Action to control cardiovascular risks in diabetes (ACCORD ) : The accord long-term follow-up results are just out in NEJM March 2011 http://www.nejm.org/doi/full/10.1056/NEJMoa1001286
The ACCORD study which created a huge buzz in 2008 when it was prematurely terminated for fear of bad outcome , with aggressive blood sugar lowering (Hb A1 c <6 %) .The negative trend was confirmed in the aggressive* group even after switching to non aggressive group at further 1.7 years follow-up till late 2009.
*Intensive /Aggressive is used interchangeably in this article .
Why should aggressive glucose lowering be harmful ?
This question is struggling to get a logical answer for over 5 decades. To answer this question, it need to realised our fundamental understanding of diabetes itself is flawed , as we have equated it with high blood sugar.
A persistent state of high blood sugar can never be used as a synonym for diabetes melites. There is much . . . much more , to it ! Patients , lay persons and pharma industry may think like that but it is unfortunate many physicians have the same thinking pattern . The fault lies there .
Diabetes is a systemic metabolic disorder apparently due to lack of insulin( or relative excess of it ! as in insulin resistance ) in which hyperglycemia is one of grossly visible abnormality.
It is estimated there can be at least 100 invisible or less visible biochemical abnormality in every diabetic individual.In fact , DM has more profound effect on lipid metabolism than carbohydrate metabolism. Almost every microproteins in our body gets glycated . That can be either be reversible or irreversible .We know how difficult it to reverse diabetic nephropathy or retinopathy
If we realise the above reality there is absolutely no surprise why lowering blood sugar alone does not reverse diabetic complications !
The second major issue is the modalities we use to target the blood sugar
Right from the days of early sulphonyl ureas and biguanides ( of Tolbutmide and Phenphormin etc ) one thing was very clear (or unclear ! ) vigorous control of blood sugar has always been a doubtful intervention in controlling diabetic complications .
If high blood sugar causes excess mortality, why bringing it to normal levels does not reduce long-term mortality convincingly ?
Is the Madness lie in the methods ?
It seems so. ACCORD study has strong reasons to suggest the worse outcome in aggressive management is due to multiple , drugs used in a random fashion.
Then there is always this question . . .How good is HB A1c to assess the adequacy of DM control. ? Biochemically this molecule still has lots of issues regarding its reproducibility.
Individuals who control blood sugar by natural means and by minimal drugs seem to do well. Early diabetics and pre diabetics should be our targets.
One should also remember the drugs we have today to control DM have yet to prove the long-term safety records (Say for a span of 30-40 years)
Modern medicine usually does not bother about the future . . . it simply shrugs of the issue with a caution statement . . . that the ” Drugs you take are well-tested and thought to be safe and useful with the current level of research !”
What is aggression in DM management ?
No one has defined it so far. But the any of the following may fit in with the definition
- Any DM patients prescribed more than two drugs and Insulin
- Premature start of Insulin
- Lack of diet and exercise management and trying to substitute them with incremental drugs and insulin
- Finally ,any patient who is always tensed up about his HBA1C and switches his physician frequently end up in early complication than the ones who follow simple non pharmacological approach.
How good is the idea , to define aggressive thrapy with reference to HBA1 levels ?
ACCORD defines aggressive approach with HBA1C as less than 6 % and Non aggressive as 7-8% ( or is it 6-7 %)
Not withstanding the limitations of HBA1C , there can be many patients who will require multiple drugs and insulin to maintain the HBA1C even at 7-8 %
How do yo label them ? Aggression by number of drug used . . . but still considered Non aggresive control by HBA1c criteria .
If ACCORD study fixes the indiscriminate use of drugs as a cause for bad outcome , then the very definition of aggressive approach need to be changed !
ACCORD says it all . Never be aggressive on diabetic patients. The aggression we show with drugs can be more dangerous than the deadly diabetes itself.