|
E-mail this page to a friend!
Senior Citizen Health & Medicine
Finding of Increased Heart Attack, Death in Diabetes
Patients from Avandia(rosiglitazone) Sparks FDA Alert
FDA issues immediate alert on the drug marketed as
Avandia.
 May 21, 2007 Rosiglitazone, a drug widely used to
treat type 2 diabetes, was found to significantly increase the risk of
heart attacks and death from cardiovascular causes in a study of a wide
range of data and clinical trials. The Food and Drug Administration
immediately issued an alert on the drug marketed as
Avandia. The study's authors also
question the approval process used by the FDA for the approval of drugs
to treat diabetes.
(Read FDA Alert below this news story.)
| |
Related Stories |
|
| |
Better Diabetes Care
May Lead to Reduced Blindness, Kidney
and Heart Disease
One of the first studies of quality improvement in
diabetes care
May 18, 2007
Diabetes Drug Spending May Surge 70% by 2010, Cancer
Now Drives Specialty Drugs
Medco finds generics, Medicare Part D
keeping increases down
May 17, 2007
Women with Heart Disease and Diabetes Get Less Care
Than Men
Women on Medicare fare better than those on private
insurance
May 14, 2007
Senior Citizens Who Experience Depression More
Likely to Get Diabetes
2 million older adults experience depression, 15.3%
of over 65 have diabetes
April 24, 2007
Increasing Rate of Diabetes Linked to Increased
Cardiovascular Disease
Call for aggressive efforts to prevent
diabetes, control CVD risks
March 28, 2007
Diabetes, High Blood Pressure Trump Race in Causing
Heart Failure Among Older Americans
African-Americans have more heart failure because
they have more diabetes, hypertension
March 27, 2007
Read the latest news on Senior
Health & Medicine |
|
The New England Journal of Medicine published the
study online today, ahead of its print publication on June 14, along
with an editorial calling for changes in the current bill being shaped
in Congress to make changes in the practices of the FDA.
"Rosiglitazone was associated with a significant
increase in the risk of myocardial infarction and with an increase in
the risk of death from cardiovascular causes that had borderline
significance," write the study authors, Steven E. Nissen, M.D.,
Department of Cardiovascular Medicine, Cleveland Clinic, and Kathy
Wolski, M.P.H.
The authors do note, "Our study was limited by a
lack of access to original source data, which would have enabled
time-to-event analysis.
"Despite these limitations, patients and providers
should consider the potential for serious adverse cardiovascular effects
of treatment with rosiglitazone for type 2 diabetes."
| |
Major Heart, Diabetes Groups Urge Caution in Wake of
Avandia Warning
Study raises concerns; Groups advise patients with
diabetes to talk to their doctor
May 22, 2007 The risk of heart attack and death
for type 2 diabetes patients taking the drug Avandia appears to be
small, but must be considered carefully, says a statement issued
Monday by the American College of Cardiology, American Diabetes
Association and American Heart Association. They advise patients using
this drug should talk to their health care provider to determine the
most appropriate course of action. Read
more...
Avandia Drug Maker Disagrees with Study Saying the
Diabetes Drug Increases Heart Attacks, Deaths
GlaxoSmithKline says it's highly effective
treatment for type 2 diabetes
May 22, 2007 The maker of the diabetes drug
Avandia, GlaxoSmithKline, responded quickly to an online study published
Tuesday by the New England Journal of Medicine indicating the drug,
highly popular for treating type 2 diabetes, significantly increased the
risk of heart attack and death.
Read more...
Senate Committee Wants Answers About Avandia,
Company Defends Record
Committee leaders send letters to FDA and
GlaxoSmithKline
May 22, 2007 The Senate Finance Committee
leadership obviously had their guns loaded when the New England Journal
of Medicine published a study yesterday showing the type 2 diabetes drug
Avandia (rosiglitazone) significantly increases the risk of heart attack
and death. And, the drug-maker quickly responded to the senators.
Read more...
|
|
The study included searches of the published
literature, the Website of the FDA and clinical-trials registry
maintained by the drug manufacturer (GlaxoSmithKline). Of 116
potentially relevant studies, 42 trials met the inclusion criteria. Mean
age of subjects in the 42 trials was 56.
There were 86 myocardial infarctions in the
rosiglitazone group and 72 in the control group. There were 39 deaths
from cardiovascular cause in the rosiglitazone group and 22 in the
control group.
In the rosiglitazone group, as compared to control
group, the odds ratio for myocardial infarction was 1.43 (43%) and the odds
ratio for deaths from cardiovascular causes was 1.64 (65%).
"These emerging findings raise an important
question about the appropriateness of the current regulatory pathways
for the development of drugs to treat diabetes," the authors write.
