CHICAGO, Nov. 17, 2010 /PRNewswire-FirstCall/ -- Amylin
Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company
(NYSE: LLY) today announced results from a retrospective study of
nearly 375,000 type 2 diabetes patients evaluating the incidence of
events related to cardiovascular disease (CVD) and all-cause
hospitalizations among initiators of BYETTA® (exenatide) injection
compared to initiators of other commonly used diabetes medications.
These findings were presented at the American Heart Association
Scientific Sessions in Chicago.
In the study, BYETTA was associated with a lower incidence of
CVD-related events than insulin, thiazolidinediones (TZDs) and
sulfonylureas and a comparable incidence versus metformin and
Januvia® (sitagliptin). BYETTA was also associated with a lower
incidence of all-cause hospitalizations than insulin, TZDs and
sulfonylureas; a comparable incidence versus metformin and a higher
incidence than Januvia.
The study used data accrued over nearly four years from the IMS
LifeLink™ Health Plan Claims Database, comprised of medical and
pharmaceutical claims for more than 65 million patients from 98
health plans across the U.S. The incidence of CVD-related events
was assessed in approximately 22,000 patients who were treated with
BYETTA relative to nearly 353,000 patients who were treated with
other diabetes therapies. Baseline lipid levels, blood pressure,
obesity and evidence of prior cardiovascular disease were higher in
patients treated with BYETTA than patients treated with most other
therapies.
"Heart disease and stroke account for nearly two-thirds of
deaths in people with type 2 diabetes, so it is critically
important for us to understand how treatment may affect
cardiovascular risk, either positively or negatively," said
Orville G. Kolterman, M.D., senior
vice president, chief medical officer, Amylin Pharmaceuticals. "Our
EXSCEL cardiovascular outcomes study will further explore this area
and the role of exenatide."
EXSCEL (EXenatide Study of Cardiovascular Event Lowering) is
designed to determine if there are favorable cardiovascular effects
of exenatide treatment, using the investigational product BYDUREON™
(exenatide extended-release for injectable suspension), compared to
standard of care with traditional diabetes medications. The study
is underway and will include approximately 9,500 patients, with
results expected as early as 2016.
Study Design and Findings
The study presented today was designed to assess the relative
incidence rate of first CVD-related events in a real-world setting
among adult patients with type 2 diabetes. Analyses included
patients initiating a new prescription for a diabetes therapy
between June 1, 2005, and
March 31, 2009, without a
prescription for the same agent in the prior nine months. Patients
were followed until one of the following occurred: CVD event (acute
myocardial infarction, stroke or coronary revascularization
procedure), insurance disenrollment or study end. An
intention-to-treat analysis of CVD events was adjusted for more
than 300 potential differences in clinical and demographic
characteristics using propensity-score-weighted methods.
Based on the hazard ratio (HR) and 95 percent confidence
interval (CI), BYETTA-treated patients were less likely to have had
a CVD event than patients treated with insulin (HR=0.72; CI,
0.66-0.79; P less than 0.0001), TZDs (HR=0.92; CI, 0.85-1.00; P
less than 0.05) or sulfonylureas (HR=0.91; CI, 0.83-0.99; P less
than 0.05); they were equally likely to have had a CV event
compared to patients treated with Januvia (HR=1.00; CI, 0.9-1.12; P
greater than 0.05) or metformin (HR=1.01; CI, 0.93-1.09; P greater
than 0.05). BYETTA-treated patients had a significantly lower
incidence of all-cause hospitalization than patients treated with
insulin (HR=0.70; CI, 0.68-0.73; P less than 0.0001), TZDs
(HR=0.94; CI, 0.91-0.98; P less than 0.05) or sulfonylureas
(HR=0.89; CI, 0.86-0.92; P less than 0.0001); a comparable
incidence to patients treated with metformin (HR=1.02; CI,
0.99-1.06; P greater than 0.05) and a higher incidence than
patients treated with Januvia (HR=1.10; CI, 1.05-1.16; P less than
0.001). The observed differences between therapies in this study
may have resulted from decreased CVD risk from BYETTA, increased
CVD risk with certain other diabetes medications or some
combination of each of these.
About Diabetes
Diabetes affects more than 24 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 approximately $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 FDA-approved GLP-1 receptor agonist for the
treatment of type 2 diabetes. BYETTA exhibits many of the same
effects as the human incretin hormone glucagon-like peptide-1
(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
recommended to be taken with insulin. BYETTA is not for people with
type 1 diabetes or people with diabetic ketoacidosis.
BYETTA provides sustained A1C control and low incidence of
hypoglycemia when used alone or in combination with metformin or a
TZD, with potential weight loss (BYETTA is not a weight-loss
product). BYETTA was approved in April
2005 and has been used by more than 1.3 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 post-marketing data, BYETTA has been associated with
acute pancreatitis, including fatal and non-fatal hemorrhagic or
necrotizing pancreatitis. 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. Severe allergic
reactions can happen with BYETTA.
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 study 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) The International Diabetes Federation Diabetes Atlas.
Available at:
http://www.diabetesatlas.org/content/some-285-million-people-worldwide-will-live-diabetes-2010.
Accessed November 12, 2010.
(ii) Diabetes Statistics. American Diabetes Association.
Available at
http://www.diabetes.org/diabetes-basics/diabetes-statistics/.
Accessed November 12, 2010.
(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 November 12, 2010.
(iv) Saydah SH, Fradkin J and 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. 2007;30 Suppl 1:S48-65.
(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.
(Logo:
http://photos.prnewswire.com/prnh/20101117/LA02582LOGO)
(Logo:
http://www.newscom.com/cgi-bin/prnh/20101117/LA02582LOGO)
SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company