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1. Impact of 2018 EU Risk Minimisation Measures and Revised Pregnancy Prevention Programme on Utilisation and Prescribing Trends of Medicinal Products Containing Valproate: An Interrupted Time Series Study

Author

Abtahi, Shahab, Pajouheshnia, Romin, Durán, Carlos E., Riera-Arnau, Judit, Gamba, Magdalena, Alsina, Ema, Hoxhaj, Vjola, Andersen, Morten, Bartolini, Claudia, Kristiansen, Sarah Brøgger, Brown, Jeremy, Hallgreen, Christine Erikstrup, Garcia-Poza, Patricia, Gardarsdottir, Helga, Gini, Rosa, Girardi, Anna, Holthuis, Emily, Huerta, Consuelo, Ibánez, Luisa, Limoncella, Giorgio, Martín-Pérez, Mar, Paoletti, Olga, Roberto, Giuseppe, Souverein, Patrick, Swart, Karin M. A., Wing, Kevin, Sturkenboom, Miriam, and Klungel, Olaf

Published
2023
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2. Hydroxyzine Initiation Following Drug Safety Advisories on Cardiac Arrhythmias in the UK and Canada: A Longitudinal Cohort Study

Author

Morrow, Richard L., Mintzes, Barbara, Souverein, Patrick C., Hallgreen, Christine E., Ahmed, Bilal, Roughead, Elizabeth E., De Bruin, Marie L., Kristiansen, Sarah Brøgger, Lexchin, Joel, Kemp-Casey, Anna, Sketris, Ingrid, Mangin, Dee, Pearson, Sallie-Anne, Puil, Lorri, Lopert, Ruth, Bero, Lisa, Gnjidic, Danijela, Sarpatwari, Ameet, and Dormuth, Colin R.

Published
2022
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5. Impact of the 2018 revised Pregnancy Prevention Programme by the European Medicines Agency on the use of oral retinoids in females of childbearing age in Denmark, Italy, Netherlands, and Spain: an interrupted time series analysis

Author

Durán, Carlos E., primary, Riera-Arnau, Judit, additional, Abtahi, Shahab, additional, Pajouheshnia, Romin, additional, Hoxhaj, Vjola, additional, Gamba, Magdalena, additional, Alsina, Ema, additional, Martin-Perez, Mar, additional, Garcia-Poza, Patricia, additional, Llorente-Garcia, Ana, additional, Gonzalez-Bermejo, Diana, additional, Ibánez, Luisa, additional, Sabaté, Mònica, additional, Vidal, Xavier, additional, Ballarín, Elena, additional, Sanfélix-Gimeno, Gabriel, additional, Rodríguez-Bernal, Clara, additional, Peiró, Salvador, additional, García-Sempere, Aníbal, additional, Sanchez-Saez, Francisco, additional, Ientile, Valentina, additional, Ingrasciotta, Ylenia, additional, Guarneri, Claudio, additional, Tanaglia, Matilde, additional, Tari, Michele, additional, Herings, Ron, additional, Houben, Eline, additional, Swart-Polinder, Karin, additional, Holthuis, Emily, additional, Huerta, Consuelo, additional, Gini, Rosa, additional, Roberto, Giuseppe, additional, Bartolini, Claudia, additional, Paoletti, Olga, additional, Limoncella, Giorgio, additional, Girardi, Anna, additional, Hyeraci, Giulia, additional, Andersen, Morten, additional, Kristiansen, Sarah Brøgger, additional, Hallgreen, Christine Erikstrup, additional, Klungel, Olaf, additional, and Sturkenboom, Miriam, additional

Published
2023
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6. Impact of the 2018 revised Pregnancy Prevention Programme by the European Medicines Agency on the use of oral retinoids in females of childbearing age in Denmark, Italy, Netherlands, and Spain: an interrupted time series analysis

