WEDNESDAY, March 23 (HealthDay News) -- Researchers report that
taking the diabetes drug Actos helped people who had prediabetes
avoid getting type 2 diabetes.
"Pioglitazone [Actos] was extremely effective in preventing diabetes," said study author Dr. Ralph DeFronzo, deputy director of the Texas Diabetes Institute and chief of the diabetes division at the University of Texas Health Science Center in San Antonio. The actual reduction in risk was 72 percent.
"The reason that people go from prediabetes to diabetes is that the insulin-producing beta cells fail. By the time someone is diagnosed with prediabetes, they may have lost 70 percent to 80 percent of beta cell function. Pioglitazone improves how the body responds to insulin and protects the beta cells from failing," he explained.
The study, which was funded by the drug's manufacturer, Takeda
Pharmaceuticals, is published in the March 24 issue of the
New England Journal of Medicine.
The U.S. Centers for Disease Control and Prevention estimates
that as many as 79 million Americans may have prediabetes, with
about half of those cases in people older than 65. Changes in
lifestyle -- losing 5 percent of body weight and exercising at
least 30 minutes a day most days of the week -- often helps prevent
prediabetes from turning into type 2 diabetes. However, most people
aren't able to maintain those lifestyle changes over the long term,
After diet and exercise, the next recommended therapy is a drug
called metformin. "Metformin can reduce the risk of diabetes by
about 30 percent," said Dr. Vivian Fonseca, president-elect of
medicine and science for the American Diabetes Association.
The current study was designed to assess whether or not Actos
was more effective than a placebo in reducing the risk of
developing type 2 diabetes.
The study included 602 people over the age of 18 who had been
diagnosed with prediabetes. All of the study participants had a
body-mass index over 25, which meant that they were either
overweight or obese.
Study participants were randomly assigned to receive either 45
milligrams of pioglitazone daily or a placebo. Each participant had
fasting blood sugar tests done quarterly, and glucose tolerance
testing done annually to check for diabetes. The average follow-up
time was 2.4 years.
The average rate that type 2 diabetes developed in the study
participants was 2.1 percent for the pioglitazone group and 7.6
percent in the placebo group. And, nearly half of those on
pioglitazone returned to normal blood sugar levels, while just 28
percent of those in the placebo group did.
In addition, people in the pioglitazone group averaged lower
blood pressure, and had reduced inta-media carotid thickening (a
measure of plaque build-up in the carotid artery). Levels of "good"
HDL cholesterol also increased in the pioglitazone group.
The news wasn't all good, however. The people in the
pioglitazone group experienced more adverse events (151 vs. 121)
and gained an average of about nine pounds, and experienced more
fluid retention (edema), than people taking the placebo. (The U.S.
Food and Drug Administration has warned that, as with other
thiazolidinediones, pioglitazone can cause fluid retention,
potentially leading to or exacerbating heart failure.)
However, DeFronzo said that the weight gain was somewhat
paradoxical because the drug causes fat deposits in superficial
tissues, and moves fat out of the liver, heart and abdomen, where
it's more detrimental to your health.
Fonseca said the results from this study look excellent, but
added, "One has to consider the lack of knowledge of long-term
safety in a population that's already at risk of disease."
"People with prediabetes should seriously think about healthy lifestyle changes first, and if you can't achieve a healthy lifestyle, you should talk to your doctor about medical treatments," said Fonseca. He said the American Diabetes Association recommends metformin as the first-line treatment if lifestyle changes don't work. Metformin is much cheaper than Actos because it's available as a generic. In addition, he said, it's been available for decades so its side effect profile is well-known.
Although Fonseca was not involved in this study, he disclosed
that he is a paid consultant to Takeda Pharmaceuticals as a member
of its new drug data safety monitoring board.
DeFronzo, however, recommended initiating drug treatment and
lifestyle changes at the same time in people who are at a high risk
of developing type 2 diabetes. People at high risk of type 2
diabetes include people with a family history of diabetes, women
who've had gestational diabetes, Hispanics, blacks or Native
Americans, people with metabolic syndrome, people who are
overweight or obese, and those who have higher levels of glucose
intolerance, he said.
"If someone is at high risk, then I would, in addition to trying to get them to lose weight and exercise, recommend medication, and personally, I favor pioglitazone. If you can really lose 30 pounds -- or whatever it is you need to lose -- then you might be able to discontinue the medication," said DeFronzo. "It's important to intervene early, rather than later, to save beta cell function."
Learn more about prediabetes from the
American Diabetes Association.
Please be aware that this information is provided to supplement the care provided by your physician. It is neither intended nor implied to be a substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the advice of your physician or other qualified health provider prior to starting any new treatment or with any questions you may have regarding a medical condition.
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