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1. Frequency and timing of adverse reactions to COVID-19 vaccines; A multi-country cohort event monitoring study

Author

Raethke, Monika, van Hunsel, Florence, Luxi, Nicoletta, Lieber, Thomas, Bellitto, Chiara, Mulder, Erik, Ciccimarra, Francesco, Riefolo, Fabio, Thurin, Nicolas H., Roy, Debabrata, Morton, Kathryn, Villalobos, Felipe, Batel Marques, Francisco, Farcas, Andreea, Sonderlichová, Simona, Belitser, Svetlana, Klungel, Olaf, Trifirò, Gianluca, Sturkenboom, Miriam C., Raethke, Monika, van Hunsel, Florence, Luxi, Nicoletta, Lieber, Thomas, Bellitto, Chiara, Mulder, Erik, Ciccimarra, Francesco, Riefolo, Fabio, Thurin, Nicolas H., Roy, Debabrata, Morton, Kathryn, Villalobos, Felipe, Batel Marques, Francisco, Farcas, Andreea, Sonderlichová, Simona, Belitser, Svetlana, Klungel, Olaf, Trifirò, Gianluca, and Sturkenboom, Miriam C.

Abstract

Introduction: During the COVID-19 pandemic, EMA set-up a large-scale cohort event monitoring (CEM) system to estimate incidence rates of patient-reported adverse drug reactions (ADRs) of different COVID-19 vaccines across the participating countries. This study aims to give an up to date and in-depth analysis of the frequency of patient-reported ADRs after the 1st, 2nd, and booster vaccination, to identify potential predictors in developing ADRs and to describe time-to-onset (TTO) and time-to-recovery (TTR) of ADRs. Methods: A CEM study was rolled out in a period ranging from February 2021 to February 2023 across multiple European countries; The Netherlands, Belgium, France, the United Kingdom, Italy, Portugal, Romania, Slovakia and Spain. Analysis consisted of a descriptive analyses of frequencies of COVID-19 vaccine-related ADRs for 1st, 2nd and booster vaccination, analysis of potential predictors in developing ADRs with a generalized linear mixed-effects model, analysis of TTO and TTR of ADRs and a sensitivity analysis for loss to follow-up (L2FU). Results: A total of 29,837 participants completed at least the baseline and the first follow-up questionnaire for 1st and 2nd vaccination and 7,250 participants for the booster. The percentage of participants who reported at least one ADR is 74.32% (95%CI 73.82–74.81). Solicited ADRs, including injection site reactions, are very common across vaccination moments. Potential predictors for these reactions are the brand of vaccine used, the patient's age, sex and prior SARS-CoV-2 infection. The percentage of serious ADRs in the study is low for 1st and 2nd vaccination (0.24%, 95%CI 0.19––0.31) and booster (0.26%, 95%CI 0.15, 0.41). The TTO was 14 h (median) for dose 1 and slightly longer for dose 2 and booster dose. TTR is generally also within a few days. The effect of L2FU on estimations of frequency is limited. Conclusion: Despite some limitations due to study design and study-roll out, CEM studies can allow prompt

Published
2024

2. What is the Safety of COVID-19 Vaccines in Immunocompromised Patients? Results from the European “Covid Vaccine Monitor” Active Surveillance Study

Author

Data Science & Biostatistiek, Child Health, Infection & Immunity, Bellitto, Chiara, Luxi, Nicoletta, Ciccimarra, Francesco, L’Abbate, Luca, Raethke, Monika, van Hunsel, Florence, Lieber, Thomas, Mulder, Erik, Riefolo, Fabio, Villalobos, Felipe, Thurin, Nicolas H., Marques, Francisco B., Morton, Kathryn, O’Shaughnessy, Fergal, Sonderlichová, Simona, Farcas, Andreea, Janneke, Giele Eshuis, Sturkenboom, Miriam C., Trifirò, Gianluca, Data Science & Biostatistiek, Child Health, Infection & Immunity, Bellitto, Chiara, Luxi, Nicoletta, Ciccimarra, Francesco, L’Abbate, Luca, Raethke, Monika, van Hunsel, Florence, Lieber, Thomas, Mulder, Erik, Riefolo, Fabio, Villalobos, Felipe, Thurin, Nicolas H., Marques, Francisco B., Morton, Kathryn, O’Shaughnessy, Fergal, Sonderlichová, Simona, Farcas, Andreea, Janneke, Giele Eshuis, Sturkenboom, Miriam C., and Trifirò, Gianluca

Published
2024

3. Regional administrative data and their role in planning, programming and controlling at regional level

Author

Marzona, Irene, Stella, Paolo, Trifirò, Gianluca, Corrao, Giovanni, Marzona, Irene, Stella, Paolo, Trifirò, Gianluca, and Corrao, Giovanni

Abstract

Regional administrative data may help public administrations in organizing their information, identifying problems, defining solutions and verifying results of the actions taken. The objective of this work is to present the discussion output of the working group (GDL) “The use of regional pharmaceutical data to facilitate health planning and outcome monitoring” which was held during the Regional Pharmaceutical Policy Forum of 2023. The GDL focused on identifying a model for planning, programming and monitoring health resources based on the data-driven approach and on the use of already existing regional administrative data, defining some gaps and developing proposals to implement this strategy. In particular, were highlighted the needs to adopt a broader perspective that considers healthcare costs as a whole (and not, specifically, oriented towards the governance of pharmaceutical assistance), to create ad-hoc training courses focused on the use of real-world data, and, similarly to some European Countries, to move towards an open access policy (accessible data) that can be useful to improve citizens’ health protection services, in compliance with the GDPR.

Published
2024

4. Safety Monitoring of COVID-19 Vaccines in Persons with Prior SARS-CoV-2 Infection: A European Multi-Country Study

Author

Data Science & Biostatistiek, Child Health, Ciccimarra, Francesco, Luxi, Nicoletta, Bellitto, Chiara, L'Abbate, Luca, Raethke, Monika, van Hunsel, Florence, Lieber, Thomas, Mulder, Erik, Riefolo, Fabio, Dureau-Pournin, Caroline, Farcas, Andreea, Batel Marques, Francisco, Morton, Kathryn, Roy, Debabrata, Sonderlichová, Simona, Thurin, Nicolas H, Villalobos, Felipe, Sturkenboom, Miriam C, Trifirò, Gianluca, Data Science & Biostatistiek, Child Health, Ciccimarra, Francesco, Luxi, Nicoletta, Bellitto, Chiara, L'Abbate, Luca, Raethke, Monika, van Hunsel, Florence, Lieber, Thomas, Mulder, Erik, Riefolo, Fabio, Dureau-Pournin, Caroline, Farcas, Andreea, Batel Marques, Francisco, Morton, Kathryn, Roy, Debabrata, Sonderlichová, Simona, Thurin, Nicolas H, Villalobos, Felipe, Sturkenboom, Miriam C, and Trifirò, Gianluca

Published
2024

5. Frequency and timing of adverse reactions to COVID-19 vaccines; A multi-country cohort event monitoring study

Author

RWE/Causal inference, Global Health, Circulatory Health, JC onderzoeksprogramma Methodologie, Data Science & Biostatistiek, Child Health, Infection & Immunity, Raethke, Monika, van Hunsel, Florence, Luxi, Nicoletta, Lieber, Thomas, Bellitto, Chiara, Mulder, Erik, Ciccimarra, Francesco, Riefolo, Fabio, Thurin, Nicolas H, Roy, Debabrata, Morton, Kathryn, Villalobos, Felipe, Batel Marques, Francisco, Farcas, Andreea, Sonderlichová, Simona, Belitser, Svetlana, Klungel, Olaf, Trifirò, Gianluca, Sturkenboom, Miriam C, RWE/Causal inference, Global Health, Circulatory Health, JC onderzoeksprogramma Methodologie, Data Science & Biostatistiek, Child Health, Infection & Immunity, Raethke, Monika, van Hunsel, Florence, Luxi, Nicoletta, Lieber, Thomas, Bellitto, Chiara, Mulder, Erik, Ciccimarra, Francesco, Riefolo, Fabio, Thurin, Nicolas H, Roy, Debabrata, Morton, Kathryn, Villalobos, Felipe, Batel Marques, Francisco, Farcas, Andreea, Sonderlichová, Simona, Belitser, Svetlana, Klungel, Olaf, Trifirò, Gianluca, and Sturkenboom, Miriam C

Published
2024

6. Frequency and timing of adverse reactions to COVID-19 vaccines; A multi-country cohort event monitoring study

Author

Afd Pharmacoepi & Clinical Pharmacology, PECP - Centre for Pharmacoepidemiology, Pharmacoepidemiology and Clinical Pharmacology, Raethke, Monika, van Hunsel, Florence, Luxi, Nicoletta, Lieber, Thomas, Bellitto, Chiara, Mulder, Erik, Ciccimarra, Francesco, Riefolo, Fabio, Thurin, Nicolas H., Roy, Debabrata, Morton, Kathryn, Villalobos, Felipe, Batel Marques, Francisco, Farcas, Andreea, Sonderlichová, Simona, Belitser, Svetlana, Klungel, Olaf, Trifirò, Gianluca, Sturkenboom, Miriam C., Afd Pharmacoepi & Clinical Pharmacology, PECP - Centre for Pharmacoepidemiology, Pharmacoepidemiology and Clinical Pharmacology, Raethke, Monika, van Hunsel, Florence, Luxi, Nicoletta, Lieber, Thomas, Bellitto, Chiara, Mulder, Erik, Ciccimarra, Francesco, Riefolo, Fabio, Thurin, Nicolas H., Roy, Debabrata, Morton, Kathryn, Villalobos, Felipe, Batel Marques, Francisco, Farcas, Andreea, Sonderlichová, Simona, Belitser, Svetlana, Klungel, Olaf, Trifirò, Gianluca, and Sturkenboom, Miriam C.

