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* 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) 2,3,4. 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.6
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.
Experts believe the long-term clinical efficacy of galantamine may be a result of its unique 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 unique modulating effect on the brain's nicotinic receptors, which is believed to increase their effectiveness.7 Nicotinic receptors are thought to play a key role in attention, memory and learning.
Johnson & Johnson Pharmaceutical Research & Development developed REMINYL® (galantamine) under a co-development and licensing agreement with UK-based Shire Pharmaceuticals Group plc. REMINYL® is approved for the treatment of mild to moderate Alzheimer's disease in 66 countries. REMINYL® 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.
For further information, contact:
Brigitte Byl
Johnson & Johnson Pharmaceutical Services
Global Pharmaceutical Communications
Europe, Middle-East, Africa
32-2-749-2772 (Belgium)
Bbyl@gpcbe.jnj.com
Hayley Baruch
Resolute Communications
Ground Floor
The Blue Building
London, SE1 3LA
44-2-073-578-187
hayley.baruch@resolutecommunications.com
Notes to editors (*) Data for dementia patients from three randomised, placebo-controlled clinical trials of galantamine and subsequent open label follow-up studies were supplemented with data collected retrospectively on former trial patients in 2004. Patients included in those 3 initial clinical trials and follow-up studies were dementia patients diagnosed with Alzheimer Disease (Gal INT 1 and GAL INT 2) and patients diagnosed with either Alzheimer Disease, Alzheimer Disease combined with Cerebro-Vascular Disease or probable Vascular Dementia (GAL INT 6) . Patients from 7 countries were included: Canada, Denmark, Finland, France, Norway, Sweden and the United Kingdom. All patients were resident in a private household at entry into the clinical trial and came from one of the 66 sites where the investigators participated in a retrospective data collection study. All patients were resident in a private household at entry into the clinical trial. This study included a large number of patients with a long-term follow-up (some up to seven years), but drop-out bias may have been possible.
The trade name, regulatory status of medicines and approved indications, as discussed in this document may vary from country to country.
References
1. Pirttilä T, van Baelen B, Kavanagh S. Effect of galantamine on time to residential or nursing home admission. Poster presented at the 17th European Congress of Neuropsychopharmacology, Stockholm, Sweden 2004.
2. Wilcock GK, Lilienfeld S, Gaens E. Efficacy and safety of galantamine in patients with mild to moderate Alzheimer's disease: multi-centre randomised controlled trial. BMJ 2000; 321:1445-9.
3. Rockwood K, Mintzer J, Truyen L, Wessel T et al. Effects of a flexible galantamine dose in Alzheimer's disease: a randomised controlled trial. J Neurol Neurosurg Psychiatry 2001; 71:589-95.
4. Erkinjuntti T et al. Efficacy of galantamine in probable vascular dementia and Alzheimer's disease combined with cerebrovascular disease: a randomised trial. Lancet 2002; 359:139-50.
5. Feldman H, van Baelen B, Kavanagh S. Admission to nursing home: Evidence from US studies of galatamine. Poster presented at the 8th International Montreal/Springfield Symposium on Advances in Alzheimer Therapy, Montreal, Canada, April 2004.
6. Nilsson AK et al. C3 and factor B deficient mice as a tool to study the role of the complement system in the pathogenesis of AD; Presented at Neuroscience Day, Lund. http://www.formonline.se/nd2000/abstracts/abstr39.html.
7. Maelicke A et al. Allosteric sensitization of nicotinic receptors by galantamine, a new treatment strategy for Alzheimer's disease. Biol Psychiatr 2001;49 (3):279–88.