The FDA approved BYETTA (exenatide) injection as an add-on therapy to improve blood sugar control in people with type 2 diabetes who have not achieved adequate control on a thiazolidinedione, or TZD. The drug was approved for use with two other diabetes treatments, metformin, sulfonylureas, in 2005.In a clinical trial designed to evaluate BYETTA for use in combination with a TZD, 62 percent of patients who added BYETTA to their existing medicines achieved an A1C (a measure of blood glucose levels over time) of 7 percent or less, compared to 16 percent of the patients on placebo.
People taking BYETTA also lost an average of 3.3 pounds over 16 weeks, compared to an average weight reduction of 0.4 pounds in the other group, according to Amylin. The most common adverse event associated with BYETTA was nausea, which occurred in 40 percent of patients.
“Due to the progressive nature of type 2 diabetes, previous approaches to management frequently failed to achieve target levels of A1C, or resulted in subsequent failure over one to three years,” said Dr. Robert Ratner, vice president for scientific affairs at the MedStar Research Institute in Washington, D.C. “The combination of exenatide with metformin, sulfonylureas, or TZDs not only expands our options to achieve optimal glycemic control, but does so with accompanying weight loss.”
BYETTA is designed to improve blood sugar control by lowering both post-meal and fasting, or early morning, glucose levels resulting in better long-term control as measured by A1C. BYETTA controls blood sugar through?several physiologic actions, including the stimulation of insulin secretion only when blood sugar is high. The drug is designed to restore the first-phase insulin response - an activity of the cells in the pancreas that is lost in patients who have type 2 diabetes, decrease glucose output from the liver, regulate gastric emptying, and decrease food intake. The majority of patients in long-term BYETTA clinical studies also experienced weight loss.
“Almost half a million people with type 2 diabetes have used BYETTA to help reduce their blood sugar,” said Ginger L. Graham, chief executive officer of Amylin. “Now, even more people — those who use another common category of oral medicines, TZDs — have a new treatment option and have the opportunity to benefit from the unique clinical benefits of BYETTA.”
Amylin has a profit sharing agreemen with Eli Lilly for BYETTA. Amylin developed the drug and Eli Lilly has conducted its marketing. The companies split the US profits 50/50 and outside of the US, Amylin receives royalties. The new expanded FDA approval only covers the US.
Vince Mihalik, global brand development leader for diabetes and endocrine at Eli Lilly explained that there are two core defects to type 2 diabetes, beta cell failure and insulin resistance.
“The ability of BYETTA to improve beta cell responsiveness and lower weight complements the TZD effect on insulin resistance very nicely,” he said.
BYETTA is the first in a new 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, or GLP-1. GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the intestine, 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 despite using the commonly prescribed oral medications metformin, a sulfonylurea, or a thiazolidinedione.
Chinese scientists say they have identified a molecule that may hold the key to developing new pills to treat diabetes, a growing health concern affecting almost 21 million Americans.
The compound, called Boc5, helped mice reduce food intake when given orally or through needles, according to findings published online Monday by the Proceedings of the National Academy of Sciences. Researchers say more potent doses may be used to develop a new class of pills that can treat adult-onset diabetes more easily than injectable drugs now used.
Boc5 mimicked the body’s own glucose-regulating hormones in the mice in a way similar to the treatment mechanism of Byetta, an injection sold by Eli Lilly & Co. and Amylin Pharmaceuticals Inc. Byetta, used to control blood sugar, must be injected because it would be broken down too quickly in the stomach if taken orally.
“The considerable promise” of drugs such as Byetta “may be diminished by their need for injection,” researchers from China’s National Center for Drug Screening in Shanghai wrote in their study.
About 20.8 million Americans had diabetes as of 2005, or 7 percent of the population, according to the National Institute of Diabetes and Digestive and Kidney Diseases.
– bloomberg news
Report flags acute homesickness
Almost everyone experiences occasional homesickness, but many young people suffer an intense form that interferes with normal activities, according to a new study by the American Academy of Pediatrics. The report in the January issue of the journal Pediatrics offers tips to physicians for recognizing risk fa?tors among patients leaving home for the first time.”Leaving home is a universal developmental milestone,” said Dr. Edward Walton, co-author of the report and an assistant professor of pediatrics and emergency medicine at the University of Michigan. “Our goal is for them not to lose time and experience in the adjusting,” he said.
Walton co-wrote the study with Christopher Thurber, staff psychologist at Phillips Exeter Academy, a boarding school in New Hampshire.
About 95 percent of young people say they miss something about home the first time they are away, Thurber said. But a smaller percentage — about 1 in 14 — suffer from what Thurber calls “intense homesickness.”
“They’re not eating or sleeping right, not playing with others,” Thurber said. “Or they have an intense preoccupation with home; they’re not thinking about anything else.”
That can “seriously impair” experiences at camp, boarding school, college or the hospital, he said. – Associated Press
Coral reefs may mitigate tsunamis
Healthy coral reefs may be able to reduce tsunamis’ run-up on land by half, according to a study published in December in the journal Geophysical Research Letters.
Using computer models, three scientists calculated that broad and shallow reefs are especially effective at curbing the impact of tsunamis on volcanic islands.
The authors — former Princeton student Catherine Kunkel, NOAA Geophysical Fluid Dynamics Laboratory scientist Robert Hallberg and Princeton geosciences and public policy professor Michael Oppenheimer — note that reefs could not have significantly softened the blow from the 2004 Indian Ocean tsunami on Banda Aceh, Indonesia, because the waves were so large and the reefs so close to shore. But they added, “for many islands, the reef is significantly far offshore to allow significant dissipation of tsunami energy over the reef” in a computer-generated scenario.
Oppenheimer said the healthier a reef, the better it can limit a tsunami’s reach when it hits land. According to the paper, about 30 percent of the world’s reefs are seriously damaged and nearly 60 percent may die by 2030 because of factors including climate change.
“Coral reefs aren’t just a matter of aesthetics,” Oppenheimer said. “Saving coral reefs can be a matter of saving lives.” – washington post
Caution urged with OTC painkillers
A recent Food and Drug Administration (FDA) proposal to add stronger warning labels to several popular types of over-the-counter painkillers — noting they pose a risk of liver and stomach damage — shouldn’t scare most consumers into avoiding the products entirely, experts say.
But the news should remind patients to take the lowest dose needed for the shortest possible time and to be aware of the ingredients contained in all of their medications, particularly when taking more than one medicine.
Under the proposal, warnings would be added to the labels of all OTC medicines with acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs) — including aspirin, naproxen and ibuprofen — which are used to treat headaches, pain, fever, menstrual cramps and muscle aches. Affected products include such popular brands as Tylenol, Aleve, Motrin and Advil.
The warnings would “include important safety information regarding the potential for stomach bleeding and liver damage and when to consult a doctor,” the FDA reports. – WASHINGTON post