Published
2024

7. Cohort Event Monitoring of Adverse Reactions to COVID-19 Vaccines in Seven European Countries: Pooled Results on First Dose

Author

Raethke, Monika, van Hunsel, Florence, Thurin, Nicolas H., Dureau-Pournin, Caroline, Mentzer, Dirk, Kovačić, Barbara, Mirošević Skvrce, Nikica, De Clercq, Evelien, Sabbe, Martine, Trifirò, Gianluca, Luxi, Nicoletta, Giovanazzi, Alexia, Shakir, Saad, Klungel, Olaf H., Schmikli, Sandor, Sturkenboom, Miriam, Raethke, Monika, van Hunsel, Florence, Thurin, Nicolas H., Dureau-Pournin, Caroline, Mentzer, Dirk, Kovačić, Barbara, Mirošević Skvrce, Nikica, De Clercq, Evelien, Sabbe, Martine, Trifirò, Gianluca, Luxi, Nicoletta, Giovanazzi, Alexia, Shakir, Saad, Klungel, Olaf H., Schmikli, Sandor, and Sturkenboom, Miriam

Abstract

Introduction: COVID-19 vaccines were rapidly authorised, thus requiring intense post-marketing re-evaluation of their benefit-risk profile. A multi-national European collaboration was established with the aim to prospectively monitor safety of the COVID-19 vaccines through web-based survey of vaccinees. Methods: A prospective cohort event monitoring study was conducted with primary consented data collection in seven European countries. Through the web applications, participants received and completed baseline and up to six follow-up questionnaires on self-reported adverse reactions for at least 6 months following the first dose of COVID-19 vaccine (Netherlands, France, Belgium, UK, Italy) and baseline and up to ten follow-up questionnaires for one year in Germany and Croatia. Rates of adverse reactions have been described by type (solicited, non-solicited; serious/non-serious; and adverse events of special interest) and stratified by vaccine brand. We calculated the frequency of adverse reaction after dose 1 and prior to dose 2 among all vaccinees who completed at least one follow-up questionnaire. Results: Overall, 117,791 participants were included and completed the first questionnaire in addition to the baseline: 88,196 (74.9%) from Germany, 27,588 (23.4%) from Netherlands, 984 (0.8%) from France, 570 (0.5%) from Italy, 326 (0.3%) from Croatia, 89 (0.1%) from the UK and 38 (0.03%) from Belgium. There were 89,377 (75.9%) respondents who had received AstraZeneca vaccines, 14,658 (12.4%) BioNTech/Pfizer, 11,266 (9.6%) Moderna and 2490 (2.1%) Janssen vaccines as a first dose. Median age category was 40–49 years for all vaccines except for Pfizer where median age was 70–79 years. Most vaccinees were female with a female-to-male ratio of 1.34, 1.96 and 2.50 for AstraZeneca, Moderna and Janssen, respectively. BioNtech/Pfizer had slightly more men with a ratio of 0.82. Fatigue and headache were the most commonly reported solicited systemic adverse reactions and inject

Published
2023

8. Cohort Event Monitoring of Adverse Reactions to COVID-19 Vaccines in Seven European Countries: Pooled Results on First Dose

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, PECP - Centre for Pharmacoepidemiology, Raethke, Monika, van Hunsel, Florence, Thurin, Nicolas H., Dureau-Pournin, Caroline, Mentzer, Dirk, Kovačić, Barbara, Mirošević Skvrce, Nikica, De Clercq, Evelien, Sabbe, Martine, Trifirò, Gianluca, Luxi, Nicoletta, Giovanazzi, Alexia, Shakir, Saad, Klungel, Olaf H., Schmikli, Sandor, Sturkenboom, Miriam, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, PECP - Centre for Pharmacoepidemiology, Raethke, Monika, van Hunsel, Florence, Thurin, Nicolas H., Dureau-Pournin, Caroline, Mentzer, Dirk, Kovačić, Barbara, Mirošević Skvrce, Nikica, De Clercq, Evelien, Sabbe, Martine, Trifirò, Gianluca, Luxi, Nicoletta, Giovanazzi, Alexia, Shakir, Saad, Klungel, Olaf H., Schmikli, Sandor, and Sturkenboom, Miriam

Published
2023

9. Real-world patient characteristics and use of disease-modifying anti-rheumatic drugs in patients with rheumatoid arthritis:a cross-national study

Author

Ingrasciotta, Ylenia, Jin, Yinzhu, Foti, Saveria S., Landon, Joan E., Tari, Michele, Mattace-Raso, Francesco, Kim, Seoyoung C., Trifirò, Gianluca, Ingrasciotta, Ylenia, Jin, Yinzhu, Foti, Saveria S., Landon, Joan E., Tari, Michele, Mattace-Raso, Francesco, Kim, Seoyoung C., and Trifirò, Gianluca

Abstract

Introduction: Rheumatoid arthritis (RA) is associated with significant morbidity and economic burden. This study aimed to compare baseline characteristics and patterns of anti-inflammatory drug use and disease-modifying anti-rheumatic drug (DMARD) use among patients with RA in Southern Italy versus the United States. Method: Using Caserta Local Health Unit (Italy) and Optum’s de-identified Clinformatics® Data Mart (United States) claims databases, patients with ≥ 2 diagnosis codes for RA during the study period (Caserta: 2010–2018; Optum: 2010–2019) were identified. Baseline patient characteristics, as well as proportion of RA patients untreated/treated with NSAIDs/glucocorticoids/conventional DMARDs (csDMARDs)/biological/targeted synthetic DMARDs (b/tsDMARDs) during the first year of follow-up, and the proportion of RA patients with ≥ 1 switch/add-on between the first and the second year of follow-up, were calculated. These analyses were then stratified by age group (< 65; ≥ 65). Results: A total of 9227 RA patients from Caserta and 195,951 from Optum databases were identified (two-thirds were females). During the first year of follow-up, 45.9% RA patients from Optum versus 79.9% from Caserta were exclusively treated with NSAIDs/glucocorticoids; 17.2% versus 11.3% from Optum and Caserta, respectively, were treated with csDMARDs, mostly methotrexate or hydroxychloroquine in both cohorts. Compared to 0.6% of RA patients from Caserta, 3.2% of the Optum cohort received ≥ 1 b/tsDMARD dispensing. Moreover, 61,655 (33.7%) patients from Optum cohort remained untreated compared to 748 (8.3%) patients from the Caserta cohort. The subgroup analyses stratified by age showed that 42,989 (39.8%) of elderly RA patients were untreated compared to 18,666 (24.9%) young adult RA patients in Optum during the first year of follow-up. Moreover, a higher proportion of young adult RA patients was treated with b/tsDMARDs, with and without csDMARDs, compared to elderly RA patients (Op

Published
2023

10. Acid sphingomyelinase deficiency (ASMD): addressing knowledge gaps in unmet needs and patient journey in Italy-a Delphi consensus

Author

Scarpa, M, Barbato, A, Bisconti, A, Burlina, A, Concolino, D, Deodato, F, Di Rocco, M, Dionisi-Vici, C, Donati, M, Fecarotta, S, Fiumara, A, Galeone, C, Giona, F, Giuffrida, G, Manna, R, Mariani, P, Pession, A, Scopinaro, A, Spada, M, Spandonaro, F, Trifirò, G, Carubbi, F, Cappellini, M, Scarpa, Maurizio, Barbato, Antonio, Bisconti, Annalisa, Burlina, Alberto, Concolino, Daniela, Deodato, Federica, Di Rocco, Maja, Dionisi-Vici, Carlo, Donati, Maria Alice, Fecarotta, Simona, Fiumara, Agata, Galeone, Carlotta, Giona, Fiorina, Giuffrida, Gaetano, Manna, Raffaele, Mariani, Paolo, Pession, Andrea, Scopinaro, Annalisa, Spada, Marco, Spandonaro, Federico, Trifirò, Gianluca, Carubbi, Francesca, Cappellini, Maria Domenica, Scarpa, M, Barbato, A, Bisconti, A, Burlina, A, Concolino, D, Deodato, F, Di Rocco, M, Dionisi-Vici, C, Donati, M, Fecarotta, S, Fiumara, A, Galeone, C, Giona, F, Giuffrida, G, Manna, R, Mariani, P, Pession, A, Scopinaro, A, Spada, M, Spandonaro, F, Trifirò, G, Carubbi, F, Cappellini, M, Scarpa, Maurizio, Barbato, Antonio, Bisconti, Annalisa, Burlina, Alberto, Concolino, Daniela, Deodato, Federica, Di Rocco, Maja, Dionisi-Vici, Carlo, Donati, Maria Alice, Fecarotta, Simona, Fiumara, Agata, Galeone, Carlotta, Giona, Fiorina, Giuffrida, Gaetano, Manna, Raffaele, Mariani, Paolo, Pession, Andrea, Scopinaro, Annalisa, Spada, Marco, Spandonaro, Federico, Trifirò, Gianluca, Carubbi, Francesca, and Cappellini, Maria Domenica

Abstract

Acid sphingomyelinase deficiency (ASMD) is an ultra-rare disease, and several gaps of knowledge on various issues remain, particularly at a regional/national level. Expert opinions collected through well-defined consensus methodologies are increasingly used to make available reliable information in the context of rare/ultra-rare diseases. With the aim to provide indications on infantile neurovisceral ASMD (also formerly known as Niemann–Pick disease type A), chronic neurovisceral ASMD (formerly known as Niemann–Pick disease type A/B) and chronic visceral ASMD (formerly known as Niemann–Pick disease type B) in Italy, we conducted a Delphi consensus of experts focused on five main areas: (i) patients and disease characteristics; (ii) unmet needs and quality of life; (iii) diagnostic issues; (iv) treatment-related aspects; and (v) patient journey. Pre-specified, objective criteria were used to outline the multidisciplinary panel, based on 19 Italian experts in ASMD in paediatric and adult patients from different Italian Regions, including both clinicians (n = 16) and ASMD patients’ advocacy or payors with expertise in rare diseases (n = 3). During two Delphi rounds, a high ratio of agreement was found on several topics related to ASMD characteristics, diagnosis, management and disease burden. Our findings may provide valuable indications for management of ASMD at a public health level in Italy.

