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Senior Citizen Health & Medicine
JAMA Releases Early Reports Finding Increased Heart,
Kidney Risks from COX-2 and NSAID Pain Relievers
 September
12, 2006 – Although two COX-2 inhibitors have already been withdrawn
from the market: rofecoxib (Vioxx) and valdecoxib (Bextra), the evidence
continues to accumulate on the on the potential danger of cardiovascular
risk from a broad range of COX-2 inhibitors and NSAIDS. Two new review
studies evaluating the safety of the pain-relieving medications COX-2
inhibitors and non-steroidal anti-inflammatory drugs (NSAIDs) find
increased cardiovascular and kidney risks. The studies and an editorial
were posted online today by the Journal of the American Medical
Association JAMA because of the public health implications of the
findings.
The articles will appear in the October 4 print
issue of JAMA.
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on
Health & Medicine |
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“It is estimated that more than 30 million people
worldwide take nonsteroidal anti-inflammatory drugs (NSAIDs) daily for
treatment of pain and inflammation,” according to background information
provided in one of the articles.
Adverse effects of some conventional NSAIDs include
toxic gastrointestinal (GI) effects, as well as adverse renal (kidney)
effects.
“Overall, an estimated 2.5 million individuals in
the United States annually experience adverse renal effects caused by
use of NSAIDs,” the authors write.
“With decreased risk of adverse GI effects, a class
of drugs that selectively inhibits COX-2 enzyme was introduced for
analgesia (pain relief) and the treatment of arthritis.”
According to the authors, the adverse renal effects
of selective COX-2 (cyclooxygenase 2) inhibition are unclear.
Jingjing Zhang, M.D., Ph.D., from Brigham and
Women’s Hospital and Harvard Medical School, Boston, and colleagues
evaluated the adverse risks of renal events and arrhythmia (disturbance
of the normal heart rhythm) events in patients prescribed COX-2
inhibitors from a systematic review of the medical literature to
determine if these negative side-effects involve every drug in this
class.
“In this comprehensive meta-analysis of 114
randomized trials of COX-2 inhibitors comprised of 116,094 participants,
rofecoxib uniquely increased risks of renal events (peripheral edema,
renal dysfunction, hypertension) and arrhythmia events, with apparent
adverse effects by the end of year 2000 and 2004, respectively,” the
researchers write.
“However, the results did not show adverse effects
of other COX-2 inhibitors on renal events and arrhythmia, indicating no
overall evidence for a COX-2 inhibitor class effect.”
In conclusion, the authors write: “Notably for
policy and clinical decision making, our results also suggest that a
time-cumulative meta-analytic approach for examining available trial
safety data would have helped clarify apparently adverse effects several
years earlier than the current report.
"The knowledge of all potential adverse effects is
important and indeed time-sensitive, for physicians and patients both
need complete information about risks and benefits to properly use COX-2
inhibitors and other clinical treatments.”
They continue, “future drug safety monitoring of
emerging clinical treatments may benefit from continuous cumulative
meta-analytic aggregation of safety data for all drug-approval
applications and experimental agents.”
Editor's Note: Corresponding author Mr. Ding was
supported by a grant from the National Institute of Diabetes, Digestive,
and Kidney Diseases (NIDDK) and by an institutional training grant from
the National Cancer Institute, National Institutes of Health. Dr. Song
was supported by grants from the NIDDK, National Institutes of Health.
Additional Report Looks at Cardiovascular Risk
 In
a related study, Patricia McGettigan, M.B.B.S., B.Pharm., F.R.A.C.P.,
Ph.D., and David Henry, M.B., Ch.B., F.R.C.P., from The University of
Newcastle, New South Wales, Australia, conducted a meta-analysis of the
observational studies in the medical literature to compare the risks of
serious cardiovascular events (predominantly, myocardial infarction
[heart attack]) with individual NSAIDs and cyclooxygenase 2 inhibitors
(COX-2).
