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| |  AAT: Aricept (Donepezil) Significantly Improves Cognition/Daily Living over Reminyl (Galantamine) in Alzheimer’s Disease GENEVA, SWITZERLAND -- April 4 2002 -- Results from the first head-to-head study comparing Aricept® (donepezil HCl tablets) and Reminyl® (galantamine HBr tablets) demonstrated significantly greater improvements in cognition and activities of daily living (ADLs) in mild to moderate Alzheimer's disease (AD) patients treated with Aricept versus Reminyl. Aricept-treated patients showed significant benefit over patients receiving Reminyl as measured by the modified 13-item Alzheimer's Disease Assessment Scale-cognitive subscale (modified ADAS-cog), achieved significant improvements on the Mini-Mental State Examination (MMSE), and had significantly greater improvements in ADLs, as measured by the Disability Assessment for Dementia (DAD) scale total score. The study was primarily designed to evaluate safety and tolerability. The first-ever presentation of these data took place at the 7th International Geneva/Springfield Symposium on Advances in Alzheimer Therapy (AAT) in Geneva, Switzerland. "By comparing two available Alzheimer's disease medications, physicians now have clinical evidence that will help them prescribe the most appropriate treatment for their patients," said study investigator Roy Jones, MD, Research Institute for the Care of the Elderly, St Martin's Hospital, Bath, England. "This three month study is encouraging news for mild to moderate Alzheimer's disease patients currently on Aricept, as well as those who have yet to initiate treatment." The 12-week, multinational (England, Finland, Norway and Germany), head-to-head, randomised open-label study was designed primarily to evaluate the safety and tolerability of Aricept (n= 64) and Reminyl (n= 56) in 120 patients with possible or probable mild to moderate Alzheimer's disease. The study also investigated the effects of both treatments on cognition and ADLs, such as meal preparation and finance and correspondence. Trained raters who were blinded to study medication and trial results administered testing, using the modified ADAS-cog and the MMSE to measure cognition. ADLs were assessed with the DAD scale, a 40-item scale developed to assess both instrumental and basic ADLs across the full spectrum of AD. More patients were able to tolerate and remain on the maximum daily dose of Aricept (10 mg once daily) than the maximum daily dose of Reminyl (12 mg twice daily) (92 percent versus 71 percent) until study end or final patient visit. Almost one-quarter of Reminyl-treated patients titrated down from the maximum dose to a lower maintenance dose due to tolerability. Significantly greater improvements in cognition were observed for Aricept compared with Reminyl. At Week 12 and endpoint (Week 12 LOCF), Aricept-treated patients showed at least a two-point advantage over patients receiving Reminyl on the 13-item modified ADAS-cog scale (p-value < 0.05). Modified ADAS-cog assesses elements of cognition including the ability to recognize and recall words, comprehend spoken language, and name fingers and objects. The modified version used in this trial added two additional items: delayed recall and concentration/distractibility. At endpoint, Aricept-treated patients achieved significant improvements over patients receiving Reminyl, as measured using the MMSE (p-value < 0.05). Patients receiving Aricept had significantly greater improvements in ADLs than those receiving Reminyl, according to the DAD total score (p-value <0.05 at both Week 12 and endpoint). DAD assesses instrumental and basic ADLs such as preparing meals, handling finances and correspondence and eating. More gastrointestinal adverse events were observed in Reminyl-treated patients than the Aricept treatment group. More patients taking Reminyl reported nausea and diarrhea than those taking Aricept (23.2 percent versus 15.6 percent and 14.3 percent versus 9.4 percent, respectively). Almost 13 percent of patients on Reminyl reported vomiting as compared to zero patients on Aricept. During a 12-week period, patients with an average age of 73.8 years were treated with Aricept, while patients with an average age of 75.1 were treated with Reminyl. Patients were treated according to the recommended dosing on the approved product labeling and dosing adjustments were allowed to reflect real world clinical practice. "This study shows that more than 92 percent of patients were able to tolerate and remain on the maximum effective dose of Aricept treatment until their final visit," said David Geldmacher, MD, clinical director, University Memory & Aging Center, Case Western Reserve University, Cleveland, Ohio. "For patients and their caregivers, these results, along with a simple dosing regimen, will likely mean better ability to tolerate the medication, fewer phone calls and less frequent office visits for managing problematic side effects." In this study, the most frequent treatment-emergent adverse events for Aricept versus Reminyl included: nausea (15.6 percent vs. 23.2 percent); vomiting (0 percent vs. 12.5 percent); anorexia (4.7 percent vs. 8.9 percent); diarrhea (9.4 percent vs. 14.3 percent); headache (6.3 percent vs. 5.4 percent); dizziness (1.6 percent vs. 5.4 percent); and urinary tract infection (3.1 percent vs. 7.1 percent). In a previous, comparative, open-label study between Aricept and Exelon® (rivastigmine tartrate), another cholinesterase inhibitor, results showed that almost twice as many patients were able to remain at the maximum effective daily dose of Aricept than Exelon at the final study visit (87.5 percent vs. 47.3 percent, respectively). Furthermore, Aricept was better tolerated than Exelon in patients with mild to moderate Alzheimer's disease. These data were first presented at the 13th European College of Neuropsychopharmacology Congress (ECNP) in September 2000. SOURCE: Eisai Ltd. (European Office) and Pfizer Inc.
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