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Patients Treated With Alzheimer's Drug Reminyl (Galantamine HBr) Require Less Caregiver Time

TITUSVILLE, NJ -- October 28, 2003 -- Caregivers of patients with mild to moderate Alzheimer's disease being treated with the drug Reminyl(R) (galantamine HBr) spend less time providing care each day than do those caring for a patient taking a placebo, according to a newly published study. Patients treated with Reminyl may also be unsupervised for more time per day compared to those taking placebo. The study appears in this month's issue of the peer-reviewed International Journal of Geriatric Psychiatry.

"Galantamine has been shown to have positive effects on cognition, function, global response and behavior in patients with mild-to-moderate Alzheimer's disease," according to Mary Sano, PhD, director of the Alzheimer's Disease Research Center, Mt. Sinai School of Medicine in New York City, and one of the study's authors. "The results of this study show that the drug is also associated with benefits to the caregiver."

More than four million Americans are estimated to have Alzheimer's disease. According to the Alzheimer's Association, more than 70 percent live at home, with 75 percent of their daily care being handled by family members.

Early in the disease, caregivers provide assistance with complex tasks, such as managing personal finances and legal matters. As the disease progresses, caregivers provide assistance in cooking, bathing, dressing and toileting. Because of the risk of wandering, falls and other accidents, caregivers also spend considerable time supervising the person with Alzheimer's disease, which detracts from their ability to participate in social events and employment. In fact, at the beginning of the study, many caregivers estimated that the person they cared for could be unsupervised for four or fewer hours per day.

This study analyzed data pooled from two large, placebo-controlled, randomized, six-month trials involving 825 patients with mild to moderate Alzheimer's disease. At various points throughout the trial, caregivers recorded the amount of time they spent assisting with activities of daily living and time patients could be left unsupervised each day.

Caregivers of patients in the Reminyl-treated group spent an average of 32 minutes (p=0.011) less per day assisting with activities of daily living. The effect was more pronounced among caregivers of patients with moderate- stage disease being treated with Reminyl, who spent nearly an hour (53 minutes; p=0.021) less each day.

Researchers also found that patients in the Reminyl treatment group could spend more time unsupervised than those in the group taking placebo. Overall, Reminyl patients could be unsupervised for 27 minutes more per day than those taking a placebo. This translates to slightly more than three hours per week.

Analyses also showed that caregivers of patients treated with Reminyl were almost twice as likely to report an increase in the amount of time that patients could be left unsupervised compared with caregivers of patients taking placebo (p=0.015).

"Caregiver burden is one of the main considerations when deciding whether or not to move a family member with Alzheimer's disease into a nursing home," said Dr. Sano. "Results of this study show that treatment with galantamine may help reduce that burden."

Reminyl is used to treat patients with mild to moderate Alzheimer's disease. The most frequent adverse events are nausea, vomiting, diarrhea, anorexia and weight loss. They are usually mild and temporary.

Reminyl 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. 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.

For more information, refer to the full prescribing information for Reminyl or visit http://www.reminyl.com. Janssen Pharmaceutica Products, L.P., also supports a web site dedicated to caregivers, http://www.SharingCare.com.


SOURCE: Janssen Pharmaceutica Products, L.P.

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