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Omontys (Peginesatide): The first pegylated erythropoiesis-stimulating agent for the treatment of anemia due to CKD in adults undergoing dialysis
New molecular entity: FDA approved the synthetic, pegylated erythropoiesis-stimulating agent (ESA) peginesatide (Omontys, Affymax) for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis.
On March 27, 2012, FDA approved the synthetic, pegylated erythropoiesis-stimulating agent (ESA) peginesatide (Omontys, Affymax) for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis. Peginesatide is the first ESA to gain FDA approval for this indication since 2001.
Efficacy. Peginesatide's efficacy was evaluated as part of 2 randomized, active-controlled, open-label, multicenter clinical trials in patients with CKD who were on dialysis. In total, these trials randomized a total of 1,608 patients with hemoglobin levels initially stabilized on epoetin 1 to 3 times weekly to receive either peginesatide administered once monthly or to continue their epoetin therapy. In both studies, peginesatide was found to be non-inferior to epoetin in maintaining hemoglobin concentrations within the pre-specified hemoglobin range of 10 to 12 g/dL. Additionally, the proportion of patients receiving transfusions was similar between treatment groups in both studies. No difference in cardiovascular event rates were observed with peginesatide compared to epoetin in a pooled analysis of these clinical trials (HR=0.95; 95% CI, 0.77–1.17).
Safety. The most common side effects observed in ≥10% of dialysis patients treated with peginesatide during clinical trials included diarrhea, vomiting, hypertension, and joint, back, leg, or arm pain. Myocardial infarction, stroke, and thromboembolism are known serious adverse effects of ESAs, and targeting hemoglobin levels >11 g/dL when using ESAs is known to increase patients' risk of these cardiovascular adverse events. Consequently, the lowest dose of peginesatide sufficient to reduce the need for red blood cell (RBC) transfusions should always be used. Peginesatide is not indicated or recommended for the treatment of anemia in patients with CKD who are not on dialysis because trials demonstrated a higher risk of cardiovascular adverse events when compared to darbepoetin (HR=1.32; 95% CI, 0.97–1.81). Peginesatide and other ESAs should not be used in patients receiving treatment for cancer as they may cause tumor progression or recurrence. Peginesatide is contraindicated in uncontrolled hypertension.
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.
