Source: Washington Post

WEDNESDAY, Feb. 6 (HealthDay News) -- A large North American trial designed to aggressively lower the blood sugar of type 2 diabetics at risk of heart disease has been halted because of an unexpected number of deaths among those receiving the drug therapy.

Federal health officials announced Wednesday that 257 people who received the intensive therapy had died, compared with 203 in patients in a standard treatment group. But they could not pinpoint the reason for the heightened risk, and they appeared to rule out any of the diabetes drugs that were used.

A segment of the trial, called the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study, was stopped 18 months early because of the findings.

"After thoroughly reviewing the data collected to date, ACCORD investigators found that among these adults with type 2 diabetes who are at especially high risk of cardiovascular disease, a medical treatment strategy to intensively lower their blood sugar levels below the current guidelines increased the risk of death compared to standard blood sugar lowering treatment." Dr. Elizabeth G. Nabel, director of the U.S. National Heart, Lung, and Blood Institute (NHLBI), said during a teleconference.

Washington Post

Read more: http://www.washingtonpost.com/wp-dyn/content/article/2008/02/06/AR2008020602860.html

[Richard_C]

1. diabetes drugs

This is nothing new; it happened back in the 1960's with two drugs called tolbutamide and phenformin. Both of these drugs lowered blood glucose for Type II diabetics, but actually hurt overall health and longevity. We should all admit to ourselves that doctors do NOT have all the answers. People need to have all the information and make decisions for themselves. Naturally, drug companies and the FDA want to make decisions for us.

[Robbien]

3. Too bad the NIH just didn't look at the 1960's study

instead of spending all that time, money and death on a new study which comes to the same 1960's conclusion.

[TrogL]

4. They were testing a different drug

This time it's rosiglitazone.

[superconnected]

2. Thanks for posting this.

[McCamy Taylor]

5. Moral: overaggressive blood sugar lowering may be dangerous if you have heart disease

There could be several mechanisms for this. The most likely is that when you aggressively lower the blood sugar, you are more likely to have episodes of low blood sugar or borderline low blood sugar. The natural response to this is the release of catecholamines or epinephrine. The problem here is that epinephrine can be very hard on a heart that already has some underlying heart disease. Epinephrine or adrenalin makes the heart speed up. It also constricts blood vessels, so that the heart has to work harder. If the heart is already working as hard as it can, this can make the difference between no heart attack and a heart attack.

Influenza causes heart attacks because the body releases epinephrine to help the lungs breathe easier. If you keep blood sugars too low, the same thing could happen. Obviously, this is more likely to be a problem in people who already have diseased hearts. New diabetics--those with healthy hearts---can probably benefit from tight blood sugar control to prevent heart disease.

There are medications that block the effects of epinephrine on the heart (beta blockers) that can reduce problems caused by epinephrine. However, they will not completely eliminate all stress and strain on the heart. Nor can they block the effects of other causes of inflammation that might be circulating in the blood from repeated episodes of low blood sugar.

Remember, the body's number one priority is to get nutrients to the brain. If glucose or oxygen are repeatedly low, the body will respond by doing everything it can to increase glucose and oxygen to the brain even if it means putting stress and strain on the kidneys and heart. So, in addition to releasing epinephrine when blood sugar is low, the body might start releasing other, not yet identified factors that increase heart function---to feed the brain---that end up taxing a diseased heart.

[Hannah Bell]

8. same thing with the recent trials of statin+

another drug. The combo not only didn't reduce cholesterol more, there was evidence of increased cholesterol deposit.

Personally, I won't be surprised when the whole cholesterol-lowering thing turns out to be a major misreading of the clinical evidence.

Like the latest generation of mood-alterants are increasingly being found "no better than placebo."

Three generations of psych drugs, each time with lots of initial hype & over-prescription, followed, years later, with findings of down-side & ineffectivity.

& don't get me started on drugs for "add/adhd/oppositional defiant disorder" or whatever. modern trepanning.

License to steal & kill.

[yardwork]

11. Thank you for explaining this.

I'm concerned about the underlying reason for this epidemic of diabetes.

It seems troubling to me that we are spending so much technology and marketing on foods with poor nutritional value - the proliferation of sugar-containing prepackaged snack foods in my lifetime has been amazing - while simultaneously spending a lot of money and technology developing drugs to attempt to combat the effect of poor nutrition and other bad habits that marketers encourage people to consume.

I know that this is an oversimplification, but I see a trend. What do you think?

[kickysnana]

6. Duh! To low blood sager puts you into shock and you die...

The premise of this study is wrong. Unless you are being monitored 24/7 it only takes one episode of low blood sugar to kill you immediately.* What is with all this Johnny one note studies that cannot see the forest for the trees?

Happened to my Aunt in the hospital after her stroke, twice. Happened almost daily the first 10 days after they transfered her to the nursing home for rehab because she was requiring less and less insulin and the rules say they HAVE TO GIVE HER THE REQUIRED DOSE EVEN IF SHE IS TESTING LOW. It took 10 day6s before the doctor lowered the dose (same reasoning as the trial mentioned here)They then would try to fix it by giving her orange juice which you can do if you are still conscious. She gained 10 pounds in that 10 days.

*Christmas Eve afternoon 1985 big mall shopping center. I see a young man acting "spastic" at the packed candy store and his friend is frantically trying to get the clerks attention. Suddenly the one acting spastic hits the floor like a ton of bricks, backward splitting his scalp. They called 911. Someone did CPR. His obituary showed up the day after Christmas 19 years old. My then tween age sons remember that Christmas the most vividly.

[la la]

7. my spouse

had a stroke the day after Christmas---went to hosp- discovered high blood pressure and diabetes--after coming home from hospital, 'new' doctor put him on metformin and glyburide.( I think I'm spelling them correctly)

In the next two weeks, husband's sugar went down to 43--after giving him OJ and calling dr in a panic---he says--take him off the glyburide- lowers sugar too much- next day- we go to neurologist- who is SERIOUSLY pissed about this--and discovers hubby had had another stroke--a more serious one.

I know this was long, but has anyone else had an experience like this? I'm wondering if the second stroke had anything to do with the shock from the low sugar---of course, drs won't say.

[Hannah Bell]

9. No. they never will.

That would reveal them to be mere mortals like the rest of us.

[knitter4democracy]

12. No, it's probably because there are too many variables.

It might have been the drug, but it might not have. There are just too many possible reasons and variables the doctors can't control or account for.

[knitter4democracy]

13. I'm so sorry. What a terrible way to lose someone you love.

:hug:

The problem with blood sugar levels is that everyone responds differently to meds and takes a bit of tweaking to get it just right. Hubby's always messing with his patients' treatment regimens. Some do better on one than another, and some need more than he'd think or less, and it's hard until you get it right (and it may not stay that way for the rest of their lives). Unfortunately, bad things can happen in the meantime. I'm so sorry.

[Jim Lane]

10. Testing new drugs is a good thing

Some drugs will prove ineffective, and there's a risk that some (as in this instance) will prove harmful. It's a necessary step to developing new treatments, though.

My bias is that I probably wouldn't be alive today if pharmaceutical knowledge were still stuck where it was a few decades ago.

I was also a volunteer test subject for a different drug therapy (a double-blind study where I didn't know until the end whether I was getting the drug or a placebo). My participation contributed a tiny bit toward helping other people. I'm proud of that. I don't understand the implicit hostility toward drug trials that I see in some posts in this thread.

[hedgehog]

14. AS someone who works with industrial controls, I can tell you that there

is a difference between trying for the lowest possible set point and aiming to keep the set point within a given range (between a minumum and maximum level).