Eisai and Pfizer: ARICEPT(R) (donepezil HCl) Maintains Functional Ability in The Majority of Alzheimer's Disease Patients on Therapy for One Year

New Data from a One-Year U.S. Study Reinforces European Findings ARICEPT(R) (donepezil HCl) treatment significantly extends the functional ability of patients with mild to moderate Alzheimer's disease, according to new one-year data presented today at the 12th European College of Neuropsychopharmacology (ECNP) Congress. ARICEPT is a clinically proven, once-a-day prescription medication that is indicated for symptomatic treatment of mild to moderately severe Alzheimer's dementia. Results of this study confirm that treatment with the medication for up to one year allows patients to maintain their ability to perform activities of daily living such as dressing, eating meals, doing chores and enjoying hobbies, and therefore helps them maintain their independence. "This is the first U.S. study of acetylcholinesterase inhibitors to evaluate the effects of one years' therapy in patients with Alzheimer's disease," said Richard Mohs, Ph.D., professor, department of psychiatry, Mount Sinai School of Medicine and the study's lead investigator. "These findings suggest that prolonged treatment with ARICEPT(R) (donepezil HCl) is an important weapon to improve or maintain patients' independence while living with the disease." During the double-blind, placebo-controlled study, researchers evaluated the time to reach clinically significant decline in function in patients with Alzheimer's disease taking ARICEPT(R) compared to placebo. Patients who met predetermined criteria for clinically significant decline in function were discontinued from the study. These criteria included a decline in the patient's ability to perform one or more basic activities of daily living; a reduction of 20 percent in ability to perform one or more instrumental activities of daily living, such as preparing meals and using household appliances; or a one-point increase in the global Clinical Dementia Rating, a clinically validated measure of disease severity. Of the 431 patients, 214 took 10-mg of ARICEPT(R) once daily, and the other 217 participants took placebo. Assessments of patient function were conducted at baseline and at six-week intervals for 54 weeks. At 48 weeks, patients taking ARICEPT(R) had a 51 percent probability of maintaining function compared to a 35 percent probability for those on placebo. In addition, patients on ARICEPT(R) maintained their functional ability for about five months longer (median time) than those on placebo. This means that ARICEPT(R)-treated patients showed a 62 percent chance of maintaining their functional ability over that of patients on placebo in this one-year study. "The study shows that time to functional loss is delayed in patients who are treated with ARICEPT(R)," Dr. Mohs added. "Our results complement an earlier one-year European trial and provide powerful evidence that ARICEPT(R) is effective in treating symptoms in patients with Alzheimer's disease." The new findings reinforce data from the one-year Nordic Study presented at the Ninth Congress of the International Psychogeriatric Association in August. Results of that randomized, double-blind, placebo-controlled trial demonstrated that ARICEPT(R) (donepezil HCl) had beneficial effects on global and cognitive functioning and activities of daily living of study patients treated for one year. These are the first one-year placebo-controlled trials in Alzheimer's disease with a cholinesterase inhibitor. Alzheimer's disease is a progressive, degenerative brain disorder that results in impaired memory and thinking, behavior changes, and loss of language and motor skills. Currently, approximately 15 million people suffer from the disorder worldwide. ARICEPT(R) is indicated for symptomatic treatment of mild to moderately severe Alzheimer's dementia. ARICEPT(R) is well- tolerated, with a low incidence of side effects, offers convenient once-daily dosing and can be taken with or without food. In controlled trials that supported the U.S. Food and Drug Administration marketing approval of ARICEPT(R), it was found that the drug's most common side effects include nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue and anorexia. These effects were often mild, transient and resolved with continued treatment. People at risk for ulcers should inform their doctor when taking ARICEPT(R). In pivotal clinical trials, syncopal episodes have been reported in patients taking ARICEPT(R) (2 percent vs. 1 percent for placebo). ARICEPT(R) is clinically effective at the starting dose of 5-mg/day and the dose can be escalated to 10-mg/day after four to six weeks if clinically indicated. Currently, ARICEPT(R) is