BYETTA(R) Treatment for Three and a Half Years Associated with Reductions in Cardiovascular Risk Factors in People with Type 2 D
June 23 2007 - 12:00PM
PR Newswire (US)
- BYETTA also Showed Sustained Improvements in Blood Glucose
Control and Progressive Weight Loss - CHICAGO, June 23
/PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc.
(NASDAQ:AMLN) and Eli Lilly and Company (NYSE:LLY) today announced
results from a study that showed BYETTA(R) (exenatide) injection
sustained improvements in blood sugar levels and progressive weight
loss through three and a half years of therapy. BYETTA treatment
was also associated with improvements in cardiovascular risk
factors in people with type 2 diabetes. These findings were
presented at the 67th Annual Scientific Sessions of the American
Diabetes Association (ADA) in Chicago. People with type 2 diabetes
are at increased risk for various cardiovascular problems,
including high blood pressure and cholesterol. In this study, 151
people with type 2 diabetes who had taken part in a 30-week
placebo-controlled trial were followed in open-label extension
studies. After three and a half years, participants using BYETTA
(10 mcg) twice daily with oral medication showed sustained
reductions in blood sugar as measured by A1C (-0.8 +/- 0.1 percent)
and fasting blood glucose (-24 +/- 4 mg/dL), consistent with
findings from previous studies. Treatment with BYETTA in
combination with common oral medications was also associated with
progressive weight loss (-11.68 +/- 1.1 lbs), improved triglyceride
levels (-44.4 +/- 12.1 mg/dL or 12 percent), and lower systolic and
diastolic blood pressure (-3.5 +/- 1.2 mmHg or 2 percent and -3.3
+/- 0.8 mmHg or 4 percent, respectively). Results also showed an
increase in HDL, or "good" cholesterol levels after three and a
half years (+8.5 +/- 0.6 mg/dL or 24 percent) and a decrease in
LDL, or "bad" cholesterol levels (-11.8 +/- 2.9 mg/dL or 6
percent).(1,2) "The sustained improvements in blood glucose control
and the secondary benefits of progressive weight loss seen with
BYETTA are well documented," said David Kendall, Executive
Director, Medical Affairs, Amylin Pharmaceuticals, Inc. "These
studies document that BYETTA may have additional and important
effects on cardiovascular disease risk factors providing
interesting areas for further study, including additional metabolic
advantages of weight loss in people with diabetes." BYETTA was
generally well-tolerated in this study, and the side effects were
consistent with those seen in previous studies. In clinical trials
and post-approval adverse event reports, the most common side
effect is mild-to- moderate nausea, which affects fewer than half
of patients and usually decreases over time. BYETTA is indicated
for use as an adjunctive therapy for people with type 2 diabetes
who are not achieving blood sugar control using metformin, a
sulfonylurea, or a thiazolidinedione. Over three million
prescriptions have been written in the U.S. since being approved by
the Food and Drug Administration (FDA) in 2005. For more
information, visit http://www.byetta.com/. About BYETTA(R)
(exenatide) injection BYETTA is the first in a class of drugs for
the treatment of type 2 diabetes called incretin mimetics. 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 approved by the FDA
for use by people with type 2 diabetes who are unsuccessful at
controlling their blood sugar levels. BYETTA is an add-on therapy
for people currently using metformin, a sulfonylurea, or a
thiazolidinedione. BYETTA provides sustained A1C control, low
incidence of hypoglycemia when used with metformin or a
thiazolidinedione, and progressive weight loss. For full
prescribing information, visit http://www.byetta.com/. About
Diabetes Diabetes affects more than 20 million in the United States
and an estimated 246 million adults worldwide.(3,4) Approximately
90-95 percent of those affected have type 2 diabetes. Diabetes is
the fifth leading cause of death by disease in the United States
and costs approximately $132 billion per year in direct and
indirect medical expenses.(5) 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.(6) Important Safety Information for BYETTA(R)
(exenatide) injection BYETTA improves glucose (blood sugar) control
in patients with type 2 diabetes who are taking metformin, a
sulfonylurea, or a thiazolidinedione. BYETTA is not a substitute
for insulin in patients whose diabetes requires insulin treatment.