Published
2023

11. Cohort Event Monitoring of Adverse Reactions to COVID-19 Vaccines in Seven European Countries: Pooled Results on First Dose

Author

RWE/Causal inference, Raethke, Monika, van Hunsel, Florence, Thurin, Nicolas H, Dureau-Pournin, Caroline, Mentzer, Dirk, Kovačić, Barbara, Mirošević Skvrce, Nikica, De Clercq, Evelien, Sabbe, Martine, Trifirò, Gianluca, Luxi, Nicoletta, Giovanazzi, Alexia, Shakir, Saad, Klungel, Olaf H, Schmikli, Sandor, Sturkenboom, Miriam, RWE/Causal inference, Raethke, Monika, van Hunsel, Florence, Thurin, Nicolas H, Dureau-Pournin, Caroline, Mentzer, Dirk, Kovačić, Barbara, Mirošević Skvrce, Nikica, De Clercq, Evelien, Sabbe, Martine, Trifirò, Gianluca, Luxi, Nicoletta, Giovanazzi, Alexia, Shakir, Saad, Klungel, Olaf H, Schmikli, Sandor, and Sturkenboom, Miriam

Published
2023

12. From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding

Author

Thurin, Nicolas H, Pajouheshnia, Romin, Roberto, Giuseppe, Dodd, Caitlin, Hyeraci, Giulia, Bartolini, Claudia, Paoletti, Olga, Nordeng, Hedvig, Wallach-Kildemoes, Helle, Ehrenstein, Vera, Dudukina, Elena, MacDonald, Thomas, De Paoli, Giorgia, Loane, Maria, Damase-Michel, Christine, Beau, Anna-Belle, Droz-Perroteau, Cécile, Lassalle, Régis, Bergman, Jorieke, Swart, Karin, Schink, Tania, Cavero-Carbonell, Clara, Barrachina-Bonet, Laia, Gomez-Lumbreras, Ainhoa, Giner-Soriano, Maria, Aragón, María, Neville, Amanda J, Puccini, Aurora, Pierini, Anna, Ientile, Valentina, Trifirò, Gianluca, Rissmann, Anke, Leinonen, Maarit K, Martikainen, Visa, Jordan, Sue, Thayer, Daniel, Scanlon, Ieuan, Georgiou, Mary E, Cunnington, Marianne, Swertz, Morris, Sturkenboom, Miriam, Gini, Rosa, Thurin, Nicolas H, Pajouheshnia, Romin, Roberto, Giuseppe, Dodd, Caitlin, Hyeraci, Giulia, Bartolini, Claudia, Paoletti, Olga, Nordeng, Hedvig, Wallach-Kildemoes, Helle, Ehrenstein, Vera, Dudukina, Elena, MacDonald, Thomas, De Paoli, Giorgia, Loane, Maria, Damase-Michel, Christine, Beau, Anna-Belle, Droz-Perroteau, Cécile, Lassalle, Régis, Bergman, Jorieke, Swart, Karin, Schink, Tania, Cavero-Carbonell, Clara, Barrachina-Bonet, Laia, Gomez-Lumbreras, Ainhoa, Giner-Soriano, Maria, Aragón, María, Neville, Amanda J, Puccini, Aurora, Pierini, Anna, Ientile, Valentina, Trifirò, Gianluca, Rissmann, Anke, Leinonen, Maarit K, Martikainen, Visa, Jordan, Sue, Thayer, Daniel, Scanlon, Ieuan, Georgiou, Mary E, Cunnington, Marianne, Swertz, Morris, Sturkenboom, Miriam, and Gini, Rosa

Abstract

In 2019, the Innovative Medicines Initiative (IMI) funded the ConcePTION project-Building an ecosystem for better monitoring and communicating safety of medicines use in pregnancy and breastfeeding: validated and regulatory endorsed workflows for fast, optimised evidence generation-with the vision that there is a societal obligation to rapidly reduce uncertainty about the safety of medication use in pregnancy and breastfeeding. The present paper introduces the set of concepts used to describe the European data sources involved in the ConcePTION project and illustrates the ConcePTION Common Data Model (CDM), which serves as the keystone of the federated ConcePTION network. Based on data availability and content analysis of 21 European data sources, the ConcePTION CDM has been structured with six tables designed to capture data from routine healthcare, three tables for data from public health surveillance activities, three curated tables for derived data on population (e.g., observation time and mother-child linkage), plus four metadata tables. By its first anniversary, the ConcePTION CDM has enabled 13 data sources to run common scripts to contribute to major European projects, demonstrating its capacity to facilitate effective and transparent deployment of distributed analytics, and its potential to address questions about utilization, effectiveness, and safety of medicines in special populations, including during pregnancy and breastfeeding, and, more broadly, in the general population.

Published
2022

13. From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Thurin, Nicolas H, Pajouheshnia, Romin, Roberto, Giuseppe, Dodd, Caitlin, Hyeraci, Giulia, Bartolini, Claudia, Paoletti, Olga, Nordeng, Hedvig, Wallach-Kildemoes, Helle, Ehrenstein, Vera, Dudukina, Elena, MacDonald, Thomas, De Paoli, Giorgia, Loane, Maria, Damase-Michel, Christine, Beau, Anna-Belle, Droz-Perroteau, Cécile, Lassalle, Régis, Bergman, Jorieke, Swart, Karin, Schink, Tania, Cavero-Carbonell, Clara, Barrachina-Bonet, Laia, Gomez-Lumbreras, Ainhoa, Giner-Soriano, Maria, Aragón, María, Neville, Amanda J, Puccini, Aurora, Pierini, Anna, Ientile, Valentina, Trifirò, Gianluca, Rissmann, Anke, Leinonen, Maarit K, Martikainen, Visa, Jordan, Sue, Thayer, Daniel, Scanlon, Ieuan, Georgiou, Mary E, Cunnington, Marianne, Swertz, Morris, Sturkenboom, Miriam, Gini, Rosa, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Thurin, Nicolas H, Pajouheshnia, Romin, Roberto, Giuseppe, Dodd, Caitlin, Hyeraci, Giulia, Bartolini, Claudia, Paoletti, Olga, Nordeng, Hedvig, Wallach-Kildemoes, Helle, Ehrenstein, Vera, Dudukina, Elena, MacDonald, Thomas, De Paoli, Giorgia, Loane, Maria, Damase-Michel, Christine, Beau, Anna-Belle, Droz-Perroteau, Cécile, Lassalle, Régis, Bergman, Jorieke, Swart, Karin, Schink, Tania, Cavero-Carbonell, Clara, Barrachina-Bonet, Laia, Gomez-Lumbreras, Ainhoa, Giner-Soriano, Maria, Aragón, María, Neville, Amanda J, Puccini, Aurora, Pierini, Anna, Ientile, Valentina, Trifirò, Gianluca, Rissmann, Anke, Leinonen, Maarit K, Martikainen, Visa, Jordan, Sue, Thayer, Daniel, Scanlon, Ieuan, Georgiou, Mary E, Cunnington, Marianne, Swertz, Morris, Sturkenboom, Miriam, and Gini, Rosa

Published
2022

14. From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Thurin, Nicolas H, Pajouheshnia, Romin, Roberto, Giuseppe, Dodd, Caitlin, Hyeraci, Giulia, Bartolini, Claudia, Paoletti, Olga, Nordeng, Hedvig, Wallach-Kildemoes, Helle, Ehrenstein, Vera, Dudukina, Elena, MacDonald, Thomas, De Paoli, Giorgia, Loane, Maria, Damase-Michel, Christine, Beau, Anna-Belle, Droz-Perroteau, Cécile, Lassalle, Régis, Bergman, Jorieke, Swart, Karin, Schink, Tania, Cavero-Carbonell, Clara, Barrachina-Bonet, Laia, Gomez-Lumbreras, Ainhoa, Giner-Soriano, Maria, Aragón, María, Neville, Amanda J, Puccini, Aurora, Pierini, Anna, Ientile, Valentina, Trifirò, Gianluca, Rissmann, Anke, Leinonen, Maarit K, Martikainen, Visa, Jordan, Sue, Thayer, Daniel, Scanlon, Ieuan, Georgiou, Mary E, Cunnington, Marianne, Swertz, Morris, Sturkenboom, Miriam, Gini, Rosa, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Thurin, Nicolas H, Pajouheshnia, Romin, Roberto, Giuseppe, Dodd, Caitlin, Hyeraci, Giulia, Bartolini, Claudia, Paoletti, Olga, Nordeng, Hedvig, Wallach-Kildemoes, Helle, Ehrenstein, Vera, Dudukina, Elena, MacDonald, Thomas, De Paoli, Giorgia, Loane, Maria, Damase-Michel, Christine, Beau, Anna-Belle, Droz-Perroteau, Cécile, Lassalle, Régis, Bergman, Jorieke, Swart, Karin, Schink, Tania, Cavero-Carbonell, Clara, Barrachina-Bonet, Laia, Gomez-Lumbreras, Ainhoa, Giner-Soriano, Maria, Aragón, María, Neville, Amanda J, Puccini, Aurora, Pierini, Anna, Ientile, Valentina, Trifirò, Gianluca, Rissmann, Anke, Leinonen, Maarit K, Martikainen, Visa, Jordan, Sue, Thayer, Daniel, Scanlon, Ieuan, Georgiou, Mary E, Cunnington, Marianne, Swertz, Morris, Sturkenboom, Miriam, and Gini, Rosa

