Interim data - RECORD study
GlaxoSmithKline PLC
05 June 2007
INTERIM DATA FROM RECORD STUDY SHOW NO SIGNIFICANT DIFFERENCE
BETWEEN AVANDIA AND STANDARD THERAPY
IN RISK OF CARDIOVASCULAR HOSPITALIZATION OR DEATH
"Patients and physicians should find these data reassuring"
Philadelphia, PA June 5, 2007 - GlaxoSmithKline (NYSE:GSK) said today that
findings from an interim analysis of RECORD (Rosiglitazone Evaluated for Cardiac
Outcomes and Regulation of glycemia in Diabetes), a prospective clinical trial
designed specifically to determine cardiovascular outcomes in more than 4,400
patients with type 2 diabetes, adds further evidence to the overall
cardiovascular safety profile of Avandia(R) (rosiglitazone maleate). The study
results, authored by Philip D. Home and colleagues on the RECORD Steering
Committee, were published Tuesday in the online edition of The New England
Journal of Medicine.
The study compares cardiovascular hospitalization and death in patients treated
with Avandia dual therapy (Avandia plus metformin or sulfonylurea) and in
patients treated with metformin and sulfonylurea in combination. After
following patients for an average of 3.75 years, the interim analysis found a
low number of events overall, and a similar number of events in each group. The
study is scheduled to complete in late 2008.
Like all interim analyses, these data do not offer final conclusions. Based on
the interim analysis, key findings include:
• The interim data show no significant difference between the Avandia and
control groups in the key outcomes of hospitalization or death due to
cardiovascular events.
• There was no difference between the groups in mortality, whether
cardiovascular deaths or deaths from all causes.
• The interim data show that Avandia was not significantly different than the
control groups in several secondary outcomes, including heart attack.
• A significant difference between the Avandia and control groups was seen
only in the secondary outcome of congestive heart failure (CHF), where
significantly more cases were seen in Avandia patients - consistent with the
well known association between fluid retention and TZDs, the class of medicine
to which Avandia belongs. Fluid retention can worsen or lead to CHF.
Importantly, despite the increase in CHF, there was no difference between the
Avandia group and the control groups in the key outcome of cardiovascular
hospitalizations and death.
"The interim findings do not show evidence of a significant difference in
cardiovascular death and heart attack between Avandia and the control groups,
and therefore do not confirm the hypothesis generated by the recently published
meta-analysis in the New England Journal of Medicine that raised concerns about
these events with Avandia," said Moncef Slaoui, chairman, R&D for GSK. "They
add to the weight of evidence, from both previously published long-term clinical
trials and other studies, that the overall ischemic cardiovascular safety
profile of Avandia is comparable to the traditional anti-diabetes treatments.
Patients and physicians should find these data reassuring."
Because Avandia has been shown to control blood sugar for longer than other
traditional oral anti-diabetic medicines, it is an important option for
physicians who often need to prescribe a combination of diabetes medicines to
help their patients maintain blood sugar levels.
Professor Home, Vice President, International Diabetes Federation, University of
Newcastle-upon-Tyne, UK, and chairman of the RECORD Steering Committee, said
that although the study is not expected to be complete until late 2008, the
committee concluded that an interim analysis should be published as soon as
possible. "Ideally, we would have allowed RECORD to complete before analyzing
and releasing the results," Home said. "However, in light of the questions
raised recently about Avandia, we felt it critical that interim data from this
important study be made available to physicians and patients immediately so that
treatment decisions may be based on all the available evidence."
Richard Nesto, MD, Chairman of the Department of Cardiovascular Medicine at the
Lahey Clinic Medical Center, said these new findings provide important
information for physicians caring for diabetic patients. "Despite its
limitations, the recent meta-analysis in the New England Journal of Medicine
raised important questions about the cardiac safety of rosiglitazone. These
questions can only be answered with better evidence from clinical trials. This
interim analysis of RECORD, a randomized prospective clinical trial, helps to
establish the overall cardiac safety profile of the drug," said Dr. Nesto, who
is an author of the American Heart Association and American Diabetes Association
consensus statement on the use of thiazolidinediones in diabetic patients with
heart disease. "Additional clinical trials are underway to specifically address
this issue, but the data from RECORD should be reassuring for physicians who
need effective drugs to lower blood sugar levels - the main cornerstone of
treatment for diabetic patients."
The RECORD study's robust design and breadth make it uniquely suited to answer
questions about cardiovascular risk with Avandia.
First, the study was designed to include a wide range of Type 2 diabetes
patients, including those with and without existing cardiovascular disease,
making it highly representative of real-world diabetes patients. Second,
patients in RECORD were managed such that blood sugar remained within current
guidelines, thereby eliminating a variable that may affect results, as
inadequate blood sugar control is itself associated with cardiovascular events.
Third, although an open-label design, each cardiovascular event was verified by
an independent panel of physicians who did not know which medicines the patients
were taking.
Under these rigorous standards, the interim analysis shows that the incidence of
cardiovascular hospitalization and death were comparable for the patients taking
the Avandia combination and the patients taking the metformin-sulfonylurea
combination.
GSK remains committed to the fight against diabetes. Avandia is an effective
medicine that is a valuable treatment for millions of patients who are using it
to control their diabetes, a disease with potentially devastating consequences
if left unmanaged.
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and
healthcare companies - is committed to improving the quality of human life by
enabling people to do more, feel better and live longer. For company
information, visit GlaxoSmithKline on the World Wide Web at www.gsk.com.
Simon Bicknell
Company Secretary
5th June 2007
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. For some people taking Avandia,
possible side effects include heart failure or other heart problems. Further
information regarding potential heart-related risks is currently under review by
the FDA.
Talk to your doctor as FDA has made information on potential heart-related risks
available to physicians on its website at www.fda.gov. 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.
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation
Reform Act of 1995, the company cautions investors that any forward-looking
statements or projections made by the company, including those made in this
Announcement, are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Factors that may affect the
Group's operations are described under 'Risk Factors' in the 'Business Review'
in the company's Annual Report on Form 20-F for 2006.
Inquiries
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European Analyst/Investor inquiries: Anita Kidgell (020) 8047 5542
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