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Islets of Hope treatment options for persons with diabetes |
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Article by Lahle Wolfe. For article use and reprint infomration please contact: Sources IOH links to more information about Byetta Byetta Mini Site Index Visit Islets of Hope's Blog and talk about Byetta!
Information about Byetta is available by calling the Amylin Lilly Customer Support Center toll-free at 1-800-868-1190. Can't afford Byetta? Amylin and Lilly offer an assistance program for persons that are uninsured or have a financial need. Call their Reimbursement Hotline toll-free: 1-800-330-7647 for more information. Specialists are available Monday through Friday from 8 am to 6 pm, Eastern Time. Patients with no other source of coverage may be referred to the Patient Assistance Program. You can also visit Islets of Hope's section on assistance & insurance programs for persons with diabetes.
IOH health tips for taking Byetta Disclaimer: These tips are for general information only and not intended as a substitute advice of your personal physician. -- Not listed on package insertion as of May 2006, but reported by many patients is tooth pain. Byetta has asked the you report any pain in your teeth or allergy-type symptoms to your doctor or pharmacist, or call the Amylin Lilly Customer Support Center toll-free at 1-800-868-1190. -- After reading several Byetta patient blogs, I noticed that persons who reported nausea and vomiting seemed to feel that these side effects were triggered, or made worse, by high-fat, or high-caloric meals. Following a healthy, sensible diet seems to be an important fact in minimizing or alleviating these symptoms. -- Byetta is an injection. For those who have never had to give themselves shots before, it can be worrisome. Spend some time reading over support sites and blogs. Knowing how Byetta has or has not worked for others, and what the possible side effects are and how others cope, may help you to make a decision about whether or not to add this drug into your daily care routine. Remember! Always discuss whatever information you find through chats, support groups,and on the Internet (Islets of Hope included) with your doctor -- only he/she can help you make the best choice for your health care needs. If your doctor suggests Byetta and you refuse based on something you read or heard other says, tell your doctor what that reason is. Give your doctor the chance to clear up any misinformation you might have read. Byetta support and blogs Visit Islets of Hope's Blog and talk about Byetta! Byetta posts section Diabetes Day-to-Day; Understanding Byetta; Johns Hopkins DB's Medical Rants: Byetta information links Here is what I definitely know about Byetta; By Betty McGreevey RN, MN, CNS, CLNC, CS Gerontology Diabetes Conference: Byetta Facts; ADA Conference June 10, 2006 You might also be interested in Diabetes Medications Diabetes Treatments Diabetes Care Did you know? ... that Byetta is a synthetic version of a protein found in the saliva of the Gila monster that works remarkably similar to human GLP-1? ... that, because Byetta was derived from Gila monster saliva, many using the drug refer to is as "Lizzie" or "Gilly?" Sources of information for this article (1) Byetta homepage -- html format Download Free Adobe reader to view .pdf files Byetta studies links Long-Term Data on BYETTA(TM) show sustained improvements in glucose control and progressive weight reduction in people with type 2 diabetes; 06/10/2004 BYETTA (exenatide) injections: Clinical Milestones Backgrounder
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BYETTA (exenatide) Mini Site Index General information about BYETTA Byetta is pronounced (bye-A-tuh) and is a registered trademark of Amylin Pharmaceuticals, Inc. All other brand names are the property of their respective owners. Brand name - BYETTA; Scientific name: Exenatide Drug class - Incretin Mimetic. This is an entirely new class of type 2 diabetes drugs that "mimics" the effects of naturally occurring hormones from the intestines. FDA Approval - Byetta was approved by the FDA on April 28, 2005 for use by adults with type 2 diabetes who have been unsuccessful at controlling their blood glucose (sugar) levels while using the prescribed antidiabetes oral medications like metformin (Glucophage), a sulfonylurea drug or both. However, according to an article in the Associated Press (04/29/2005) "The FDA encouraged the manufacturers [of Byetta] to submit additional studies to show whether Byetta could eventually become a stand-alone treatment for Type 2 diabetes." FDA approval was granted based on the results of three, 30-week clinical trials. In the trial, 1,446 patients with diabetes were given 5 or 10 mg of exenatide per day. Patients continued on existing antidiabetes medications and care routines during the trial. The study show a significant reduction in participant's hemoglobin A1c (HbA1c) levels from baseline (beginning HbA1c levels) in a dose-dependent manner. What is Byetta? Byetta is in the class of drugs called "incretin mimetics." This brand-new class of drugs "mimics" and has many of the same effects as the natural human incretin hormone called glucagon-like peptide-1 (GLP-1). Byetta is a synthetic version of a protein found in the saliva of the Gila monster that works remarkably similar to human GLP-1. GLP-1 is a hormone that is secreted when a person eats. It works in the pancreas, stomach, liver, and brain to regulate blood glucose (blood sugar) levels. GLP-1 is both able to stimulate the secretion of insulin when blood glucose levels rise, but when a person is euglycemic (has normal