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Link between widely
used Osteoporosis Drugs and Heart Problems
probed
Newswise — New research at Wake Forest
University School of Medicine evaluated the
link between a common class of drugs used to
prevent bone fractures in osteoporosis
patients and the development of irregular
heartbeat.
The study’s findings appear in the current
issue of Drug Safety, a publication of the
International Society of Pharmacovigilance
covering the safe and proper use of
medicines.
“Some trials show there could be a potential
link between the use of bisphosphonates and
the development of serious heart rhythm
problems, but in our study the link wasn’t
conclusive,” said Sonal Singh, M.D., M.P.H.,
an assistant professor of internal medicine
and lead investigator for the study.
“So we urge that additional investigations
be conducted.”
Bisphosphonates, found in prescription drugs
including BonivaTM, FosomaxTM, ReclastTM and
ActonelTM, inhibit the breakdown of bones,
which reduces the risk of fractures,
especially those of the spine and hips in
older patients. The first such drugs were
approved for use in the mid-1990s.
Early studies indicated that the use of
bisphosphonates might cause problems with
heart rhythm, or atrial fibrillation, which
increases the risk for stroke or heart
attack.
For the study published this month,
researchers analyzed the data from previous
observational studies and clinical trials to
determine the link between bisphosphonate
therapy and irregular heart beat.
Researchers found that bisphosphonate use
was associated with a significant increase
in the incidence of “serious” heart rhythm
disturbances, classified by hospitalization,
disability or death resulting from the
condition.
However, when they included “non-serious”
cases in their analysis, they found no
overall increased risk of atrial
fibrillation, the study shows.
“Our findings were discordant, with
conflicting results,” Singh said. “The
challenge now is to figure out what it all
means.”
In the clinical trials reviewed, medical
records of more than 13,000 patients who had
osteoporosis or fractures and were given
bisphosphonates were compared to the records
of more than 13,000 patients who received a
placebo during study participation.
Researchers
were looking for the incidence of irregular
heartbeat first, and then stroke or death
caused by stroke or heart attack as a
secondary outcome.
The patient files reviewed were primarily of
women who were treated with bisphosphonates
and were generally in their early 70s,
according to the study.
“We found no risk of stroke and
cardiovascular mortality in the trials,”
Singh said. “That was very reassuring.”
The observational studies evaluated the risk
of irregular heartbeat in patients treated
with bisphosphonates compared with those who
had not received the drug.
A
review of these studies found different
results. One study showed an increased risk
of irregular heartbeat in patients taking
the drugs and others showed no associated
risk.
“The amount of data on the outcome of
bisphosphonate use is insufficient to make a
definitive conclusion,” said Vinodh
Jeevanantham, M.D., an instructor of
internal medicine and co-researcher on the
School of Medicine study.
The federal Food and Drug Administration
called the results of the previous
bisphosphonate studies “discordant” in a
November 2008 update to its safety review of
the drug.
The agency’s review of four previous trials
also found no link between bisphosphonates
and irregular heartbeat but suggested the
need for more research.
Given these results, physicians should not
change they way they prescribe the drugs for
the majority of patients with osteoporosis,
Singh said, and patients should not stop
taking them.
He cautioned, however, that patients with
pre-existing heart conditions and those with
risk factors for rhythm disturbance should
be especially vigilant for the development
of atrial fibrillation, and doctors should
continue to closely monitor patients at risk
for atrial fibrillation who are taking
bisphosphonates.
“People who develop atrial fibrillation
after using bisphosphonates should be
reporting it to regulatory agencies,” Singh
said.
Yoon K. Loke, M.D., MBBS, of the University
of East Anglia, Norwich, United Kingdom,
also participated in this study, which
received no external funding.
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 1,056 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.
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