available by prescription in more than 39 countries. In November 1994, Eisai Co., Ltd. and Pfizer Inc announced the formation of a strategic alliance for the promotion of ARICEPT(R) and development of new treatments for Alzheimer's disease and other cognitive disorders. First launched in the United States in February 1997, ARICEPT(R) (donepezil HCl) has been well-received in the Alzheimer's disease community with more than 232 million days of patient use worldwide (as of June 1999). Pfizer Inc, with headquarters in New York, is a research-based pharmaceutical company with global operations. In 1998 the company reported sales of $13.5 billion, and invested more than $2.3 billion in research and development. Eisai Co., Ltd. is a research-based human health care company which discovers, develops and markets products in more than 30 countries. Through its global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide health care systems. The company reported sales of $2.5 billion in 1997 with approximately 15 percent of sales spent for research and development. ARICEPT(R) U.K. prescribing information follows. ARICEPT(R) U.S. prescribing information is available upon request. Brief Prescribing Information ARICEPT(R) (donepezil hydrochloride) Please refer to the SmPC before prescribing ARICEPT 5mg or ARICEPT 10 mg. Indication: Symptomatic treatment of mild to moderately severe Alzheimer's dementia. Dose and administration: Adults/elderly; 5mg daily which may be increased to 10mg once daily after at least one month. No dose adjustment necessary for patients with renal or mild-moderate hepatic impairment. Children; Not recommended. Contra-Indications: Pregnancy. Hypersensitivity to donepezil, piperidine derivatives or any excipients used in ARICEPT. Lactation: Excretion into breast unknown. Women on donepezil should not breast feed. Warning and Precautions: Initiation and supervision by a physician with experience of Alzheimer's dementia. A caregiver should be available to monitor compliance. Regular monitoring to ensure continued therapeutic benefit, consider discontinuation when evidence of a therapeutic effect ceases. Exaggeration of succinylcholine-type muscle relaxation. Avoid concurrent use of anticholinesterases, cholinergic agonist, cholinergic antagonists. Possibility of vagotonic effect on the heart which may be particularly important with "sick sinus syndrome," and supraventricular conduction conditions. Careful monitoring of patients at risk of ulcer disease including those receiving NSAIDs. Cholinomimetics may cause bladder outflow obstruction. Seizures occur in Alzheimer's disease and cholinomimetics have the potential to cause seizures. Care in patients suffering asthma and obstructive pulmonary disease. As with all Alzheimer's patients, routine evaluation of ability to drive/operate machinery. Drug Interactions: Experience of use with concomitant medications is limited, consider possibility of as yet unknown interactions. Interactions possible with inhibitors or inducers of Cytochrome P450; use such combinations with care. Possible synergistic activity with succinylcholine-type muscle relaxants, beta blockers, cholinergic or anticholinergic agents. Side effects: Most commonly diarrhoea, muscle cramps, fatigue, nausea, vomiting, and insomnia. Other common effects in clinical trials (greater than or equal to 5%, and greater than or equal to placebo) headache, pain, accident, common cold, abdominal disturbance and dizziness. Rare cases of syncope, bradycardia, heart block and seizures. Rare reports of liver dysfunction including hepatitis. Psychiatric disturbances, including hallucinations, agitation and aggressive behaviour have been reported; these resolved on dose reduction or discontinuation. There have been some reports of anorexia, gastric and duodenal ulcers and gastrointestinal haemorrhage. Minor increases in muscle creatine kinase. Presentation and basic NHS costs: Blister packed in strips of 14. ARICEPT 5mg; white, film coated tablets marked 5 and Aricept, packs of 28 68.32 pounds sterling. ARICEPT 10mg; yellow, film coated tablets marked 10 and Aricept, packs 28 95.76 pounds. Marketing authorisation numbers: ARICEPT 5mg; PL 1055/0006. ARICEPT 10mg; PL 10555/0007. Marketing authorisation holder: Eisai Ltd. Further information from/Marketed by: Eisai Ltd, Hammersmith International Centre, 3 Shortlands, London, W6 8EE and Pfizer Ltd, Sandwich, Kent, CT13 9NJ. Legal Category: POM Date of preparation: May 1999 ots Original Text Service: Pfizer Inc; Eisai Co., Ltd. Internet: http://www.newsaktuell.de Contact: Celeste Torello of Pfizer, 212-733-6471; or Diane DiBello of Porter Novelli, 212-601-8235, for Pfizer

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