SAN DIEGO, June 24, 2011 /PRNewswire/ -- Amylin
Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company
(NYSE: LLY) today announced results from a retrospective analysis
of more than 778,000 patients that showed the addition of BYETTA®
(exenatide) injection to pre-existing diabetes treatment regimens
was associated with a reduced likelihood of heart failure,
especially among patients receiving insulin. These findings will be
presented in a poster session at the 71st Scientific Sessions of
the American Diabetes Association in San
Diego on June 25 from
11:30 a.m. to 1:30 p.m. PDT.
The retrospective analysis used data from the GE Healthcare
Centricity electronic medical record to analyze the likelihood of
heart failure for BYETTA in combination with certain other diabetes
treatments compared with control groups of patients not treated
with BYETTA. Across all therapies, patients who received BYETTA
were 54 percent less likely to experience heart failure compared to
patients not treated with BYETTA.
"Compared with the general population, people with diabetes have
an increased risk of heart disease, with at least double the risk
of developing heart failure. That's why it is imperative that we
understand the role diabetes treatments may play in patients'
cardiovascular health," said Christian
Weyer, M.D., senior vice president, research and
development, Amylin Pharmaceuticals. "In addition to retrospective
analyses like this one, our EXSCEL cardiovascular outcomes study is
underway to thoroughly and prospectively evaluate cardiovascular
effects of exenatide."
EXSCEL (EXenatide Study of Cardiovascular Event Lowering) is
designed to determine if there are favorable cardiovascular effects
of exenatide treatment, using BYDUREON™ (exenatide extended-release
for injectable suspension), compared to standard of care with
traditional diabetes medications. The study began in 2010 and will
include approximately 9,500 patients, with results expected as
early as 2016. BYDUREON is the proposed brand name for an
investigational, once-weekly formulation of exenatide, the active
ingredient in BYETTA.
Analysis Design and Findings
This retrospective matched cohort analysis used data obtained
from the national Medical Quality Improvement Consortium of more
than 14,000 healthcare providers from ambulatory medical practices
with the GE Healthcare Centricity electronic medical record. Heart
failure was defined as heart failure diagnosis (ICD-9 code 428.xx)
and a brain natriuretic peptide concentration of greater than 100
pg/mL. A total of 778,408 patients with type 2 diabetes receiving a
prescription for BYETTA, insulin (any type) and/or another
glucose-lowering therapy prescribed serially or concomitantly
between January 2005 and September 2010 were identified. (The use of
BYETTA with basal insulin is currently under FDA review and not yet
an approved indication.) Patients receiving BYETTA were randomly
matched to those not receiving BYETTA based on gender, age,
follow-up time and use of thiazolidinediones. The weighted Charlson
Comorbidity Index was used to adjust for disease severity.
Patients who received BYETTA in combination with insulin and
another therapy were 57 percent less likely to develop heart
failure than those receiving insulin in combination with another
therapy (odds ratio [OR]=0.43, 95 percent CI=0.35-0.53, n=50,330).
With BYETTA plus other non-insulin therapies, the likelihood was 31
percent lower than with the other therapies alone, though this
finding was not statistically significant (OR=0.69, 95 percent
CI=0.44-1.07, n=53,446). Across all therapies, patients receiving
BYETTA were 54 percent less likely to develop heart failure
(OR=0.46, 95 percent CI=0.38-0.56, n=103,776) than the control
group of patients not receiving BYETTA.
About Diabetes
Diabetes affects nearly 26 million people in the U.S. and an
estimated 285 million adults worldwide.(i),(ii) Approximately 90-95
percent of those affected have type 2 diabetes. Diabetes costs more
than $174 billion per year in direct
and indirect medical expenses.(iii)
According to the Centers for Disease Control and Prevention's
National Health and Nutrition Examination Survey, approximately 60
percent of people with diabetes do not achieve their target blood
sugar levels with their current treatment regimen.(iv) In addition,
85 percent of type 2 diabetes patients are overweight and 55
percent are considered obese.(v) Data indicate that weight loss
(even a modest amount) supports patients in their efforts to
achieve and sustain glycemic control.(vi),(vii)
About BYETTA® (exenatide) injection
BYETTA was the first glucagon-like peptide-1 (GLP-1) receptor
agonist to be approved by the FDA for the treatment of type 2
diabetes. BYETTA exhibits many of the same effects as the human
incretin hormone GLP-1. GLP-1 improves blood sugar after food
intake through multiple effects that work in concert on the
stomach, liver, pancreas and brain.
BYETTA is an injectable prescription medicine that may improve
blood sugar (glucose) control in adults with type 2 diabetes
mellitus, when used with a diet and exercise program. BYETTA is not
insulin and should not be taken instead of insulin. BYETTA is not
currently recommended to be taken with insulin. BYETTA is not for
people with type 1 diabetes or people with diabetic ketoacidosis.
BYETTA has not been studied in people who have pancreatitis.
BYETTA provides sustained A1C control and low incidence of
hypoglycemia when used alone or in combination with metformin or a
thiazolidinedione, with potential weight loss (BYETTA is not a
weight-loss product). BYETTA was approved in the U.S. in
April 2005 and in Europe in November
2006 and has been used by more than 1.8 million patients
since its introduction. See important safety information below.
Additional information about BYETTA is available at
www.BYETTA.com.
