Intensive Blood Sugar Treatment Strategy in Clinical Trial of Diabetes and Cardiovascular Disease Changed

6 February 2008

The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health has stopped one treatment within a large, ongoing North American clinical trial of diabetes and cardiovascular disease 18 months early due to safety concerns after review of available data. The study will continue, but it will be slightly modified.

The study is the ACCORD (Action to Control Cardiovascular Risk in Diabetes) study, which has enrolled 10,251 participants.

In the ACCORD study, adults with type 2 diabetes were recruited, especially people at higher risk for diabetes and stroke. These participants were divided into two groups and were treated in one of two ways (depending on which group they were in):

• lowering of blood glucose (sugar) below current recommendations, by intensive methods
  
• lowering of blood glucose (sugar) below current recommendations by a less-intensive method
  

After four years, the participants in the intensive method for lowering blood glucose levels had a slightly higher rate of death than the less-intensive group. The slightly higher death rate concerned the Data and Safety Monitoring Board (DSMB), who advised the research study lead, Elizabeth G. Nabel, M.D to stop the group receiving the higher intensity strategy for lowering blood glucose levels. This means that there is now only one group of participants, those receiving the less-intensive strategy to lower their blood glucose levels.

Of the participants, 257 in the intensive group died, while 203 in the standard treatment group died in the four years of treatment. The study researchers advise that the death rates of both groups (about 3 per 1,000) are lower than in other, similar studies.

The Data and Safety Monitoring Board (DSMB) are an independent advisory group of experts in diabetes, cardiovascular disease, epidemiology, patient care, biostatistics, medical ethics, and clinical trial design that has been monitoring ACCORD since it began.

“A thorough review of the data shows that the medical treatment strategy of intensively reducing blood sugar below current clinical guidelines causes harm in these especially high-risk patients with type 2 diabetes,” said Elizabeth G. Nabel, M.D., director, NHLBI. “Though we have stopped this part of the trial, we will continue to care for these participants, who now will receive the less-intensive standard treatment. In addition, we will continue to monitor the health of all participants, seek the underlying causes for this finding, and carry on with other important research within ACCORD.”



Resources
The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health. For Safety, NHLBI Changes Intensive Blood Sugar Treatment Strategy in Clinical Trial of Diabetes and Cardiovascular Disease. Accessed 9 February 2008

Undernourished Stroke Patients Tend to Have Poor Outcomes

A recent Korean university study has shown that if acute ischemic stroke patients are undernourished at the time they are admitted to hospital, they tend to remain underfed while undergoing surgery and treatment and usually have poorer outcomes as a result of their undernourishment. The study found that when acute ischemic stroke patients who were properly nourished when they were admitted to hospital, had much more positive outcomes and less complications.

The undernourishment of ischemic stroke patients increased the risks of possible complications after surgery.

In terms of ischemic stroke patients, undernourishment is a common problem, with about 16% of all patients showing signs and symptoms of being undernourished when they are taken to hospital.

Undernourishment is defined when the patient did not consume enough overall calories, or did not consume enough of one or more nutrients (vitamins, minerals) in their daily diet. The study authors have asserted that while undernourishment is a common factor in stroke patients, the effect of undernourishment in these patients (and others with medical problems) has not been effectively studied to determine exactly what the impact is on the patient's overall outcome from their condition. The researchers have advised that it is necessary to treat undernourishment of an ischemic stroke patient while they are undergoing treatment, to ensure a better recovery. Sung-Hee Yoo, R.N., M.S., University of Ulsan College of Medicine, Seoul, South Korea, the lead researcher and his team studied 131 ischemic stroke patients within 24 hours of their admittance to hospital and about seven days after their release from hospital. The research team then looked at the patients overall outcome at three months after they were released from hospital.

The researchers discovered that those patients who were undernourished at the time of admittance to hospital continued to be undernourished after they were released too and that there was a significant link between undernutrition at the moment of hospitalization and continued undernutrition one week later and complications following the stroke.

The conclusion of the research was that strategic nutritional support, particularly in patients with baseline undernutrition, could improve clinical outcomes for patients with suffering acute ischemic stroke.

Other research has also concluded that better nutrition is required to assist the body with recovering from ischemic stroke and that undernourishment leads to much worse outcomes for the patient following treatment. They have also advised that these patients be treated for the undernourishment at the same time they are treated for ischemic stroke to prevent unwanted complications from the stroke.


References
Undernutrition as a Predictor of Poor Clinical Outcomes in Acute Ischemic Stroke Patients - published in Archives of Neurology, January 2008
Nutritional Support After Ischemic Stroke - More Food For Thought - published in Archives of Neurology, January 2008