Saturday, January 28, 2012

News report " Diabetes treatments Deemed Harmful " The rest of the story

Diabetes Treatments Deemed Harmful

By MAYS Submitted At January 8 Views 201 Likes A major diabetes study has found that common treatments don't reduce heart trouble and some may actually cause harm. Elaine Quijano speaks with Russ Mitchell about this revealing study.

This was reported on CBS news Jan 8, 2012 and the video was shown again on Diabetes Connect  today.

I could not let this pass without telling you the rest of the story. They reported that heart disease and strokes are a major cause of death and disability for people with type 2 diabetes which is correct. They also reported that lowering blood pressure from 140 to 120 systolic or that combining simvastatin ( Zocor ) and fenofibrate (tricor)  did not reduce cardiovascular risk.

I believe they are referring to the ACCORD study.

The ACCORD trial, sponsored by the National Heart, Lung and Blood Institute (NHLBI), was set up to test the efficacy of 3 medical treatment strategies (blood glucose lowering, blood pressure lowering, and lipid altering) in reducing cardiovascular events in middle-aged and older people with type 2 diabetes plus established cardiovascular disease (CVD) or additional (≥ 2) cardiovascular risk factors.[1,2] The multicenter, double 2×2 factorial design ACCORD trial recruited 10,251 patients in the United States and Canada.

I have read a number of articles about the pros and cons of this study and came away with the idea that this study did make some good points;

     #1 " if it ain't broke don't fix it "
     #2   Ours current guides lines for the treatment of Lipids , Blood pressure and blood sugar are pretty  good
     #3   The treatment of diabetes is not a one size fit all disease. The treatment recommendations that we make
            as physicians and other health care providers has to be  tailored to fit the life situations of the person 
            setting in front of us at that moment in time.
I would like to discuss the  " if ain't broke don't fix it " idea today. 

This refers to the treatment of elevated triglycerides and low HDL  as a cause for something called "residual risk ".
We have some very good tools ( primarily Statins ) for lowering LDL Cholesterol and lowering but not removing the  risk of heart disease and stroke. This residual risk is thought to be related to the problems of low HDL  ( <40 in men and < 50 mg/dl in women )and high triglycerides ( >150 mg/dl ).

The ACCORD trail hoped to clarify some of the issues around this problem of residual risk .The study did prove one thing " if it ain't broke don't fix it" . The use of simvastatin  was so effective at lowering LDL cholesterol to an average of 78mg/dl  and decreasing Triglycerides and raising HDL  that only 17 % of the group receiving fenofibrate met the criteria for it's use. This means that in real life  , in your doctors office ,83 % of the people would not have been treated with any thing other than simvastatin . It is unfortunate that that the study design got in the way of more helping us resolve the question of residual risk. It is no real surprise that they were unable to demonstrate any benefit from the use of fenofibrate.

Tomorrow . More on triglycerides , HDL and risk 

Have fun , be smart and defeat diabetes 
David Calder,MD

 The idea of "if it ain't broke don't fix it " idea came from the article below.

Cardiovasc Diabetol. 2010 Jun 15;9:24.

"If it ain't broke, don't fix it": a commentary on the positive-negative results of the ACCORD Lipid study.
Tenenbaum A, Fisman EZ.

The Action to Control Cardiovascular Risk in Diabetes (ACCORD) study investigated whether combination therapy with a statin plus a fibrate, as compared with statin monotherapy, would reduce the risk of cardiovascular disease in patients with type 2 diabetes mellitus. However, relevant patients with atherogenic dyslipidemia represented less than 17 percent of the ACCORD Lipid population (941 out of 5518 patients). 

This means that 83 % of the people treated with the combination of Simvastatin/ fenofibrate would not have been treated with fenofibrate according to the recommendation for using the drug. Low HDL and elevated triglycerides

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Your comments and questions are appreciated. David Calder,MD