Lixisenatide and Cardiovascular Outcomes: The Burden of Proof

April 22, 2016

After cardiovascular (CV) safety concerns emerged with rosiglitazone use, the Food and Drug Administration (FDA) now requires outcome studies to be performed for all new diabetes medications.   The first CV safety study (ELIXA) for a drug in the glucagon-like peptide 1-receptor agonist (GLP-1 RA) class – lixisenatide - was published in December 2015.  Lixisenatide is a once-daily injectable GLP-1 RA approved for use in Europe and awaits FDA approval in the United States.

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Drug Treatment for Agitation in Alzheimer’s Disease: A Conundrum

April 8, 2016

Managing behavioral health in persons withdementia is an enormous and growing problem. Most patients with Alzheimer's disease (AD) have challengingneuropsychiatric symptoms such as agitation. These symptoms are distressing andoften overwhelming for caregivers often resulting in institutionalization andincreased healthcare utilization. Several medications are used off-labelto treat these symptoms including antidepressants, antipsychotics,anticonvulsants, anxiolytics and cholinesterase inhibitors.   But manyregulatory bodies, professional associations, and patient advocacy groups havepromoted initiatives to decrease the inappropriate use of medications andencourage the use of alternatives, particularly behavioral interventions. The combination of dextromethorphan hydrobromideand quinidine sulfate (Nuedexta) has been recently studied for the off-labeltreatment of agitation in Alzheimer’s disease.  A patient-centered, systematic, andevidence-based approach should be considered when addressing the behavioral and psychological symptoms of dementia.

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