Author

Durán, Carlos E, Riera-Arnau, Judit, Abtahi, Shahab, Pajouheshnia, Romin, Hoxhaj, Vjola, Gamba, Magdalena, Alsina, Ema, Martin-Perez, Mar, Garcia-Poza, Patricia, Llorente-Garcia, Ana, Gonzalez-Bermejo, Diana, Ibánez, Luisa, Sabaté, Mònica, Vidal, Xavier, Ballarín, Elena, Sanfélix-Gimeno, Gabriel, Rodríguez-Bernal, Clara, Peiró, Salvador, García-Sempere, Aníbal, Sanchez-Saez, Francisco, Ientile, Valentina, Ingrasciotta, Ylenia, Guarneri, Claudio, Tanaglia, Matilde, Tari, Michele, Herings, Ron, Houben, Eline, Swart-Polinder, Karin, Holthuis, Emily, Huerta, Consuelo, Gini, Rosa, Roberto, Giuseppe, Bartolini, Claudia, Paoletti, Olga, Limoncella, Giorgio, Girardi, Anna, Hyeraci, Giulia, Andersen, Morten, Kristiansen, Sarah Brøgger, Hallgreen, Christine Erikstrup, Klungel, Olaf, Sturkenboom, Miriam, Durán, Carlos E, Riera-Arnau, Judit, Abtahi, Shahab, Pajouheshnia, Romin, Hoxhaj, Vjola, Gamba, Magdalena, Alsina, Ema, Martin-Perez, Mar, Garcia-Poza, Patricia, Llorente-Garcia, Ana, Gonzalez-Bermejo, Diana, Ibánez, Luisa, Sabaté, Mònica, Vidal, Xavier, Ballarín, Elena, Sanfélix-Gimeno, Gabriel, Rodríguez-Bernal, Clara, Peiró, Salvador, García-Sempere, Aníbal, Sanchez-Saez, Francisco, Ientile, Valentina, Ingrasciotta, Ylenia, Guarneri, Claudio, Tanaglia, Matilde, Tari, Michele, Herings, Ron, Houben, Eline, Swart-Polinder, Karin, Holthuis, Emily, Huerta, Consuelo, Gini, Rosa, Roberto, Giuseppe, Bartolini, Claudia, Paoletti, Olga, Limoncella, Giorgio, Girardi, Anna, Hyeraci, Giulia, Andersen, Morten, Kristiansen, Sarah Brøgger, Hallgreen, Christine Erikstrup, Klungel, Olaf, and Sturkenboom, Miriam

Abstract

Background: In March 2018, the European pregnancy prevention programme for oral retinoids was updated as part of risk minimisation measures (RMM), emphasising their contraindication in pregnant women. Objective: To measure the impact of the 2018 revision of the RMMs in Europe by assessing the utilisation patterns of isotretinoin, alitretinoin and acitretin, contraceptive measures, pregnancy testing, discontinuation, and pregnancy occurrence concomitantly with a retinoid prescription. Methods: An interrupted time series (ITS) analysis to compare level and trend changes after the risk minimisation measures implementation was conducted on a cohort of females of childbearing age (12-55 years of age) from January 2010 to December 2020, derived from six electronic health data sources in four countries: Denmark, Netherlands, Spain, and Italy. Monthly utilisation figures (incidence rates [IR], prevalence rates [PR] and proportions) of oral retinoids were calculated, as well as discontinuation rates, contraception coverage, pregnancy testing, and rates of exposed pregnancies to oral retinoids, before and after the 2018 RMMs. Results: From 10,714,182 females of child-bearing age, 88,992 used an oral retinoid at any point during the study period (mean age 18.9-22.2 years old). We found non-significant level and trend changes in incidence or prevalence of retinoid use in females of child-bearing age after the 2018 RMMs. The reason of discontinuation was unknown in >95% of cases. Contraception use showed a significant increase trend in Spain; for other databases this information was limited. Pregnancy testing was hardly recorded thus was not possible to model ITS analyses. After the 2018 RMM, rates of pregnancy occurrence during retinoid use, and start of a retinoid during a pregnancy varied from 0.0 to 0.4, and from 0.2 to 0.8, respectively. Conclusion: This study shows a limited impact of the 2018 RMMs on oral retinoids utilisation patterns among females of child-bearing

Published
2023

7. Impact of the 2018 revised Pregnancy Prevention Programme by the European Medicines Agency on the use of oral retinoids in females of childbearing age in Denmark, Italy, Netherlands, and Spain: an interrupted time series analysis

