Dementia patients receiving long-term treatment with Reminyl may be able to stay at home for longer compared

Nov 10 2004

Shire Pharmaceuticals Group has announced that Dementia patients receiving long-term treatment with Reminyl (more than 36 months) may be able to stay at home for longer compared to those receiving treatment for shorter periods of time. The results of this retrospective study were presented at a recent international congress.

Five hundred and ninety-six patients, from seven countries (Canada, Denmark, Finland, France, Norway, Sweden and the United Kingdom) were included in this retrospective analysis(x) of patients who originally participated in one of the three randomised, placebo-controlled clinical trials of galantamine and their subsequent open label follow-up studies (3-4 years). This data was supplemented with data collected retrospectively on former trial patients in 2004. All patients lived at home at entry into the clinical trials, and some of the patients in this study were observed for up to seven years.

Three years after entering the original clinical trial, 92.5 % of patients who had received continuous galantamine treatment were still at home compared to 65 % of patients treated for 24 to 36 months, 48 % of patients treated for 12 to 24 months and 54 % of patients treated for 12 months or less respectively.

Further statistical analyses were employed that took into account the effects of risk factors for institutionalisation such as disease severity, disability with activities of daily living and the absence of a co-resident caregiver. The results of these analyses found that long-term treatment with galantamine was associated with a 27% relative risk reduction for institutionalisation for each additional year of galantamine treatment.

Commenting on these findings, Tuula Pirttilä, study investigator and Professor in Neurology at Kuopio University Hospital, Department of Neurology, Kuopio, Finland said: "For many patients with Alzheimer's disease and their families, postponing admission to a residential or nursing home for as long as possible is very important. This retrospective study suggests that long-term treatment with galantamine may significantly delay the need for residential or nursing home care, prolonging independence and the time patients can spend at home with their families."

Unlike previous pharmaco-economic studies of galantamine, which were based on long-term projections from results of short-term clinical trials, these analyses employed data from long-term studies. The results of this retrospective study are consistent with a similar study on nursing home admission carried out in the USA, suggesting that long-term treatment with galantamine may be associated with a reduced risk of institutionalisation.

Dementia, a progressive brain dysfunction, leads to a gradual loss of the ability to carry out daily activities. The most common and well-known type of dementia is Alzheimer's disease, affecting cognitive function (ability to think, reason and learn), personality and behaviour. Alzheimer's disease is the fourth-leading cause of death in Western countries, preceded only by myocardial infarction, cancer and stroke.

Alzheimer patients are often admitted to a nursing home when they have become totally reliant on a caregiver, often a family member, for day-to-day care. At this stage, the burden of care is so extensive that caregivers can no longer cope with the day-to-day commitment required for such an emotionally and physically demanding job.

Galantamine has a dual mode of action: like other Alzheimer's disease treatments, galantamine enhances levels of the neurotransmitter acetylcholine (a chemical `messenger' responsible for sending signals between nerve cells in the brain), which is typically deficient in Alzheimer's disease. However, unlike other treatments, galantamine also has a recognised modulating effect on the brain's nicotinic receptors, which is believed to increase their effectiveness.

Johnson & Johnson Pharmaceutical Research & Development developed Reminy (galantamine) under a co-development and licensing agreement with Shire Pharmaceuticals Group plc. Reminy is approved for the treatment of mild to moderate Alzheimer's disease in 66 countries. Reminy is marketed by Janssen-Cilag in most European countries with the exception of the UK and Ireland where the product is registered and marketed by Shire.