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| |  Aricept (Donepezil HCl) Better Tolerated Than Exelon (Rivastigmine Tartrate) In Mild And Moderate Alzheimer’s NEW YORK, NY -- September 27, 2000 -- Results from the first head-to-head study between Aricept® (donepezil hydrochloride) (Eisai Inc. and Pfizer Inc.) and Exelon® (rivastigmine tartrate) (Novartis Pharma AG) showed that in this open-label study Aricept was better tolerated than Exelon in patients with mild to moderate Alzheimer's disease.(1) Data were presented at a scientific conference earlier this month in Munich, Germany. "This study, using manufacturers' recommended dosages,(1) provides previously unavailable information on the comparative tolerability and ease of use of two current Alzheimer's treatment options," said Jeff Gelblum, MD, Associate Professor of neurology, University of Miami. "The study found that twice as many patients taking Exelon discontinued treatment due to side effects, compared with Aricept."(1) The multinational, head-to-head, open-label study was designed to compare the tolerability and ease of use of Aricept® (donepezil hydrochloride) (Eisai Inc. and Pfizer Inc.) and Exelon® (rivastigmine tartrate) (Novartis Pharma AG) in 111 patients with mild to moderate Alzheimer's disease.(1) The two treatment groups had similar improvements from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) scores throughout the 12-week treatment period. ADAS-cog is a clinically validated measure of cognitive function. Testing was administered by independent raters who were blinded to study medication.(1) Key study findings: --Almost four times as many patients in the Exelon-treatment group reported nausea compared with the Aricept-treatment group (41.8 percent vs 10.7 percent).(1) "Despite the often devastating nature of the disease, tolerability is still very important to patients with Alzheimer's disease," said David Wilkinson, MD, director of the Memory Assessment and Research Centre, Moorgreen Hospital, Southampton, England, and an investigator in the study. "Patients tend to be elderly and often have other medical conditions that can make treating Alzheimer's disease more complex. It is therefore important to treat patients with medications that are well tolerated and easy to use, such as Aricept." During the 12-week, open-label trial, 111 patients (59 percent female) with an average age of 74.5 years (51-90 years) were randomized and treated with either Aricept (donepezil hydrochloride) or Exelon (rivastigmine tartrate) for 12 weeks.(1) Patients were dosed according to the approved product labeling for each medication.(2,3) Patients in the Aricept study arm received 5 mg once daily for four weeks and 10 mg once daily thereafter, if tolerated.(1) Patients in the Exelon study arm received 1.5 mg twice daily for 2 weeks, with dose increases of 1.5 mg twice daily every two weeks until reaching 12 mg (6 mg twice daily), if tolerated.(1) Patients who could not tolerate higher doses were allowed to continue in the study at the next lower tolerated dose. Patients who could not tolerate at least 5 mg daily of Aricept or 6 mg daily (3 mg twice daily) of Exelon were discontinued from the study. 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).(1) Other data presented at the symposium included results from two one-year, placebo-controlled clinical studies with Aricept. In the one-year US study, patients treated with Aricept (donepezil hydrochloride) maintained function significantly longer (median time about five months longer) than those treated with placebo.(4) In the multinational one-year study, cognition was maintained at or near baseline for one year as measured by the Mini Mental State Examination (MMSE) in patients treated with Aricept.(5) To date, more than 1.2 million people in the United States have received a prescription for Aricept contributing to a total of 394 million days of patient use worldwide.(1) Aricept is well tolerated but may not be for everyone. Some people may experience nausea, diarrhea, insomnia, vomiting, muscle cramps, fatigue, or loss of appetite. In studies, these side effects were usually mild and temporary. Some people taking Aricept may experience fainting. People at risk for ulcers should tell their doctors because their condition may get worse.(2) In a progressively degenerative disease such as Alzheimer's, no further decline or a less than expected decline is considered a favorable response. Improvement, stabilization and decline have been observed in patients treated with Aricept in clinical trials. Individual responses to treatment may vary.(6) References: Related Links: Aricept (donepezil hydrochloride), Pfizer Inc., Eisai Inc., Exelon (rivastigmine tartrate) and Novartis Pharma AG.
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