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Results published for first one-year, head-to-head study comparing Reminyl and Aricept for Alzheimer's

TITUSVILLE, N.J., Aug. 19, 2003 -- Results from the first one-year, head-to-head study comparing Reminyl (galantamine hydrobromide) and Aricept* (donepezil hydrochloride) -- two treatments for mild to moderate Alzheimer's disease -- are published in this month's issue of the peer-reviewed journal, Drugs and Aging.

The study found that both drugs maintained activities of daily living to an equal degree through month nine and had a comparable effect on abnormal behaviors. However, an advantage for Reminyl was suggested on two secondary measures of "caregiver burden" in mild to moderate Alzheimer's disease, and on two assessments of cognition (the ability to think clearly, reason and learn new information).

"This year-long study demonstrates once again that medication is effective in slowing the progression of symptoms in Alzheimer's disease," said study co- author Roger Bullock, Department of Old Age Psychiatry, Kingshill Research Centre, Victoria Hospital, Swindon, UK, adding that it is a "tragedy" that an estimated 70 percent or more of people diagnosed with the illness are not being treated with medications approved to treat the disorder.

"However, while we found that there were similarities between these two treatments, there also were differences in cognition and caregiver burden among patients with moderate Alzheimer's disease, which prescribers may want to take into consideration."

The rater-blinded, randomized study followed 182 patients who took 24 mg of Reminyl or 10 mg of Aricept daily. Participants met criteria classifying them as having moderate to advanced Alzheimer's disease. At a duration of 12 months, this is the longest study of its kind.

The study found that Reminyl provided benefit comparable to Aricept in maintaining basic activities of daily living (such as bathing and grooming), as measured by the Bristol Activities of Daily Living (BrADL) scale (the primary efficacy assessment used in this research). Patients' functional ability remained relatively constant for both treatment groups for nine months, after which a small decline was observed.

Likewise, both medications affected abnormal behaviors (such as paranoia and agitation) to a similar degree (specifically, no significant difference from scores at the beginning of the study), as measured by the Neuropsychiatric Inventory (NPI).

When comparing participants' cognitive performance, the study found some differences between the two drugs. The Mini-Mental State Examination (MMSE) found that as a group, patients taking Reminyl maintained levels of cognitive performance that were similar to those shown at the start of the study. In contrast, the Aricept group deteriorated significantly. This between-group difference did not reach statistical significance at the end of the study for the overall participating group.

However, an analysis of patients who responded to one of the treatments (as shown by a lack of deterioration in their MMSE scores) found that "galantamine treatment provided significantly more sustained cognitive benefits than donepezil treatment." At 12 months, more than half (55.2%) of those receiving Reminyl had maintained or improved their cognitive performance, compared with only one-third (32.5%) of patients taking Aricept. A similar advantage for Reminyl was also observed for patients with moderate stage disease, with 57.9% of Reminyl patients maintained or improved cognitive performance vs. 29.9% of Aricept patients. This group of patients, with MMSE scores of 12 to 18, accounted for about 85 percent of study participants.

Cognitive performance also was measured using the Alzheimer's Disease Assessment Scale (ADAS-cog/11). While results for the total study population were similar for both drugs, the patients with moderate disease showed a significant benefit for Reminyl compared to Aricept at 52 weeks. Among these patients, 48.1% of those taking Reminyl maintained or improved ADAS-cog/11 scores vs. 30.0% of those taking Aricept.

Finally, the study also assessed caregiver burden (the frequency and severity of distressing experiences reported by family members or other non- professionals caring for the patient), using the Screen for Caregiver Burden (SCGB). After 52 weeks of treatment, more than two-thirds of the caregivers of patients taking Reminyl reported the same or reduced caregiver burden, (67% and 68% for frequency and severity, respectively). This compared to about half (51% and 49%) of those caring for patients taking Aricept.

Both therapies were generally safe and well tolerated. When used according to the recommended dosing schedule, the most frequent side effects of Reminyl include nausea, vomiting, diarrhea, anorexia and weight loss. These side effects tend to occur when starting or increasing the doses of the medication, and are usually mild and temporary. For more information, refer to the full prescribing information for Reminyl or visit Janssen Pharmaceutica Products, LP, which markets Reminyl, also supports a Web site dedicated to caregivers,

Reminyl is thought to inhibit an enzyme that breaks down acetylcholine -- a neurotransmitter in the brain that plays a key role in memory and learning. In addition, it is believed that Reminyl modulates the brain's nicotinic receptors, to which acetylcholine binds. The clinical significance of these mechanisms is unknown.

The medication was developed by J&JPRD under a co-development and licensing agreement with UK-based Shire Pharmaceuticals Group plc. Reminyl is marketed by Janssen Pharmaceutica Products, L.P. and Ortho-McNeil Pharmaceutical in the United States, Janssen-Ortho in Canada and Janssen-Cilag elsewhere -- with the exception of the United Kingdom and Ireland, where it is registered and marketed by Shire under co-promotion agreement with Janssen- Cilag. The product is approved for the treatment of mild to moderate Alzheimer's disease in more than 30 countries, and also is being studied in individuals with vascular dementia and mild cognitive impairment (believed to be a precursor to Alzheimer's disease).

* The Aricept trademark is owned by Eisai Inc.

Source: Janssen Pharmaceutica Products;

Posted: August 2003