About Alzheimer's DiseaseAlzheimer's disease, the most common form of dementia, is a degenerative brain disease that is not a normal part of aging. Alzheimer's disease gradually destroys a person's cognitive and functional abilities, including memory and the ability to perform activities of daily living, such as bathing and eating.
Alzheimer's disease is the sixth leading cause of death in the United States, estimated to affect more than five million people. It is estimated that there were 35.6 million people with dementia, including Alzheimer's disease, worldwide in 2010. This number is projected to nearly double every 20 years, increasing to 65.7 million in 2030 and 115.4 million in 2050. The total worldwide costs of dementia, including Alzheimer's disease, were estimated to be around one percent of global gross domestic product (GDP) in 2010, at more than US $600 billion. This includes costs attributed to informal unpaid care, community or residential-based care and treatment.
About Galantamine
Galantamine is an acetylcholinesterase inhibitor approved to treat symptoms of mild to moderate Alzheimer's disease such as memory loss. There is no evidence that galantamine alters the course of the underlying process of dementia. While the precise mechanism of galantamine's action is unknown, it is believed to achieve its therapeutic effect by increasing the concentration of the neurotransmitter acetylcholine by inhibition of the enzyme cholinesterase which breaks down acetylcholine.
Although the cause of cognitive impairment in Alzheimer's disease is not fully understood, it has been reported that neurons that produce acetylcholine, a neurotransmitter, degenerate in the brains of patients with Alzheimer's. The degree of this neuronal loss has been correlated with degree of cognitive impairment and density of amyloid plaques, a neuropathological hallmark of Alzheimer's disease.
In the United States, galantamine is sold as RAZADYNE® and RAZADYNE® ER by Janssen Pharmaceuticals, Inc.
Important Safety Information
In clinical trials, once-daily treatment with RAZADYNE® ER was well tolerated and the adverse events were similar to those seen with twice daily RAZADYNE® tablets.
Anesthesia
Cholinesterase inhibitors, such as galantamine HBr, are likely to exaggerate the neuromuscular blocking effects of succinylcholine-type and similar neuromuscular blocking agents during anesthesia.
Cardiovascular events
Because of their pharmacologic action, cholinesterase inhibitors have vagotonic effects on the sinoatrial (SA) and atrioventrical (AV) nodes, leading to bradycardia and AV block. These actions may be particularly important to patients with superventricular cardiac conduction disorders, or to patients taking other drugs concomitantly that significantly slow heart rate. In clinical trials, galantamine HBr was associated with more frequent reports of bradycardia and syncope vs placebo. Post marketed surveillance of marketed anticholinesterase inhibitors has shown that bradycardia and all types of heart block have been reported in patients both with and without known underlying cardiac conduction abnormalities. All patients should be considered at risk for adverse effects on cardiac conduction.
Gastrointestinal
Cholinesterase inhibitors may increase gastric acid secretion. Patients should be monitored closely for symptoms of active or occult gastrointestinal bleeding, especially those with an increased risk of developing ulcers, eg, those with a history of ulcer disease or patients using concurrent nonsteroidal anti-inflammatory drugs.
Genitourinary
Cholinesterase inhibitors may cause bladder outflow obstruction.
Neurological conditions
Cholinesterase inhibitors are believed to have some potential to cause generalized convulsions. Seizure activity may also be a manifestation of Alzheimer's disease. In clinical trials, there was no increase in the incidence of convulsions with galantamine HBr compared with placebo.
Pulmonary conditions
Cholinesterase inhibitors should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease.
Deaths in subjects with mild cognitive impairment (MCI)
In controlled trials in elderly subjects with MCI, 13 subjects on RAZADYNE® (n=1026) and 1 subject on placebo (n=1022) died of various causes. About half of the RAZADYNE® deaths appeared to result from various vascular causes (myocardial infarction, stroke, and sudden death). RAZADYNE® and RAZADYNE® ER are not indicated for the treatment of MCI.
Hepatic or renal impairment
In patients with moderately impaired hepatic or renal function, dose titration should proceed cautiously. The use of RAZADYNE® or RAZADYNE® ER in patients with severe hepatic impairment or severely impaired renal function (Cl cr
Most common Adverse Events
The most common adverse events in clinical studies occurring at rate of at least 5% and at least twice that of placebo at the recommended maintenance dose of either 16 or 24 mg/day under conditions of every 4 week dose escalation for each 8-mg increase were nausea, vomiting, diarrhea, anorexia, and weight decrease.
About Janssen Research & Development, LLC
At Janssen Research & Development, LLC, we are united and energized by one mission—to discover and develop innovative medicines that ease patients' suffering, and solve the most important unmet medical needs of our time. As one of the Janssen Pharmaceutical Companies of Johnson & Johnson, our strategy is to identify the biggest unmet medical needs and match them with the best science, internal or external, to find solutions for patients worldwide. We leverage our world-class discovery and development expertise, and operational excellence, to bring innovative, effective treatments in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. For more information on Janssen R&D, visit http://www.janssenrnd.com/.
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