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

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.

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

  1. Janet Alton MNIMH 8 February 2008 at 1:41 pm #

    More and more commentators are putting out this message now. Sooner or later (hopefully) it will be heeded. There is a new book out by Gary Taubes called The Diet Delusion where he argues that obesity (and by extension, insulin resistance/diabetes) is caused by over-consumption of carbohydrate.

  2. Terry 8 February 2008 at 2:43 pm #

    Absolutely correct, Dr Briffa. I am a Type 1 diabetic who has also suffered a heart attack four years ago.

    Within just 24 hours of changing from a life long high carbohydrate diet to a low carb, high protein, low insulin diet (after reading Dr Bernstein’s book), I was able to perform my usual daily two mile walk without any of the usual breathlessness and rest periods I normally needed during such exercise when on a high carb diet.

    In the succeeding three or four days, I was able to DOUBLE my walking distance AND pace of walking WITHOUT any symptoms whatsoever! This has continued to the point where I am now back to jogging interspersed with fifty yard sprints!

    Yes, I have voted for Dr Bernstein as diabetologist of the year!

  3. Alison Grimston 10 February 2008 at 11:41 am #

    Hi John,

    Great post again. My gut feeling is that we are overtreating patients with diabetes, but it is rare that I can feel armed with sufficient evidence to go against the flow of polypharmacy with the sole aim of continually reducing HbA1c, LDL. Triglycerides, blood pressure & weight.

    As far as diet is concerned, I feel that it is so individual that I cannot give advice to any particular patient. The leaflets that we are armed with continually push the low saturated fat, high carbohydrate diet as you suggest.

    One eye-opening approach that I have found is nutritional kinesiology, which could result in a taylor made diet for each individual, leading them to have more energy, feel great & reduce their blood sugar. However, insufficient practitioners and the skewed funding of an NHS that considers staffing hours more expensive than multiple repeat prescriptions make this option for NHS patients unlikely to be taken forward. Add to that the skew for evidence based medicine, focussing on large trials rather than inidvidual cases (to reduce bias, as we know) and many of these complementary approaches will not get a look in.

    We doctors can only advise to the extent that our education allows us, and your articles are always eye opening – keep up the good work!

    Alison Grimston

  4. Sue 13 February 2008 at 2:38 am #

    Alison, low saturated fat, high carb does not work for diabetes. We don’t need to complicate things – low carb works so just prescribe it to your patients. Keep monitoring them and see how they go.
    Yes, people are individual but diabetes is a problem with blood sugar and insulin so needs to be treated the same.

  5. Neil 13 February 2008 at 7:02 pm #

    I think Alison was actually being critical of the fact that the only leaflets available for health professionals to give to patients are the standard low-fat high carb ones.

    And also that increasing patients medications over the years seems to be more important (cheaper in the short term??) to the establishment than using staff time to educate people properly and making long term improvements such as reducing medication and morbidity

  6. Hilda 14 February 2008 at 1:11 pm #

    Hi Did you know that the info given in leaflets to the professional community is published by the SUGAR BUREAU. Enough said.


  1. Aggressive treatment of type 2 diabetes with medication can kill | Dr Briffa's Blog - 10 March 2011

    […] Actually, this part of the study had to be terminated early when it was noticed that those in the aggressively treated group were more likely to die compared to those who were less aggressively treated. I wrote about this at the time here. […]

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