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Long-Term Treatment With Reminyl(R) (galantamine) may be Associated With a Reduced Risk of Institutionalisation in Patients With Dementia

BASINGSTOKE, England, November 9 /PRNewswire/ -- Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announces that Dementia patients receiving long-term treatment with REMINYL(R) (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.(1)

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) (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.(5)

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.

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.(7),(8)

Johnson & Johnson Pharmaceutical Research & Development developed REMINY(R) (galantamine) under a co-development and licensing agreement with Shire Pharmaceuticals Group plc. REMINY(R) is approved for the treatment of mild to moderate Alzheimer's disease in 66 countries. REMINY(R) 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.

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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.

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.

8. Reminyl, Summary of Product Characteristics

Notes to Editors

(x) 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 tradename, regulatory status of medicines and approved indications as discussed in this document may vary from country to country.

Shire Pharmaceuticals Group plc

Shire Pharmaceuticals Group plc (Shire) is a global specialty pharmaceutical company with a strategic focus on meeting the needs of the specialist physician and currently focuses on developing projects and marketing products in the areas of central nervous system (CNS), gastrointestinal (GI), and renal diseases. Shire has operations in the world's key pharmaceutical markets (US, Canada, UK, France, Italy, Spain and Germany) as well as a specialist drug delivery unit in the US.

For further information on Shire, please visit the Company's website:


Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization, the impact of competitive products, including, but not limited to, the impact of those on Shire's Attention Deficit & Hyperactivity Disorder (ADHD) franchise, patents, including but not limited to, legal challenges relating to Shire's ADHD franchise, government regulation and approval, including but not limited to the expected product approval dates of METHYPATCH(R) (methylphenidate), XAGRID(R) (anagrelide hydrochloride) and SPD417/ BIPOTROL(R) (carbamazepine), Shire's ability to secure new products for development, the implementation of the current reorganization and other risks and uncertainties detailed from time to time in Shire's filings, including its Annual Report on Form 10-K for the year ended December 31, 2003, with the Securities and Exchange Commission.

SOURCE Shire Pharmaceuticals Group plc

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