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Sunday, February 10, 2008

Lowering blood sugar are unlikely to change the way most people with Type 2 diabetes manage their illness



Diabetes Health Goes Beyond Blood Sugar
The startling findings of a major federal study on the effects of lowering blood sugar are unlikely to change the way most people with Type 2 diabetes manage their illness, doctors said Thursday.


The study, announced Wednesday, showed that an intensive program to lower blood sugar actually increased risk of death. The findings were so surprising that the study was stopped early, and they seemed to undercut the accepted wisdom that people with diabetes should do everything possible to get their blood sugar down to normal.


But the methods used in the study, called Accord (for Action to Control Cardiovascular Risk in Diabetes), bear little resemblance to the techniques most doctors and patients use to manage blood sugar levels. And the patients in the study were typically far sicker than many people with diabetes today.


"The intensity of what we did is done virtually nowhere on the planet," said Dr. John Buse, vice chairman of the study's steering committee and the president of medicine and science at the American Diabetes Association. "It's far beyond what's common in clinical practice." Dr. Buse called the study's regimen to lower blood sugar a "brutal program."


Still, doctors are likely to reconsider their emphasis on lowering blood sugar at all costs, because it is becoming clear that other factors influence the overall health of patients with diabetes.


The New England Journal of Medicine published a study this week showing that a three-pronged approach of managing sugar, blood pressure and cholesterol - combined with low doses of aspirin - prolonged the lives of people with diabetes. The patients who did best in that study did not reach the nearly normal sugar levels that were the aim of the Accord study. Instead, their levels were just slightly higher than normal.


In the Accord study, the group of patients who were randomly assigned to lower their blood sugar levels to nearly normal had 54 more deaths than the group whose levels were less rigidly controlled. The patients were in the study for an average of four years when investigators stopped the intense regimen and put all of them on the less intense one.


"When we look at mortality in patients with Type 2 diabetes, it's not only the blood sugar," said Dr. Joel Zonszein, director of the Clinical Diabetes Center at Montefiore Medical Center in the Bronx. "What the study shows is that just lowering blood sugar is not protecting you from dying sooner. Blood sugar is important, but so is blood pressure and cholesterol."


Patients with newly diagnosed diabetes still appear to have much to gain by keeping their blood sugar levels as close to normal as possible through healthful eating and exercise. But patients who have had a heart attack and have other risk factors need not feel guilty if they cannot get their blood sugar to normal levels, Dr. Buse said.


"The most important thing is get your blood pressure controlled, cholesterol controlled, and do a reasonable job on your diabetes, but don't go wild," he said. "We are backing away from notion that we always have to push, push, push to get blood sugar lower."


Today, many patients with diabetes take two or three drugs to manage their blood sugar levels. In the Accord study, many patients took multiple drugs and insulin shots, adhered to strict diets and regularly met with counselors and doctors who monitored them. No single drug treatment was prescribed; doctors used whatever combination of various treatments that appeared to work best in each patients.


The researchers still have to sift through the data on those who died to find out whether there was any pattern that might help explain why patients in the intense treatment group fared worse. It may be that they were simply sicker to begin with. It may have been the number of drugs they used or the pace at which their blood sugar dropped.


Dr. Buse said one little-discussed issue was the sheer stress of the treatment program itself. He noted that the program demanded a lot of effort from patients but that it was still exceedingly difficult for any of them to achieve the blood sugar levels that had been set for them. Many patients with diabetes feel stressed when they fail to meet blood sugar goals set by their doctors.


"At some level I just wonder if some of them were just overwhelmed by this psychologically," Dr. Buse said. "Could it be the stress of 'I'm trying so hard, but I can't get it done'?"


more.........


February 7 2008 - Results of a major government study find that aggressively driving the blood sugar of diabetes patients back to normal levels can increase their risk of dying from a heart attack or stroke.


This news resulted in many type two diabetes patients being switched from aggressive blood sugar management in a clinical trial to safer methods of managing their glucose levels.


"As always, our primary concern is to protect the safety of our study volunteers," said Elizabeth G. Nabel, director of the National Heart, Lung and Blood Institute, which is sponsoring the study.


It is unknown why aggressively treating blood sugar poses increased risk of death in high risk diabetics, but the researchers claim that there is a definite link that should not be ignored.


Over the average treatment of 4 years, there were 3 deaths per 1,000 more in the intensive treatment group compared to the standard treatment group.


"It's profoundly disappointing," said Richard Kahn, chief scientific and medical officer for the American Diabetes Association. " This presents a real dilemma to patients and their physicians. How intensive should treatment be?


Type 2 Diabetes and Excessively Low Blood Glucose may Increase Risk for Heart Attack or Stroke


The aggressive intervention of lowering blood glucose below the current recommended standards in adults with type 2 diabetes may be at a higher risk for heart attack or stroke deaths.


A clinical trial called, ACCORD (Action to Control Cardiovascular Risk in Diabetes) study is being conducted in North America by The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health of 10,251 participants, there was more deaths in the intensive treatment group than the standard treatment group. This has prompted the halt of the intensive treatment group 18 months earlier because of the current data. They will continue collecting data for the standard group for the remainder of the study and those in the other group will now be receiving the standard treatment as well.
The data showed out of the 10,251 participants there were 257 in the intensive treatment group that died compared with 203 that were in the standard treatment group. The researchers do point out that the death rates in both groups were lower than seen in similar populations in other studies. The study has been going on for around four years.


The ACCORD trial will conclude in June of 2009. The intensive group had an A1C goal of less than 6 percent. The current standard in the United States is an A1C of 7 to 7.9 percent.


The researchers do point out that those in the patients in the study are with a high cardiovascular risk factor and that it would be unlikely that you would have blood sugar levels that low as in the study. They also caution that if you have diabetes never adjust your treatment plan without first talking to your doctor.







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