blood sugars), GLP-1 suppresses abnormal elevation in glucagon secretion. GLP-1 also slows gastric emptying which may contribute to a more steady rise in blood glucose levels after eating. In other words, GLP-1 seems to know when to stimulate insulin production, and when not to. Dr. Jon Eng is credited with the discovery of a new peptide hormone, which he named exendin-4. If you would like to read more information about the works of Dr. Eng and history of Byetta, visit Lilly's article, "BYETTA (exenatide) injections: The discovery and development of a new treatment for type 2 diabetes." (html version) or (.pdf version). Download free Adobe reader to view .pdf files What is Byetta used for? (Indication, or, approved uses) Type 2 diabetes - Byetta is approved by the FDA for use in treating adults with type 2 diabetes, however, some physicians also are now prescribing Byetta as part of an overall treatment plan for insulin resistance and for women with polycystic ovarian syndrome. Byetta currently has FDA approval as a combination therapy (used in conjunction with oral medications), however, the makers of Byetta are seeking FDA approval for its use as a monotherapy (used alone, without other drugs). The FDA has expressed an estimated 6-month review of this additional submission and has not indicated any immediate or obvious reasons for denial. Studies have shown Byetta to be equally effective in treating men and women, and the action and benefits of Byetta are not affected by other considerations including race, age or body weight. Geriatric use of Byetta - Byetta was studied in 282 patients 65 years of age or older and in 16 patients 75 years of age or older. No differences in safety or effectiveness were observed between these patients and younger patients.(1) What use is not approved or considered safe? Contraindications - (uses either not approved or considered safe). Byetta is neither approved for, nor recommended by the makers of Byetta, as a treatment for type 1 diabetes, including juvenile diabetes. Byetta may not be suitable for latent autoimmune diabetes (which, although is often misdiagnosed and similar to type 2 diabetes in its early stages, typically progresses in a pattern towards type 1 characteristics of insulin dependence and beta islet cell destruction). Weight loss drug - Despite recent headlines and optimism expressed among patient forums, Byetta is not approved as a weight-loss drug and should not be used in persons who do not have diagnosed metabolic abnormalities in insulin production or insulin resistance. Type 1 diabetes and those using insulin - BYETTA is not a substitute for insulin in insulin-requiring patients. BYETTA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. The concurrent use of BYETTA with insulin, thiazolidinediones, D-phenylalanine derivatives, meglitinides, or alpha-glucosidase inhibitors has not been studied.(1) Although concurrent use (when patients use both Byetta and insulin) of Byetta and insulin has not been studied, patient insert information does state: Patients with kidney and/or digestive disorders - Byetta should not be used in patients with kidney or digestive problems as noted in Byetta's patient literature:
Eating Disorders - Although not specifically list in Byetta literature, patients with eating disorders, especially those with bulimia or those who purge, often have delayed gastric emptying and other digestive disorders including damage to the esophagus. It is important that you tell your doctor if you have in the past, or currently suffer from, an eating disorder as Byetta may be unsafe for you. Pregnancy and Byetta - Byetta is listed as a Category C drug. Exenatide has been shown to has been shown to cause reduced fetal and neonatal growth, and skeletal effects in mice at systemic exposures 3 times the human exposure resulting from the maximum recommended dose of 20 mcg/day, based on AUC. Exenatide has been shown to cause skeletal effects in rabbits at systemic exposures 12 times the human exposure resulting from the maximum recommended dose of 20 mcg/day, based on AUC. There are no adequate and well-controlled studies in pregnant women. Byetta should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.(1) Nursing mothers and Byetta - It is not known whether exenatide is excreted in human milk. Many drugs are excreted in human milk and because of the potential for clinically significant adverse reactions in nursing infants from exenatide, a decision should be made whether to discontinue producing milk for consumption or discontinue the drug, taking into account the importance of the drug to the lactating woman. Studies in lactating mice have demonstrated that exenatide is present at low concentrations in milk (less than or equal to 2.5% of the concentration in maternal plasma following subcutaneous dosing). Caution should be exercised when BYETTA is administered to a nursing woman.(1) Pediatric use of Byetta - The safety and effectiveness of Byetta have not been established in pediatric patients.(1) Prescribing and patient information How is Byetta administered? This drug is injectable and comes in a pen. What are the doses prescribed? Byetta comes prefilled, pen-injector in 5 mcg (microgram) and 10 mcg doses. Most patients are started on the lower dose to help minimize side effects. How is Byetta stored? Byetta must be stored in the refrigerator. Are there any tests I should have before or during Byetta use? Yes. Patients beginning Byetta injections should have a C-peptide test done. Your doctor should also order this test periodically (usually about every 3 months) while using Byetta until C-peptide levels are normalized. Please read our section on the C-peptide test for more information about the test, as well as how it pertains to patients using Byetta. Mechanisms of Byetta How does Byetta work? Byetta helps control blood glucose levels in adult type 2 diabetics by "mimicking" the effects of naturally occurring hormones from the intestines. This can help the body make more of its own insulin and Byetta is not a substitute for insulin and is currently FDA-approved to be used in conjunction with one or more antidiabetes oral medications including biguanides like Glucophage (metformin), a sulfonylurea like Amaryl (glimepiride), Glucotrol (glipizide), Micronase (glyburide), and others. There are three key ways in which Byetta may work for you:
