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    Monday, September 18, 2006

    Let Us Now Praise Expensive Drugs: The diabetes drug Avandia is becoming as acclaimed as Lipitor:

    The largest diabetes prevention study ever done has found that a drug already used to treat the disease also can help keep ''pre-diabetics'' from developing it. But many experts say losing weight and exercising remain a safer, cheaper approach.

    The drug, rosiglitazone, or Avandia, appeared to cut the risk of developing Type 2 diabetes by more than half, doctors reported Friday. Type 2 is the more common form of diabetes and a public health menace that afflicts more than 200 million worldwide.

    Avandia also helped restore normal blood-sugar function in many of those who took it.


    It's even better in Canadian:

    Giving a diabetes drug to people at high risk of the blood sugar disease could reduce their risk by about two-thirds, Canadian researchers are reporting.

    The new study, released Friday by the journal The Lancet, found people with "pre-diabetes" who took the drug rosiglitazone (brand name Avandia) every day for three years, along with advice on a healthy diet and exercise, were 60 per cent less likely than those on a placebo, or "dummy pill," to develop diabetes during three years of followup.

    Overall, 11.6 per cent in the drug group progressed to diabetes, versus 26 per cent on placebo.

    "This is huge, " Dr. Bernard Zinman, a member of the steering committee for the so-called DREAM trial, said Friday from Copenhagen, where the results were released at an international diabetes meeting. The findings suggest "it may be possible to alter the course of rising blood sugar levels and its consequences."


    Wait just a minute, cowboy:

    However, 14 people on the drug (0.5 per cent of those treated) developed non-fatal congestive heart failure, versus two (0.1 per cent) in the placebo group. The drug can cause fluid retention, which can lead to heart failure in people with a weak heart.

    And while the study results triggered a flurry of press releases Friday, a Canadian drug expert said the results are "misleading."

    "It is giving the impression that it prevents diabetes, when really what it is doing is delaying the diagnosis for one year," said Dr. Jim Wright, managing director of the B.C. Therapeutics Initiative and professor in the department of anesthesiology, pharmacology and therapeutics at the University of B.C.


    Given the glorious praise in the press releases it should come as no surprise that several pharmaceutical companies sponsored the research. The full study (in PDF form) is here, but here's a nice summary, complete with tables:

    In the rosiglitazone-treatment arm, investigators reported data on the 5269 patients randomized to treatment. The mean age of participants was 54 years, and all were followed for three years. During the course of the study, 18.8% of individuals experienced a primary event. Of these events, 11.6% individuals treated with rosiglitazone and 26.0% given placebo developed the composite primary outcome [diabetes or death-ed].

    Investigators also report that a larger number of participants receiving rosiglitazone regressed to normoglycemia, defined as a two-hour plasma glucose concentration of <7.8 mmol/L and fasting plasma glucose concentration of <6.1 mmol/L, than individuals treated with placebo. The effect was also observed when a more stringent definition of normal fasting glucose concentration was used. In total, 50.5% individuals in the rosiglitazone group and 30.3% in the placebo group became normoglycemic.


    Those improvements sound impressive, but they are the same improvements and the same rate of improvement that can be had by diet and lifestyle changes, a fact the authors freely admit in their conclusion. Watching the diet and walking a half hour every day is certainly less expensive than the $175 a month it costs to take Avandia at the 8mg dose in the study. Not to mention, it's healthier, what with the congestive heart failure and all.

    UPDATE: Some in the comments have said that lifestyle changes are too hard to obtain, so why not use the drug? The Diabetes Mine blog says that this is the consensus in the diabetes community, quoting a diabetes consultant:

    "'What I liked most of all today was the DREAM trial. I liked it not because of what it means commercially for GSK, but because of what it meant for the disease. ... This trial showed that they could change the course of this ravaging disease ? what congratulations they deserve! They will look back, I hope, and be proud for moving forward the research that makes the world realize that it can be done...'

    Cynics say that since lifestyle changes alone can reduce diabetes progression 58%, and Avandia reduces risk by 60%, the need for Avandia is not clear.? 'For sure, no one is saying to forget lifestyle (changes),' Close reports. 'But from a public health (or any) perspective, altering lifestyle obviously doesn't work so well -- we need other tools...'


    It's easy to say that if you aren't the one paying $175 out of your pocket for that drug. Of course, we all pay the price when expensive drugs are chosen over simple inexpensive alternatives like diet and walking regularly. We just don't realize it because no one puts a little tag on our health insurance premium when the bill comes in that says "this 14% yearly increase is due to the increase in -insert expensive drug here- among our subscribers."

    UPDATE II: Roy Poses from the Health Care Renewal blog also emailed to point out that using Avandia doesn't necessarily mean that the patients in the study didn't progress to diabetes during the trial. It may just mean that their diabetes was well controlled while taking the drug, making it impossible to diagnose since it's a diagnosis based on blood test results. Something like this happens with my patients who initially have great success controlling their diabetes with diet alone. They convince themselves that since their blood work is normal for a year, they no longer have diabetes. But they do still have it, and when they slack off and show up a year or two later, their disease is out of control. Something to think about when digesting those hyperbolic claims of the diabetes community.
     

    posted by Sydney on 9/18/2006 08:40:00 PM 3 comments

    3 Comments:

    Thank you.

    By Anonymous Anonymous, at 9:37 PM  

    Assuming that the drug is safe, which i am not, who cares if dieting and exercise produce the same results!!! I mean, no one is doing it now, its an incredibly difficult thing to do, so why even bother stating it anywhere?

    What is wrong with having a drug that allows people to live the way they want to without the added risk of pre-mature death.

    Just because dieting and exercise is not expensive, it doesnt mean that it is not costly.

    By Anonymous Anonymous, at 3:09 PM  

    Right. Altering lifestyle not working so well. We need other tools.

    Want to know what the actual diabetes community thinks of all this?

    See Avandia DREAMS at
    http://www.diabetesmine.com/2006/09/dream_news_and_.html

    By Anonymous AmyT of www.diabetesmine.com, at 2:01 AM  

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