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Drug Commonly Used in Surgery Doubles Risk of Kidney
Failure
Aprotinin, FDA-approved for 13 years, also increases
risk of heart attacks and stroke
Jan. 26, 2006 - Aprotinin (marketed as Trasylol) - a drug approved by the
FDA, marketed internationally for the last 13 years, and given to an
estimated one million surgery patients to limit bleeding - has now been
proven to double a patient’s risk of kidney failure, and increase the
risk of heart attack, heart failure, and stroke.
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"...10,000
patients may be unnecessarily on dialysis today due to aprotinin" |
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These results—published in this week’s New England
Journal of Medicine—are based on an independent (non-commercial),
observational study conducted by The Ischemia Research and Education
Foundation (IREF), in association with the McSPI Research
Group—nonprofit biomedical research organizations dedicated to saving
and extending lives.
“Our study provides compelling evidence of
aprotinin’s serious risks, and strongly suggests discontinuation of use
and replacement with either of the two alternative generic and far
less costly medications proven safe in this study.” said IREF and McSPI
founder and principal scientist, Dennis T. Mangano, Ph.D., M.D.
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Oct. 11, 2005 - After 20 years of annual increases
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Health & Medicine |
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“Certainly, our findings—coming on the heels of the
Vioxx experience—indicate that the problem of drug safety is not only
ubiquitous, but also much more elusive than previously thought. In fact,
our findings raise even more troubling concerns, for:
(1) aprotinin has been on the market for three times as long as
Vioxx, yet few comprehensive safety studies have been conducted since
approval;
(2) the life-threatening complications with aprotinin found here
occurred far more frequently than those with Vioxx; and
(3) far less expensive generic alternatives to aprotinin which are
equally effective in limiting bleeding have been available, but have
been underused.”
The article, “The Risk of Aprotinin in Cardiac
Surgery,” states that replacing aprotinin with one of two safe generic
drugs would annually prevent as many as 11,050 dialysis complications,
save at least $1 billion in healthcare (dialysis) costs, and reduce drug
costs by at least $250 million.
Each year approximately one million patients
worldwide undergo surgical treatment following a heart attack, with the
majority of these patients receiving one of three antifibrinolytic
agents to limit blood loss during surgery: aprotinin (Bayer Healthcare
Pharmaceuticals, Inc.), ε-aminocaproic acid (generic), or tranexamic
acid (generic).
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More Comments by Physicians |
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“Some surgeons were concerned about
the risk of aprotinin, but "we didn't have good hard data to
prove it," said Dr. O. Wayne Isom, chairman of
the Department of Cardiac and Thoracic Surgery at New York
Presbyterian Hospital/Weil Cornell Medical College.
"This is pretty much undebatable.”
- Los Angeles Times, January 26, 2006
“If the data is correct, it will change our practices,” said
Dr. Nicola D’Attellis, a cardiac
anesthesiologist at Cedars-Sinai Medical Center in Los Angeles.
“This is really going to push people to do other research.”
- Los Angeles Times, January 26, 2006
“Dr. Timothy J. Gardner, the medical director
of the Center for Heart and Vascular Health at the Christiana
Care Health System in Newark, Del., and a spokesman for the
American Heart Association, said the article would have
substantial effects on medical practice.
Dr. Gardner said the findings were worrisome because many
patients had been taking other drugs that increased the tendency
to bleed, and surgeons sometimes need all possible help to stop
excess blood loss.”
- New York Times, January 26, 2006
Source:
Ischemia Research and
Education Foundation |
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The two generic drugs have proven safe in limiting
blood loss, and do not have the harmful effects of aprotinin.
Aprotinin is at least ten times more expensive than
its generic competitors.
Patients scheduled for cardiac surgery should
consult their physicians and avoid this risk.
Aprotinin was approved by the U.S. Food and Drug
Administration in 1993 and is manufactured by Bayer under the brand name
Trasylol. Over the past three years, Trasylol sales have accelerated,
with 2006 sales projected in excess of $US 600 million.
“We estimate that as many as 10,000 patients may
be unnecessarily on dialysis today due to aprotinin use. This serious
impact on human lives underscores once again the necessity for
meticulous, post-approval surveillance, as well as ongoing, unbiased
analysis of drug safety—all conducted by entirely independent entities,”
said Dr. Mangano.
“This is easier said than done, however, for the
economic forces are—and will continue to be—substantial, with little
corporate incentive to identify safety problems once drugs are approved
and marketed.”
The New England Journal of Medicine article
documents how aprotinin use was associated with a two-fold increase in
renal failure requiring dialysis in patients undergoing both complex
coronary artery surgery and primary surgery (excluding prior cardiac and
current valve surgery.)
