Evidence map›Paper›PMID 27423216›Full record

ArticleCNS drugs2016

The Effect of Safety Warnings on Antipsychotic Drug Prescribing in Elderly Persons with Dementia in the United Kingdom and Italy: A Population-Based Study.

Janet Sultana, Andrea Fontana, Francesco Giorgianni, Alessandro Pasqua, Claudio Cricelli, Edoardo Spina, Giovanni Gambassi, Jelena Ivanovic, Carmen Ferrajolo, Mariam Molokhia and 4 more

Open access · greenAbstract read
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In one paragraph

Article in CNS drugs, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 3 pooled it
26.4field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 3 syntheses or guidelines pooled it, 38 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 8 institutions in 3 countries.

Janet SultanaDepartment of Clinical and Experimental Medicine, University of Messina, Via Consolare Valeria, 98125, Messina, Sicily, Italy.
Andrea FontanaUnit of Biostatistics, IRCCS Casa Sollievo della Sofferenza, Viale Cappuccini 1, 71013, San Giovanni Rotondo, Bari, Italy.
Francesco GiorgianniDepartment of Clinical and Experimental Medicine, University of Messina, Via Consolare Valeria, 98125, Messina, Sicily, Italy.
Alessandro PasquaHealth Search, Italian College of General Practitioners, Via Sestese, 61, 50141, Florence, Italy.
Claudio CricelliHealth Search, Italian College of General Practitioners, Via Sestese, 61, 50141, Florence, Italy.
Edoardo SpinaDepartment of Clinical and Experimental Medicine, University of Messina, Via Consolare Valeria, 98125, Messina, Sicily, Italy.
Giovanni GambassiDepartment of Internal Medicine, Catholic University of the Sacred Heart, 00168, Rome, Italy.
Jelena IvanovicItalian Drug Agency (AIFA), 181 Via del Tritone, 00187, Rome, Italy.
Carmen FerrajoloDepartment of Experimental Medicine, Pharmacology section, Campania Regional Centre of Pharmacovigilance and Pharmacoepidemiology, Second University of Naples, 7 Via L. De Crecchio, 80138, Naples, Italy.
Mariam MolokhiaDepartment of Primary Care and Public Health Sciences, King's College, London Capital House, 42 Weston Street, London, UK.
Clive BallardBiomedical Research Unit for Dementia, Institute of Psychiatry Psychology and Neuroscience, King's College London, De Crespigny Park, London, UK.
Samantha SharpBiomedical Research Unit for Dementia, Institute of Psychiatry Psychology and Neuroscience, King's College London, De Crespigny Park, London, UK.
Miriam SturkenboomDepartment of Epidemiology, Erasmus Medical Centre, Dr. Molewaterplein 50, 3015 GE, Rotterdam, The Netherlands.
Gianluca TrifiròDepartment of Clinical and Experimental Medicine, University of Messina, Via Consolare Valeria, 98125, Messina, Sicily, Italy. trifirog@unime.it.ORCID 0000-0001-9622-169X
University of Messina · ITKing's College London · GBSocietà Italiana di Medicina Generale · ITCasa Sollievo della Sofferenza · ITErasmus University Rotterdam · NLItalian Medicines Agency · ITUniversità Cattolica del Sacro Cuore · ITUniversity of Campania "Luigi Vanvitelli" · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAntipsychotic (AP) drugs are commonly used to manage the behavioural symptoms of dementia. Nevertheless, international (i.e. the European Medicines Agency in Europe) and national (i.e. the Medicines and Healthcare products Regulatory Agency in the UK and the Italian Drug Agency) regulatory agencies issued safety warnings against AP use in dementia in 2004 and 2009.

objectiveThe aim of this study is to investigate the short- and long-term impact of safety warnings on the use of APs in UK and Italian persons with dementia using two nationwide databases: The Health Improvement Network (THIN) from the UK and the Health Search Database-Cegedim-Strategic Data-Longitudinal Patient Database (HSD-CSD-LPD) from Italy.

methodsWe calculated the overall quarterly prevalence of AP use by class and by individual drug in persons with dementia aged ≥65 years and used generalized linear models to explore the effect of the safety warnings.

resultsWe identified 58,497 and 10,857 individuals aged ≥65 years with dementia from the THIN and HSD-CSD-LPD databases, respectively, over the period 2000-2012. After the 2004 warnings, the use of atypical APs decreased, whereas the use of conventional APs increased, in Italy and the UK until 2009. However, the trend for APs individually showed that the use of risperidone/olanzapine decreased, whereas the use of quetiapine increased in both countries. After the 2009 warnings (until 2012), the use of atypical and conventional APs decreased in the UK (from 11 to 9 and 5 to 3 %, respectively), but such use increased in Italy (from 11 to 18 and 9 to 14 %, respectively).

conclusionThe 2004 warnings led to a reduction in the use of olanzapine and risperidone and increased the use of quetiapine/conventional APs in both countries. From 2009, the use of APs decreased in persons with dementia in the UK but not in Italy. Possible reasons for the difference in AP use between the two countries include a more proactive approach towards reducing the use of APs in the UK than in Italy.

Indexed as

AgedAntipsychotic AgentsBenzodiazepinesDatabases, FactualDementiaDrug PrescriptionsFemaleHumansItalyMaleOlanzapinePractice Patterns, Physicians'Retrospective StudiesRisperidoneUnited KingdomAntipsychotic AgentsBenzodiazepinesOlanzapineRisperidone

Identifiers

PMID27423216
OpenAlexW2467653308

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.