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.
The study for the first time provided reliable evidence linking intensive blood glucose control with fewer heart attacks. Indeed, people with diabetes who maintain intensive, low blood glucose levels are significantly less likely to suffer heart attacks and coronary heart disease than those who followed standard treatment.
The intensive treatment group had a 17 percent reduction in heart attacks and a 15 percent reduction in coronary heart disease. In contrast to smaller studies which had suggested possible harm from better blood glucose control, those on intensive treatment did not suffer adverse effects on deaths from any cause.
Those of us with diabetes are at increased risk of heart disease, as I wrote here just a few days ago. We remain at high risk even when we reduce our risk by maintaining healthy blood pressure levels and keeping good lipid levels good.
"Previous studies have been inconclusive," Dr. Ray says. That leaves people with diabetes and their doctors "unsure as to whether maintaining lower blood sugar levels actually benefited the patients. Although additional research needs to be conducted, our findings provide insight into the importance of improving glucose levels which should include lifestyle changes as well as medication."The five trials involved more than 33,000 people, including 1497 heart attack cases, 2,318 cases of coronary heart disease, and 1,227 strokes. Dr. Ray and his team analyzed A1C levels in assessing the possible risk of various heart conditions.
Interestingly, ACCORD was one of the five studies included in the new meta-analysis. The others were the UKPDS, ADVANCE, VADT, and PROactive.
"These findings emphasise the importance of detecting and treating diabetes as early as possible," Dr. Ray says, "thus preventing the chances of developing heart and circulatory disease. They reinforce the need for diabetic patients to achieve and maintain better control of blood sugars long-term as a means to reduce risk of heart disease."
Now, all of us can go back to controlling our diabetes.