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Newly Approved First-in-Class Treatment for Type 2 Diabetes Is Now Available, USA
Byetta(R) (exenatide) injection is now available for Americans struggling to control their type 2 diabetes. BYETTA can help
diabetes patients manage blood sugar while potentially losing weight. Recently approved by the Food and Drug Administration
(FDA), BYETTA is now available in pharmacies across the country.
Developed by Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY), BYETTA (pronounced
bye-A-tuh) is available as an adjunctive therapy to improve blood sugar control in patients with type 2 diabetes who have not
achieved adequate control on metformin and/or a sulfonylurea, two common oral diabetes medications. BYETTA is the first in a
new class of diabetes treatment called incretin mimetics. By mimicking the mechanisms of a naturally occurring human hormone,
BYETTA is a diabetes self regulating drug that stays in the blood system, working actively only when blood sugar levels are
too high. In clinical trials, BYETTA was shown to help patients regulate blood sugar levels. Most patients in the long-term
BYETTA clinical studies also experienced reductions in weight.
"For a disease where more than two-thirds of the patients aren't achieving their target blood sugar levels, the availability
of BYETTA is a remarkable advancement for the diabetes medical community. BYETTA addresses a core defect of type 2 diabetes,
where the body fails to respond normally to food intake, causing blood sugar levels to rise and fluctuate in an unhealthy
manner," said Dr. Carol Wysham, Clinical Endocrinologist at Rockwood Clinic in Spokane, Washington and Clinical Assistant
Professor of Medicine at University of Washington.
Three different studies published since 2002 demonstrate the public health burden of diabetes and the challenge patients face
while trying to achieve adequate blood sugar control. These studies, published by the American Association of Clinical
Endocrinologists, the Journal of the American Medical Association and the American Diabetes Association (ADA), show that
nearly two- thirds of the 13 million Americans diagnosed with and being treated for diabetes are still not achieving target
blood glucose levels recommended by ADA. This collective data further substantiates the urgent need for new treatment
options.
"With BYETTA I feel in charge, no longer having to revolve everything around when and what I eat. Not only is my blood sugar
under control, but BYETTA has helped me lose weight," said David Anderson, a participant in the clinical trials.
Continuing Amylin's success in innovative therapies and Lilly's leadership in diabetes care, BYETTA offers a promising new
approach to type 2 diabetes patients who, despite the number of treatment options available, are still unable to adequately
manage the disease.
BYETTA is formulated for easy self-administration as a fixed dose injection given before meals in the morning and in the
evening, and is available in pharmacies across the country in both a 5 microgram and a 10 microgram pre-filled pen.
Safety and Tolerability
Adverse events associated with BYETTA are generally mild to moderate in intensity. In clinical trials, the most frequently
reported adverse event was mild-to-moderate, dose-dependent nausea. With continued therapy, the frequency and severity of
nausea decreased over time in most patients.
Patients receiving BYETTA in combination with a sulfonylurea may be at a higher risk of hypoglycemia, or low blood sugar. To
reduce this risk, lowering the sulfonylurea dosage may be considered. When patients begin taking BYETTA, the symptoms,
treatment, and conditions that predispose development of hypoglycemia should be explained to them, and the patient's usual
instructions for hypoglycemia management should be reviewed and reinforced.
Patients should also be advised that treatment with BYETTA may lead to a reduction in appetite, food intake, and/or body
weight, and that there is no need to modify the dosing regimen due to such effects.
BYETTA is not a substitute for insulin in insulin-requiring patients. BYETTA should not be used in patients with type 1
diabetes. Use of BYETTA is not recommended in patients with end-stage renal disease or severe renal impairment, or in
patients with severe gastrointestinal disease. BYETTA should be used with caution in patients receiving oral medications that
require rapid gastrointestinal absorption.
For complete safety profile and other important prescribing considerations, visit http://www.BYETTA.com.
About BYETTA
BYETTA is the first in a new class of drugs for the treatment of type 2 diabetes called incretin mimetics and exhibits many
of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1, secreted in response to food
intake, has multiple effects on the intestine, liver, pancreas and brain that work in concert to improve blood sugar.(1)
BYETTA was approved by the FDA for use by people with type 2 diabetes who are unsuccessful at controlling their blood sugar
levels despite using the commonly prescribed oral medications metformin, a sulfonylurea, or both. For full prescribing
information, visit http://www.BYETTA.com.
About Incretin Mimetics
Incretin mimetics is a new class of agents in the fight against diabetes. An incretin mimetic works to mimic the
anti-diabetic or glucose-lowering actions of naturally occurring human hormones called incretins. These actions include
stimulating the body's ability to produce insulin in response to elevated levels of blood sugar, inhibiting the release of a
hormone called glucagon following meals, slowing the rate at which nutrients are absorbed into the bloodstream and reducing
food intake. BYETTA is the first FDA- approved agent of this new class of medications.
About Diabetes
Diabetes affects an estimated 194 million adults worldwide(2) and more than 18 million in the United States.(3) Approximately
90-95 percent of those affected have type 2 diabetes, a condition where the body does not produce enough insulin and/or the
cells in the body do not respond normally to insulin. 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. Type 2 diabetes usually occurs
in adults over the age of 40, but is increasingly common in younger people.
According to the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, approximately
60 percent of diabetes patients do not achieve target A1C levels (less than 7.0% according to American Diabetes Association
guidelines) with their current treatment regimen.
About Amylin and Lilly
Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and
commercialization of innovative medicines. Further information on Amylin Pharmaceuticals and its pipeline in metabolism is
available at 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, Ind., 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
may not prove to be an important new therapeutic option and BYETTA may be affected by unexpected new data or technical
issues. The potential for BYETTA may also be affected by government and commercial reimbursement and pricing decisions, the
pace of market acceptance and any issues related to manufacturing and supply. These and additional risks and uncertainties
are described more fully in Amylin and Lilly's most recently filed SEC documents such as their Annual Reports on Form 10-K.
Amylin and Lilly undertake no duty to update these forward-looking statements.
P-LLY
(1) Kolterman O, Buse J, Fineman M, Gaines E, Heintz S, Bicsak T, Taylor K, Kim D, Aisporna M, Wang Y, Baron A. Synthetic
exendin-4 (exenatide) significantly reduces postprandial and fasting glucose in subjects with type 2 diabetes. Journal of
Clinical Endocrinology & Metabolism. 2003; 88(7):3082- 3089.
(2) The International Diabetes Federation Diabetes Atlas. Available at:
http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A. Accessed April 12, 2005.
(3) Center for Disease Control and Prevention (CDC) National Diabetes Fact Sheet 2005. Available at
http://www.cdc.gov/nccdphp/aag/pdf/aag_ddt2005.pdf. Accessed June 6, 2005.
http://www.lillymedia.com
View drug information on Byetta; Glucagon.
Recent autorizate Primul-in-Class pentru Tratamentul diabetului de tip 2 este acum disponibil, SUA - Newly Approved First-in-Class Treatment for Type 2 Diabetes Is Now Available, USA - articole medicale engleza - startsanatate