First Ever Study On Alzheimer's Disease Treatment In Hispanics Presented At Major Medical Meeting
Eisai Inc. and Pfizer Inc (NYSE: PFE) announced results from a new open-label study that showed Hispanics with mild to moderate Alzheimer's disease (AD) experienced significant improvement in cognition compared to baseline after 12 weeks of treatment with ARICEPT. This is the first clinical trial looking at an AD prescription medication exclusively in Hispanics, and is important given the high risk of AD among this large population. These results are consistent with pivotal ARICEPT studies in the general population and also in studies specific to African Americans, as seen in the 2006 Treatment of Alzheimer's in African American Patients (TAAAP) study. The Evaluating ARICEPT Treatment in Hispanics (EARTH) study was presented at the 2008 Alzheimer's Association International Conference on Alzheimer's Disease and Related Disorders (ICAD).
"We know the Hispanic community is in need of increased education on the benefits of diagnosing and treating AD early," said Dr. Oscar Lopez, professor, department of neurology, University of Pittsburgh, and the first author of the... EARTH poster presented at ICAD. "This news should serve as a call to action for Hispanic families to watch for early signs of AD among their loved ones and speak with a doctor as soon as possible if symptoms are suspected."
This multi-center open-label clinical trial enrolled 106 Hispanic men and women from across the U.S. Patients were at least 50 years of age and had a diagnosis of mild to moderate AD. In order to most accurately measure the efficacy of ARICEPT in Hispanics, unique measurement tools with little language bias were specifically selected for use in the EARTH study. For instance, the Fuld Object Memory Evaluation (FOME) assessment reduces dependence on spoken English, and it has been proven effective in detecting cognitive impairment and in the diagnosis of AD in Spanish-speaking individuals. The Symbol Digit Modality Test (SDMT) is also extremely sensitive for detecting dementia and has minimal cultural bias. A third, commonly used measurement included the Mini-Mental State Examination (MMSE).
The MMSE score, which measures cognitive function, significantly improved from baseline (p<0.0001) with a treatment effect that was similar to that seen in the pivotal studies for ARICEPT. The FOME, which assesses learning and memory through common object recognition, also showed significant improvement with ARICEPT (p=0.0042) in terms of retrieval scores. The FOME storage scores did not show statistically significant improvement from baseline. The SDMT measures speed of mental processing, attention and concentration functions, and also showed significant improvement from baseline (p<0.0001). Behavioral symptoms and associated caregiver distress were assessed with the Neuropsychiatric Inventory (NPI). A numeric improvement in NPI total score was observed but did not reach statistical significance; however, the NPI Caregiver Distress scale (NPI-D) total score significantly improved (p=0.0500).
The most common adverse events greater than or equal to five percent were insomnia (9.5 percent), dizziness (7.6 percent), diarrhea (5.7 percent) and nausea (5.7 percent).
"All too often, Hispanics dismiss the symptoms of AD as signs of normal aging and wait years before consulting a doctor," said Yanira Cruz, who has a doctorate in public health and is president and CEO of the National Hispanic Council on Aging (NHCOA), a national organization dedicated to improving the quality of life for Hispanic communities. "This study reminds us of the value of treating AD to slow symptoms of the disease, and I encourage primary care physicians with Hispanic patients to start screening for signs of dementia at a younger age, potentially at 55 or 60 years."
Dr. Cruz urges more attention to diagnosis and treatment of AD among Hispanics and advises family members suspecting AD symptoms in a loved one to visit http://www.losamigosdesumemoria.com to learn more about the disease and complete an online memory screener.
The EARTH study represents Eisai and Pfizer's leadership in understanding the benefits of ARICEPT in multiple populations. The TAAAP study, published in the Journal of the National Medical Association in 2006, found that African Americans with mild to moderate AD and treated with ARICEPT experienced significant improvement in cognition and function. ARICEPT has now been studied in two underserved populations, both with higher prevalence and incidence of AD than the general population.
Alzheimer's Disease in the Hispanic Community
-- There are an estimated 200,000 Hispanics living in the U.S. with AD today, and by 2050, it is estimated that approximately 1.3 million Hispanic Americans will have the disease.
-- Due to language differences and cultural barriers, Hispanics typically wait to see a doctor until they are in a later stage of the disease -- usually three years after symptoms emerge.
-- Many Hispanics living with AD remain undiagnosed and untreated (approximately 40 percent).
-- Hispanics start showing AD symptoms nearly seven years earlier than non-Hispanics.
