Study of aggressive drug treatment of diabetics halted due to enhanced risk of death

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When it comes to cholesterol and blood sugar levels and blood pressure, the general principle in medicine is ‘the lower the better’. The idea here is that the more suppressed these parameters are, the lower (supposedly) the risk of complications such as heart disease and stroke. However, as with everything in life, it’s not necessarily that simple. Just last week I reported on a study that shows that aggressive lowering of cholesterol levels with two drugs instead of one led to a tendency for individuals to develop more rapid gumming up of arteries in the body.

This study was not too far away from my mind when I read, yesterday, about a study in which two strategies (one more intensive than the other) were trialled in a group of individuals with type 2 diabetes. This study, known as the Action to Control Cardiovascular Risk In Diabetes (ACCORD) started in 2001. It involves more than 10,000 American and Canadian diabetic men and women deemed to be at high risk of cardiovascular disease.

The participants in this study were assigned to a protocol of either standard diabetic treatment, or aggressive treatment designed to get their blood sugar levels down as much as possible. An announcement on Wednesday tells us that the intensive therapy part of the trial has had to be halted. Why? Because deaths rates in this group were significantly higher than those in the more moderate treatment group.

According to one of the study authors, their initial analysis of the data has not revealed why death rates were higher in the intensively treated group.

Perhaps at some point the future the doctors and scientists may be able to pinpoint what the cause of the problem is here. But I doubt it. I read that most of people in the intensive therapy group were taking high doses of several medications which may have included rosiglitazone, metformin, insulin, a sulfonylurea, exenatide and acarbose. All of these drugs have the potential for side effects and toxicity even when given singly. It’s not too difficult to imagine that taking what amounts of a cocktail of these drugs in high dose might turn out to be counterproductive (and possibly downright dangerous) compared to a less ‘potent’ mix. Working out ‘what went wrong’ in a group of individuals taking one or more of several different drugs at potentially differing doses is a statistical nightmare.

Does this mean that diabetics should not strive for the best blood sugar control they can achieve. Absolutely not. But the manner in which they do this may have critical implications for their health. For me, the cornerstone of a diabetic’s management is generally a diet low in (or even devoid of) foods that tend to disrupt blood sugar and insulin levels. While this approach flies in the face of the conventional ‘diabetics should eat starch at every meal’ mantra, this approach makes sense, is supported by the science and, above all, it tends to work in practice.

My feeling is that carb-restricted diets exist under a bit of black cloud, perhaps partly on account of the concerted efforts some have gone to to discredit this way of eating. Thankfully, not everyone has swallowed this opinion whole without thinking. This site, for instance, contains many comments from individuals (including diabetics) who appear to have transformed their health by controlling their carbohydrate intake.

And it’s also true that some practitioners and educators have embraced the principles of carb-restricted diets in the management of their diabetic patients. Not all practitioners are vocal about this: a dietician once told me that a consultant diabetologist at the London teaching hospital where she worked recommended the Atkins diet to his patients but was clear that he didn’t want this fact ‘getting out’. However, some practitioners are more transparent in this respect.

Two such practitioners are Dr Mary Vernon and Dr Richard Bernstein, both of whom are based in the USA. I don’t know either of these individuals personally, but I am familiar with their work and support the basic principles that they espouse with regard to the management of diabetes. Some of you may already be familiar with their work.

I learned recently that these two practitioners have been nominated for ‘Diabetes Educator of the Year’ in the USA. The winner is decided by public vote. For more details about these individuals and the other nominees, and to vote, click here. Voting closes on 15th February, so if you want to show your support, you’ve only got a week to do it.

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