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, PECP - Centre for Pharmacoepidemiology, Durán, Carlos E, Riera-Arnau, Judit, Abtahi, Shahab, Pajouheshnia, Romin, Hoxhaj, Vjola, Gamba, Magdalena, Alsina, Ema, Martin-Perez, Mar, Garcia-Poza, Patricia, Llorente-Garcia, Ana, Gonzalez-Bermejo, Diana, Ibánez, Luisa, Sabaté, Mònica, Vidal, Xavier, Ballarín, Elena, Sanfélix-Gimeno, Gabriel, Rodríguez-Bernal, Clara, Peiró, Salvador, García-Sempere, Aníbal, Sanchez-Saez, Francisco, Ientile, Valentina, Ingrasciotta, Ylenia, Guarneri, Claudio, Tanaglia, Matilde, Tari, Michele, Herings, Ron, Houben, Eline, Swart-Polinder, Karin, Holthuis, Emily, Huerta, Consuelo, Gini, Rosa, Roberto, Giuseppe, Bartolini, Claudia, Paoletti, Olga, Limoncella, Giorgio, Girardi, Anna, Hyeraci, Giulia, Andersen, Morten, Kristiansen, Sarah Brøgger, Hallgreen, Christine Erikstrup, Klungel, Olaf, Sturkenboom, Miriam, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, PECP - Centre for Pharmacoepidemiology, Durán, Carlos E, Riera-Arnau, Judit, Abtahi, Shahab, Pajouheshnia, Romin, Hoxhaj, Vjola, Gamba, Magdalena, Alsina, Ema, Martin-Perez, Mar, Garcia-Poza, Patricia, Llorente-Garcia, Ana, Gonzalez-Bermejo, Diana, Ibánez, Luisa, Sabaté, Mònica, Vidal, Xavier, Ballarín, Elena, Sanfélix-Gimeno, Gabriel, Rodríguez-Bernal, Clara, Peiró, Salvador, García-Sempere, Aníbal, Sanchez-Saez, Francisco, Ientile, Valentina, Ingrasciotta, Ylenia, Guarneri, Claudio, Tanaglia, Matilde, Tari, Michele, Herings, Ron, Houben, Eline, Swart-Polinder, Karin, Holthuis, Emily, Huerta, Consuelo, Gini, Rosa, Roberto, Giuseppe, Bartolini, Claudia, Paoletti, Olga, Limoncella, Giorgio, Girardi, Anna, Hyeraci, Giulia, Andersen, Morten, Kristiansen, Sarah Brøgger, Hallgreen, Christine Erikstrup, Klungel, Olaf, and Sturkenboom, Miriam

Published
2023

8. Impact of the 2018 revised Pregnancy Prevention Programme by the European Medicines Agency on the use of oral retinoids in females of childbearing age in Denmark, Italy, Netherlands, and Spain:an interrupted time series analysis

Author

Durán, Carlos E., Riera-Arnau, Judit, Abtahi, Shahab, Pajouheshnia, Romin, Hoxhaj, Vjola, Gamba, Magdalena, Alsina, Ema, Martin-Perez, Mar, Garcia-Poza, Patricia, Llorente-Garcia, Ana, Gonzalez-Bermejo, Diana, Ibánez, Luisa, Sabaté, Mònica, Vidal, Xavier, Ballarín, Elena, Sanfélix-Gimeno, Gabriel, Rodríguez-Bernal, Clara, Peiró, Salvador, García-Sempere, Aníbal, Sanchez-Saez, Francisco, Ientile, Valentina, Ingrasciotta, Ylenia, Guarneri, Claudio, Tanaglia, Matilde, Tari, Michele, Herings, Ron, Houben, Eline, Swart-Polinder, Karin, Holthuis, Emily, Huerta, Consuelo, Gini, Rosa, Roberto, Giuseppe, Bartolini, Claudia, Paoletti, Olga, Limoncella, Giorgio, Girardi, Anna, Hyeraci, Giulia, Andersen, Morten, Kristiansen, Sarah Brøgger, Hallgreen, Christine Erikstrup, Klungel, Olaf, Sturkenboom, Miriam, Durán, Carlos E., Riera-Arnau, Judit, Abtahi, Shahab, Pajouheshnia, Romin, Hoxhaj, Vjola, Gamba, Magdalena, Alsina, Ema, Martin-Perez, Mar, Garcia-Poza, Patricia, Llorente-Garcia, Ana, Gonzalez-Bermejo, Diana, Ibánez, Luisa, Sabaté, Mònica, Vidal, Xavier, Ballarín, Elena, Sanfélix-Gimeno, Gabriel, Rodríguez-Bernal, Clara, Peiró, Salvador, García-Sempere, Aníbal, Sanchez-Saez, Francisco, Ientile, Valentina, Ingrasciotta, Ylenia, Guarneri, Claudio, Tanaglia, Matilde, Tari, Michele, Herings, Ron, Houben, Eline, Swart-Polinder, Karin, Holthuis, Emily, Huerta, Consuelo, Gini, Rosa, Roberto, Giuseppe, Bartolini, Claudia, Paoletti, Olga, Limoncella, Giorgio, Girardi, Anna, Hyeraci, Giulia, Andersen, Morten, Kristiansen, Sarah Brøgger, Hallgreen, Christine Erikstrup, Klungel, Olaf, and Sturkenboom, Miriam

