Senior Citizens Can Expect New Diabetes Drugs to Not
Increase Heart Attack Risk
FDA announces new recommendations on evaluating
cardiovascular risk in drugs to treat type 2 diabetes
Dec. 17, 2008 For senior citizens the age group
most threatened by diabetes and cardiovascular problems the
announcement today by the Food and Drug Administration was good news.
The FDA says manufacturers developing new drugs and biologics to treat
type 2 diabetes need to provide evidence that the therapy will not
increase the risk of such cardiovascular events as a heart attack.
The recommendation is part of a new guidance for
industry that applies to all diabetes drugs currently under development.
"We need to better understand the safety of new
antidiabetic drugs. Therefore, companies should conduct a more thorough
examination of their drugs' cardiovascular risks during the product's
development stage," said Mary Parks, M.D., director, Division of
Metabolism and Endocrinology Products, Center for Drug Evaluation and
Research (CDER), FDA. "FDA's guidance outlines the agency's
recommendations for doing such an assessment."
More than 23 million people in the United States
have been diagnosed with type 2 diabetes or diabetes mellitus, a chronic
metabolic disorder characterized by abnormally high blood sugar levels
known as hyperglycemia.
Patients with diabetes have a two- to four-times
greater risk of heart disease than their non-diabetic counterparts, and
none of the currently approved antidiabetic therapies has been
convincingly proven to reduce that risk, according to the FDA.
Because diabetes often requires life-long
treatment, prescribers and patients need to know more about whether
their antidiabetic therapies put patients at increased risk of heart
attack. This is the purpose of today's guidance, which has benefited
from the July 2008 recommendation from FDA's Endocrinologic and
Metabolic Drugs Advisory Committee.
The guidance, which is effective immediately,
defines more robust and adequate design and data collection approaches
for Phase 2 and Phase 3 clinical trials than were previously required.
Specifically, the guidance recommends that these
studies demonstrate that new antidiabetic therapies do not increase
cardiovascular risk in comparison with existing therapies -- especially
when the drugs are used by patients of advanced age or by those with
advanced diabetes or renal impairment.
The FDA also recommends that manufacturers have any
cardiovascular events in their clinical trials analyzed by committees of
outside cardiologists who are unaware of which patients received the
tested products and which were on placebo.
Based on these evaluations, the FDA can better
ensure that product labeling includes comprehensive information on
safety and effectiveness. This will enable prescribers and patients to
make better-informed decisions on the management of type 2 diabetes.
The FDA says it remains confident that currently
marketed antidiabetic therapies are safe and effective when used
according to approved labeling and advises patients to work with their
healthcare professionals to select the most appropriate therapy to
achieve adequate blood glucose control.
The FDA says it is continuing to evaluate how
today's recommendations will be applied to already approved antidiabetic
drugs and expects to release further guidance on this issue in the
future.
The FDA's guidance and its ongoing evaluation of
this issue supports our approach to drug regulation throughout the
product life-cycle, by evaluating a drug's safety before and after its
approval," said Janet Woodcock, M.D., director, CDER, FDA.
"Diabetes Mellitus Evaluating Cardiovascular
Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes" is posted
on FDA's website at
http://www.fda.gov/cder/guidance/8576fnl.pdf. It will be published
in the Federal Register on December 19, 2008. In addition, the FDA has
provided written notice of the recommendations from this guidance to
more than 100 manufacturers who have submitted investigational new drug
applications for type 2 diabetes treatment.
More News on Diabetes from SeniorJournal.com
Archives
About Rosiglitazone,
marketed as Avandia
Combination products: Avandaryl (containing
rosiglitazone and glimepiride) and Avandamet (containing rosiglitazone
and metformin)
Why is this medication prescribed?
Rosiglitazone is used along with a diet and
exercise program and sometimes with one or more other medications to
treat type 2 diabetes (condition in which the body does not use insulin
normally and, therefore, cannot control the amount of sugar in the
blood). Rosiglitazone is in a class of medications called
thiazolidinediones. It works by increasing the body's sensitivity to
insulin, a natural substance that helps control blood sugar levels.
Rosiglitazone is not used to treat type 1 diabetes (condition in which
the body does not produce insulin and, therefore, cannot control the
amount of sugar in the blood) or diabetic ketoacidosis (a serious
condition that may occur if high blood sugar is not treated).
How should this medicine be used?
Rosiglitazone comes as a tablet to take by mouth.
It is usually taken once or twice daily with or without meals. Take
rosiglitazone at about the same time(s) every day. Follow the directions
on your prescription label carefully, and ask your doctor or pharmacist
to explain any part you do not understand. Take rosiglitazone exactly as
directed. Do not take more or less of it or take it more often than
prescribed by your doctor.
Your doctor may increase your dose of rosiglitazone
after 8-12 weeks, based on your body's response to the medication.
Rosiglitazone helps control type 2 diabetes but
does not cure it. It may take 2 weeks for your blood sugar to decrease,
and 2-3 months or longer for you to feel the full benefit of
rosiglitazone. Continue to take rosiglitazone even if you feel well. Do
not stop taking rosiglitazone without talking to your doctor.
Other uses for this medicine
This medication may be prescribed for other uses;
ask your doctor or pharmacist for more information.
Warning:
Rosiglitazone and other similar medications
for diabetes may cause or worsen congestive heart failure
(condition in which the heart is unable to pump enough blood to
the other parts of the body). Some studies have shown that
people who take rosiglitazone and insulin are more likely to
have a heart attack or to die of heart problems than people who
take insulin alone. Before you start to take rosiglitazone, tell
your doctor if you have or have ever had congestive heart
failure, especially if your heart failure is so severe that you
must limit your activity and are only comfortable when you are
at rest or you must remain in a chair or bed. Also tell your
doctor if you were born with a heart defect, and if you have or
have ever had swelling of the arms, hands, feet, ankles, or
lower legs; heart disease, high blood pressure; coronary artery
disease (narrowing of the blood vessels that lead to the heart);
a heart attack; an irregular heartbeat; or high cholesterol or
fats in the blood. Your doctor may tell you not to take
rosiglitazone or may monitor you carefully during your
treatment.
If you develop congestive heart failure or
other heart problems, you may experience certain symptoms. Tell
your doctor immediately if you have any of the following
symptoms, especially when you first start taking rosiglitazone
or after your dose is increased: large weight gain in a short
period of time; shortness of breath;swelling of the arms, hands,
feet, ankles, or lower legs; chest pain.swelling or pain in the
stomach; waking up short of breath during the night; needing to
sleep with extra pillows in order to breathe while lying down;
frequent dry cough; or increased tiredness.
Talk to your doctor about the risks of
taking rosiglitazone.
Thiazolidinediones medications (including rosiglitazone
(Avandia)
produced a significantly increased risk of heart attack, congestive
heart failure and death
Dec. 17, 2008 For senior citizens the age group
most threatened by diabetes and cardiovascular problems the
announcement today by the Food and Drug Administration was good news.
The FDA says manufacturers developing new drugs and biologics to treat
type 2 diabetes need to provide evidence that the therapy will not
increase the risk of such cardiovascular events as a heart attack. 
Dec.
17, 2008