Diabetes study halted after safety review reveals risk

[Celebration]

http://www.usatoday.com/news/health/2008-02-06-diabetes_N.htm

The government said Wednesday it has stopped aggressive diabetes treatment in a major trial after a safety review showed that pushing blood sugar to record low levels sharply increased patients' risk of death.

The 10,000-patient trial, called ACCORD, was halted 18 months early, after the trial's Data Safety and Monitoring Board found that intensive treatment increased patients' risk of dying by 25%.

The finding calls into question the new dogma of diabetes care, the notion that aggressively lowering blood sugar, which prevents blindness and nerve damage, protects the heart. It's also likely to rekindle debate over the drug Avandia, used in the intensive-treatment group.

Last May, researchers linked Avandia to an increased risk of heart attacks. But findings in the new study failed to link the excess deaths to "any medication or medications," according to a statement released by the National Heart Lung and Blood Institute.

[mac2]

1. Pills have not proven to be safe for Diabetics but they give them

anyway. According to Public Citizen only Insulin is safe along with diet and exercise.

Hey..if a drug company says it's Ok the doctor gives it to patients.

[grasswire]

2. I'd like to see any more info on this...

...if anyone sees other articles. Veddy interesting. This means that Dr. Bernstein's recommendations may not be valid, although he's lived 50 years with type I by driving his blood sugar very low.

[54anickel]

3. Here's another article with more detail. Seems it's proven for Type 1 but may be harmful for Type 2

http://www.latimes.com/news/nationworld/nation/la-sci-diabetes7feb07,1,345278.story?track=crosspromo&ctrack=1&cset=true

Lowering blood sugar to near-normal levels is a proven treatment for Type 1 diabetics, but it may not be the best treatment for those with Type 2 diabetes, particularly those with heart disease or multiple risk factors for heart disease, government scientists said today.

Researchers had to curtail a major clinical trial of intensive treatment for such patients after concluding that patients with the lowest blood sugar levels had an increased risk of dying compared to those with a more modest reduction of sugar levels.

The findings were a surprise to researchers, who expected to see a clear benefit from the lower sugar levels, and their source remains a mystery. Analysis has been unable to link the increased death rate to episodes of hypoglycemia -- low blood sugar -- or to any drug or combination of drugs used in the study.

snip>

Half of the patients were treated with conventional drugs and lifestyle modifications targeted at reducing their blood sugar levels to about 7% to 7.5%, the level most commonly targeted by physicians. The other half received the same drugs, but in higher doses and in multiple combinations, to reduce sugar levels to about 6%, the same level as in healthy individuals. Most had levels of about 8.2% at entry into the study, a little higher than in the average diabetic.

snip>

The incidence of heart attacks and strokes was about 10% lower in the intensively treated group, Friedewald said in a telephone news conference. But when those events did occur in the intensively treated group, they were more likely to result in death. There were also more unexpected deaths in the group.

more...

[grasswire]

4. fascinating, thanks

I guess I wasted $30 bucks on a book urging people to get down to the 70s in blood sugar through near elimination of carbs.

[Celebration]

5. Don't make hasty judgments

The trial that was stopped used medications to decrease blood sugar levels. There is a big problem with Avandia and heart disease, for example. Even using insulin in Type 2 is problematic because it can cause hyperinsulinemia--another risk of heart disease.

I don't have a study to prove this, but I am thinking that it would be helpful, rather than harmful, to use non drug methods to decrease blood sugar levels in Type 2 diabetes. Anything that can minimize the amount of all types of medication seems as if it would be helpful.

At the very least, be careful not to draw conclusions from this that are too broad.

[Celebration]

6. medication side effects?