Abstract

Background: In March 2018, the European pregnancy prevention programme for oral retinoids was updated as part of risk minimisation measures (RMM), emphasising their contraindication in pregnant women. Objective: To measure the impact of the 2018 revision of the RMMs in Europe by assessing the utilisation patterns of isotretinoin, alitretinoin and acitretin, contraceptive measures, pregnancy testing, discontinuation, and pregnancy occurrence concomitantly with a retinoid prescription. Methods: An interrupted time series (ITS) analysis to compare level and trend changes after the risk minimisation measures implementation was conducted on a cohort of females of childbearing age (12–55 years of age) from January 2010 to December 2020, derived from six electronic health data sources in four countries: Denmark, Netherlands, Spain, and Italy. Monthly utilisation figures (incidence rates [IR], prevalence rates [PR] and proportions) of oral retinoids were calculated, as well as discontinuation rates, contraception coverage, pregnancy testing, and rates of exposed pregnancies to oral retinoids, before and after the 2018 RMMs. Results: From 10,714,182 females of child-bearing age, 88,992 used an oral retinoid at any point during the study period (mean age 18.9–22.2 years old). We found non-significant level and trend changes in incidence or prevalence of retinoid use in females of child-bearing age after the 2018 RMMs. The reason of discontinuation was unknown in >95% of cases. Contraception use showed a significant increase trend in Spain; for other databases this information was limited. Pregnancy testing was hardly recorded thus was not possible to model ITS analyses. After the 2018 RMM, rates of pregnancy occurrence during retinoid use, and start of a retinoid during a pregnancy varied from 0.0 to 0.4, and from 0.2 to 0.8, respectively. Conclusion: This study shows a limited impact of the 2018 RMMs on oral retinoids utilisation patterns among females of child-bearing

Published
2023

9. Impact of 2018 EU Risk Minimisation Measures and Revised Pregnancy Prevention Programme on Utilisation and Prescribing Trends of Medicinal Products Containing Valproate:An Interrupted Time Series Study

Author

Abtahi, Shahab, Pajouheshnia, Romin, Durán, Carlos E., Riera-Arnau, Judit, Gamba, Magdalena, Alsina, Ema, Hoxhaj, Vjola, Andersen, Morten, Bartolini, Claudia, Kristiansen, Sarah Brøgger, Brown, Jeremy, Hallgreen, Christine Erikstrup, Garcia-Poza, Patricia, Gardarsdottir, Helga, Gini, Rosa, Girardi, Anna, Holthuis, Emily, Huerta, Consuelo, Ibánez, Luisa, Limoncella, Giorgio, Martín-Pérez, Mar, Paoletti, Olga, Roberto, Giuseppe, Souverein, Patrick, Swart, Karin M.A., Wing, Kevin, Sturkenboom, Miriam, Klungel, Olaf, Abtahi, Shahab, Pajouheshnia, Romin, Durán, Carlos E., Riera-Arnau, Judit, Gamba, Magdalena, Alsina, Ema, Hoxhaj, Vjola, Andersen, Morten, Bartolini, Claudia, Kristiansen, Sarah Brøgger, Brown, Jeremy, Hallgreen, Christine Erikstrup, Garcia-Poza, Patricia, Gardarsdottir, Helga, Gini, Rosa, Girardi, Anna, Holthuis, Emily, Huerta, Consuelo, Ibánez, Luisa, Limoncella, Giorgio, Martín-Pérez, Mar, Paoletti, Olga, Roberto, Giuseppe, Souverein, Patrick, Swart, Karin M.A., Wing, Kevin, Sturkenboom, Miriam, and Klungel, Olaf

