Posted on 08/28/2008 6:08:56 PM PDT by neverdem
Contact: Jessica Guenzel jguenzel@wfubmc.edu 336-716-3487 Wake Forest University Baptist Medical Center
WINSTON-SALEM, N.C. –A class of oral drugs used to treat type 2 diabetes may make heart failure worse, according to an editorial published online in Heart Wednesday by two Wake Forest University School of Medicine faculty members.
"We strongly recommend restrictions in the use of thiazolidinediones (the class of drugs) and question the rationale for leaving rosiglitazone on the market," write Sonal Singh, M.D., M.P.H., assistant professor of internal medicine, and Curt D. Furberg, M.D., Ph.D., professor of public health sciences. Rosiglitazone and pioglitazone are the two major thiazolidinediones.
In the editorial Singh and Furberg say, "At this time, justification for use of thiazolidinediones is very weak to non-existent."
Oral drugs are given to control diabetes by lowering blood sugar.
But diabetics also experience elevated rates of high blood pressure and high levels of cholesterol and triglyceride, which "further compound their already increased risk of developing ischemic heart disease," Singh and Furberg say. Heart disease and high blood pressure "represent conditions that are major precursors of congestive heart failure."
About 22 percent of diabetics have heart disease. Among elderly patients with diabetes, more than half will develop congestive heart failure over a 10-year period, the editorial says.
The thiazolidinediones were approved for use based on the ability to reduce blood sugar.
In contrast, "we reported [in the journal Diabetes Care] in June 2007 that thiazolidinediones doubled the risk of congestive heart failure in patients with type 2 diabetes," is says. "The increased heart failure appears to be a class effect."
Singh and Furberg reported in The Journal of the American Medical Association in 2007 after an analysis of four long-term trials that use of rosiglitazone was associated both with increased heart attacks and a doubling of heart failure.
They said that results from three large randomized clinical trials published this past June all failed to demonstrate that intensive control of blood sugar reduces mortality or events from cardiovascular disease in patients with type 2 diabetes.
The three trials were ACCORD, ADVANCE, and the Veterans Affairs Diabetes study. In ACCORD, the patients who received intensive treatment to control blood sugar actually had more cardiovascular disease mortality than patients receiving standard treatment.
In ADVANCE, intensive control of blood sugar produced no benefit; there was no effect on cardiovascular events or deaths from cardiovascular causes compared to standard oral diabetes agents.
In the VA Diabetes trial, when intensive blood sugar control produced levels of blood sugar that were too low and led to loss of consciousness, that was a strong predictor of future cardiovascular events.
"The unfavorable findings from the three trials have not been fully realized by the medical community," Singh and Furberg say.
They say that at a recent U.S. Food and Drug Administration advisory committee meeting, there was "overwhelming support for requiring reductions" of heart disease and heart failure "before approval of new oral hypoglycemic agents."
Singh said in an interview, "Safer, cheaper and more effective treatment alternatives are available that do not carry these negative cardiovascular risks in patients with diabetes. The rationale for the use of the thiazolidinediones is unclear."
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Media Relations Contacts: Jessica Guenzel, jguenzel@wfubmc.edu, (336) 716-3487, Bonnie Davis, bdavis@wfubmc.edu, (336) 716-4977, or Shannon Koontz, shkoontz@wfubmc.edu, (336) 716-2415
Wake Forest University Baptist Medical Center (www.wfubmc.edu) is an academic health system comprised of North Carolina Baptist Hospital, Brenner Children's Hospital, Wake Forest University Physicians, and Wake Forest University Health Sciences, which operates the university's School of Medicine and Piedmont Triad Research Park. The system comprises 1,154 acute care, rehabilitation and long-term care beds and has been ranked as one of "America's Best Hospitals" by U.S. News & World Report since 1993. Wake Forest Baptist is ranked 32nd in the nation by America's Top Doctors for the number of its doctors considered best by their peers. The institution ranks in the top third in funding by the National Institutes of Health and fourth in the Southeast in revenues from its licensed intellectual property.
Pioglitazone is the generic name of Actos. It is also one of the active ingredients in Actoplus Met and Duetact.
Don't stop taking them without informing your doc.
My doc would like to see me off Actos, and working out more.
Heart failure aka congestive heart failure, CHF
FReepmail me if you want on or off the diabetes ping list.
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FReepmail me if you want on or off my health and science ping list.
May I suggest the book, Worried Sick, by Nortin Hadler? He has interesting things to say about the rush to bring new drugs to market and then to promote them heavily. It’s quite an eye-opener concerning how much of what is done in medicine causes more harm than good or at least, does not pass the risk/benefit test.
Thanks for the ping!
I asked my doctor to take me off Actos after being on it for two years because my ankles swelled up like balloons and I retained water like a 9 month pregnant women
He sort of blew me off, because he thought I was not trying to lose weight and sticking to my diet. I told him it was the Actos making it impossible to loss weight. I was really trying
Next time I saw him, he told me I was coming off Actos. It wasn't a statement, it was like a command
He must have been reading up.
In a week, I lost about 10 lbs in fluid and felt like a human again.
I continue to lose weight and the blood sugar is a little shaky some days, (Jamumet) but at least I can exercise again
This is off topic, but does anybody know if there is a correlation between pancreatic cancer and diabetes type II.
My husband was diagnosed with diabetes last June 2007. He went from 247 lbs. to 197 lbs. after his diagnosis. Now, Aug 08, they just found a tumor in the neck of his pancreas. So I’m wondering if pancreatic cancer’s 1st symptom is diabete. TIA
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