For Diabetics: Lowering Blood Sugar Aggressively May Have Fatal Outcome

The current buzz among diabetic experts this week is the puzzling results observed from the ACCORD Trial, or more lengthily known as the Action to Control Cardiovascular Risk in Diabetes. I even got an email from my good friend, Jay, who was equally surprised, and is very concerned why diabetics who are trying to lower their blood sugar will suddenly die.

Jay, along with other health-conscious diabetics around the world, has every reason to be alarmed. The conventional wisdom in diabetes management is that the lower the blood sugar, the better it is. Why then, did 257 people enrolled in the study die unexpectedly, when they were under a strict and very intensive treatment program to lower their blood sugar?

Before answering that question, let's have a brief background about the ACCORD Trial....

1. It is a large clinical study involving 10,251 adults (average age of 62) from the US and Canada, with established type 2 diabetes who are at especially high risk of cardiovascular disease (CVD).



2. The trial seeks to test 3 treatment approaches: (1) aggressive lowering of blood sugar levels compared to a more standard blood sugar treatment; (2) intensive lowering of blood pressure compared to standard blood pressure treatment; and (3) treatment of blood lipids by a fibrate plus a statin compared to a statin alone.
   



3. WHY does the study seek to test the 3 treatment approaches? Because previous clinical studies have shown that both blood sugar lowering and blood pressure lowering reduce diabetic complications involving the eye, kidney, and nerves, and statin treatment lowers CVD events like stroke and heart attacks, researchers would like to know if aggressive treatment modalities can lengthen and improve the lives of affected patients.



4. Differentiating between aggressive and standard treatment targets: In the ACCORD Trial, the standard treatment group were treated to a target A1C level of 7 to 7.9 percent, while for those in the aggressive blood sugar treatment group, the target is to achieve an A1C of less than 6 percent, a level of blood sugar that is similar to that of a person without diabetes.



5. What was so alarming about current results? After almost four years of treatment, 257 participants in the aggressive treatment group died, compared with 203 within the standard-treatment group.



6. Medications used in the study to lower blood sugar - metformin; thiazolidinediones, or TZD's (rosiglitazone, pioglitazone); injectable insulins; sulfonylureas (gliclazide, glimepiride, glipizide, glyburide); and acarbose and exenatide.

Should Jay and other diabetics be alarmed with these findings? Nothing can be more frustrating than having all your "sacrifices" (read as boring and tasteless diets, exercising regularly, and religiously taking your prescribed medicine). My friend Jay is one of those obedient patients. Telling him that everything he does to remain healthy is useless will surely disappoint him, and may send him backsliding to his old unhealthy lifestyle before.

The answer is NO. There is no need to be alarmed.

Reasons why Jay should not worry about the ACCORD Trial results:

1. The deaths that occurred were under an experimental diabetic treatment approach --- lowering blood sugar to an A1C of less than 6 percent --- which is very aggressive in my opinion. I am sure Jay's doctor is only using the standard regimen on him. The aggressive treatment might have taxed the trial's subjects too much. Imagine taking four shots of insulin and three pills and checking their blood-sugar levels four times a day! Too much stress kills, remember? How much more in patients who were very vulnerable?



2. The yearly death rates for both standard and aggressive treatment groups are 1.4 percent and 1.1 percent respectively, which are still way, way below the 5 percent typical of other diabetic patients at similarly high risk. This means that generally speaking, the diabetic treatment protocols still are better than not getting any treatment at all.



3. The mean age of the participants is 62, and are not only type 2 diabetics but are also selected to be included in the study because of their "especially high risk of cardiovascular disease (CVD)." Jay is 40, has controlled blood sugar, controlled blood pressure, has stopped smoking, and is not obese. He exercises regularly and even ran his first marathon weeks ago.

In my practice, my treatment strategy had always been conservative. I resort to aggressive strategies only when there's an emergent need for it. I have always believed that the human body is not used to abrupt rollercoaster-ups-and-downs. During disease states, its ability to adapt becomes even more compromised. Going slow might be the more prudent approach. Instant and abrupt cures might cause more harm than benefit, as we have seen from the latest ACCORD Trial results.

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UPDATE: The ADVANCE Trial, a similar prospective study like ACCORD conducted on more than 11,000 patients from Canada, Europe,  Australia, and Asia (including the Philippines), did NOT find a similar increase in deaths among patients receiving the most intense therapy for 5 years (average).