Important Safety Information for BYETTA® (exenatide)
injection
Based on postmarketing data BYETTA has been associated with
acute pancreatitis, including fatal and non-fatal hemorrhagic or
necrotizing pancreatitis. Patients should be observed for signs and
symptoms of pancreatitis after initiation or dose escalation of
BYETTA. The risk for getting low blood sugar is higher if BYETTA is
taken with another medicine that can cause low blood sugar, such as
a sulfonylurea. BYETTA should not be used in people who have severe
kidney problems and should be used with caution in people who have
had a kidney transplant. Patients should talk with their healthcare
provider if they have severe problems with their stomach, such as
delayed emptying of the stomach (gastroparesis) or problems with
digesting food. Antibodies may develop with use of BYETTA. Patients
who develop high titers to exenatide could have worsening or
failure to achieve adequate glycemic control. Consider alternative
therapy if this occurs. Severe allergic reactions can happen with
BYETTA. There have been no clinical studies establishing conclusive
evidence of macrovascular risk reduction with BYETTA or any other
antidiabetic drug.
The most common side effects with BYETTA include nausea,
vomiting, diarrhea, dizziness, headache, feeling jittery, and acid
stomach. Nausea most commonly happens when first starting BYETTA,
but may become less over time.
These are not all the side effects from use of BYETTA. A
healthcare provider should be consulted about any side effect that
is bothersome or does not go away.
For additional important safety information about
BYETTA, please see the full Prescribing Information
(www.byetta.com/pi) and Medication Guide
(www.byetta.com/mg).
About Amylin and Lilly
Amylin Pharmaceuticals is a biopharmaceutical company dedicated
to improving lives of patients through the discovery, development
and commercialization of innovative medicines. Amylin has developed
and gained approval for two first-in-class medicines for diabetes,
SYMLIN® (pramlintide acetate) injection and BYETTA® (exenatide)
injection. Amylin's research and development activities leverage
the Company's expertise in metabolism to develop potential
therapies to treat diabetes and obesity. Amylin is headquartered in
San Diego. Further information on
Amylin Pharmaceuticals is available at www.amylin.com.
Through a long-standing commitment to diabetes care, Lilly seeks
to provide patients with breakthrough treatments that enable them
to live longer, healthier and fuller lives. Since 1923, Lilly has
been an industry leader in pioneering therapies to help healthcare
professionals improve the lives of people with diabetes, and
research continues on innovative medicines to address the unmet
needs of patients. For more information about Lilly's current
diabetes products, visit www.lillydiabetes.com.
Lilly, a leading innovation-driven corporation, is developing a
growing portfolio of pharmaceutical products by applying the latest
research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered
in Indianapolis, Lilly provides
answers -- through medicines and information -- for some of the
world's most urgent medical needs. Additional information about
Lilly is available at www.lilly.com.
This press release contains forward-looking statements about
Amylin and Lilly. Actual results could differ materially from those
discussed or implied in this press release due to a number of risks
and uncertainties, including the risk that BYETTA, and/or the
revenues generated from BYETTA, may be affected by competition;
unexpected new data; safety and technical issues; the analysis
results mentioned in this press release not being predictive of
real-world results; clinical trials, including the EXSCEL trial
mentioned in this press release, not being completed in a timely
manner, not confirming previous results, not being predictive of
real-world use, or not achieving the intended clinical endpoints;
label expansion requests not receiving regulatory approval; or
manufacturing and supply issues. The potential for BYETTA may also
be affected by government and commercial reimbursement and pricing
decisions; the pace of market acceptance; or scientific, regulatory
and other issues and risks inherent in the development and
commercialization of pharmaceutical products, including those
inherent in the collaboration with and dependence upon Amylin
and/or Lilly. These and additional risks and uncertainties are
described more fully in Amylin's and Lilly's most recent SEC
filings, including their Quarterly Reports on Form 10-Q and Annual
Reports on Form 10-K. Amylin and Lilly undertake no duty to update
these forward-looking statements.
BYETTA® is a registered trademark and
BYDUREON™ is a trademark of Amylin Pharmaceuticals, Inc. All other
marks are the marks of their respective owners.
P-LLY
(i) Diabetes Statistics. American Diabetes Association.
Available at:
http://www.diabetes.org/diabetes-basics/diabetes-statistics/.
Accessed June 17, 2011.
(ii) The International Diabetes Federation Diabetes Atlas.
Available at:
http://www.diabetesatlas.org/content/some-285-million-people-worldwide-will-live-diabetes-2010.
Accessed June 17, 2011.
(iii) Direct and Indirect Costs of Diabetes in
the United States. American
Diabetes Association. Available at:
http://www.diabetes.org/how-to-help/action/resources/cost-of-diabetes.html.
Accessed June 17, 2011.
(iv) Saydah SH, Fradkin J, Cowie CC. Poor control of risk
factors for vascular disease among adults with previously diagnosed
diabetes. JAMA. 2004;291:335-42.
(v) Bays HE, Chapman RH, Grandy S. The relationship of
body mass index to diabetes mellitus, hypertension and
dyslipidaemia: comparison of data from two national surveys. Int
J Clin Pract. 2007;61:737-47.
(vi) Nutrition Recommendations and Interventions for
Diabetes: a position statement of the American Diabetes
Association. Diabetes Care. 2008;31 Suppl 1;S61-78.
(vii) Anderson JW, Kendall CW, Jenkins DJ. Importance of weight
management in type 2 diabetes: review with meta-analysis of
clinical studies. J Am Coll Nutr. 2003;22:331-9.
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SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company