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| |  In a Newly Published Study, More Alzheimer's Disease Patients Were Able to Benefit from ARICEPT® (donepezil) Treatment than Exelon® (rivastigmine) KIRKLAND, QC -- August 6, 2002 -- Newly published results from the first head-to-head study between ARICEPT® (donepezil) and Exelon® (rivastigmine) demonstrated that ARICEPT was better tolerated than Exelon in patients with mild to moderate Alzheimer’s disease (AD), allowing more patients on ARICEPT to benefit from treatment. Almost twice as many patients were able to remain at the maximum effective daily dose of ARICEPT (88 percent vs. 47 percent) due to a lower occurrence of treatment-related side effects. Furthermore, when surveyed, physicians and caregivers significantly favored ARICEPT versus Exelon with respect to satisfaction and ease of use. Findings from this study are published in the July issue of the peer-reviewed journal, International Journal of Clinical Practice. "It is important to use effective medications that are well tolerated and easy to use, such as ARICEPT, so that Alzheimer’s patients can remain on therapy and sustain the maximum benefit possible over time," said study investigator David Wilkinson, MD, director of the Memory Assessment and Research Centre, Moorgreen Hospital, Southampton University, Southampton, England. "Publication of these data provides physicians with very practical clinical information regarding the tolerability and safety of two of the available AD treatments to help them prescribe the most appropriate therapy for their patients." "Thus, although both agents improved cognition similarly, more patients in the donepezil group were able to benefit from the improvements," said Dr. Serge Gauthier, McGill Centre of Studies in Aging, Montreal, Quebec. "It is important to note that 88 percent of patients not only tolerated but remained on the maximum effective dose of ARICEPT treatment until their final visit. This is significant for patients and their caregivers because ease of use is important and facilitates Alzheimer patients remaining on therapy and experiencing maximum benefit over time." The multinational, randomized, head-to-head, open-label study was designed to compare the tolerability, safety, and ease of use of ARICEPT to Exelon in 111 patients with mild to moderate Alzheimer’s disease. The secondary endpoint assessed cognition. Key Study Findings: Safety and Tolerability *Almost three times as many patients in the Exelon-treatment group discontinued treatment due to side effects judged to be treatment related compared with the ARICEPT-treatment group (20 percent vs. 7 percent). *Almost twice as many patients were able to remain at the maximum effective daily dose of ARICEPT, 10 mg once a day, than the maximum daily dose of Exelon, 12 mg daily (6 mg twice a day) (88 percent vs. 47 percent), until the end of the study or the patient’s final visit. *Almost four times as many patients in the Exelon-treatment group reported nausea, and three times as many reported vomiting, compared with the ARICEPT-treatment group (42 percent vs. 11 percent) and (24 percent vs. 7 percent), respectively. Satisfaction/Ease of Use Cognition Similar results were seen in the Mini-Mental State Examination (MMSE), which was administered by clinicians who were not blinded to study medication. ARICEPT vs. Exelon Study Details Patients were randomized to receive ARICEPT (n=56) or Exelon (n=55). Patients were treated according to the recommended dosing on the approved product monograph, and dosing adjustments were allowed, based on the clinician’s judgement. Patients receiving ARICEPT were given 5 mg once daily for 28 days, which was increased to 10 mg per day. Exelon-treated patients received 1.5 mg twice daily, then their dosage was increased to 3 mg at day 14, 4.5 mg at day 28 and 6 mg at day 42 (all twice daily with food). Patients who could not tolerate higher dosages of either drug were allowed to continue in the study at the next lower tolerated effective dosage, and attempts were made to increase the dosage again at the next scheduled visit. In this study, the most frequent treatment-emergent adverse events for ARICEPT versus Exelon included: nausea (10.7 percent vs. 41.8 percent); vomiting (7.1 percent vs. 23.6 percent); headache (7.1 percent vs. 18.2 percent); anorexia (1.8 percent vs. 9.1 percent); abnormal dreams (7.1 percent vs. 1.8 percent); back pain (7.1 percent vs. 0.0 percent); somnolence (1.8 percent vs. 5.5 percent); and urinary tract infection (5.4 percent vs. 0.0 percent).+ "The ARICEPT vs. Exelon results support those of the previous study of ARICEPT compared to Reminyl4 (galantamine) which found that 92 percent of patients treated with ARICEPT were able to remain on the maximum effective daily dose of treatment, versus 71 percent for Reminyl," said Dr. Gauthier. "These comparisons provide important clinical evidence for physicians which is useful in prescribing an appropriate treatment for their patients." Information about ARICEPT 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. Individual responses to treatment may vary. Available in 5-mg/day and 10-mg/day dosages, both clinically effective, ARICEPT does not require titration and is taken in a simple once-a-day dose with or without food, which is convenient for the patients and their caregivers. In all clinical trials, ARICEPT was well tolerated by patients. Most common side effects included nausea, diarrhea, insomnia, fatigue or loss of appetite and were usually mild and transient. It is estimated that over 350,000 Canadians are diagnosed with one form or another of dementia. With the aging of Canada’s population, it is estimated that by 2031, close to 780,000 Canadians will be diagnosed with dementia. AD is the most common form of dementia, accounting for 60 to 70 percent of all cases. This progressive and ultimately fatal disease robs a person’s memory along with the individual’s ability to think, communicate and take care of her/himself. Today, some 240,000 Canadians are affected by AD and by the year 2031, the number is expected to rise to 500,000. Discovered by the Japanese pharmaceutical firm Eisai, ARICEPT is marketed in Canada by Pfizer Canada Inc. It has been available in Canada since August 1997 when it was approved by Health Canada for the symptomatic treatment of mild to moderate AD. ARICEPT is the number one prescribed Alzheimer’s medication in the world and is available by prescription in 50 countries, including Canada, the United States, the United Kingdom and other European countries. To date, the number of patients’ days has surpassed 717 million worldwide. Pfizer Inc discovers, develops, manufactures and markets leading prescription medicines, for human and animals, and many of the world’s best-known consumer products. In Canada, Pfizer employs 2,300 people. Canadian headquarters of the Pfizer Pharmaceuticals Group is in Kirkland, Quebec. ARICEPT® is a registered trademark of Eisai Co., Ltd. Pfizer Canada Inc., licensee. For further information, please contact: SOURCE: Pfizer Pharmaceuticals Group
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