Abstract

Introduction: Due to established teratogenicity of valproates, the EU risk minimisation measures (RMMs) with a pregnancy prevention programme (PPP) for valproate were updated in March 2018. Objectives: To investigate the effectiveness of the 2018 EU RMMs on valproate utilisation in five European countries/regions. Methods: A multi-database, times series study of females of childbearing potential (12–55 years) was conducted using electronic medical records from five countries/regions (01.01.2010–31.12.2020): Denmark, Tuscany (Italy), Spain, the Netherlands, and the UK. Clinical and demographic information from each database was transformed to the ConcePTION Common Data Model, quality checks were conducted and a distributed analysis was performed using common scripts. Incident and prevalent use of valproate, proportion of discontinuers and switchers to alternative medicine, frequency of contraception coverage during valproate use, and occurrence of pregnancies during valproate exposure were estimated per month. Interrupted time series analyses were conducted to estimate the level or trend change in the outcome measures. Results: We included 69,533 valproate users from 9,699,371 females of childbearing potential from the five participating centres. A significant decline in prevalent use of valproates was observed in Tuscany, Italy (mean difference post-intervention −7.7%), Spain (−11.3%), and UK (−5.9%) and a non-significant decline in the Netherlands (−3.3%), but no decline in incident use after the 2018 RMMs compared to the period before. The monthly proportion of compliant valproate prescriptions/dispensings with a contraceptive coverage was low (<25%), with an increase after the 2018 RMMs only in the Netherlands (mean difference post-intervention 12%). There was no significant increase in switching rates from valproates to alternative medicine after the 2018 intervention in any of the countries/regions. We observed a substantial number of concurrent pregnanci

Published
2023

10. Impact of 2018 EU Risk Minimisation Measures and Revised Pregnancy Prevention Programme on Utilisation and Prescribing Trends of Medicinal Products Containing Valproate: An Interrupted Time Series Study

Author

Pharmacoepidemiology and Clinical Pharmacology, Afd Pharmacoepi & Clinical Pharmacology, PECP - Centre for Pharmacoepidemiology, Abtahi, Shahab, Pajouheshnia, Romin, Durán, Carlos E, Riera-Arnau, Judit, Gamba, Magdalena, Alsina, Ema, Hoxhaj, Vjola, Andersen, Morten, Bartolini, Claudia, Kristiansen, Sarah Brøgger, Brown, Jeremy, Hallgreen, Christine Erikstrup, Garcia-Poza, Patricia, Gardarsdottir, Helga, Gini, Rosa, Girardi, Anna, Holthuis, Emily, Huerta, Consuelo, Ibánez, Luisa, Limoncella, Giorgio, Martín-Pérez, Mar, Paoletti, Olga, Roberto, Giuseppe, Souverein, Patrick, Swart, Karin M A, Wing, Kevin, Sturkenboom, Miriam, Klungel, Olaf, Pharmacoepidemiology and Clinical Pharmacology, Afd Pharmacoepi & Clinical Pharmacology, PECP - Centre for Pharmacoepidemiology, Abtahi, Shahab, Pajouheshnia, Romin, Durán, Carlos E, Riera-Arnau, Judit, Gamba, Magdalena, Alsina, Ema, Hoxhaj, Vjola, Andersen, Morten, Bartolini, Claudia, Kristiansen, Sarah Brøgger, Brown, Jeremy, Hallgreen, Christine Erikstrup, Garcia-Poza, Patricia, Gardarsdottir, Helga, Gini, Rosa, Girardi, Anna, Holthuis, Emily, Huerta, Consuelo, Ibánez, Luisa, Limoncella, Giorgio, Martín-Pérez, Mar, Paoletti, Olga, Roberto, Giuseppe, Souverein, Patrick, Swart, Karin M A, Wing, Kevin, Sturkenboom, Miriam, and Klungel, Olaf

Published
2023

11. Impact of the 2018 revised Pregnancy Prevention Programme by the European Medicines Agency on the use of oral retinoids in females of childbearing age in Denmark, Italy, Netherlands, and Spain: an interrupted time series analysis

