Adverse drug reactions in patients with Alzheimer's disease and related dementia in France: a national multicentre cross-sectional study

Authors

  • Marie-Laure Laroche,

    Corresponding author
    1. EA 6310 HAVAE, University of Limoges, Limoges, France
    • Regional Centre of Pharmacovigilance, Pharmacology–Toxicology–Pharmacovigilance Unit, University Hospital, Limoges, France
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  • Marie-Christine Perault-Pochat,

    1. Regional Centre of Pharmacovigilance, Clinical Pharmacology and vigilances, University Hospital, Poitiers, France
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  • Isabelle Ingrand,

    1. Regional Centre of Pharmacovigilance, Clinical Pharmacology and vigilances, University Hospital, Poitiers, France
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  • Louis Merle,

    1. Regional Centre of Pharmacovigilance, Pharmacology–Toxicology–Pharmacovigilance Unit, University Hospital, Limoges, France
    2. EA 6310 HAVAE, University of Limoges, Limoges, France
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  • Carmen Kreft-Jais,

    1. Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSaPS), Saint-Denis, France
    2. Institut National de Prévention et d'Education pour la Santé (INPES), Saint-Denis, France
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  • Anne Castot-Villepelet,

    1. Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSaPS), Saint-Denis, France
    2. Agence Régionale de la Santé (ARS) Ile-de-France, Paris, France
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  • Geneviève Durrieu,

    1. Pharmacology, Pharmacovigilance and Pharmacoepidemiology Department, University Hospital, Toulouse, France
    2. INSERM U1027, University of Toulouse, Toulouse, France
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  • Valérie Gras,

    1. Regional Centre of Pharmacovigilance, University Hospital, Amiens, France
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  • Claire Guy,

    1. Regional Centre of Pharmacovigilance, University Hospital, Saint-Etienne, France
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  • Marie-Josèphe Jean-Pastor,

    1. Regional Centre of Pharmacovigilance, University Hospital (AP-HP), Marseille, France
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  • Annie-Pierre Jonville-Béra,

    1. Regional Centre of Pharmacovigilance, Clinical Pharmacology Unit, University Hospital, Tours, France
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  • Isabelle Merlet-Chicoine,

    1. Department of geriatrics, University Hospital, Poitiers, France
    2. Memory Centre (CM2R), University Hospital, Poitiers, France
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  • Ghada Miremont-Salamé,

    1. Regional Centre of Pharmacovigilance, University Hospital, Bordeaux, France
    2. INSERM U657, University of Bordeaux, Bordeaux, France
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  • Fati Nourhashemi,

    1. Department of Internal Medicine and Geriatrics, Gerontopole, University Hospital, Toulouse, France
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  • Jean-Pierre Charmes,

    1. Centre of Dialysis, ALURAD, Limoges, France
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  • the French Centres of Pharmacovigilance Network

    1. French Centres of Pharmacovigilance Network
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    • List of Collaborators: Moragny J (Amiens), Jamet A (Angers), Favre G (Besançon), Heil M (Bordeaux), Guihard C (Brest), Fedrizzi-Crespin S (Caen), de la Gastine B (Caen), Fournier-Choma C (Clermont-Ferrand), Grandvuillemin A (Dijon), Schir E (Grenoble), Gautier S (Lille), Crepin S (Limoges), Millaret A (Lyon), Castellan-Laugier D (Marseille), Pinzani V (Montpellier), Veyrac G (Nantes), Petitpain N (Nancy), Baldin B (Nice), Ginisty S (Paris-Fernand Widal), Hessaïne S (Paris-HEGP), Lebrun-Vignes B (Paris-Pitié Salpêtrière), Biour M (Paris-Saint-Antoine), Moachon L (Paris-Saint-Vincent de Paul), Chavant F (Poitiers), Trenque T (Reims), Picard S (Rennes), Massy N (Rouen), Beyens MN (St-Etienne), Tebacher-Alt M (Strasbourg), Bagheri H (Toulouse), Cissoko H (Tours)

Correspondence to: M.-L. Laroche, Regional Centre of Pharmacovigilance, University Hospital, 2 avenue Martin Luther King, 87042 Limoges Cedex, France. E-mail: marie-laure.laroche@chu-limoges.fr

ABSTRACT

Purpose

To assess the prevalence of adverse drug reactions (ADRs) occurring in patients with Alzheimer's disease (AD) or other dementia in France.

Methods

A cross-sectional multicentre study was conducted by the French network of the 31 regional pharmacovigilance centres on a given day. The subjects were selected by random draw to be a representative sample of French patients with dementia: consultations of dementia clinics, nursing-homes, acute and long care geriatric units, rehabilitation care geriatric units. The staff of each medical structure together with that of the pharmacovigilance centre defined a day for including the patients. Socio-demographic data, history, ADR and drugs given were registered.

Results

There were 1332 subjects included, 51.1% living at home, 48.8% in institutions, aged 82.0 ± 8.0 years (46–108); 61.3% suffered from AD. Mean number of drugs was 6.3 ± 3.1. Anti-dementia drugs were given to 66.4% subjects. ADR prevalence was 5.0% (95% CI: 3.9–6.2) without a significant difference between at home and institutionalized patients. ADR consisted of gastro-intestinal (23.2%), central nervous system (17.4%) and psychiatric disorders (8.7%). Of the ADR, 31.9% were serious, and 47.8% preventable. The drugs most often involved were anti-dementia (28.9%), cardio-vascular (28.9%) and psychotropic drugs (26.4%, anxiolytics, hypnotics, antidepressants, neuroleptics).

Conclusion

This national scale study showed that iatrogenesis in patients with AD and related dementia can at times be serious and preventable. Therefore, special attention is required when prescribing psychotropic and anti-dementia drugs, as they are frequently used and induce half of the ADR in this population. Copyright © 2013 John Wiley & Sons, Ltd.

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