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Exenatide extended-release (Bydureon): A once-weekly treatment (along with diet and exercise) to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings
New formulation: FDA approved Exenatide extended-release, a once-weekly treatment (along with diet and exercise) to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings
More than 25 million Americans (≥20 years of age) are thought to have type 2 diabetes mellitus (T2DM). On January 27, 2012, FDA approved exenatide extended-release (Bydureon) injectable suspension as a once weekly treatment (along with diet and exercise) to improve glycemic control in adults with T2DM in multiple clinical settings. However, it is not recommended as first-line therapy for patients inadequately controlled on diet and exercise. Exenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist, enhances glucose-dependent insulin secretion by the pancreatic beta-cell, suppresses inappropriately elevated glucagon secretion, and slows gastric emptying.
Efficacy. Bydureon's efficacy was established in a 24-week, randomized, open-label trial. The trial compared the efficacy of Bydureon (n=129) to immediate-release exenatide (Byetta) (n=123) in patients with T2DM and inadequate glycemic control. Patients were previously treated with diet and exercise alone, single oral antidiabetic therapy (metformin, a sulfonylurea, or a thiazolidinedione), or a combination of the 2 therapies. The trial's primary end point was change in HbA1c from baseline to week 24. Bydureon produced a statistically significant reduction in HbA1c (-0.7%; 95% CI, -0.9, -0.4) and fasting plasma glucose (-20 mg/dL, 95% CI, -31, -10) in comparison to Byetta. Moreover, a larger percentage of patients reached an HbA1c of <7% at week 24 with Bydureon compared to Byetta (58% vs 30%, P<.001). Both drugs reduced body weight compared to baseline (-2.3 kg for Bydureon vs -1.4 kg for Byetta).
Safety. In these clinical trials, the most common adverse events (occurring in ≥5%) associated with Bydureon were nausea, diarrhea, headache, vomiting, constipation, injection-site pruritus, injection-site nodule, and dyspepsia. Bydureon may cause hypoglycemia, particularly when administered with a sulfonylurea. Bydureon may cause thyroid C-cell tumors, and therefore, is contraindicated in patients with a family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. Bydureon may also cause pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis; alternatives should be considered in patients with a history of pancreatitis. If pancreatitis is suspected, Bydureon should be discontinued, and if confirmed, the drug should not be restarted.
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