Author

RWE/Causal inference, Epi Infectieziekten Team 2, Data Science & Biostatistiek, Child Health, Durán, Carlos E, Riera-Arnau, Judit, Abtahi, Shahab, Pajouheshnia, Romin, Hoxhaj, Vjola, Gamba, Magdalena, Alsina, Ema, Martin-Perez, Mar, Garcia-Poza, Patricia, Llorente-Garcia, Ana, Gonzalez-Bermejo, Diana, Ibánez, Luisa, Sabaté, Mònica, Vidal, Xavier, Ballarín, Elena, Sanfélix-Gimeno, Gabriel, Rodríguez-Bernal, Clara, Peiró, Salvador, García-Sempere, Aníbal, Sanchez-Saez, Francisco, Ientile, Valentina, Ingrasciotta, Ylenia, Guarneri, Claudio, Tanaglia, Matilde, Tari, Michele, Herings, Ron, Houben, Eline, Swart-Polinder, Karin, Holthuis, Emily, Huerta, Consuelo, Gini, Rosa, Roberto, Giuseppe, Bartolini, Claudia, Paoletti, Olga, Limoncella, Giorgio, Girardi, Anna, Hyeraci, Giulia, Andersen, Morten, Kristiansen, Sarah Brøgger, Hallgreen, Christine Erikstrup, Klungel, Olaf, Sturkenboom, Miriam, RWE/Causal inference, Epi Infectieziekten Team 2, Data Science & Biostatistiek, Child Health, Durán, Carlos E, Riera-Arnau, Judit, Abtahi, Shahab, Pajouheshnia, Romin, Hoxhaj, Vjola, Gamba, Magdalena, Alsina, Ema, Martin-Perez, Mar, Garcia-Poza, Patricia, Llorente-Garcia, Ana, Gonzalez-Bermejo, Diana, Ibánez, Luisa, Sabaté, Mònica, Vidal, Xavier, Ballarín, Elena, Sanfélix-Gimeno, Gabriel, Rodríguez-Bernal, Clara, Peiró, Salvador, García-Sempere, Aníbal, Sanchez-Saez, Francisco, Ientile, Valentina, Ingrasciotta, Ylenia, Guarneri, Claudio, Tanaglia, Matilde, Tari, Michele, Herings, Ron, Houben, Eline, Swart-Polinder, Karin, Holthuis, Emily, Huerta, Consuelo, Gini, Rosa, Roberto, Giuseppe, Bartolini, Claudia, Paoletti, Olga, Limoncella, Giorgio, Girardi, Anna, Hyeraci, Giulia, Andersen, Morten, Kristiansen, Sarah Brøgger, Hallgreen, Christine Erikstrup, Klungel, Olaf, and Sturkenboom, Miriam

Published
2023

12. Impact of 2018 EU Risk Minimisation Measures and Revised Pregnancy Prevention Programme on Utilisation and Prescribing Trends of Medicinal Products Containing Valproate: An Interrupted Time Series Study

Author

RWE/Causal inference, Epi Infectieziekten Team 2, Apotheek O&O&O, Child Health, Infection & Immunity, Regenerative Medicine and Stem Cells, Data Science & Biostatistiek, Abtahi, Shahab, Pajouheshnia, Romin, Durán, Carlos E, Riera-Arnau, Judit, Gamba, Magdalena, Alsina, Ema, Hoxhaj, Vjola, Andersen, Morten, Bartolini, Claudia, Kristiansen, Sarah Brøgger, Brown, Jeremy, Hallgreen, Christine Erikstrup, Garcia-Poza, Patricia, Gardarsdottir, Helga, Gini, Rosa, Girardi, Anna, Holthuis, Emily, Huerta, Consuelo, Ibánez, Luisa, Limoncella, Giorgio, Martín-Pérez, Mar, Paoletti, Olga, Roberto, Giuseppe, Souverein, Patrick, Swart, Karin M A, Wing, Kevin, Sturkenboom, Miriam, Klungel, Olaf, RWE/Causal inference, Epi Infectieziekten Team 2, Apotheek O&O&O, Child Health, Infection & Immunity, Regenerative Medicine and Stem Cells, Data Science & Biostatistiek, Abtahi, Shahab, Pajouheshnia, Romin, Durán, Carlos E, Riera-Arnau, Judit, Gamba, Magdalena, Alsina, Ema, Hoxhaj, Vjola, Andersen, Morten, Bartolini, Claudia, Kristiansen, Sarah Brøgger, Brown, Jeremy, Hallgreen, Christine Erikstrup, Garcia-Poza, Patricia, Gardarsdottir, Helga, Gini, Rosa, Girardi, Anna, Holthuis, Emily, Huerta, Consuelo, Ibánez, Luisa, Limoncella, Giorgio, Martín-Pérez, Mar, Paoletti, Olga, Roberto, Giuseppe, Souverein, Patrick, Swart, Karin M A, Wing, Kevin, Sturkenboom, Miriam, and Klungel, Olaf

