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Aggressive Treatment for Type 2's Should Begin at Diagnosis

Posted: Sunday, February 14, 2010

A year and a half ago, San Antonio's Dr. Ralph DeFronzo stood before thousands of doctors and told them the way most treat their diabetic patients just doesn't work very well and we need to be more aggressive. What we are doing now is just not working. A lengthy paper signed by DeFronzo and 15 other diabetes experts from the United States and Europe, slated for publication, also argues against the current ADA guidelines.

Starting patients on one inexpensive drug until it stops working, then adding another, until daily insulin injections finally are needed to keep blood sugar levels from soaring -- as the American Diabetes Association recommends -- is the wrong approach, DeFronzo argued. Instead, a full-scale assault using three powerful drugs from the beginning should be used on almost all patients.

It was a throw-down of sorts, delivered at the keynote address of the association's annual scientific meeting.

When it was over, the ADA in effect gave DeFronzo a challenge of its own: prove it.

Now a three-year, head-to-head comparison of DeFronzo's three-drug combination treatment vs. the ADA's treatment guidelines -- the standard of care for millions of diabetics -- has begun in San Antonio, with the ADA paying for the study.

"If we do a study that destroys the ADA (treatment) algorithm, in a study that they sponsored, I think it would be impossible for them not to revise their guidelines," said DeFronzo, chief of the diabetes division at the University of Texas Health Science Center. "They might say cost is always an issue. And it is. But they cannot say the clinical results don't favor the triple therapy."

"I think clinicians are frustrated that this is a progressive disease and we have to keep adding medications," said Dr. Richard Bergenstal, the ADA's president of science and medicine. "But that is the nature of it at the moment, and I think Ralph's trying to test whether you throw the kitchen sink at them early, so maybe it won't have to be progressive. I think it's a very good hunch, a good idea, and worthy of testing,"

Still, the study -- which will follow 200 to 400 patients for at least three years -- probably won't be big enough or last long enough to change the guidelines even if successful, Bergenstal said. It almost certainly would, however, lead to a larger study that could.

After trying diet and exercise, doctors typically start patients on metformin, an inexpensive drug that reduces the body's resistance to insulin. When that stops working, they often prescribe a sulfonylurea, also available as a generic. Eventually many patients often end up injecting themselves with insulin.

But that downward spiral is caused by the gradual loss of insulin-producing beta cells in the pancreas, DeFronzo believes. Those cells eventually burn themselves out by overcompensating for the body's resistance to insulin, the main defect in Type 2 diabetes. Neither metformin nor sulfonylureas protect those insulin-producing cells.

"Insurance companies love it because metformin and sulfonylurias are the cheapest drugs," DeFronzo said. "For $4 month you can get (generic) metformin. For $4 a month you can get sulfonylurias." But two newer -- and expensive -- drugs do seem to protect the beta cells, DeFronzo said. Pioglitazone and exenatide -- which is injected twice a day -- work in different ways to control blood sugar.

Given with metformin, the drugs can aggressively lower blood sugar over time, he said. Exenatide also seems to cause weight loss in many patients, which improves diabetes. And neither causes low blood sugar -- a dangerous risk for those on insulin injections.

They do, however, have other side effects. Pioglitazone can cause fluid retention that can lead to heart failure, requiring careful monitoring by doctors. Exenatide can cause pancreatitis and gastrointestinal problems. And while the drugs are approved, their effectiveness over many years hasn't been established, Bergenstal said. Nor has their safety been proven when given together. And then there's the cost. Even with generic metformin thrown in, the drugs can cost $300 to $400 a month. Most insurers don't cover the three-drug combination.

DeFronzo, also medical director of the University Health System's Texas Diabetes Institute, takes advantage of free medication programs offered by pharmaceutical companies for needy patients. And he said a generic form of pioglitazone may become available by year's end, making the regimen much cheaper. "So far it's worked for me," said Irma Aguirre, 55, diagnosed last year. Since beginning the triple treatment in June, her A1c level -- a measurement of long-term blood sugar control -- went from a dangerous 8.5 to a healthy 6. She also lost 19 pounds. Side effects have included some nausea and diarrhea, which have lessened over time, she said.

DeFronzo isn't alone in his criticism of ADA guidelines. A lengthy paper signed by DeFronzo and 15 other diabetes experts from the United States and Europe, slated for publication in an upcoming European diabetes journal, also argues against them, saying doctors should be able to prescribe the newer drugs earlier in the disease.

Source: Diabetes In Control: Banting Lecture. From the Triumvirate to the Ominous Octet: A New Paradigm for the Treatment of Type 2 Diabetes Mellitus http://diabetes.diabetesjournals.org/content/58/4/773.full

 
 
 
 
 
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