Published
2022

15. Italian guidelines on management of persons with multimorbidity and polypharmacy

Author

Onder, Graziano, Vetrano, Davide Liborio, Palmer, Katie, Trevisan, Caterina, Amato, Laura, Berti, Franco, Campomori, Annalisa, Catalano, Lucio, Corsonello, Andrea, Kruger, Paola, Medea, Gerardo, Nobili, Alessandro, Trifirò, Gianluca, Vecchi, Simona, Veronese, Nicola, Marengoni, Alessandra, Onder, Graziano, Vetrano, Davide Liborio, Palmer, Katie, Trevisan, Caterina, Amato, Laura, Berti, Franco, Campomori, Annalisa, Catalano, Lucio, Corsonello, Andrea, Kruger, Paola, Medea, Gerardo, Nobili, Alessandro, Trifirò, Gianluca, Vecchi, Simona, Veronese, Nicola, and Marengoni, Alessandra

Abstract

Multimorbidity and polypharmacy are emerging health priorities and the care of persons with these conditions is complex and challenging. The aim of the present guidelines is to develop recommendations for the clinical management of persons with multimorbidity and/or polypharmacy and to provide evidence-based guidance to improve their quality of care. The recommendations have been produced in keeping with the Grading of Recommendations Assessment, Development and Evaluation (GRADE). Overall, 14 recommendations were issued, focusing on 4 thematic areas: (1.) General Principles; (2.) target population for an individualized approach to care; (3.) individualized care of patients with multimorbidity and/or polypharmacy; (4.) models of care. These recommendations support the provision of individualized care to persons with multimorbidity and/or polypharmacy as well as the prioritization of care through the identification of persons at increased risk of negative health outcomes. Given the limited available evidence, recommendations could not be issued for all the questions defined and, therefore, some aspects related to the complex care of patients with multimorbidity and/or polypharmacy could not be covered in these guidelines. This points to the need for more research in this field and evidence to improve the care of this population.

Published
2022
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16. From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Thurin, Nicolas H, Pajouheshnia, Romin, Roberto, Giuseppe, Dodd, Caitlin, Hyeraci, Giulia, Bartolini, Claudia, Paoletti, Olga, Nordeng, Hedvig, Wallach-Kildemoes, Helle, Ehrenstein, Vera, Dudukina, Elena, MacDonald, Thomas, De Paoli, Giorgia, Loane, Maria, Damase-Michel, Christine, Beau, Anna-Belle, Droz-Perroteau, Cécile, Lassalle, Régis, Bergman, Jorieke, Swart, Karin, Schink, Tania, Cavero-Carbonell, Clara, Barrachina-Bonet, Laia, Gomez-Lumbreras, Ainhoa, Giner-Soriano, Maria, Aragón, María, Neville, Amanda J, Puccini, Aurora, Pierini, Anna, Ientile, Valentina, Trifirò, Gianluca, Rissmann, Anke, Leinonen, Maarit K, Martikainen, Visa, Jordan, Sue, Thayer, Daniel, Scanlon, Ieuan, Georgiou, Mary E, Cunnington, Marianne, Swertz, Morris, Sturkenboom, Miriam, Gini, Rosa, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Thurin, Nicolas H, Pajouheshnia, Romin, Roberto, Giuseppe, Dodd, Caitlin, Hyeraci, Giulia, Bartolini, Claudia, Paoletti, Olga, Nordeng, Hedvig, Wallach-Kildemoes, Helle, Ehrenstein, Vera, Dudukina, Elena, MacDonald, Thomas, De Paoli, Giorgia, Loane, Maria, Damase-Michel, Christine, Beau, Anna-Belle, Droz-Perroteau, Cécile, Lassalle, Régis, Bergman, Jorieke, Swart, Karin, Schink, Tania, Cavero-Carbonell, Clara, Barrachina-Bonet, Laia, Gomez-Lumbreras, Ainhoa, Giner-Soriano, Maria, Aragón, María, Neville, Amanda J, Puccini, Aurora, Pierini, Anna, Ientile, Valentina, Trifirò, Gianluca, Rissmann, Anke, Leinonen, Maarit K, Martikainen, Visa, Jordan, Sue, Thayer, Daniel, Scanlon, Ieuan, Georgiou, Mary E, Cunnington, Marianne, Swertz, Morris, Sturkenboom, Miriam, and Gini, Rosa

Published
2022

17. From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Thurin, Nicolas H, Pajouheshnia, Romin, Roberto, Giuseppe, Dodd, Caitlin, Hyeraci, Giulia, Bartolini, Claudia, Paoletti, Olga, Nordeng, Hedvig, Wallach-Kildemoes, Helle, Ehrenstein, Vera, Dudukina, Elena, MacDonald, Thomas, De Paoli, Giorgia, Loane, Maria, Damase-Michel, Christine, Beau, Anna-Belle, Droz-Perroteau, Cécile, Lassalle, Régis, Bergman, Jorieke, Swart, Karin, Schink, Tania, Cavero-Carbonell, Clara, Barrachina-Bonet, Laia, Gomez-Lumbreras, Ainhoa, Giner-Soriano, Maria, Aragón, María, Neville, Amanda J, Puccini, Aurora, Pierini, Anna, Ientile, Valentina, Trifirò, Gianluca, Rissmann, Anke, Leinonen, Maarit K, Martikainen, Visa, Jordan, Sue, Thayer, Daniel, Scanlon, Ieuan, Georgiou, Mary E, Cunnington, Marianne, Swertz, Morris, Sturkenboom, Miriam, Gini, Rosa, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Thurin, Nicolas H, Pajouheshnia, Romin, Roberto, Giuseppe, Dodd, Caitlin, Hyeraci, Giulia, Bartolini, Claudia, Paoletti, Olga, Nordeng, Hedvig, Wallach-Kildemoes, Helle, Ehrenstein, Vera, Dudukina, Elena, MacDonald, Thomas, De Paoli, Giorgia, Loane, Maria, Damase-Michel, Christine, Beau, Anna-Belle, Droz-Perroteau, Cécile, Lassalle, Régis, Bergman, Jorieke, Swart, Karin, Schink, Tania, Cavero-Carbonell, Clara, Barrachina-Bonet, Laia, Gomez-Lumbreras, Ainhoa, Giner-Soriano, Maria, Aragón, María, Neville, Amanda J, Puccini, Aurora, Pierini, Anna, Ientile, Valentina, Trifirò, Gianluca, Rissmann, Anke, Leinonen, Maarit K, Martikainen, Visa, Jordan, Sue, Thayer, Daniel, Scanlon, Ieuan, Georgiou, Mary E, Cunnington, Marianne, Swertz, Morris, Sturkenboom, Miriam, and Gini, Rosa

Published
2022

18. From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Thurin, Nicolas H, Pajouheshnia, Romin, Roberto, Giuseppe, Dodd, Caitlin, Hyeraci, Giulia, Bartolini, Claudia, Paoletti, Olga, Nordeng, Hedvig, Wallach-Kildemoes, Helle, Ehrenstein, Vera, Dudukina, Elena, MacDonald, Thomas, De Paoli, Giorgia, Loane, Maria, Damase-Michel, Christine, Beau, Anna-Belle, Droz-Perroteau, Cécile, Lassalle, Régis, Bergman, Jorieke, Swart, Karin, Schink, Tania, Cavero-Carbonell, Clara, Barrachina-Bonet, Laia, Gomez-Lumbreras, Ainhoa, Giner-Soriano, Maria, Aragón, María, Neville, Amanda J, Puccini, Aurora, Pierini, Anna, Ientile, Valentina, Trifirò, Gianluca, Rissmann, Anke, Leinonen, Maarit K, Martikainen, Visa, Jordan, Sue, Thayer, Daniel, Scanlon, Ieuan, Georgiou, Mary E, Cunnington, Marianne, Swertz, Morris, Sturkenboom, Miriam, Gini, Rosa, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Thurin, Nicolas H, Pajouheshnia, Romin, Roberto, Giuseppe, Dodd, Caitlin, Hyeraci, Giulia, Bartolini, Claudia, Paoletti, Olga, Nordeng, Hedvig, Wallach-Kildemoes, Helle, Ehrenstein, Vera, Dudukina, Elena, MacDonald, Thomas, De Paoli, Giorgia, Loane, Maria, Damase-Michel, Christine, Beau, Anna-Belle, Droz-Perroteau, Cécile, Lassalle, Régis, Bergman, Jorieke, Swart, Karin, Schink, Tania, Cavero-Carbonell, Clara, Barrachina-Bonet, Laia, Gomez-Lumbreras, Ainhoa, Giner-Soriano, Maria, Aragón, María, Neville, Amanda J, Puccini, Aurora, Pierini, Anna, Ientile, Valentina, Trifirò, Gianluca, Rissmann, Anke, Leinonen, Maarit K, Martikainen, Visa, Jordan, Sue, Thayer, Daniel, Scanlon, Ieuan, Georgiou, Mary E, Cunnington, Marianne, Swertz, Morris, Sturkenboom, Miriam, and Gini, Rosa

