Intensive Control Does Work

All over the world people with diabetes are slacking off how well they control their diabetes. Their A1C levels are climbing to 7.0 percent or more, apparently blessed by scientific research.

Researchers designed the Action to Control Cardiovascular Risk in Diabetes trial, universally known as ACCORD, hoped to prove that we would have fewer heart attacks and strokes when we able to bring our A1C levels below 6.0 percent. Instead, they were surprised to discover that 257 patients in the intensive-therapy group died, compared with 203 patients in the standard-therapy group. Consequently, they terminated the intensive therapy regime 17 months before the scheduled end of the study.

The shock waves of that study continue to reverberate. At the recent annual meeting of the American Association of Clinical Endocrinologists in Houston earlier this month a panel of experts brought up this issue, and I responded.

"I can't help but wondering," I asked, "if the problem wasn't tight control, but rather the drugs that the patients had to take in order to achieve tight control. Can we separate tight control from the drugs for it?"

"Great question," replied the moderate Dr. Frederick Williams, an endocrinologist who practices in Louisville, Kentucky, and who is a member of AACE's board of directors. "Hard question."

"It's a very good question," continued the speaker, Dr. Etie Moghissi, an endocrinologist who is in private practice in Inglewood, California, and who is also a member of AACE's board. "We have to keep blood glucose in as close to a normal range as possible without the risk of hypoglycemia."

"Maybe we just flogged them too hard to get their sugar levels down," was the earlier speculation of John Buse, a member of the ACCORD steering committee and the immediate past president of the American Diabetes Association. "The intensive group had extremely rigorous treatment, with some patients taking four shots of insulin and three pills and checking their blood-sugar levels four times a day. Perhaps this was just too many drugs at too high a dosage, and the effort required just stressed them out too much."

As good as the ACCORD study was, it had several other limitations, according to Karen LaVine, a Certified Diabetes Educator in Albuquerque. "The key points are," she wrote me, "the higher the A1C, the more slowly you should bring it down. We have to pay attention not only to blood glucose levels but also to blood pressure and LDL levels and the triglyceride-to-HDL ratio. Don't just bring down blood glucose by ramping up medication. We have to provide detailed dietary and exercise recommendations and the support to learn how to apply them."

I never believed that the ACCORD study proved that we should relax our control. The apparent finding was counter-intuitive, contradicting everything we knew about controlling diabetes starting with the first major studies in the 1990s, the UKPDS and the DCCT.

And now we have proof that ACCORD was an aberration. On Saturday The Lancet, one of the world's most prestigious medical journals, published a meta-analysis of the five randomized controlled trials of the effect of intensive control on heart attacks and coronary heart disease. While only the abstract is available free online, the lead author, Kausik Ray, M.D., of the University of Cambridge kindly sent me a PDF of the full-text.