In background information, the authors write that
interest in the cardiovascular effects of the relatively selective
inhibitors of COX-2 has been intense. Although rofecoxib (Vioxx) was
withdrawn from world markets, celecoxib (Celebrex) “continues to be
widely used, despite meta-analyses of randomized controlled trials
showing an increased risk of myocardial infarction.”
The authors add, “attention has turned to the
cardiovascular safety of the older non-selective non-steroidal
anti-inflammatory drugs (NSAIDs). These agents are used extensively and
some are available in many countries without prescription.”
The authors based their analysis on 17 case-control
analyses that included 86,193 cases with cardiovascular events and over
500,000 controls, and six cohort analyses that included 75,520 users of
selective COX-2 inhibitors, 375,619 users of nonselective NSAIDs, and
nearly 600,000 unexposed participants.
“A dose-related risk was evident with rofecoxib
(relative risk 1.33 with 25 milligrams or less per day and 2.19 with
more than 25 mg/day),” the authors report.
“The risk was elevated during the first month of
treatment. Celecoxib was not associated with an elevated risk of
vascular occlusion. Among older non-selective drugs, diclofenac had the
highest risk with a summary relative risk of 1.40. The other drugs had
summary relative risks close to one: naproxen, 0.97; piroxicam, 1.06;
and ibuprofen 1.07.”
The authors state that this review “contradicts
claims of a ‘protective’ effect of naproxen and raises serious questions
about the safety of diclofenac…”
“In conclusion, controlled data from observational
and randomized studies confirm a dose-related risk of cardiovascular
events with selective COX-2 inhibitors. The observational data indicate
that the risk increases early in treatment. An older NSAID, diclofenac,
seems to share this risk and, unlike celecoxib, it appears to be harmful
at commonly used doses. We believe there are grounds for reviewing its
regulatory status.”
Editor's Note: Funding for this review was
provided through project grants from the National Health and Medical
Research Council of Australia and the National Heart Foundation
Australia.
EDITORIAL: The Seduction of Common Sense
 In
an accompanying editorial, David J. Graham, M.D., M.P.H., from Silver
Spring, MD writes, “in this issue of JAMA, two systematic reviews [by
Zhang et al and by McGettigan and Henry] provide clarity on a topic that
has been dominated more by disinformation than reason.” He also
discusses the findings of these two new studies and places them in
context of other reports on risks associated with COX-2 inhibitors and
other NSAIDS.
Dr. Graham writes, “What does this all mean? First,
rofecoxib increases the risk of acute MI at low and high doses. … There
is no initial 18-month period of immunity from risk. Celecoxib also
increases risk at doses higher than 200 mg/d; at lower doses, the
potential risk is less clear. Several other NSAIDs increase risk,
including the COX-2 selective NSAIDs diclofenac and meloxicam, and the
non-selective NSAID indomethacin and probably ibuprofen. Meta-analyses
of randomized clinical trials and observational studies agree that
naproxen is neutral for MI risk.”
Dr. Graham also mentions that another COX-2
inhibitor NSAID, etoricoxib (which is not approved for use in the United
States), recently was reported to have a risk of thrombotic
cardiovascular events similar to diclofenac, with the implication that
etoricoxib is safe from a cardiovascular perspective.
However, he points out that “etoricoxib was
compared with diclofenac, a drug shown to substantially increase the
risk of acute MI” in another previous study and in the meta-analysis by
McGettigan and Henry.
Dr. Graham concludes, “if the lessons of recent
history have been learned, the FDA’s concerns will now be squarely
focused on patient safety rather than corporate profitability, and,
ultimately, common sense will prevail.”
Editor's Note: Dr. Graham reported no financial
conflicts of interest, but reported that he was subpoenaed as a federal
government expert by plaintiffs, for the purpose of providing testimony
(in May 2006) that may be used in a number of Vioxx-related lawsuits,
and reported that he received no compensation for this activity, other
than his federal salary.
Dr. Graham is an employee of the U.S. Food and
Drug Administration. This editorial was written by Dr. Graham as an
officially approved outside activity in his private capacity and not as
a Food and Drug Administration employee. The views expressed in this
Editorial are the author’s own, and do not reflect the official policy
or position of the Food and Drug Administration.
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