Published
2022

19. Overview of the European post-authorisation study register post-authorization studies performed in Europe from September 2010 to December 2018

Author

Sultana, Janet, Crisafulli, Salvatore, Almas, Mariana, Antonazzo, Ippazio Cosimo, Baan, Esme, Bartolini, Claudia, Bertuccio, Maria Paola, Bonifazi, Fedele, Capuano, Annalisa, Didio, Antonella, Ehrenstein, Vera, Felisi, Mariagrazia, Ferrajolo, Carmen, Fontana, Andrea, Francisca, Remy, Fourrier-Reglat, Annie, Fortuny, Joan, Gini, Rosa, Hyeraci, Giulia, Hoeve, Christel, Kontogiorgis, Christos, Isgrò, Valentina, Lalagkas, Panagiotis Nikolaos, L'Abbate, Luca, Layton, Deborah, Landi, Annalisa, Narduzzi, Silvia, Roque Pereira, Leonardo, Poulentzas, Georgios, Rafaniello, Concetta, Roberto, Giuseppe, Scondotto, Giulia, Sportiello, Liberata, Toma, Maddalena, Toussi, Massoud, Verhamme, Katia, Volpe, Elisabetta, Trifirò, Gianluca, Sultana, Janet, Crisafulli, Salvatore, Almas, Mariana, Antonazzo, Ippazio Cosimo, Baan, Esme, Bartolini, Claudia, Bertuccio, Maria Paola, Bonifazi, Fedele, Capuano, Annalisa, Didio, Antonella, Ehrenstein, Vera, Felisi, Mariagrazia, Ferrajolo, Carmen, Fontana, Andrea, Francisca, Remy, Fourrier-Reglat, Annie, Fortuny, Joan, Gini, Rosa, Hyeraci, Giulia, Hoeve, Christel, Kontogiorgis, Christos, Isgrò, Valentina, Lalagkas, Panagiotis Nikolaos, L'Abbate, Luca, Layton, Deborah, Landi, Annalisa, Narduzzi, Silvia, Roque Pereira, Leonardo, Poulentzas, Georgios, Rafaniello, Concetta, Roberto, Giuseppe, Scondotto, Giulia, Sportiello, Liberata, Toma, Maddalena, Toussi, Massoud, Verhamme, Katia, Volpe, Elisabetta, and Trifirò, Gianluca

Abstract

Background: The European post-authorisation study (EU PAS) register is a repository launched in 2010 by the European Medicines Agency (EMA). All EMA-requested PAS, commonly observational studies, must be recorded in this register. Multi-database studies (MDS) leveraging secondary data have become an important strategy to conduct PAS in recent years, as reflected by the type of studies registered in the EU PAS register. Objectives: To analyse and describe PAS in the EU PAS register, with focus on MDS. Methods: Studies in the EU PAS register from inception to 31st December 2018 were described concerning transparency, regulatory obligations, scope, study type (e.g., observational study, clinical trial, survey, systematic review/meta-analysis), study design, type of data collection and target population. MDS were defined as studies conducted through secondary use of >1 data source not linked at patient-level. Data extraction was carried out independently by 14 centres with expertise in pharmacoepidemiology, using publicly available information in the EU PAS register including study protocol, whenever available, using a standardised data collection form. For validation purposes, a second revision of key fields for a 15% random sample of studies was carried out by a different centre. The inter-rater reliability (IRR) was then calculated. Finally, to identify predictors of primary data collection-based studies/versus those based on secondary use of healthcare databases) or MDS (vs. non-MDS), odds ratios (OR) and 95% confidence intervals (CI) were calculated fitting univariate logistic regression models. Results: Overall, 1426 studies were identified. Clinical trials (N = 30; 2%), systematic reviews/meta-analyses (N = 16; 1%) and miscellaneous study designs (N = 46; 3%) were much less common than observational studies (N = 1227; 86%). The protocol was available for 63% (N = 360) of 572 observational studies requested by a competent authority. Overall, 36% (N = 446) of

Published
2022

20. From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding

Author

Data Science & Biostatistiek, Thurin, Nicolas H, Pajouheshnia, Romin, Roberto, Giuseppe, Dodd, Caitlin, Hyeraci, Giulia, Bartolini, Claudia, Paoletti, Olga, Nordeng, Hedvig, Wallach-Kildemoes, Helle, Ehrenstein, Vera, Dudukina, Elena, MacDonald, Thomas, De Paoli, Giorgia, Loane, Maria, Damase-Michel, Christine, Beau, Anna-Belle, Droz-Perroteau, Cécile, Lassalle, Régis, Bergman, Jorieke, Swart, Karin, Schink, Tania, Cavero-Carbonell, Clara, Barrachina-Bonet, Laia, Gomez-Lumbreras, Ainhoa, Giner-Soriano, Maria, Aragón, María, Neville, Amanda J, Puccini, Aurora, Pierini, Anna, Ientile, Valentina, Trifirò, Gianluca, Rissmann, Anke, Leinonen, Maarit K, Martikainen, Visa, Jordan, Sue, Thayer, Daniel, Scanlon, Ieuan, Georgiou, Mary E, Cunnington, Marianne, Swertz, Morris, Sturkenboom, Miriam, Gini, Rosa, Data Science & Biostatistiek, Thurin, Nicolas H, Pajouheshnia, Romin, Roberto, Giuseppe, Dodd, Caitlin, Hyeraci, Giulia, Bartolini, Claudia, Paoletti, Olga, Nordeng, Hedvig, Wallach-Kildemoes, Helle, Ehrenstein, Vera, Dudukina, Elena, MacDonald, Thomas, De Paoli, Giorgia, Loane, Maria, Damase-Michel, Christine, Beau, Anna-Belle, Droz-Perroteau, Cécile, Lassalle, Régis, Bergman, Jorieke, Swart, Karin, Schink, Tania, Cavero-Carbonell, Clara, Barrachina-Bonet, Laia, Gomez-Lumbreras, Ainhoa, Giner-Soriano, Maria, Aragón, María, Neville, Amanda J, Puccini, Aurora, Pierini, Anna, Ientile, Valentina, Trifirò, Gianluca, Rissmann, Anke, Leinonen, Maarit K, Martikainen, Visa, Jordan, Sue, Thayer, Daniel, Scanlon, Ieuan, Georgiou, Mary E, Cunnington, Marianne, Swertz, Morris, Sturkenboom, Miriam, and Gini, Rosa

Published
2022

21. Withdrawal Syndrome Following Discontinuation of 28 Antidepressants: Pharmacovigilance Analysis of 31,688 Reports from the WHO Spontaneous Reporting Database

Author

Gastaldon, Chiara; https://orcid.org/0000-0001-7257-2962, Schoretsanitis, Georgios, Arzenton, Elena, Raschi, Emanuel, Papola, Davide, Ostuzzi, Giovanni, Moretti, Ugo, Seifritz, Erich, Kane, John M, Trifirò, Gianluca, Barbui, Corrado, Gastaldon, Chiara; https://orcid.org/0000-0001-7257-2962, Schoretsanitis, Georgios, Arzenton, Elena, Raschi, Emanuel, Papola, Davide, Ostuzzi, Giovanni, Moretti, Ugo, Seifritz, Erich, Kane, John M, Trifirò, Gianluca, and Barbui, Corrado

Abstract

Introduction: Evidence is lacking on withdrawal syndrome related to individual antidepressants and relevant risk factors for severe reactions. Objective: To ascertain whether antidepressants are associated with an increased reporting of withdrawal syndrome as compared with other medications, and to investigate risk factors for severe reactions. Methods: This is a case/non-case pharmacovigilance study, based on the VigiBase®, the WHO global database of individual case safety reports of suspected adverse drug reactions. We performed a disproportionality analysis of reports of antidepressant-related withdrawal syndrome (calculating reporting odds ratio [ROR] and Bayesian information component [IC]). We compared antidepressants to all other drugs, to buprenorphine (positive control), and to each other within each class of antidepressants (selective serotonin reuptake inhibitors [SSRIs], tricyclics and other antidepressants). Antidepressants with significant disproportionate reporting were ranked in terms of clinical priority. Serious versus non-serious reactions were compared. Results: There were 31,688 reports of antidepressant-related withdrawal syndrome were found. A disproportionate reporting was detected for 23 antidepressants. The estimated ROR for antidepressants altogether, compared to all other drugs, was 14.26 (95% CI 14.08-14.45), 17.01 for other antidepressants (95% CI 16.73-17.29), 13.65 for SSRIs (95% CI 13.41-13.90) and 2.8 for tricyclics (95% CI 2.59-3.02). Based on clinical priority ranking, the strongest disproportionate reporting was found for paroxetine, duloxetine, venlafaxine and desvenlafaxine, being comparable to buprenorphine. Withdrawal syndrome was reported as severe more often in males, adolescents, persons in polypharmacy, and with a longer antidepressant treatment duration (p < 0.05). Conclusions: Antidepressants are associated with an increased reporting of withdrawal syndrome compared with other drug classes. When prescribing and disconti

Published
2022

22. The International Society for Pharmacoepidemiology's Comments on the Core Recommendations in the Summary of the Heads of Medicines Agencies (HMA) - EMA Joint Big Data Task Force