BYETTA is not recommended for use in patients with severe problems
with the stomach or food digestion, or those who have severe kidney
disease. Before using BYETTA, patients should tell their healthcare
provider if they are pregnant, plan to become pregnant, or are
breastfeeding. BYETTA has not been studied in children. When BYETTA
is used with a medicine that contains a sulfonylurea, hypoglycemia
(low blood sugar) is a possible side effect. To reduce this
possibility, the dose of sulfonylurea medicine may need to be
reduced while using BYETTA. Other common side effects with BYETTA
include nausea, vomiting, diarrhea, dizziness, headache, feeling
jittery, and acid stomach. Nausea is most common when first
starting BYETTA, but decreases over time in most patients. BYETTA
may reduce appetite, the amount of food eaten, and body weight.
These are not all the side effects with BYETTA. A healthcare
provider should be consulted about any side effect that is
bothersome or does not go away. For complete safety profile and
other important prescribing considerations, visit
http://www.byetta.com/. About Amylin and Lilly Amylin
Pharmaceuticals is a biopharmaceutical company committed to
improving lives through the discovery, development and
commercialization of innovative medicines. Amylin has developed and
gained approval for two first- in-class medicines for diabetes.
Amylin's research and development activities leverage the company's
expertise in metabolism to develop potential therapies to treat
diabetes and obesity. Amylin is located in San Diego, California
with over 1,600 employees nationwide. For more information about
Amylin and the company's diabetes products, visit
http://www.amylin.com/. Through a long-standing commitment to
diabetes care, Lilly provides patients with breakthrough treatments
that enable them to live longer, healthier and fuller lives. Since
1923, Lilly has been the industry leader in pioneering therapies to
help health care 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 http://www.lillydiabetes.com/.
Lilly, a leading innovation-driven corporation, is developing a
growing portfolio of first-in-class and best-in-class
pharmaceutical products by applying the latest research from its
own worldwide laboratories and from collaborations with eminent
scientific organizations. Headquartered in Indianapolis, Indiana,
Lilly provides answers -- through medicines and information -- for
some of the world's most urgent medical needs. Additional
information about Lilly is available at http://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 the revenues
generated from BYETTA may be affected by competition, unexpected
new data, technical issues, clinical trials not confirming previous
results or predicting future results, label expansion requests not
being submitted in a timely manner or 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 commercialization of pharmaceutical products. These and
additional risks and uncertainties are described more fully in
Amylin and Lilly's most recently filed SEC documents such as their
Quarterly Reports on Form 10-Q. Amylin and Lilly undertake no duty
to update these forward-looking statements. (Logo:
http://www.newscom.com/cgi-bin/prnh/20040122/LILLYAMYLINLOGO )
P-LLY (1) Kendall D, Blonde L, Mac S, Guan X, Holcombe J, Okerson
T, Kim D, and Bhole D. "Improvements in Cardiovascular Risk Factors
Accompanied Improved Glycemic Control Weight Reduction in Patients
With Type 2 Diabetes Treated With Exenatide for 3.5 y." Abstract
0557-P. (2) American Heart Association. "LDL and HDL Cholesterol:
What's Bad and What's Good?" Available at:
http://www.americanheart.org/presenter.jhtml?identifier=180.
Accessed June 14, 2007. (3) The International Diabetes Federation
Diabetes Atlas. Available at:
http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A.
Accessed June 14, 2007. (4)"All About Diabetes." American Diabetes
Association. Available at:
http://www.diabetes.org/about-diabetes.jsp. Accessed June 14, 2007.
(5)"Direct and Indirect Costs of Diabetes in the United States."
American Diabetes Association. Available at:
http://www.diabetes.org/diabetes-statistics/cost-of-diabetes-in-us.jsp.
Accessed June 14, 2007. (6) Saydah SH, Fradkin J, Cowie CC. "Poor
Control of Risk Factors for Vascular Disease Among Adults with
Previously Diagnosed Diabetes." JAMA. 2004: 291(3), 335-342.
http://www.newscom.com/cgi-bin/prnh/20040122/LILLYAMYLINLOGO
http://photoarchive.ap.org/ DATASOURCE: Eli Lilly and Company
CONTACT: Kindra Strupp of Lilly, +1-317-277-5170 office,
+1-317-554-9577 cell; or Alice Bahner Izzo of Amylin,
+1-858-642-7272 office, +1-858-232-9072 cell Web site:
http://www.lilly.com/ http://www.amylin.com/
http://www.lillydiabetes.com/ http://www.byetta.com/
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