I don't know, but I am suspicious. Doctors in that group were allowed to use all FDA approved medications. I bet a bunch of them were on "cocktails." All this drug cocktail business is going to bankrupt our country, if it doesn't kill us. To get blood sugars that low, there is no telling what the doctors were throwing at them. To me, if anything, this would tell me to try to control my blood sugar by methods other than medications, if possible.

http://www.nih.gov/news/health/feb2008/nhlbi-06.htm

Most participants in the intensive treatment group achieved their lower blood sugar goals with combinations of Food and Drug Administration-approved diabetes medications. For both the intensive and standard treatment groups, study clinicians could use all major classes of diabetes medications available: metformin, thiazolidinediones (TZDs, primarily rosiglitazone), insulins, sulfonylureas, exanatide, and acarbose.

"Because of the recent concerns with rosiglitazone, our extensive analysis included a specific review to determine whether there was any link between this particular medication and the increased deaths. We found no link," said William T. Friedewald, M.D., ACCORD Steering Committee Chair and Clinical Professor of Medicine and Public Health at Columbia University.

ACCORD researchers will continue to monitor participants and conduct additional analyses to try and explain the findings. Investigators are preparing a report of the findings for a peer-reviewed publication.

[mac2]

7. My father-in-law

had side effects from the Diabetes pill. It gave him a kidney infection. Don't remember which one it was. He's having big problems now with his toe and an infection. They have him only on Insulin in the hospital.

It should be important to find out what is bad and what is good for Diabetics since our country has a epidemic of Type II now. Why is that?

There are side effects of Insulin such as weight gain (some have Type I from weight gain). Other drugs can cause Diabetes too such as HRT (makes women gain weight, etc.). No drug is really that safe. Look up the side effects, etc. before taking any drug even if the doctor recommends it. You are responsible for your own care in the end.

Bio-identical HRT for women is the safest yet they are trying to ban it from the market. I'd rather take that then horse urine extract. They've been using it in Europe for years. The inventor of BHRT gave it to women free so there is no patent or high cost for drug companies. Call your representative to stop the ban by pharmaceutical companies.

[grasswire]

8. horse urine extract?

what's that in? HRT?

[54anickel]

9. One more article, explains the demographics of the group as "high-risk"

I'm very interested in this stuff as well since diabetes runs in the family and my FBG is coming in as pre-diabetic. Most of the info I'm finding on the net by diabetic "bloggers" is it's best to strive for as close to normal glucose levels as you can. I can see where doing it with this high-risk group may be a problem - my sister would fall into this group and I couldn't imagine bringing her glucose levels below 100 - she acts like a hypo at that point. They sure do seem to be going out of their way in most of the articles to say it has nothing to do with Avandia though.


http://www.usnews.com/blogs/on-medicine/2008/2/7/deciphering-unexpected-deaths-in-a-diabetes-study.html

snip>

On Monday, the National Heart, Lung, and Blood Institute at the National Institutes of Health shut down part of a $300 million study called ACCORD that had been following more than 10,000 very high-risk diabetic patients at 77 medical centers for as long as seven years. All had not only long-standing diabetes but also two or more other major cardiovascular risks such as obesity, smoking, or a previous heart-disease history. An unexpectedly large number of deaths had occurred among patients who were being aggressively treated to bring their blood sugar level below currently recommended standards. There were 257 deaths, about 25 percent higher than the 203 deaths in patients who got the usual care. (Because all patients were carefully monitored and managed, the annual death rate for both groups, about 1.4 percent and 1.1 percent respectively, was far below the 5 percent typical of other patients at similarly high risk.)

Diabetes is hard on the heart and the blood vessels. The rates of strokes and heart attacks and of microvascular complications like blindness, kidney failure, and nerve damage are far higher than in those free of the disease. To lower the risk, doctors constantly urge patients to push their blood sugar down and keep it under control. The desirable target for most is thought to be a blood glucose level (termed A1C level) of below 7 percent, compared with about 4 to 6 percent in the nondiabetic population. An important question that one part of the ACCORD trial was trying to answer was whether achieving a goal of below 6 percent could bring down the number of major heart events. So half of the patients were assigned a target A1C of below 6 percent and got an intensive glucose-lowering regimen of medication and close management; the other half got standard care and a typical target of 7 to 7.9 percent.