Author

Pottegård, Anton, Klungel, Olaf, Winterstein, Almut, Huybrechts, Krista, Hallas, Jesper, Schneeweiss, Sebastian, Evans, Stephen, Bate, Andrew, Pont, Lisa, Trifirò, Gianluca, Smith, Meredith, Bourke, Alison, Pottegård, Anton, Klungel, Olaf, Winterstein, Almut, Huybrechts, Krista, Hallas, Jesper, Schneeweiss, Sebastian, Evans, Stephen, Bate, Andrew, Pont, Lisa, Trifirò, Gianluca, Smith, Meredith, and Bourke, Alison

Published
2019

23. Measuring the Effectiveness of Safety Warnings on the Risk of Stroke in Older Antipsychotic Users : A Nationwide Cohort Study in Two Large Electronic Medical Records Databases in the United Kingdom and Italy

Author

Sultana, Janet, Fontana, Andrea, Giorgianni, Francesco, Tillati, Silvia, Cricelli, Claudio, Pasqua, Alessandro, Patorno, Elisabetta, Ballard, Clive, Sturkenboom, Miriam, Trifirò, Gianluca, Sultana, Janet, Fontana, Andrea, Giorgianni, Francesco, Tillati, Silvia, Cricelli, Claudio, Pasqua, Alessandro, Patorno, Elisabetta, Ballard, Clive, Sturkenboom, Miriam, and Trifirò, Gianluca

Published
2019

24. Measuring the Effectiveness of Safety Warnings on the Risk of Stroke in Older Antipsychotic Users : A Nationwide Cohort Study in Two Large Electronic Medical Records Databases in the United Kingdom and Italy

Author

Sultana, Janet, Fontana, Andrea, Giorgianni, Francesco, Tillati, Silvia, Cricelli, Claudio, Pasqua, Alessandro, Patorno, Elisabetta, Ballard, Clive, Sturkenboom, Miriam, Trifirò, Gianluca, Sultana, Janet, Fontana, Andrea, Giorgianni, Francesco, Tillati, Silvia, Cricelli, Claudio, Pasqua, Alessandro, Patorno, Elisabetta, Ballard, Clive, Sturkenboom, Miriam, and Trifirò, Gianluca

Published
2019

25. The International Society for Pharmacoepidemiology's Comments on the Core Recommendations in the Summary of the Heads of Medicines Agencies (HMA) - EMA Joint Big Data Task Force

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Pottegård, Anton, Klungel, Olaf, Winterstein, Almut, Huybrechts, Krista, Hallas, Jesper, Schneeweiss, Sebastian, Evans, Stephen, Bate, Andrew, Pont, Lisa, Trifirò, Gianluca, Smith, Meredith, Bourke, Alison, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Pottegård, Anton, Klungel, Olaf, Winterstein, Almut, Huybrechts, Krista, Hallas, Jesper, Schneeweiss, Sebastian, Evans, Stephen, Bate, Andrew, Pont, Lisa, Trifirò, Gianluca, Smith, Meredith, and Bourke, Alison

Published
2019

26. Measuring the Effectiveness of Safety Warnings on the Risk of Stroke in Older Antipsychotic Users : A Nationwide Cohort Study in Two Large Electronic Medical Records Databases in the United Kingdom and Italy

Author

Sultana, Janet, Fontana, Andrea, Giorgianni, Francesco, Tillati, Silvia, Cricelli, Claudio, Pasqua, Alessandro, Patorno, Elisabetta, Ballard, Clive, Sturkenboom, Miriam, Trifirò, Gianluca, Sultana, Janet, Fontana, Andrea, Giorgianni, Francesco, Tillati, Silvia, Cricelli, Claudio, Pasqua, Alessandro, Patorno, Elisabetta, Ballard, Clive, Sturkenboom, Miriam, and Trifirò, Gianluca

Published
2019

27. The International Society for Pharmacoepidemiology's Comments on the Core Recommendations in the Summary of the Heads of Medicines Agencies (HMA) - EMA Joint Big Data Task Force

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Pottegård, Anton, Klungel, Olaf, Winterstein, Almut, Huybrechts, Krista, Hallas, Jesper, Schneeweiss, Sebastian, Evans, Stephen, Bate, Andrew, Pont, Lisa, Trifirò, Gianluca, Smith, Meredith, Bourke, Alison, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Pottegård, Anton, Klungel, Olaf, Winterstein, Almut, Huybrechts, Krista, Hallas, Jesper, Schneeweiss, Sebastian, Evans, Stephen, Bate, Andrew, Pont, Lisa, Trifirò, Gianluca, Smith, Meredith, and Bourke, Alison

Published
2019

28. Measuring the Effectiveness of Safety Warnings on the Risk of Stroke in Older Antipsychotic Users: A Nationwide Cohort Study in Two Large Electronic Medical Records Databases in the United Kingdom and Italy

Author

JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Global Health, Sultana, Janet, Fontana, Andrea, Giorgianni, Francesco, Tillati, Silvia, Cricelli, Claudio, Pasqua, Alessandro, Patorno, Elisabetta, Ballard, Clive, Sturkenboom, Miriam, Trifirò, Gianluca, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Global Health, Sultana, Janet, Fontana, Andrea, Giorgianni, Francesco, Tillati, Silvia, Cricelli, Claudio, Pasqua, Alessandro, Patorno, Elisabetta, Ballard, Clive, Sturkenboom, Miriam, and Trifirò, Gianluca

Published
2019

29. The International Society for Pharmacoepidemiology's Comments on the Core Recommendations in the Summary of the Heads of Medicines Agencies (HMA) - EMA Joint Big Data Task Force

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, PECP - Centre for Pharmacoepidemiology, Pottegård, Anton, Klungel, Olaf, Winterstein, Almut, Huybrechts, Krista, Hallas, Jesper, Schneeweiss, Sebastian, Evans, Stephen, Bate, Andrew, Pont, Lisa, Trifirò, Gianluca, Smith, Meredith, Bourke, Alison, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, PECP - Centre for Pharmacoepidemiology, Pottegård, Anton, Klungel, Olaf, Winterstein, Almut, Huybrechts, Krista, Hallas, Jesper, Schneeweiss, Sebastian, Evans, Stephen, Bate, Andrew, Pont, Lisa, Trifirò, Gianluca, Smith, Meredith, and Bourke, Alison

Published
2019

30. The Role of European Healthcare Databases for Post-Marketing Drug Effectiveness, Safety and Value Evaluation: Where Does Italy Stand?

Author

Trifirò, G, Gini, R, Barone-Adesi, F, Beghi, E, Cantarutti, A, Capuano, A, Carnovale, C, Clavenna, A, Dellagiovanna, M, Ferrajolo, C, Franchi, M, Ingrasciotta, Y, Kirchmayer, U, Lapi, F, Leone, R, Leoni, O, Lucenteforte, E, Moretti, U, Mugelli, A, Naldi, L, Poluzzi, E, Rafaniello, C, Rea, F, Sultana, J, Tettamanti, M, Traversa, G, Vannacci, A, Mantovani, L, Corrao, G, Trifirò, Gianluca, Gini, Rosa, Barone-Adesi, Francesco, Beghi, Ettore, Cantarutti, Anna, Capuano, Annalisa, Carnovale, Carla, Clavenna, Antonio, Dellagiovanna, Mirosa, Ferrajolo, Carmen, Franchi, Matteo, Ingrasciotta, Ylenia, Kirchmayer, Ursula, Lapi, Francesco, Leone, Roberto, Leoni, Olivia, Lucenteforte, Ersilia, Moretti, Ugo, Mugelli, Alessandro, Naldi, Luigi, Poluzzi, Elisabetta, Rafaniello, Concita, Rea, Federico, Sultana, Janet, Tettamanti, Mauro, Traversa, Giuseppe, Vannacci, Alfredo, Mantovani, Lorenzo, Corrao, Giovanni, Trifirò, G, Gini, R, Barone-Adesi, F, Beghi, E, Cantarutti, A, Capuano, A, Carnovale, C, Clavenna, A, Dellagiovanna, M, Ferrajolo, C, Franchi, M, Ingrasciotta, Y, Kirchmayer, U, Lapi, F, Leone, R, Leoni, O, Lucenteforte, E, Moretti, U, Mugelli, A, Naldi, L, Poluzzi, E, Rafaniello, C, Rea, F, Sultana, J, Tettamanti, M, Traversa, G, Vannacci, A, Mantovani, L, Corrao, G, Trifirò, Gianluca, Gini, Rosa, Barone-Adesi, Francesco, Beghi, Ettore, Cantarutti, Anna, Capuano, Annalisa, Carnovale, Carla, Clavenna, Antonio, Dellagiovanna, Mirosa, Ferrajolo, Carmen, Franchi, Matteo, Ingrasciotta, Ylenia, Kirchmayer, Ursula, Lapi, Francesco, Leone, Roberto, Leoni, Olivia, Lucenteforte, Ersilia, Moretti, Ugo, Mugelli, Alessandro, Naldi, Luigi, Poluzzi, Elisabetta, Rafaniello, Concita, Rea, Federico, Sultana, Janet, Tettamanti, Mauro, Traversa, Giuseppe, Vannacci, Alfredo, Mantovani, Lorenzo, and Corrao, Giovanni

Abstract

Enormous progress has been made globally in the use of evidence derived from patients’ clinical information as they access their routine medical care. The value of real-world data lies in their complementary nature compared with data from randomised controlled trials: less detailed information on drug efficacy but longer observational periods and larger, more heterogeneous study populations reflecting clinical practice because individuals are included who would not usually be recruited in trials. Real-world data can be collected in various types of electronic sources, such as electronic health records, claims databases and drug or disease registries. These data sources vary in nature from country to country, according to national healthcare system structures and national policies. In Italy, a growing number of healthcare databases have been used to evaluate post-marketing drug utilisation and safety in the last two decades. The aim of this narrative review is to describe the available Italian sources of real-world data and their contribution to generating post-marketing evidence on drug use and safety. We also discuss the strengths and limitations of the most commonly used Italian healthcare databases in addressing various research questions concerning drug utilisation, comparative effectiveness and safety studies, as well as health technology assessment and other areas

Published
2019

31. Management of cancer-associated anemia with erythropoiesis-stimulating agents: ASCO/ASH clinical practice guideline update.

