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    Friday, June 14, 2002

    Bayer Promotes Drug with "Research": A study of one of Bayer's diabetes drugs has been published in The Lancet and has the media abuzz with the news. The drug in question is arcarbose, which basically prevents you from absorbing sugar-producing food from your gut. It hasn't caught on much as a treatment for diabetes because people complain too much about the side effects. It makes you gassy. Very gassy. One of my patients went on a trip with a group of friends and got kicked out of the car because of it. That's how bad it is. Well, now along comes a study, funded by Bayer of course, which suggests the drug can prevent diabetes:

    The study, funded by Bayer, involved 1,400 people from nine countries who had pre-diabetes, known scientifically as impaired glucose tolerance. Half were given acarbose pills and half were given fake pills. After more than three years, 32 percent of the patients who were taking acarbose had progressed to diabetes, compared with 42 percent of those taking the dummy tablets. The results mean the people taking acarbose were 25 percent less likely than the others to develop diabetes.

    That's the press release take on the study. Now, let's look at the abstract of the actual study:

    We randomly allocated 714 patients with impaired glucose tolerance to acarbose and 715 to placebo. We excluded 61 (4%) patients because they did not have impaired glucose tolerance or had no postrandomisation data. 211 (31%) of 682 patients in the acarbose group and 130 (19%) of 686 on placebo discontinued treatment early. 221 (32%) patients randomised to acarbose and 285 (42%) randomised to placebo developed diabetes... Furthermore, acarbose significantly increased reversion of impaired glucose tolerance to normal glucose tolerance. At the end of the study, treatment with placebo for 3 months was associated with an increase in conversion of impaired glucose tolerance to diabetes. The most frequent side-effects to acarbose treatment were flatulence and diarrhoea.

    First of all, many more people who were taking the drug dropped out of the study than were taking the placebo, 211 compared to 130. That means that the side effects of the drug must have been frequent and must have been unpleasant. It is also a much greater difference than the difference seen between the two groups in the development of diabetes. 221 patients who took the drug developed diabetes compared to 285 people who did not take the drug. That’s only a difference of 64 people between the two groups. You can also look at the data this way: out of the group who took acarbose, 1/3 stopped it because of side effects, 1/3 developed diabetes, and 1/3 did not develop diabetes. In contrast, in the group who didn't take the drug, only 2/5 of them went on to develop full-blown diabetes. Since the condition in question can be easily remedied with diet modifications and exercise, the whole thing seems senseless, as this diabetic specialist points out:

    "It clearly does not make huge sense for people to swallow food and then take tablets to stop them digesting it," said Dr. Edwin Gale, a professor of diabetic medicine at the University of Bristol in England who was not connected with the study. "The best thing you can do is take exercise once or twice a week for 20 minutes. That will halve your risk."

    Yep, but that approach won't profit Bayer at all.
     

    posted by Sydney on 6/14/2002 08:28:00 AM 0 comments

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