Popular Class of Diabetes Drugs Doubles Risk of Fractures in Women

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Source: Wake Forest University Baptist Medical Center Released: Mon

08-Dec-2008, 11:50 ET

Embargo expired: Wed 10-Dec-2008, 00:00 ET

http://www.newswise.com/articles/view/547175/?sc=dwhn

Popular Class of Diabetes Drugs Doubles Risk of Fractures in Women

Description

New findings out of Wake Forest University School of Medicine and the

University of East Anglia show that long-term use of a popular class of

oral diabetic drugs doubles the risk of fractures in women with type 2

diabetes.

Newswise — New findings out of Wake Forest University School of Medicine

and the University of East Anglia show that long-term use of a popular

class of oral diabetic drugs doubles the risk of fractures in women with

type 2 diabetes.

The findings appear online today on the Web site for the Canadian

Medical Association Journal and will appear in the January 6 issue.

“We knew going into this study that there was an association between

thiazolidinediones and fracture risk, however the magnitude of risk had

not been evaluated,” said Sonal Singh, M.D., M.P.H., an assistant

professor of internal medicine and a co-researcher for the study. “This

study shows that these agents double the risk of fractures in women with

type 2 diabetes, who are already at higher risk before taking the therapy.”

In absolute terms, Singh said, if thiazolidinediones (TZDs) are used by

elderly, postmenopausal women (around 70 years) with type 2 diabetes for

one year, one additional fracture would occur among every 21 women.

Among younger women (around 56 years), use of the drugs for one year or

longer would result in one additional fracture for every 55 women.

TZDs are oral medications given to control diabetes by lowering blood

sugar. The two currently available drugs in this class are

rosiglitazone, marketed as AvandiaTM by GlaxoKline, and

pioglitazone, marketed as ActosTM by Takeda Pharmaceuticals.

For the study, researchers reviewed 10 previously completed trials that

lasted at least one year. All of the studies included participants with

impaired glucose tolerance and type 2 diabetes, and all compared the

risk of fracture among patients with type 2 diabetes who were taking TZD

therapy and patients not taking the therapy. Nearly 14,000 participants

were included in the studies. Data was broken down by gender in five of

the studies.

Overall, the results showed that use of TZDs significantly increased the

risk of fractures among patients with type 2 diabetes and was associated

with changes in bone mineral density at the lumbar spine and the hip.

Data from the studies that reported sex-specific results showed that

TZDs significantly increased the risk of fractures among women. They

were not, however, associated with the same increase of fracture risk in

men. The studies also showed a consistent decline in bone mineral

density in women exposed to TZD therapy.

“Women with type 2 diabetes are at an increased risk of nonvertebral

fractures, with a near doubling in the risk of hip fractures,” the

researchers wrote in their findings. “Any additional risk from

thiazolidinedione therapy could have considerable impact.”

In 2006, there were nearly 4 million patients in the United States

taking TZDs, half of whom were likely women, Singh said.

While the underlying cause for the sex-specific effect of TZDs needs

further investigation, researchers suggest that the drugs may cause

fractures by replacing bone marrow with fat cells.

Other recent studies of TZDs have focused on the adverse cardiovascular

effects of rosiglitazone and pioglitazone.

In the June 2007 issue of Diabetes Care, Singh and colleagues reported

that TZDs doubled the risk of congestive heart failure in patients with

type 2 diabetes. They also reported in The Journal of the American

Medical Association that use of rosiglitazone was associated both with

increased heart attacks and a doubling of heart failure. In August 2008,

Singh and colleagues commented in an online editorial for Heart that,

“At this time, justification for use of thiazolidinediones is very weak

to non-existent.”

“The relatively modest benefits of thiazolidinediones must be balanced

against their significant long-term effects on bone and the

cardiovascular system,” the researchers wrote in their most recent findings.

Clinicians should consider the updated 2008 guidelines of the American

Diabetes Association and European Association for Study of Diabetes

consensus recommendations, which do not consider thiazolidinediones

among the well-validated core therapies for type 2 diabetes and

uniformly advised against the use of rosiglitazone. (Diabetes Care, Oct.

22, 2008)

Co-researchers on the study were Curt D. Furberg, M.D., Ph.D., a

professor of public health sciences at Wake Forest University School of

Medicine, and Yoon K. Loke, M.D., MBBS, of the University of East

Anglia, Norwich, UK.

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.

--

ne Holden, MS, RD

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