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

Smoking Increases Risks of Sleep Disturbance

5 February 2008

New research by scientists at the Johns Hopkins University School of Medicine shows that cigarette smokers are four times as likely as non-smokers to report feeling tired and not rested after a night’s sleep. The study also revealed that smokers spend less time in REM (deep) sleep and more time in lighter sleep than non-smokers. Researchers think less restful sleep pattern is due to the withdrawal effects of nicotine when the smoker sleeps.

“It is possible that smoking has time-dependent effects across the sleep period,” said study author Naresh M Punjabi, MD, PhD, FCCP, Johns Hopkins University School of Medicine, Baltimore, MD. “Smokers commonly experience difficulty falling asleep due to the stimulating effects of nicotine. As night evolves, withdrawal from nicotine may further contribute to sleep disturbance.”

Dr Punjabi and his fellow researchers compared the sleep patterns of 40 smokers and 40 non-smokers with a home polysomnography. The participants of this study were healthy (free of any significant disease) and were not taking any medication, in order to remove all health factors that could contribute to bad sleep patterns.

The study was also analysed using both a conventional method - visual classification of electroencephalogram (EEG) patterns - and a non-conventional method - power spectral analysis of the EEG, which relies on a mathematical analysis of different frequencies contained within the sleep EEG. These two methods gave a better picture of the sleep patterns of the individuals in the study.

The participants were questioned about sleep quality:

• 22.5% of smokers reported lack of restful sleep
• 5.0% of non-smokers reported lack of restful sleep

The scientific results correlated with the participants report of lack of sleep and this supports the researchers theory that nicotine's effects are strongest in the early stages of sleep and potentially decrease throughout the sleep cycle. The researchers advised that this research may have implications in ways to help people stop smoking.

“The long-term effects of smoking on respiratory and cardiovascular health are well-known,” said Alvin V. Thomas, Jr., MD, FCCP, and President of the ACCP. “However, this study is significant because it suggests that smokers may also be deprived of the much-needed restorative effects of sleep. This study provides yet one more reason to stop smoking or to never start.”

The study appears in the February issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians (ACCP).



Resources
American College of Chest Physicians. Smoking linked to sleep disturbances. Accessed 8 February 2008

Insomnia Patients Denied Treatment if They Have Mental Disorder

5 February 2008

New researcher by scientists at Ohio State University, suggests that when patients have insomnia, but also have a mental health disorder, they are not prescribed medication for their sleep disorder, which could make the symptoms of their mental disorder (anxiety or depression), even worse.

The researchers at Ohio state university examined treatment data for insomniacs and found that many doctors were reluctant to prescribe even non-dependent sleep medication, if their patients also had depression, anxiety or any other mood disorder. On the other hand, it was discovered that psychiatrists were twice as likely as doctors to prescribe medication for insomnia.

“Insomnia can cause you to have anxiety and depression, and depression and anxiety can cause you to have insomnia. It’s a chicken-and-egg type of story. But research has shown that if one of the conditions is left untreated it can exacerbate the other condition,” said senior study author Rajesh Balkrishnan, the Merrell Dow professor of pharmacy at Ohio State University.

Dr Balkrishnan stated that new guidelines need to be formulated in the treatment of insomnia, which takes into account the different types of patients, because insomnia is a major public health problem. It is estimated that 20% of Americans have some type of sleep disorder, with about 10% of people having some type of chronic sleep disorder. These figures would correlate to other developed countries, such as Australia and the UK.

The major hesitation of primary care physicians (doctors) from prescribing sleep medication is that they can cause dependence, which could prove problematic for someone with an existing mental health disorder.

Older types of sleep medication, called benzodiazepines, have addictive properties and are often abused. New types of sleep medication, on the market, called non-benzodiazepines are not addictive and are effective sleep aids, which these patients should have ready access.

Dr Balkrishnan advised that the research highlights the fact that there are many patients with insomnia who also have a mental health disorder. He also cautioned that the presence of the psychiatric condition should not preclude these patients from proper treatment of the insomnia.



Resources
Ohio State University. Insomnia Patients Often Denied Sleep Treatment When They Have Mental Health Conditions. Accessed 9 February 2008