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Tuesday, November 23, 2010

Avandia gets its death certificate

For three years now, the once-promising diabetes medication rosiglitazone (Avandia) has been waiting for the axe to fall. Sales plummeted after a 2007 meta-analysis in the New England Journal of Medicine linked the drug to a sharply increased risk of heart attack.

Since then, further studies and observational data from Medicare have only confirmed that rosiglitazone increases heart attack risk in diabetic patients by 30 to 80%. Equally damning was data showing that this is not a class effect common to the thiazolidinediones – in fact rosiglitazone’s direct competitor pioglitazone has a fairly good cardiovascular risk profile.

Many diabetologists have suggested that rosiglitazone remains a useful option in reducing glycemia, so long as it’s used with care, and only in patients without heart problems. But pioglitazone’s better showing really kicks the last leg out from under this argument. Rosiglitazone delivers nothing that pioglitazone doesn’t, except for extra cardiovascular risk.

Rosiglitazone has had a Health Canada warning in its monongraph since 2007, issued a few weeks after the FDA gave it one of their notorious “black box” warnings. Its indications for use were also tightened considerably. Since then, sales have fallen by about two-thirds. The end has been drawing near, and this time, Health Canada beat the FDA to the punch.

From now on, the drug will only be prescribed in Canada if patients sign a consent form acknowledging that they’re aware of added dangers of heart attack, angina and heart failure, plus unspecified “other risks”. The patient must also certify their awareness that “there are other options to treat my diabetes.”

The physician, meanwhile, is enjoined not to use rosiglitazone-containing products except in cases when “all other oral antidiabetic agents, in monotherapy or in combination, do not result in adequate glycemic control or are inappropriate due to contraindications or intolerance.”

So farewell, then, Avandia. Neither patient nor physician is likely to go along with that, especially when there’s a boatload of promising new diabetes drugs hitting the market. Drugs whose hidden pitfalls, if any, have yet to be revealed.

What lesson may be gleaned from all of this? One reason rosiglitazone’s dangers went unnoticed for so long is that, while the drug brought much more cardiovascular risk than placebo, the effect was less noticeable when compared to other antihyperglycemic drugs like sulfonylureas and even the reliable standby metformin – because all of these drugs also increase the risk of lethal heart problems.

It may seem odd that, when cardiovascular disease is the thing most likely to kill diabetic patients, we routinely treat diabetes with drugs that increase the risk of cardiovascular disease. It seems even odder when we consider that there’s a safe, cost-free way to reduce blood sugar that actually improves cardiovascular health … that is, exercising and eating a healthy diet of low glycemic index foods.

Oddest of all, surely, is the fact that so many patients are apparently more comfortable with the idea of popping multiple pills with potentially grim side effects than they are with the idea of eating a few more vegetables and a bit less ice cream.
Owen Dyer

21 comments:

  1. sharon [aka purley quirt]November 24, 2010 at 9:26 AM

    RE: the impact of the physician's dependence on promoting a " designer drug" cure for all ills

    Check out:

    + the history of" Ibuprofen" from the point where it was (key)banned from use in Canada for causing retroperitoneal adhesions in people over 60 years of age (? 1970's)

    + when and why it reappeared in the marketplace

    + if it still causes retroperitoneal adhesions

    + why no one addresses the imbalance

    RE: signing a consent

    The elements in the consent you profile here are signed everyday by patients undergoing surgery.
    Essentially if you create an issue where the patient's choice rests between two evils (i.e. depending on their own limited knowledge OR possibly the physician's limited knowledge) they often feel they have no other choices.

    RE: what to do?

    Therefore, the real issue is " patient education" on how the body works and how to keep it healthy. .....gosh.... do you see this happening in a society that is going to get it's energy boost from a cardiac-arresting cocktail they can simply pick up at the store without the physician as advising intermediate?

    As they say... keep your friends close......and our enemies even closer...

    The benevolent, caring society ? designed to provide safety for you is not running on the same fuel you are in terms of your interest in "self" preservation.
    If you have lost your " sense of other" you are to them as they are to you :(

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  2. Avandia -- Congestive Heart Failure One of those side-effects they don't tell you about, until AFTER you experience it, is congestive heart failure. I learned this the hard way. Not only was the medicine not effective, it nearly killed me.

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  3. Another study found Avandia increases risk of stroke more than alternative drug.

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  4. Avandia is known that it's increasing this risk so... was obivious to take care.

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