-- Reasons for increased AD risk in the Hispanic community include the growing senior population (age is the number one risk for disease), higher rates of diabetes and hypertension (known risk factors), and familial risk (genetics and heredity).
-- Hispanic participation in AD clinical trials remains historically low. Information About ARICEPT Treatment in Alzheimer's Disease
ARICEPT is the only AD treatment to be approved in the U.S. for mild, moderate and severe dementia of the Alzheimer's type. While there is no cure for AD, ARICEPT can help slow the progression of symptoms. Extensive data derived from clinical studies with thousands of patients have demonstrated that ARICEPT helps cognition and function.
ARICEPT is an acetylcholinesterase inhibitor and is believed to work by inhibiting the breakdown of acetylcholine, thereby increasing available levels of this chemical in the brain. There is an established association between the loss of acetylcholine, a brain chemical involved in memory and thinking, and AD.
In a progressively degenerative disease such as Alzheimer's, improvement, stabilization or a less-than-expected decline over time is considered a positive response to treatment. These types of responses have been observed in patients treated with ARICEPT in clinical trials for AD. Individual responses to treatment vary, and some patients may not respond.
ARICEPT is well tolerated, but may not be for everyone. People at risk for stomach ulcers or who take certain other medicines should tell their doctors because serious stomach problems, such as bleeding, may get worse. Some people who take ARICEPT may experience fainting. Some people may have nausea, vomiting, diarrhea, bruising, or not sleep well. Some people may have muscle cramps or loss of appetite or may feel tired. In studies these were usually mild and temporary.
About Eisai Inc.
Eisai Inc. is a U.S. pharmaceutical subsidiary of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: neurology, gastrointestinal disorders and oncology/critical care. Established in 1995 and ranked among the top-20 U.S. pharmaceutical companies (based on retail sales), Eisai Inc. began marketing its first product in the United States in 1997 and has rapidly grown to become an integrated pharmaceutical business with fiscal year 2007 (year ended March 31, 2008) sales of approximately $3 billion, including the results of the acquisition of MGI PHARMA, Inc.
Eisai Inc. employs approximately 1,500 people at its headquarters in Woodcliff Lake, NJ, at its state-of-the-art pharmaceutical production and formulation research and development facility in Research Triangle Park, NC, and in the field. For more information about Eisai, please visit http://www.eisai.com.
About Pfizer Inc
Founded in 1849, Pfizer is the world's largest research-based pharmaceutical company. Pfizer is taking new approaches to advancing better health as it discovers, develops, manufactures and delivers quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. Pfizer also partners with healthcare providers, governments and local communities around the world to expand access to medicines and to provide better quality health care and health system support. At Pfizer, more than 85,000 colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide. For more information visit http://www.pfizer.com.
Pfizer Inc
"We know the Hispanic community is in need of increased education on the benefits of diagnosing and treating AD early," said Dr. Oscar Lopez, professor, department of neurology, University of Pittsburgh, and the first author of the... EARTH poster presented at ICAD. "This news should serve as a call to action for Hispanic families to watch for early signs of AD among their loved ones and speak with a doctor as soon as possible if symptoms are suspected."
This multi-center open-label clinical trial enrolled 106 Hispanic men and women from across the U.S. Patients were at least 50 years of age and had a diagnosis of mild to moderate AD. In order to most accurately measure the efficacy of ARICEPT in Hispanics, unique measurement tools with little language bias were specifically selected for use in the EARTH study. For instance, the Fuld Object Memory Evaluation (FOME) assessment reduces dependence on spoken English, and it has been proven effective in detecting cognitive impairment and in the diagnosis of AD in Spanish-speaking individuals. The Symbol Digit Modality Test (SDMT) is also extremely sensitive for detecting dementia and has minimal cultural bias. A third, commonly used measurement included the Mini-Mental State Examination (MMSE).
The MMSE score, which measures cognitive function, significantly improved from baseline (p<0.0001) with a treatment effect that was similar to that seen in the pivotal studies for ARICEPT. The FOME, which assesses learning and memory through common object recognition, also showed significant improvement with ARICEPT (p=0.0042) in terms of retrieval scores. The FOME storage scores did not show statistically significant improvement from baseline. The SDMT measures speed of mental processing, attention and concentration functions, and also showed significant improvement from baseline (p<0.0001). Behavioral symptoms and associated caregiver distress were assessed with the Neuropsychiatric Inventory (NPI). A numeric improvement in NPI total score was observed but did not reach statistical significance; however, the NPI Caregiver Distress scale (NPI-D) total score significantly improved (p=0.0500).
