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Mixed Meds: A Dangerous Prescription for Heart Patients

Tue Jul 1,11:48 PM ET

 

By Amanda Gardner

HealthDay Reporter

(HealthDay is the new name for HealthScoutNews.)

 

 

In HealthOvercoming Depression

 

 

More from Health: • Check your symptoms • How is it diagnosed? • New

treatments

 

TUESDAY, July 1 (HealthDayNews) -- Patients with diabetes and heart failure seem

to be routinely receiving medications that may aggravate one condition even if

they help the other.

 

 

Specifically, metformin (brand name Glucophage) and a class of medications

called thiazolidinediones -- both of which help control glucose levels in

diabetics (news - web sites) -- may cause serious complications in patients with

heart failure.

 

 

The findings are detailed in a study in the July 2 issue of the Journal of the

American Medical Association (news - web sites).

 

 

" The number of patients with diabetes has increased dramatically in the country

over the last 10 years and increasingly these medications are being used as part

of their therapy, " says Dr. Sid Smith, director of the Center for Cardiovascular

Science and Medicine at the University of North Carolina.

 

 

" Because of the observations of fluid retention and weight gain [in the case of

thiazolidinediones], it's very important that they not be used in patients with

known heart failure or, if necessary, that possible problems be monitored very

carefully, " adds Smith, who is a past president of the American Heart

Association (news - web sites).

 

Part of the problem is that so many patients, especially patients with diabetes,

have other health conditions as well.

 

 

" The typical heart failure patients are patients who have many concurrent

illnesses and complications and can end up on a lot of different medications, "

says study author Dr. Harlan M. Krumholz, a professor of medicine and

epidemiology and public health at Yale University School of Medicine.

 

 

" As people end up going to a specialist, there's often not a lot of cross-talk.

We need to pay a lot more attention to the integration of our approaches and

taking into account a variety of conditions, " Krumholz says.

 

 

But there's also the issue of whether physicians are paying attention to U.S.

Food and Drug Administration (news - web sites) (FDA) " black box " warnings on

medications. Such warnings are the most serious category of health side effects.

 

 

" There's a discordance between what the FDA is saying and what's going on in

practice, " Krumholz says. " We're potentially undermining the entire system. "

 

 

The black-box warning for metformin indicates the drug could lead to lactic

acidosis -- or acid in the blood, a potentially life-threatening problem for

people with heart failure. And thiazolidinediones may cause fluid retention,

again a serious condition for heart failure patients.

 

 

" Good care of a chronic condition of heart failure entails getting people into

the right balance. And if they're on medications that cause them to retain

fluid, it may turn them in the wrong direction and tip them over and cause them

to be hospitalized, " Krumholz says.

 

 

For this study, Krumholz and his colleagues pored through the medical records of

Medicare beneficiaries who had been hospitalized with heart failure and diabetes

from April 1998 to March 1999 and July 2000 to June 2001.

 

 

The earlier sample consisted of 12,505 patients, 7.1 percent of whom were

discharged with a prescription for metformin, 7.2 percent with a prescription

for a thiazolidinedione, and 13.5 percent with a prescription for one or the

other.

 

 

In the second sample, which consisted of 13,158 patients, 11.2 percent got

metformin, 16.1 percent got a thiazolidinedione, and 24.4 percent one or the

other.

 

 

The study authors did not look at how many people had adverse reactions, simply

how many patients were prescribed the drugs.

 

 

 

 

It's not entirely clear why this disconnect is happening, the researchers say.

Physicians may simply not be aware of the dangers or they may think the benefits

outweigh the risks. Or they may have decided that the risks aren't as high as

advertised.

 

" We have a problem when the FDA is saying one thing with respect to the safety

of a medication and clinicians are so frequently doing something else, " Krumholz

says.

 

" We need to determine the best way to treat patients, " he says. " It is a problem

when the FDA's black-box warning is not being heeded. Either the FDA has

overreacted or clinicians are exposing their patients to unnecessary risk, and

we [have] to know which it is. "

 

And it's not just an issue for heart failure patients with diabetes, although

this is a group that warrants more attention.

 

" It raises the issue about the way that we deliver health care in this country, "

says Dr. Kenneth Hupart, chief of endocrinology, diabetes and metabolism at

Nassau University Medical Center in East Meadow, N.Y.

 

" Are we either having doctors who are generalists taking care of these

complicated illnesses too much, or are we balkanizing it too much and having

super-specialists taking care of [patients] and sometimes lacking the broad

picture? We have to reexamine the way we provide health care to people in this

country. We can hypothesize but we can't really know from a study like this. It

invites further studies. "

 

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