Ah, the powers that be have decided that the new medicine Rosiglitazone, causes heart attacks, and the papers are blaring a huge number of deaths: 50,000 I think it was.

Stop the presses! Stop the medicine! Headlines please!
But in Medscape (registration required) several experts involved in the study said: Whoa.
Yes, we need to know these things, but the journal chose experts whose expertise is blaming drugs to write the editorial. Then there is a minor problem with the “metanalysis” : the differences were subtle, (i.e. tiny differences in the group, so that statistically it might be coincidence). Finally, by blaring the study in the press, you might end up with patients stopping the medicine, and a lot of people might die, either of uncontrolled diabetes or heart attacks from uncontrolled diabetes.

Why am I skeptical?

Well, to begin with, we only use Rosiglitazone on type II diabetics with “metabolic syndrome”: people prone to be fat, not old people.
It is expensive, and so we only use it for the patients hard to control on diet alone.

But it does cause people to gain weight from over control of blood sugar (the blood sugar is overcontrolled, so it drops down and you get hungry). And it makes some people retain fluid (this is called congestive heart failure). Both these things (Obesity, fluid overload) can increase heart attack rates.

Yet before we had this drug, these patients’ blood sugar was often poorly controlled. I mean, in our Diabetic clinic we had a lot of people who could not or would not use shots, and so we were happy to have their blood sugar below 300 (newer test, HemoglobinA1C below 8….normal is 5-6).

When you run around with a 300 blood sugar, the long term problems are heart attacks and kidney disease. But you also feel lousy, get tired easily, and if you get a tiny cut on your foot, you can end up losing your leg.

So what do you use instead of this medicine? These people are insulin resistant. They might get poor control on 60 units twice a day–if they will give themselves shots, which many of my patients won’t do. And since I usually use the other medicines first, I only add Rosiglitazone when the cheaper medicines don’t work.

The second reason I am skeptical is that if you look at the data, you see the “doubling” of heart attacks is…a tiny increase…and might not be real.

“1.2% of rosiglitazone vs 0.9% of control patients, with neither result reaching statistical significance.

The only significantly relevant finding in the ADOPT trial was an excess of congestive heart failure episodes for rosiglitazone-treated patients compared with glyburide (22 vs 9 events), the editorial adds.”

So the “problem” we know about, the fluid retention, is statistically real. But since aspirin, motrin, and potato chips can also cause fluid retention, this is a risk we know about. This small risk might be better than the real risk of high blood sugar with it’s complications of infection, fatigue etc.

However, what about the cardiovascular risk, and what should we do?
Well, considering the study was “only” 24 months, one wonders if the difference was a tiny blood clotting difference, since it takes longer than 24 months to see a difference (good or bad) in Arteriosclerosis. (translation: changing cholesterol takes a while until you clear the clogs from the walls of the blood vessels).

The deaths also might be from cardiotoxicity (translation: the drug makes the heart beat more irregularly). What type of cardiovascular deaths were listed together? Were there autopsies?

Did one check other criteria? For example, a table shows the patients were all poorly controlled before the study, but what about afterward?

There was an “18%” increase in a blood cholesterol. Well, did the patients take a cholesterol medicine during the study? Was the increase in cholesterol from the medicine, or the weight gain?

And finally, what was the total death rate?
In the early days of cholesterol medicine, a study showed that if you took it, the heart attack death rate went down, but the total death rate was the same, because there was an increased death rate in one study from bowel cancer, and in another study, the death rate was the same because of the risk of homicide/suicide/accidents.

Furthur studies showed that the statistics were a coincidence.

This brings up the third reason I am skeptical.

You see, a similar study was done in 1970:the University Group Diabetes Project . That showed  a similar increase in heart attacks in those taking the first diabetes pill, Orinase. But like the Rosiglitazone study, it had a lot of flaws.

In the Boston clinics, well educated yuppies might watch their diet, exercize, and take insulin, but we rural docs knew our coalminers, farmers, truckdrivers, migrant workers and Native American patients needed something simple to keep their sugar from going sky high, and the pill was better than nothing. So we kept using the pill.

So what should you do if you take the pill?

For heaven’s sake, don’t stop it. Ask your doc. If there is another pill that works, and makes you feel okay, then take it. Metformin is good, if it doesn’t bother your liver and make you nauseous. And if you are obsessive compulsive and not afraid of shots, take Insulin.

But for most people, I suspect that docs will simply keep you on Rosaglitazone because it makes you feel better, or switch to an older pill, or change to another “glitizone” , one of the newer ones, which may or may not have the same side effects,but hasn’t hit the headlines and make their patients worry.

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Nancy Reyes is a retired physician living in the Philippines. Her webpage is Finest Kind Clinic and fishmarket, and she writes medical essays to HeyDoc Xanga Blog

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