Publications by authors named "Anne Castot-Villepelet"

2 Publications

  • Page 1 of 1

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

Pharmacoepidemiol Drug Saf 2013 Sep 24;22(9):952-60. Epub 2013 Jun 24.

Regional Centre of Pharmacovigilance, Pharmacology-Toxicology-Pharmacovigilance Unit, University Hospital, Limoges, 87042, France.

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.
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September 2013

Complications of BCG vaccine SSI® recent story and risk management plan: the French experience.

Pharmacoepidemiol Drug Saf 2013 Apr 5;22(4):359-64. Epub 2012 Dec 5.

Department of Dermatology, CHU de Saint Etienne (Saint Etienne University Hospital), Saint Etienne, France.

Introduction: As of January 2006, the BCG vaccine SSI® became the only BCG vaccine available for tuberculosis vaccination in France. The use of this vaccine led to significant changes in vaccination technique which were accompanied by a rapid increase in the number of adverse reactions (ADRs) reported. A national pharmacovigilance follow-up began in February 2006, and a risk management plan (RMP) was put in place in April 2006, made of three phases (carried out in June 2006, July 2006 and September 2006) with risk minimisation measures. The goal of this study was to evaluate the impact of the RMP on the amount of ADRs reported.

Methods: Based on data collected by the regional pharmacovigilance centres and the MSD laboratory, the cases of locoregional ADRs spontaneously reported were analysed retrospectively from January 2005 to February 2006, and then prospectively up to June 2008, the date at which the national follow-up ended. The locoregional ADRs were divided into three categories: abscesses, local reactions or lymphadenopathy of more than 1 cm and suppurative lymphadenopathy. A parallel was then drawn between these data and the different phases of the RMP.

Results: During the entire follow-up period, we note 1050 locoregional ADRs, of which 764 were abscesses (73% of all cases), 266 were local reactions and 20 involved suppurative lymphadenopathy.Locoregional ADRs increased rapidly from January 2006 onward, reaching a peak in August 006 and then falling and stabilising from December 2007 onward.The RMP was implemented when there was an increase in the number of ADRs reported. The drop in the number of these effects began 3 months after the first phase and 2 months after the second phase of the RMP. The third phase was not accompanied by a variation in the number of ADRs reported.

Conclusion: The RMP appears to have positive effect on the evolution of the number of ADRs, their decrease occurring rapidly after the risk minimisation measures of the first two phases. Nonetheless, these data should be confirmed by other studies on the efficacy of RMPs.
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April 2013