To summarize how Byetta works, I will quote from the Byetta information website: BYETTA may give you better control of your blood sugar by helping your body manage its own blood sugar levels. BYETTA works when you need it — not when you don't Cautions and side effects Hypoglycemia - When Byetta is used with a medicine that contains a sulfonylurea, hypoglycemia (low blood sugar/glucose) is a possible side effect. Report all episodes of hypoglycemia to your doctor who may lower the dose of your sulfonylurea while you are taking Byetta. Do not take Byetta if your are already in a state of hypoglycemia. Wait until your blood sugars are stable or skip a dose. The following is an excerpt from Byetta's patient information insert:(1) Hypoglycemia In the 30-week controlled clinical trials with BYETTA, a hypoglycemia episode was recorded as an adverse event if the patient reported symptoms associated with hypoglycemia with an accompanying blood glucose <60 mg/dL or if symptoms were reported without an accompanying blood glucose measurement. When BYETTA was used in combination with metformin, no increase in the incidence of hypoglycemia was observed over that of placebo in combination with metformin. In contrast, when BYETTA was used in combination with a sulfonylurea, the incidence of hypoglycemia was increased over that of placebo in combination with a sulfonylurea. Therefore, patients receiving BYETTA in combination with a sulfonylurea may have an increased risk of hypoglycemia (see ADVERSE REACTIONS, Table 2). To reduce the risk of hypoglycemia associated with the use of a sulfonylurea, reduction in the dose of sulfonylurea may be considered (see DOSAGE AND ADMINISTRATION). BYETTA did not alter the counter-regulatory hormone responses to insulin-induced hypoglycemia in a randomized, double-blind, controlled study in healthy subjects. Does Byetta affect the timing, dose, or action of other medications? The effect of BYETTA to slow gastric emptying may reduce the extent and rate of absorption of orally administered drugs. BYETTA should be used with caution in patients receiving oral medications that require rapid gastrointestinal absorption. For oral medications that are dependent on threshold concentrations for efficacy, such as contraceptives and antibiotics, patients should be advised to take those drugs at least 1 hour before BYETTA injection. If such drugs are to be administered with food, patients should be advised to take them with a meal or snack when BYETTA is not administered. The effect of BYETTA on the absorption and effectiveness of oral contraceptives has not been characterized.(1) Known and possible side effects of Byetta - Hypoglycemia (see above "Cautions"). Also, other common side effects with Byetta include nausea, vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach. Many patients also report a profound sense of fatigue and headaches when starting on Byetta. Nausea is most common when first starting Byetta, and most side effects decrease over time in most patients. Weight loss can be a side effect of Byetta, but varies between patients. You should report any additional suspected side effects while taking this medication to your doctor, pharmacist or call the Amylin Lilly Customer Support Center toll-free at 1-800-868-1190. Carcinogenesis, Mutagenesis, Impairment of Fertility - The following information is an excerpt from the Byetta patient information package insert: A 104-week carcinogenicity study was conducted in male and female rats at doses of 18, 70, or 250 mcg/kg/day administered by bolus SC injection. Benign thyroid C-cell adenomas were observed in female rats at all exenatide doses. The incidences in female rats were 8% and 5% in the two control groups and 14%, 11%, and 23% in the low-, medium-, and high-dose groups with systemic exposures of 5, 22, and 130 times, respectively, the human exposure resulting from the maximum recommended dose of 20 mcg/day, based on plasma area under the curve (AUC). In a 104-week carcinogenicity study in mice at doses of 18, 70, or 250 mcg/kg/day administered by bolus SC injection, no evidence of tumors was observed at doses up to 250 mcg/kg/day, a systemic exposure up to 95 times the human exposure resulting from the maximum recommended dose of 20 mcg/day, based on AUC. Exenatide was not mutagenic or clastogenic, with or without metabolic activation, in the Ames bacterial mutagenicity assay or chromosomal aberration assay in Chinese hamster ovary cells. Exenatide was negative in the in vivo mouse micronucleus assay. In mouse fertility studies with SC doses of 6, 68 or 760 mcg/kg/day, males were treated for 4 weeks prior to and throughout mating and females were treated 2 weeks prior to and throughout mating until gestation day 7. No adverse effect on fertility was observed at 760 mcg/kg/day, a systemic exposure 390 times the human exposure resulting from the maximum recommended dose of 20 mcg/day, based on AUC.(1)
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