Author

Bohlius, Julia, Bohlke, Kari, Castelli, Roberto, Djulbegovic, Benjamin, Lustberg, Maryam B, Martino, Massimo, Mountzios, Giannis, Peswani, Namrata, Porter, Laura, Tanaka, Tiffany N., Trifirò, Gianluca, Yang, Hushan, Lazo-Langner, Alejandro, Bohlius, Julia, Bohlke, Kari, Castelli, Roberto, Djulbegovic, Benjamin, Lustberg, Maryam B, Martino, Massimo, Mountzios, Giannis, Peswani, Namrata, Porter, Laura, Tanaka, Tiffany N., Trifirò, Gianluca, Yang, Hushan, and Lazo-Langner, Alejandro

Abstract

PURPOSE: To update the American Society of Clinical Oncology (ASCO)/American Society of Hematology (ASH) recommendations for use of erythropoiesis-stimulating agents (ESAs) in patients with cancer. METHODS: PubMed and the Cochrane Library were searched for randomized controlled trials (RCTs) and meta-analyses of RCTs in patients with cancer published from January 31, 2010, through May 14, 2018. For biosimilar ESAs, the literature search was expanded to include meta-analyses and RCTs in patients with cancer or chronic kidney disease and cohort studies in patients with cancer due to limited RCT evidence in the cancer setting. ASCO and ASH convened an Expert Panel to review the evidence and revise previous recommendations as needed. RESULTS: The primary literature review included 15 meta-analyses of RCTs and two RCTs. A growing body of evidence suggests that adding iron to treatment with an ESA may improve hematopoietic response and reduce the likelihood of RBC transfusion. The biosimilar literature review suggested that biosimilars of epoetin alfa have similar efficacy and safety to reference products, although evidence in cancer remains limited. RECOMMENDATIONS: ESAs (including biosimilars) may be offered to patients with chemotherapy-associated anemia whose cancer treatment is not curative in intent and whose hemoglobin has declined to < 10 g/dL. RBC transfusion is also an option. With the exception of selected patients with myelodysplastic syndromes, ESAs should not be offered to most patients with nonchemotherapy-associated anemia. During ESA treatment, hemoglobin may be increased to the lowest concentration needed to avoid transfusions. Iron replacement may be used to improve hemoglobin response and reduce RBC transfusions for patients receiving ESA with or without iron deficiency. Additional information is available at www.asco.org/supportive-care-guidelines and www.hematology.org/guidelines.

Published
2019

32. Comparing safety information of biosimilars with their originators: A cross-sectional analysis of European risk management plans

Author

Lepelaars, Leroy R.A., Renda, Francesca, Pani, Luca, Pimpinella, Giuseppe, Leufkens, Hubert G.M., Trifirò, Gianluca, Tafuri, Giovanni, Mantel-Teeuwisse, Aukje K., Trotta, Francesco, Lepelaars, Leroy R.A., Renda, Francesca, Pani, Luca, Pimpinella, Giuseppe, Leufkens, Hubert G.M., Trifirò, Gianluca, Tafuri, Giovanni, Mantel-Teeuwisse, Aukje K., and Trotta, Francesco

Abstract

Background and aims: Biosimilars have been available in the European Union (EU) since 2006. However, their uptake in routine care is heterogeneous across countries. The aim of the present study was to compare the safety information of biosimilars and their originators based on the information in the European risk management plan (RMP). Methods: A cross-sectional analysis on publicly available regulatory documents (RMPs and Summaries of Product Characteristics) of biosimilars and corresponding originators up to 1 November 2015 was performed. The safety concerns were extracted and merged into general safety concerns, and clinical relevance was assessed. The frequency of safety concerns and the representation of these safety concerns per general safety concern were assessed by either comparing RMPs of biosimilars and originators (if available for both) or comparing RMPs with the Summary of Product Characteristics of the originator. Results: Nineteen biosimilars and six originators were included. Overall, 55 general safety concerns (12 low, 21 medium and 22 highly clinically relevant) were identified. For all active substances, except for infliximab, no or only one difference was found in the listed general safety concerns. Comparison of regulatory documents for infliximab identified three medium clinically relevant general safety concerns more for infliximab biosimilars and two general safety concerns more for its originator. Conclusion: Based on publicly available information filed for regulatory purposes, no substantial differences were observed in the reporting of safety information for biosimilars and related originators. A direct comparison between biosimilars and related originators through formal postmarketing studies is needed to evaluate specific safety issues emerging during the products' life cycle.

Published
2018

34. Can information on functional and cognitive status improve short-term mortality risk prediction among community-dwelling older people? : A cohort study using a UK primary care database

Author

Sultana, Janet, Fontana, Andrea, Giorgianni, Francesco, Basile, Giorgio, Patorno, Elisabetta, Pilotto, Alberto, Molokhia, Mariam, Stewart, Robert, Sturkenboom, Miriam, Trifirò, Gianluca, Sultana, Janet, Fontana, Andrea, Giorgianni, Francesco, Basile, Giorgio, Patorno, Elisabetta, Pilotto, Alberto, Molokhia, Mariam, Stewart, Robert, Sturkenboom, Miriam, and Trifirò, Gianluca

Published
2018

36. Can information on functional and cognitive status improve short-term mortality risk prediction among community-dwelling older people? : A cohort study using a UK primary care database

Author

Sultana, Janet, Fontana, Andrea, Giorgianni, Francesco, Basile, Giorgio, Patorno, Elisabetta, Pilotto, Alberto, Molokhia, Mariam, Stewart, Robert, Sturkenboom, Miriam, Trifirò, Gianluca, Sultana, Janet, Fontana, Andrea, Giorgianni, Francesco, Basile, Giorgio, Patorno, Elisabetta, Pilotto, Alberto, Molokhia, Mariam, Stewart, Robert, Sturkenboom, Miriam, and Trifirò, Gianluca

Published
2018

38. Can information on functional and cognitive status improve short-term mortality risk prediction among community-dwelling older people? : A cohort study using a UK primary care database

Author

Sultana, Janet, Fontana, Andrea, Giorgianni, Francesco, Basile, Giorgio, Patorno, Elisabetta, Pilotto, Alberto, Molokhia, Mariam, Stewart, Robert, Sturkenboom, Miriam, Trifirò, Gianluca, Sultana, Janet, Fontana, Andrea, Giorgianni, Francesco, Basile, Giorgio, Patorno, Elisabetta, Pilotto, Alberto, Molokhia, Mariam, Stewart, Robert, Sturkenboom, Miriam, and Trifirò, Gianluca

Published
2018

39. Comparing safety information of biosimilars with their originators: A cross-sectional analysis of European risk management plans

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, PECP - Centre for Pharmaceutical Policy and Regulation, Lepelaars, Leroy R.A., Renda, Francesca, Pani, Luca, Pimpinella, Giuseppe, Leufkens, Hubert G.M., Trifirò, Gianluca, Tafuri, Giovanni, Mantel-Teeuwisse, Aukje K., Trotta, Francesco, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, PECP - Centre for Pharmaceutical Policy and Regulation, Lepelaars, Leroy R.A., Renda, Francesca, Pani, Luca, Pimpinella, Giuseppe, Leufkens, Hubert G.M., Trifirò, Gianluca, Tafuri, Giovanni, Mantel-Teeuwisse, Aukje K., and Trotta, Francesco

Published
2018

40. Can Electronic Health Records Databases Complement Spontaneous Reporting System Databases?: A Historical-Reconstruction of the Association of Rofecoxib and Acute Myocardial Infarction

Author

Global Health, Patadia, Vaishali K., Schuemie, Martijn J., Coloma, Preciosa M., Herings, Ron, van der Lei, Johan, Sturkenboom, Miriam, Trifirò, Gianluca, Global Health, Patadia, Vaishali K., Schuemie, Martijn J., Coloma, Preciosa M., Herings, Ron, van der Lei, Johan, Sturkenboom, Miriam, and Trifirò, Gianluca

Published
2018

41. Can information on functional and cognitive status improve short-term mortality risk prediction among community-dwelling older people?: A cohort study using a UK primary care database

Author

Global Health, Sultana, Janet, Fontana, Andrea, Giorgianni, Francesco, Basile, Giorgio, Patorno, Elisabetta, Pilotto, Alberto, Molokhia, Mariam, Stewart, Robert, Sturkenboom, Miriam, Trifirò, Gianluca, Global Health, Sultana, Janet, Fontana, Andrea, Giorgianni, Francesco, Basile, Giorgio, Patorno, Elisabetta, Pilotto, Alberto, Molokhia, Mariam, Stewart, Robert, Sturkenboom, Miriam, and Trifirò, Gianluca

Published
2018

42. Adherence of Elderly Patients with Cardiovascular Disease to Statins and the Risk of Exacerbation of Chronic Obstructive Pulmonary Disease: Evidence from an Italian Real-World Investigation

