Amylin Pharmaceuticals, a biopharmaceutical company based in San Diego, CA, recently announced the results of clinical trials of its new medication, Bydureon. The medication was shown to encourage significant improvements in cardiovascular risk factors compared to patients who were prescribed other typical diabetes medications. Patients who had Type 2 diabetes and were treated with Bydureon showed improvements in body weight, blood pressure, and lipid levels. The results of the study will be presented at the annual meeting European Association for the Study of Diabetes (EASD) in Lisbon, Portugal. It will be the 47th meeting of the EASD.
“Patients with diabetes are at least twice as likely as people without the disease to have heart disease or a stroke. Having other chronic conditions including obesity, high blood pressure or high cholesterol further increases this risk,” says James Malone, M.D., global exenatide medical director for Lilly Diabetes. Commenting on the necessity of treating patients for complications often related to diabetes, Malone continued: “These data underscore the need to consider not only glycemic control but also the important role played by other medical conditions that are common among patients with type 2 diabetes.”
In one phase of the trial, patients received either Bydureon or Lantus in addition to metformin, or metformin plus sulfonylurea. After 84 weeks of this medication, the patients taking Bydureon showed improvements in several key areas. They had a significant reduction in body weight (9.8 pounds more than did the patients taking Lantus). They also met a composite endpoint of A1C less than 7% plus target systolic blood pressure (at less than 130mmHg) and LDL cholesterol (at less than 100mg/dL).
In another phase of the trial, participants were divided into groups and treated with one of four drug therapies: Bydureon, metformin, Actos, or Januvia. After analyzing the data, researchers found that participants taking Bydureon or metformin had a better chance of achieving composite goals than the patients treated with Actos or Januvia.
Among the side effects reported in the participants taking Bydureon, gastrointestinal events were the most commonly reported. However, the number of reported cases declined as the trial continued. In another phase of the study, patients taking Bydureon reported nausea and diarrhea as the most common side effects, which falls in line with previously reported adverse side effects of the drug.
Bydureon is the tentative name for exenatide extended-release, an injectable medication for Type 2 diabetes that delivers continuous therapeutic doses of exenatide with one weekly dose. Exenatide is the active ingredient in Byetta, which has been in use since 2005 in the U.S. and in 70 countries around the world as a medication for Type 2 diabetes. Byetta is also an injectable medication typically used in concert with a diet and exercise program to improve glycemic control in adults with Type 2 diabetes. It is also used in combination with metformin or a thiazolidinedione. The drug has been associated with some significant adverse side effects, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. It has been used by over 1.8 million patients since it was introduced.
Bydureon was granted marketing authorization in the European Union in June 2011. It is currently under review in the United States and is due for a Prescription Drug user Fee Action update in January of next year. The drug is already available in the United Kingdom and will be launching shortly in other European countries.