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Predictors of mortality in atypical antipsychotic-treated community-dwelling elderly patients with behavioural and psychological symptoms of dementia: a prospective population-based cohort study from Italy

  • Pharmacoepidemiology and Prescription
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Abstract

Purpose

To evaluate the effect of a broad range of covariates on the survival of a real-life long-term follow-up cohort of community-dwelling patients with behavioural and psychological symptoms of dementia who were new users of atypical antipsychotic medications (APMs).

Methods

This was a prospective cohort study of 1,618 subjects aged ≥65 years with dementia and BPSD (“behavioural and psychological symptoms of dementia”) who were new users of atypical APMs and registered in a Dementia Evaluation Unit of Campania Region (Italy) from September 2006 to March 2010. The potential of baseline features to predict mortality was assessed with the Cox proportional hazards model.

Results

The average follow-up was 309 days. Of the 1,618 new users of atypical antipsychotics, 9.3 % experienced at least one adverse event, including death (5.1 %), drug therapeutic failure (3.0 %), extrapyramidal symptoms (0.5 %) and stroke (0.2 %). The crude all-cause mortality rate was 6.0 per 100 person-years [95 % confidence interval (CI) 4.8–7.4]; the rate was higher in patients aged >85 years (9.0 per 100 person-years, 95 % CI 6.4–12.7) and among male patients (7.5 per 100 person-years, 95% CI 5.3–10.6). In the multivariate analysis, only age was associated to all-cause mortality [hazard ratio (HR) 1.1; 95 % CI 1.0–1.1 and HR 1.4; 95 % CI: 0.9–2.2, respectively). In contrast, hallucination (HR 0.4; 95 % CI 0.2–0.6) and dosage change (HR 0.4; 95 % CI 0.2–0.78) were significantly associated with a lower risk of all-cause mortality.

Conclusions

Among our patient cohort, the mortality rate of patients with BPSD receiving long-term treatment with atypical APMs was lower than that reported in other studies, and only age was found to be significant predictor factor of mortality.

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Clinical investigators

The following clinical investigators provided and collected data for this cohort study: Dr. Mario Scognamiglio and Dr Annalisa Di Palma, Dipartimento di Fragilità and Unità Operativa Complessa Tutela Salute Anziani, ASL Napoli 1 Centro; Dr. Schipani Giuseppe, Coordinamento Area Integrata Anziani, ASL Salerno; Dr. Cerqua Giuliano, Distretto Sanitario 23, ASL Caserta; Dr. Luigi Forgione, Distretto Sanitario 35–39, ASL Napoli 2 Nord; Dr. De Angelis Antonio, Centro sovradistrettuale aziendale, ASL Caserta; Dr. De Martino Gerardo, Centro Geriatrico “Villa delle Terrazze” (Distretto Sanitario 57), ASL Napoli 3 SUD; Dr. Maria Galdi, Servizio fasce Deboli, ASL Napoli 3 SUD; Dr. Maio Gennaro, Distretto Sanitario Benevento 1, ASL Benevento; Dr. Postiglione Alfredo, “Centro Demenze”, Medicina Geriatrica Azienda Ospedaliera Universitaria “Federico II”; Dr. Rabasca Annaflavia, Centro Demenze, ASL Avellino; Dr. Giovanni Rea, Dipartimento di salute mentale, ASL Salerno; Dr Giuseppina Arcaro, Area anziani, ASL Salerno; Dr. Anna Flavia Rabasca, Distretto Sanitario S. Angelo dei Lombardi, ASL Avellino; Dr. Luigi Caterino, Unità Operativa Complessa Organizzazione Cure Domiciliari Integrate con l’Ospedale, ASL Caserta.

Conflict of interest

None.

Ethical aspects

This observational study did not entail any additional risk for enrolled patients besides that associated with current clinical practice in the diagnosis and treatment of BPSD with atypical APMs. The study was approved by the Ethics Committee of the Polyclinic Hospital of the Second University of Naples. All data will be managed according to the Italian privacy law.

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Authors and Affiliations

  1. Department of Experimental Medicine, Regional Centre of Pharmacosurveillance and Pharmacoepidemiology, Second University of Naples, via de Crecchio 7, 80138, Naples, Italy

    Concetta Rafaniello, Carmen Ferrajolo, Liberata Sportiello, Elisabetta Parretta, Ranieri Formica, Barbara Rinaldi, Francesco Rossi & Annalisa Capuano

  2. National Institute of Health, Viale Regina Elena 299, 00161, Rome, Italy

    Flavia Lombardo, Roberto Raschetti & Nicola Vanacore

  3. Italian Medicine Agency (AIFA), Via del Tritone, 181, 00187, Rome, Italy

    Simona Potenza

  4. Department of Political Science “J. Monnet”, Second University of Naples, Viale Ellittico n. 31, 81100, Caserta, Italy

    Antonio Irpino

Authors
  1. Concetta Rafaniello
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  2. Flavia Lombardo
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  8. Barbara Rinaldi
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Corresponding authors

Correspondence to Concetta Rafaniello or Flavia Lombardo.

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Rafaniello, C., Lombardo, F., Ferrajolo, C. et al. Predictors of mortality in atypical antipsychotic-treated community-dwelling elderly patients with behavioural and psychological symptoms of dementia: a prospective population-based cohort study from Italy. Eur J Clin Pharmacol 70, 187–195 (2014). https://doi.org/10.1007/s00228-013-1588-3

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  • DOI: https://doi.org/10.1007/s00228-013-1588-3

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