Among primary surgery patients, Dr. Mangano and
colleagues found that aprotinin use also increased risk of myocardial
infarction (48 percent), heart failure (109 percent), and stroke (181
percent). Neither of aprotinin’s generic competitors, ε-aminocaproic
acid and tranexamic acid, was associated with increased renal, cardiac
or cerebral events.
The study is the first comprehensive,
observational, non-industry sponsored analysis of aprotinin’s safety.
Its findings are based on a systematic sampling scheme at 69 of the
world’s leading cardiac centers and institutions in North and South
America, Europe, the Middle East and Asia.
Approximately 7,500 data fields were collected from
4,374 patients by independent McSPI investigators.
The observational research model for assessment of
drug safety is in contrast to randomized clinical trials, which seek to
confirm the immediate safety and efficacy of a drug without examining
how the drug interacts with a multitude of other variables. The
observational approach allows researchers to collect a depth of
information about a particular behavior and to look at the association
and interaction of a particular drug with thousands of other variables
in specific groups of people—at risk populations, people over 65, or
people already sick—groups likely to be excluded in clinical trials
prior to approval.
Regarding this, Mangano stated that “Perhaps as
important as the research findings themselves is the approach taken here
to assess safety. We believe that the independent observational approach
is likely the only method practical for unbiased assessment of drug
safety in high-risk populations once a drug is marketed and practice is
imbedded.
Unfortunately, comprehensive observational studies
also are very costly, and given that there truly is no mandate or
incentive for the pharmaceutical industry to aggressively find safety
problems once a drug is marketed, it is up to society to find creative
ways to independently assess safety. Otherwise, the Vioxx—and now
Aprotinin—sagas will only be but the first of a series of public health
drug-safety failures.”
The 4,374 patients examined in the study either
received no antifibrinolytic agent, or one of the three agents
(aprotinin, ε-aminocaproic acid or tranexamic acid). The control group,
which received no antifibrinolytic, numbered 1,374. 1,295 patients
received aprotinin, 883 patients received ε-aminocaproic acid, and 822
patients received tranexamic acid.
The nonprofit Ischemia Research and Education
Foundation provided all of the funding for the study, totaling more than
$35 million, including site grants, central analysis and data
disposition and manuscript grants. The good will of the 69 participating
McSPI cardiac centers in the U.S. and worldwide contributed similar in
kind support through reduced research and data collection fees. None of
the authors received direct or indirect support from any of the
manufacturers of these three drugs.
The current finding is the fourth major cost-saving
therapeutic discovery by Dr. Mangano and IREF-McSPI colleagues over the
past decade.
In 1996, this team found that generic beta-blockers
reduced death after major surgery, saving 250,000 lives a year at a cost
of $15 per patient (New England Journal of Medicine).
In 2002, Dr. Mangano reported that giving heart
patients aspirin immediately following surgery reduced the threat of
thrombosis (New England Journal of Medicine). This is now standard
practice and saves over 25,000 lives a year at a cost of pennies per
patient.
In 2003, IREF- McSPI reported for the first time
that the COX-2 inhibitor, Bextra (valdecoxib, parecoxib), was associated
with stroke and impaired wound healing, eventually leading to its recall
(J Thoracic and Cardiovascular Surgery). The current finding around
aprotinin is IREF’s latest biomedical breakthrough using large-scale,
counterintuitive research design and implementation to uncover ways to
save and extend lives.
The full article is available at
http://content.nejm.org/
About IREF and McSPI
IREF is a California-based, independent, nonprofit
biomedical research organization founded in 1987 and dedicated to
performing quality medical and scientific research that saves and
extends lives. The Multicenter Study of Perioperative Ischemia (McSPI)
Research Group, founded in 1989 by Dr. Mangano, over the years has
included 246 research centers around the world. Since their inception,
IREF and McSPI have conducted large-scale, complex multi-center studies
addressing myocardial ischemia, infarction, stroke, and renal failure in
high-risk patients undergoing both cardiac and non-cardiac surgery.
The IREF/McSPI collaboration provides a cohesive
matured system for the accumulation of large-scale databases, as well as
the rapid commencement, conduction, and completion of complex U.S. and
global clinical trials. Find more information at
www.iref.org
The
article, “The Risk of Aprotinin in Cardiac Surgery,” is in today's issue
of the New England Journal of Medicine. It is by Dennis T. Mangano,
Ph.D., M.D., Iulia C. Tudor, Ph.D., and Cynthia Dietzel, M.D.
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