The most common adverse events greater than or equal to five percent were insomnia (9.5 percent), dizziness (7.6 percent), diarrhea (5.7 percent) and nausea (5.7 percent).
"All too often, Hispanics dismiss the symptoms of AD as signs of normal aging and wait years before consulting a doctor," said Yanira Cruz, who has a doctorate in public health and is president and CEO of the National Hispanic Council on Aging (NHCOA), a national organization dedicated to improving the quality of life for Hispanic communities. "This study reminds us of the value of treating AD to slow symptoms of the disease, and I encourage primary care physicians with Hispanic patients to start screening for signs of dementia at a younger age, potentially at 55 or 60 years."
Dr. Cruz urges more attention to diagnosis and treatment of AD among Hispanics and advises family members suspecting AD symptoms in a loved one to visit http://www.losamigosdesumemoria.com to learn more about the disease and complete an online memory screener.
The EARTH study represents Eisai and Pfizer's leadership in understanding the benefits of ARICEPT in multiple populations. The TAAAP study, published in the Journal of the National Medical Association in 2006, found that African Americans with mild to moderate AD and treated with ARICEPT experienced significant improvement in cognition and function. ARICEPT has now been studied in two underserved populations, both with higher prevalence and incidence of AD than the general population.
Alzheimer's Disease in the Hispanic Community
-- There are an estimated 200,000 Hispanics living in the U.S. with AD today, and by 2050, it is estimated that approximately 1.3 million Hispanic Americans will have the disease.
-- Due to language differences and cultural barriers, Hispanics typically wait to see a doctor until they are in a later stage of the disease -- usually three years after symptoms emerge.
-- Many Hispanics living with AD remain undiagnosed and untreated (approximately 40 percent).
-- Hispanics start showing AD symptoms nearly seven years earlier than non-Hispanics.
-- Reasons for increased AD risk in the Hispanic community include the growing senior population (age is the number one risk for disease), higher rates of diabetes and hypertension (known risk factors), and familial risk (genetics and heredity).
-- Hispanic participation in AD clinical trials remains historically low. Information About ARICEPT Treatment in Alzheimer's Disease
ARICEPT is the only AD treatment to be approved in the U.S. for mild, moderate and severe dementia of the Alzheimer's type. While there is no cure for AD, ARICEPT can help slow the progression of symptoms. Extensive data derived from clinical studies with thousands of patients have demonstrated that ARICEPT helps cognition and function.
ARICEPT is an acetylcholinesterase inhibitor and is believed to work by inhibiting the breakdown of acetylcholine, thereby increasing available levels of this chemical in the brain. There is an established association between the loss of acetylcholine, a brain chemical involved in memory and thinking, and AD.
In a progressively degenerative disease such as Alzheimer's, improvement, stabilization or a less-than-expected decline over time is considered a positive response to treatment. These types of responses have been observed in patients treated with ARICEPT in clinical trials for AD. Individual responses to treatment vary, and some patients may not respond.
ARICEPT is well tolerated, but may not be for everyone. People at risk for stomach ulcers or who take certain other medicines should tell their doctors because serious stomach problems, such as bleeding, may get worse. Some people who take ARICEPT may experience fainting. Some people may have nausea, vomiting, diarrhea, bruising, or not sleep well. Some people may have muscle cramps or loss of appetite or may feel tired. In studies these were usually mild and temporary.
About Eisai Inc.
Eisai Inc. is a U.S. pharmaceutical subsidiary of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: neurology, gastrointestinal disorders and oncology/critical care. Established in 1995 and ranked among the top-20 U.S. pharmaceutical companies (based on retail sales), Eisai Inc. began marketing its first product in the United States in 1997 and has rapidly grown to become an integrated pharmaceutical business with fiscal year 2007 (year ended March 31, 2008) sales of approximately $3 billion, including the results of the acquisition of MGI PHARMA, Inc.
Eisai Inc. employs approximately 1,500 people at its headquarters in Woodcliff Lake, NJ, at its state-of-the-art pharmaceutical production and formulation research and development facility in Research Triangle Park, NC, and in the field. For more information about Eisai, please visit http://www.eisai.com.
About Pfizer Inc
Founded in 1849, Pfizer is the world's largest research-based pharmaceutical company. Pfizer is taking new approaches to advancing better health as it discovers, develops, manufactures and delivers quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. Pfizer also partners with healthcare providers, governments and local communities around the world to expand access to medicines and to provide better quality health care and health system support. At Pfizer, more than 85,000 colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide. For more information visit http://www.pfizer.com.
Pfizer Inc