Thanks in ADVANCE
Deadly headlines sell. You probably heard some of them used in reference to the diabetes trial called ACCORD (Action to Control Cardiovascular Risk in Diabetes). What you might not know is another large study called ADVANCE (Action in Diabetes and Vascular Disease: PreterAx and DiamicoN MR Controlled Evaluation) is almost completed and provides "no evidence of an increase risk of death among those patients receiving intensive treatment to lower blood glucose."
You'll be hard pressed to find any positive media titles on this note. Can you imagine? On February 6, 2008, "Intensive Diabetes Control Kills Patients," then on February 13, 2008, "Intensive Diabetes Control Saves Lives".
To review, the ACCORD trial has 77 study sites across North America with over 10,000 type 2 participants between the ages of 40 and 82. These are individuals at high risk for cardiovascular (CV) events (heart attack and stroke) with at least two risk factors for CV disease (some of whom already had CV diagnoses, smoked, were obese, or had high blood pressure and cholesterol). Participants were divided randomly into three groups related to A1C, blood pressure and cholesterol control. The group assigned to the intensive diabetes control arm aimed to have A1Cs (three-month glucose average) less than 6%. This intensive treatment arm was stopped 18 months early because of an increase of deaths in that group when compared to the standard treatment group. The deaths were not attributable to low blood sugars or medication issues (like Avandia use).
The predicted death rate for all high-risk individuals in the study was 50 deaths per 1,000 patients per year. In the intensive management arm, with an A1C goal of less than 6%, 257 participants died within four years, whereas "only" 203 died in the group that aimed to have A1Cs between 7 to 7.9%. The death rates for both groups were lower than in people with long-standing type 2 diabetes. Due to safety concerns of the people in the intensive arm, that portion of the study was stopped.
ADVANCE involved 11,140 high-risk patients with type 2 diabetes and also studied CV outcomes on A1C goals of less than 6.5%. According to the www.advance-trial.com website, Professor Rory Collins from the University of Oxford, Chairman of the ADVANCE Data Monitoring and Safety Committee said, "The interim results from ADVANCE provide no confirmation of the adverse mortality trend reported from the ACCORD study," and further, explained ADVANCE has twice the data from which to analyze.
Research means to look again. The ACCORD trial results are not yet published. The study is due for completion next year with result expected for publication in 2010. All we have to go on for now is a press release and a lot of speculation. We cannot critique the study or the dedicated work of its researchers without having access to its design. In addition, before we change how aggressively we treat diabetes, we need to see the results replicated to ensure accuracy of data. We're not sure why there was a higher death rate. Did those individuals have higher stress levels? We hope to learn why.
Speeding kills! So does driving too slowly in the fast lane. Maybe ACCORD will show us the importance of going just the right speed with regard to A1Cs in CV complication prone patients as well as how we approach blood pressure and cholesterol targets. Who knows? To date, the ACCORD results fly in the face of everything we know and teach about diabetes self-management. For now, the jury is out.
On a humorous note, did you notice the "O" in ACCORD is missing? That's what we say when we realize the facts and say, "Oh." And why not name a study after a more stylish vehicle than an Accord, like the SMART car? And don't you love how they came up with the acronym ADVANCE? What a stretch. PLEASE: People shouLd ask bEfore chAnging Self Monitoring Goals or Risk Falling Victim to the Power of the PrEss.
Besides the obvious recommendation to discuss concerns with your healthcare provider (which some dear readers write to say theirs don't have a clue), don't throw the baby out with the bath water. Continue your efforts to control diabetes!
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NOTE: The information is not intended to be a replacement or substitute for consultation with a qualified medical professional or for professional medical advice related to diabetes or another medical condition. Please contact your physician or medical professional with any questions and concerns about your medical condition.
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I hate to even suggest this, but what if the cure never comes? What if long-term clinical human trials go on indefinitely into the future with no hope in sight? What if cinnamon is just cinnamon? What if cactus juice is just cactus juice and reptile saliva just reptile saliva? And what if the BCG drug is a vaccine for tuberculosis and nothing more? I have this terrible feeling I’ll be an old man with a long grey wizard’s beard and a walking cane made out of...