NHLBI Changes ACCORD Study Due to Concerns Over Intensive Treatment Arm Outcomes
This morning the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH) has stopped one treatment arm of the ACCORD (Action to Control Cardiovascular Risk in Diabetes) study. According to the NHLBI “In this trial of adults with type 2 diabetes at especially high risk for heart attack and stroke, the medical strategy to intensively lower blood glucose (sugar) below current recommendations increased the risk of death compared with a less-intensive standard treatment strategy.”
Before everyone goes off the deep end a few key facts are noteworthy:
1. 1. The patients in the ACCORD study were already considered high risk. According to Dr. Elizabeth Nabel, Director of NHLBI, “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.”
2. 2. The median A1C level achieved in the intensive treatment group was 6.4%, while the median A1C in the standard group was 7.5%. In the standard treatment group there were 11 deaths per 1000, compared to 14 deaths per 1000 for the intensive treatment group. According to Dr. Nabel, “it is important to recognize that this death rate is lower than what has been previously observed in individuals with type 2 diabetes at especially high risk for heart disease.”
3. 3. The goal of the intensive treatment group was lower A1C to less than 6%. To achieve this goal physicians were allowed to use a combination of drugs to reach this goal. This is an important point, based on currently available data it does not appear any one drug can be directly linked to the increase in deaths for the intensive treatment arm. It appears that the increase in deaths is more directly linked to the attempt to achieve near normal A1C levels in a high risk group of patients. According to Dr. William Friedewald, Clinical Professor of Public Health and Medicine at Columbia University, and chairman of the ACCORD Steering Committee; “with our analyses so far we have not been able to find conclusive that any medication or combination of medications is responsible for the increased risk.”
Until more data is available Diabetic Investor believes it would irresponsible to link this announcement to any one drug. The patients in this study were already considered high risk and reaching near normal A1C levels is a difficult task. We further believe this announcement will not change how physician treat type 2 diabetes. However, it is possible, even likely, type 2 patients could use this announcement as another excuse to be non-compliant with their daily therapy regimen.
As Diabetic Investor has pointed out in previous alerts, an unfortunate consequence of the Avandia controversy was the effect it had on patient compliance. This announcement today will compound patient fears and likely create more confusion in the diabetes community. In the absence of conclusive evidence patients and their physicians will once again be faced with the question; “What do I do know?”
As has become all too familiar during today’s NHLBI briefing patients were once again advised to consult with their physicians before making any changes to their treatment regimen. While Diabetic Investor understands the need for such a statement it does little to calm an already skeptical and nervous patient population. Even if patients consult with their physician it won’t be of much help as there isn’t enough data to provide a clear answer.
Once again the diabetes community is facing a crisis of confidence. First, came Rezulin, next Avandia and now the benefit of tight control is being called into question. The fact that this study involved patients who were already considered high risk will likely be ignored by the main stream media. Diabetic Investor suspects the Street will also misinterpret the announcement using it as an excuse to sell quality names in the sector.
Do not be fooled by unsubstantiated rumors or speculation here. There is no reason to abandon quality companies such as Amylin (NASDAQ:AMLN) or Novo Nordisk (NYSE:NVO).
Until more data becomes available the best course of action here is no action.