Author

Rea, F, Calusi, G, Franchi, M, Vetrano, D, Borloni, R, Bonassi, S, Kirchmayer, U, Chinellato, A, Bettiol, A, Sultana, J, Mugelli, A, Corrao, G, Agabiti, N, Bartolini, C, Bernabei, R, Caputi, A, Cascini, S, Cipriani, F, Davoli, M, Fini, M, Gini, R, Giorgianni, F, Lapi, F, Lombardi, N, Lucenteforte, E, Onder, G, Sorge, C, Tari, M, Trifirò, G, Vannacci, A, Vitale, C, Rea, Federico, Calusi, Giulia, Franchi, Matteo, Vetrano, Davide Liborio, BORLONI, ROBERTO GIUSEPPE, Bonassi, Stefano, Kirchmayer, Ursula, Chinellato, Alessandro, Bettiol, Alessandra, Sultana, Janet, Mugelli, Alessandro, Corrao, Giovanni, Agabiti, Nera, Bartolini, Claudia, Bernabei, Roberto, Caputi, Achille Patrizio, Cascini, Silvia, Cipriani, Francesco, Davoli, Marina, Fini, Massimo, Gini, Rosa, Giorgianni, Francesco, Lapi, Francesco, Lombardi, Niccolò, Lucenteforte, Ersilia, Onder, Graziano, Sorge, Chiara, Tari, Michele, Trifirò, Gianluca, Vannacci, Alfredo, Vitale, Cristiana, Rea, F, Calusi, G, Franchi, M, Vetrano, D, Borloni, R, Bonassi, S, Kirchmayer, U, Chinellato, A, Bettiol, A, Sultana, J, Mugelli, A, Corrao, G, Agabiti, N, Bartolini, C, Bernabei, R, Caputi, A, Cascini, S, Cipriani, F, Davoli, M, Fini, M, Gini, R, Giorgianni, F, Lapi, F, Lombardi, N, Lucenteforte, E, Onder, G, Sorge, C, Tari, M, Trifirò, G, Vannacci, A, Vitale, C, Rea, Federico, Calusi, Giulia, Franchi, Matteo, Vetrano, Davide Liborio, BORLONI, ROBERTO GIUSEPPE, Bonassi, Stefano, Kirchmayer, Ursula, Chinellato, Alessandro, Bettiol, Alessandra, Sultana, Janet, Mugelli, Alessandro, Corrao, Giovanni, Agabiti, Nera, Bartolini, Claudia, Bernabei, Roberto, Caputi, Achille Patrizio, Cascini, Silvia, Cipriani, Francesco, Davoli, Marina, Fini, Massimo, Gini, Rosa, Giorgianni, Francesco, Lapi, Francesco, Lombardi, Niccolò, Lucenteforte, Ersilia, Onder, Graziano, Sorge, Chiara, Tari, Michele, Trifirò, Gianluca, Vannacci, Alfredo, and Vitale, Cristiana

Abstract

Objective: The objective of this study was to investigate the relationship between adherence to statin therapy and the risk of exacerbation among elderly individuals affected by chronic obstructive pulmonary disease and cardiovascular disease. Methods: Using the healthcare utilisation databases of five Italian territorial units accounting for nearly 35% of the Italian population, we recruited a cohort of 6263 elderly persons (i.e. aged 65 years or older) with co-existing chronic obstructive pulmonary disease and cardiovascular disease who initiated statin therapy. Exposure was adherence to statins measured by the proportion of days of follow-up covered. Outcome was the first hospital admission for chronic obstructive pulmonary disease occurring in the period of observation. A proportional hazards model was used to estimate the hazard ratio and 95% confidence intervals for the exposure–outcome association, after adjusting for several covariates. A set of sensitivity analyses was performed to account for sources of systematic uncertainty. Results: During an average follow-up of about 4 years, 1307 cohort members experienced the outcome. Compared with patients with low adherence (proportion of days of follow-up covered ≤ 40%), those with intermediate (proportion of days of follow-up covered 41–80%) and high (proportion of days of follow-up covered > 80%) adherence exhibited a lower risk of exacerbation of 16% (95% confidence interval 3–27) and 23% (95% confidence interval 10–34). Conclusions: In a real-world setting, we observed evidence that adherence to statin therapy markedly reduced the risk of chronic obstructive pulmonary disease exacerbations in elderly patients with co-existing chronic obstructive pulmonary disease and cardiovascular disease. Given the limited and controversial evidence from trials, more randomised controlled trials are urgently needed to better examine the potential benefits of statins as adjunct therapy in chronic obstructive pulmonary diseas

Published
2018

43. Anticholinergic Medication Burden and 5-Year Risk of Hospitalization and Death in Nursing Home Elderly Residents With Coronary Artery Disease

Author

La Carpia, Domenico, Grande, Giulia, Casucci, Paola, Bacelli, Tiziana, Bernabei, Roberto, Onder, Graziano, Agabiti, Nera, Bartolini, Claudia, Bettiol, Alessandra, Bonassi, Stefano, Caputi, Achille Patrizio, Cascini, Silvia, Chinellato, Alessandro, Cipriani, Francesco, Corrao, Giovanni, Davoli, Marina, Fini, Massimo, Gini, Rosa, Giorgianni, Francesco, Kirchmayer, Ursula, Lapi, Francesco, Lombardi, Niccolò, Lucenteforte, Ersilia, Mugelli, Alessandro, Rea, Federico, Roberto, Giuseppe, Sorge, Chiara, Tari, Michele, Trifirò, Gianluca, Vannacci, Alfredo, Vetrano, Davide Liborio, Vigano', Roberto Giuseppe, Vitale, Cristiana, Bernabei, Roberto (ORCID:0000-0002-9197-004X), Onder, Graziano (ORCID:0000-0003-3400-4491), La Carpia, Domenico, Grande, Giulia, Casucci, Paola, Bacelli, Tiziana, Bernabei, Roberto, Onder, Graziano, Agabiti, Nera, Bartolini, Claudia, Bettiol, Alessandra, Bonassi, Stefano, Caputi, Achille Patrizio, Cascini, Silvia, Chinellato, Alessandro, Cipriani, Francesco, Corrao, Giovanni, Davoli, Marina, Fini, Massimo, Gini, Rosa, Giorgianni, Francesco, Kirchmayer, Ursula, Lapi, Francesco, Lombardi, Niccolò, Lucenteforte, Ersilia, Mugelli, Alessandro, Rea, Federico, Roberto, Giuseppe, Sorge, Chiara, Tari, Michele, Trifirò, Gianluca, Vannacci, Alfredo, Vetrano, Davide Liborio, Vigano', Roberto Giuseppe, Vitale, Cristiana, Bernabei, Roberto (ORCID:0000-0002-9197-004X), and Onder, Graziano (ORCID:0000-0003-3400-4491)

Abstract

Objectives To assess the association of the anticholinergic medication burden with hospitalization and mortality in nursing home elderly patients and to investigate the role of coronary artery disease (CAD). Design Longitudinal (5-year) retrospective observational study. Setting Nursing homes in Italy. Participants A total of 3761 nursing home older residents. Measurements A comprehensive clinical and functional assessment was carried out through the interRAI long-term care facility instrument. The anticholinergic burden was assessed through the anticholinergic cognitive burden (ACB) scale. Occurrence of hospitalization/all-cause mortality was the primary composite outcome. First hospitalization and all-cause mortality were the secondary outcomes of the study. Hazard ratios (HRs) and subdistribution HRs were obtained through Cox and competing risk (death as competing event for hospitalization) models. Results Within the sample (mean age 83 ± 7 years; 72% females) the incidence rate of the primary outcome was 10/100 person-year. After adjusting for potential confounders and compared with participants with an ACB of 0, those with an ACB of 1 [HR 1.46; 95% confidence interval (CI) 1.12–1.90] and ABC of 2+ (HR 1.41; 95% CI 1.11–1.79) presented an increased risk of developing the primary outcome. After stratification, the risk for the primary outcome increased along with the anticholinergic burden, only for participants affected by CAD (HR 1.53; 95% CI 0.94–2.50 and HR 1.71; 95% CI 1.09–2.68 for the ACB of 1 and ACB of 2+ groups). An ACB score of 2+ was marginally associated with first hospitalization, considering death as a competing risk, only for those with CAD (subdistribution HR 3.47; 95% CI 0.99–12.3). Conclusions Anticholinergic medication burden is associated to hospitalization and all-cause mortality in institutionalized older adults. CAD increases such risk. The effectiveness and safety profile of complex drug regimens should be reconsidered

Published
2016

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

Author

Sultana, Janet, Fontana, Andrea, Giorgianni, Francesco, Pasqua, Alessandro, Cricelli, Claudio, Spina, Edoardo, Gambassi, Giovanni, Ivanovic, Jelena, Ferrajolo, Carmen, Molokhia, Mariam, Ballard, Clive, Sharp, Samantha, Sturkenboom, Miriam, Trifirò, Gianluca, Gambassi, Giovanni (ORCID:0000-0002-7030-9359), Sultana, Janet, Fontana, Andrea, Giorgianni, Francesco, Pasqua, Alessandro, Cricelli, Claudio, Spina, Edoardo, Gambassi, Giovanni, Ivanovic, Jelena, Ferrajolo, Carmen, Molokhia, Mariam, Ballard, Clive, Sharp, Samantha, Sturkenboom, Miriam, Trifirò, Gianluca, and Gambassi, Giovanni (ORCID:0000-0002-7030-9359)

Abstract

Background: Antipsychotic (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. Objective: The 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. Methods: We 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. Results: We 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). Conclusion: The 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 app

Published
2016

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