"The FDA considers demonstration of a sustained
reduction in blood glucose levels with an acceptable safety profile
adequate for approval of antidiabetic agents. However, the ultimate
value of antidiabetic therapy is the reduction of the complications of
diabetes, not improvement in the laboratory measure of glycemic
control."
The editorial, Rosiglitazone and Cardiovascular
Risk, is by Bruce M. Psaty, M.D., Ph.D., and Curt D. Furberg, M.D.,
Ph.D.
They focus on the Food and Drug Administration
Revitalization Act, which was passed by the Senate on May 10 and is now
in the House.
"It has many strengths," the say but none of its
provisions would necessarily have identified the cardiovascular risks of
rosiglitazone "in a timely fashion."
They suggest "a true life-cycle approach, as
advocated by the Institute of Medicine, would continue the evaluation of
both efficacy and safety after approval convert surrogate end points
into clinically meaningful outcomes, integrate new information about
health benefits and risks, and communicate those findings effectively to
patients and physicians.
The conclude by saying "The health of the public
would benefit from additional revisions to the drug-safety legislation
as in moves through the House of Representatives."
Source: Effect of Rosiglitazone on the Risk of
Myocardial Infarction and Death from Cardiovascular Causes by Steven E.
Nissen, M.D., and Kathy Wolski, M.P.H., New England Journal of Medicine.
>>
New England Journal of Medicine Online
FDA Issues Safety Alert on Avandia
The U.S. Food and Drug Administration (FDA) is
aware of a potential safety issue related to Avandia (rosiglitazone), a
drug approved to treat type 2 diabetes. Safety data from controlled
clinical trials have shown that there is a potentially significant
increase in the risk of heart attack and heart-related deaths in
patients taking Avandia.
However, other published and unpublished data from
long-term clinical trials of Avandia, including an interim analysis of
data from the RECORD trial (a large, ongoing, randomized open label
trial) and unpublished reanalyses of data from DREAM (a previously
conducted placebo-controlled, randomized trial) provide contradictory
evidence about the risks in patients treated with Avandia.
Patients who are taking Avandia, especially those
who are known to have underlying heart disease or who are at high risk
of heart attack should talk to their doctor about this new information
as they evaluate the available treatment options for their type 2
diabetes.
FDA's analyses of all available data are ongoing.
FDA has not confirmed the clinical significance of the reported
increased risk in the context of other studies. Pending questions
include whether the other approved treatment from the same class of
drugs, pioglitazone, has less, the same or greater risks.
Furthermore, there is inherent risk associated with
switching patients with diabetes from one treatment to another even in
the absence of specific risks associated with particular treatments. For
these reasons, FDA is not asking GlaxoSmithKline, the drug's sponsor, to
take any specific action at this time. FDA is providing this emerging
information to prescribers so that they, and their patients, can make
individualized treatment decisions.
"FDA remains committed to assuring that doctors and
patients have the latest information available to make treatment and
medication use decisions. In this case, FDA is carefully weighing
several complex sources of data, some of which show conflicting results,
related to the risk of heart attack and heart-related deaths in patients
treated with Avandia," said Steven Galson, M.D., M.P.H., director of
FDA's Center for Drug Evaluation and Research. "We will complete our
analyses and make the results available as soon as possible. FDA will
take the issue of cardiovascular risk associated with Avandia and other
drugs in this class to an Advisory Committee as soon as one can be
convened."
Avandia was approved in 1999 for treatment of type
2 diabetes, a serious and life threatening disease that affects about 18
to 20 million Americans. Diabetes is a leading cause of coronary heart
disease, blindness, kidney failure and limb amputation. Since the drug
was approved, FDA has been monitoring several heart-related adverse
events (e.g., fluid retention, edema and congestive heart failure) based
on signals seen in previous controlled clinical trials of Avandia alone
and in combination with other drugs, and from postmarketing reports.
FDA has updated the product's labeling on several
occasions to reflect these new data, most recently in 2006. The most
recent labeling change for Avandia also included a new warning about a
potential increase in heart attacks and heart-related chest pain in some
individuals using Avandia. This new warning was based on the result of a
controlled clinical trial in patients with existing congestive heart
failure.
Recently, the manufacturer of Avandia provided FDA
with a pooled analysis (meta analysis) of 42 randomized, controlled
clinical trials in which Avandia was compared to either placebo or other
anti-diabetic therapies in patients with type 2 diabetes.
The pooled analysis suggested that patients
receiving short-term (most studies were 6-months duration) treatment
with Avandia may have a 30-40 percent greater risk of heart attack and
other heart-related adverse events than patients treated with placebo or
other anti-diabetic therapy. These data, if confirmed, would be of
significant concern since patients with diabetes are already at an
increased risk of heart disease.
Click to More Senior News on the
Front Page
Copyright: SeniorJournal.com |
