Results show risk of heart attack comparable to two widely used diabetes
medicines
LONDON and PHILADELPHIA, June 6 /PRNewswire-FirstCall/ -- A study of
more than 33,000 type 2 diabetes patients in a real-world setting was
published today. This study shows that the incidence of hospitalizations
for heart attack, and/or for a surgery known as coronary revascularization
for patients on Avandia is the same as for other diabetes treatments. The
study results were released in a paper titled "Coronary Heart Disease
Outcomes in Patients Receiving Antidiabetic Agents" in Pharmacoepidemiology
and Drug Safety.
These data, also described in a letter published online last week (May
30, 2007) in the medical journal The Lancet, are further evidence that the
ischemic cardiovascular safety of Avandia is comparable to the most
commonly used type 2 diabetes treatments - as evidenced in long-term
prospective trials, such as ADOPT and DREAM. The findings conflict with a
hypothesis generated by the recently published meta-analysis in the New
England Journal of Medicine that raised concerns regarding ischemic risks
with Avandia.
Based on an observational cohort study from a large U.S. managed-care
database, this research was commissioned by GlaxoSmithKline as part of its
commitment to the ongoing monitoring and assessment of the safety of
Avandia. The study was designed to compare the risk of heart attack and
coronary revascularization in type 2 diabetes patients taking Avandia,
metformin or sulfonylurea - either alone, as two medicines combined and in
combination with insulin. The study populations were matched to ensure that
the cohort groups were similar in terms of their baseline risk factors for
cardiovascular disease. Patients were followed for an average of slightly
over a year.
The results demonstrate that:
-- there was no difference in the overall incidence of heart attack and
coronary revascularization with Avandia-containing therapies (1.75
events per 100 person-years) versus non-Avandia containing therapies
(1.76 events per 100 person-years) (hazard ratio 0.93, 95% CI 0.80 -
1.10);
-- there was no difference in the risk of either heart attack (hazard
ratio 0.92, 95% CI 0.73 - 1.16) or coronary revascularization (hazard
ratio 0.94, 95% CI 0.79 - 1.12) - with Avandia-containing therapies
compared to non-Avandia containing therapies;
-- there was no difference in the risk of the composite outcome with
Avandia monotherapy compared to metformin monotherapy (hazard ratio
1.07, 95% CI: 0.85 - 1.34), and similarly with Avandia monotherapy
compared to sulfonylurea monotherapy (hazard ratio 0.82, 95% CI: 0.67 -
1.02);
-- there was no difference in the risk of composite outcome with Avandia
in combination with insulin therapy compared to other oral antidiabetic
agents in combination with insulin (hazard ratio 0.88, 95% CI: 0.59 -
1.32).
Avandia is an effective medicine that is an important treatment for
millions of patients who are using it to manage their diabetes, a disease
with potentially devastating consequences if left unmanaged.
Glossary of Terms:
Coronary revascularization - the process of restoring blood flow of oxygen
to the heart via a surgical procedure to bypass blockages or obstructions
in the coronary arteries
Cohort - a group within a given population followed over a period of time
CI (confidence interval) - quantifies the range that covers the mean via
an upper and lower limit for the actual value
Patient year - the cumulative amount of time that a patient has taken a
particular medicine as measured in years.
Important Safety Information for Avandia(R) (rosiglitazone maleate)
Avandia, along with diet and exercise, helps improve blood sugar
control. It may be taken alone or with other diabetes medicines.
Tell your doctor if you have heart problems or heart failure. Avandia
can cause your body to keep extra fluid, which leads to swelling and weight
gain. Extra body fluid can make some heart problems worse or lead to heart
failure. If you have swelling or fluid retention, shortness of breath or
trouble breathing, an unusually rapid increase in weight, or unusual
tiredness while taking Avandia, call your doctor right away.
You should not take Avandia if you have liver problems. Blood tests
should be used to check for liver problems before starting and while taking
Avandia. Tell your doctor if you have liver disease, or if you experience
unexplained tiredness, stomach problems, dark urine or yellowing of skin
while taking Avandia.
Tell your doctor about all of the medicines you are taking.
If you are taking Avandia with another diabetes medicine that lowers
blood sugar, you may be at increased risk for low blood sugar. Ask your
doctor whether you need to lower the dose of your other diabetes medicine.
Avandia may increase your risk of pregnancy. Talk to your doctor before
taking Avandia if you could become pregnant or if you are pregnant. If you
are nursing, you should not take Avandia.
Talk to your doctor for advice on how to keep your bones healthy. More
fractures, usually in the upper arm, hand, or foot, have been seen in women
taking Avandia.
Your doctor should check your eyes regularly. Very rarely, some people
have experienced vision changes due to swelling in the back of the eye
while taking Avandia.
Important Safety Information for Avandamet(R) (rosiglitazone
maleate/metformin HCl)
Avandamet, along with diet and exercise, helps improve blood sugar
control. It is a combination of two drugs -- rosiglitazone maleate and
metformin HCl.
A small number of people who have taken metformin, one of the
components of Avandamet, have developed a rare yet serious condition called
lactic acidosis (a buildup of lactic acid in the blood). Lactic acidosis
occurs most often in people with kidney problems and can be fatal in up to
one half of the cases. You should not take Avandamet if you have kidney
problems. Tests should be used to check your kidneys before and while
taking Avandamet. You should not drink alcohol excessively when taking
Avandamet. If you are taking medicines for heart failure, you may be at
increased risk of lactic acidosis.
Tell your doctor if you have heart problems or heart failure. Avandamet
can cause your body to keep extra fluid, which leads to swelling and weight
gain. Extra body fluid can make some heart problems worse or lead to heart
failure. If you have swelling or fluid retention, shortness of breath or
trouble breathing, an unusually rapid increase in weight, or unusual
tiredness while taking Avandamet, call your doctor right away.
You should not take Avandamet if you have liver problems. Blood tests
should be used to check for liver problems before starting and while taking
Avandamet. Tell your doctor if you have liver disease, or if you experience
unexplained tiredness, stomach problems, dark urine or yellowing of skin
while taking Avandamet.
Tell your doctor about all of the medicines you are taking.
Avandamet may increase your risk of pregnancy. Talk to your doctor
before taking Avandamet if you could become pregnant or if you are
pregnant. If you are nursing, you should not take Avandamet.
Talk to your doctor for advice on how to keep your bones healthy. More
fractures, usually in the upper arm, hand, or foot, have been seen in women
taking rosiglitazone, a component of Avandamet.
Your doctor should check your eyes regularly. Very rarely, some people
have experienced vision changes due to swelling in the back of the eye
while taking rosiglitazone, a component of Avandamet.
SOURCE GlaxoSmithKline
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