Saturday, February 09, 2008

Excessive Deaths Halt Large Government Diabetes Study

This is a depressing story, no matter how you look at it. The government calls it a mystery.

Study: Action to Control Cardiovascular Risk in Diabetes (ACCORD) Trial
Population: 10,251 patients with type 2 diabetes at high risk for heart disease

About half of those folks were assigned to an intensive BG treatment arm, the other half to a standard treatment arm.

Intensive Treatment Goal: HbA1C < 6.0%, fasting BG 100 mg/dl or less, 2-hour postprandial BG 140 mg/dl or less
Standard Treatment Goal: HbA1C of 7.0 to 7.9%, fasting BG of 90 mg/dl or more, postprandials not used

After about 4 years (range: 2 to 7 years), there were 254 deaths in the intensive treatment arm and 203 deaths in the standard treatment arm ... a difference of 54 deaths ... a difference which went in the wrong direction.

The ACCORD researchers say they don't know what caused the excessive deaths. They've ruled out drugs: "Based on analyses conducted to date, there is no evidence that any medication or combination of medications is responsible." Even the notoriously heart-unfriendly Avandia was given the clear.

The government (Elizabeth Nabel, director of the NHLBI) said "intensive treatment" was harmful: "The harm of the very intensive treatment outweighed the potential benefit."

So, two possible causes have surfaced for these unexpected deaths:
  1. Lower blood glucose (Although an A1C of 6.4% which is what half the intensive care group achieved is hardly low.)
  2. Harm from taking 2 or 3 diabetes medications daily, in addition to injecting "four or five shots of insulin a day" (according to the ADA's Dr. John Buse, the vice-chairman of the study’s steering committee.), in addition to taking pills to lower BP and cholesterol if needed, in addition to other non-specific meds.1
The study's sponsor is the NIH's National Heart, Lung, and Blood Institute (NHLBI).

The study is funded by:
  • Abbott Laboratories (and Fournier Laboratories)
  • AstraZeneca LP
  • Aventis Pharmaceuticals, Inc.
  • GlaxoSmithKline Pharmaceuticals
  • King Pharmaceuticals, Inc.
  • MediSense Products (Division of Abbott Laboratories)
  • Merck & Company, Inc.
  • NetGroup Diabetic Services
  • Novartis Pharmaceuticals, Inc.
  • Novo Nordisk Pharmaceuticals, Inc.
  • Omron Healthcare, Inc.
What do you think? Was it lower blood sugar that caused these deaths? Was it a possibly toxic drug cocktail? Or is it still a mystery?
1 Those receiving standard treatment were also likely to have been taking a number of medications, although doses were lower.

The photo is from a nicely written counterpoint to the argument for intensive treatment. It's from The University of Chicago: "For Some Diabetics, Burden Of Care Rivals Complications Of Disease."

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