Published
2023

13. Impact of EU label changes and revised pregnancy prevention programme for medicinal products containing valproate: utilisation and prescribing trends

Author

Klungel, Olaf, Sturkenboom, Miriam, Abtahi, Shahab, Pajouheshnia, Romin, Durán Salinas, Carlos, Riera Arnau, Judit, Dodd, Caitlin, Gardarsdottir, Helga, Souverein, Patrick, Hoxhaj, Vjola, Siiskonen, Satu Johanna, Gamba, Magdalena, Alsina, Ema, Huerta, Consuelo, Bermejo, Diana Gonzalez, Corominas, Dolores Montero, Martín-Pérez, Mar, Garcia-Poza, Patricia, García, Ana Llorente, Ibanez, Luisa, Douglas, Ian, Wing, Kevin, Brown, Jeremy, Herings, Ron, Houben, Eline, Penning-van Beest, Fernie, Swart, Karin, Holthuis, Emily, Gini, Rosa, Roberto, Giuseppe, Bartolini, Claudia, Paoletti, Olga, Limoncella, Giorgio, Girardi, Anna, Hyeraci, Giulia, Andersen, Morten, Kristiansen. Sarah Brøgger, Hallgreen, Christine Erikstrup, Kant, Agnes, van Puijenbroek, Eugene, and Lely, Titia

Subjects
Sodium valproate, congenital abnormalities, contraceptive agents, pregnancy, risk minimisation measures (RMMs), bipolar disorder, epilepsy, migraine prophylaxis
Abstract

Rationale and background In March 2018, the European risk minimisation measures (RMMs) with a Pregnancy Prevention Program (PPP) for valproate-containing medicines was updated. A pharmacoepidemiological study was conducted using longitudinal data collected in five electronic health care databases from four EU countries and the UK to investigate the use of valproates authorised in the EU before and after implementation of the 2018 revised measures for pregnancy prevention in clinical practice, and effectiveness of the 2018 intervention. Objectives Objective 1: To determine drug utilisation and prescription patterns of valproate-containing medicinal products in females of childbearing potential, and to investigate whether significant changes in prescribing patterns occurred (pre-/post-intervention). Objective 2: To determine prescribers’ compliance with the recommendations in the Summary of Products Characteristics (SmPC) for valproate-containing medicinal products, by indication, age group, duration of use, and database. Objective 3: To determine patients’ use of effective contraception in compliance with recommendations in the SmPC for valproate-containing medicinal products, by indication, age group, method of contraception, and database. Objective 4: To determine drug utilisation and prescription patterns over time for alternative medicines prescribed in women who became pregnant, where valproate-containing medicinal products had previously been prescribed or discontinued, by indication, by age group and by database. Objective 5: Based on the results of the above, to estimate the effectiveness of the 2018 RMMs for valproates. Methods We performed an observational times series study including all female subjects of childbearing age (aged 12 to 55 years) from the corresponding databases in Denmark (Danish National Registers, DNR), Italy (ARS Tuscany), the Netherlands (PHARMO Database Network), Spain (Base de datos para la Investigación Farmacoepidemiológica en Atención Primaria, BIFAP), and UK (Clinical Practice Research Datalink, CPRD) between 01 January 2010 to 31 December 2020. In Objective 1, the incident use, prevalent use and rate of discontinuation thereof was estimated per month in each data source, in addition to the change in level and trend in use after the implementation of the 2018 EU RMMs, using an interrupted time series (ITS) analysis design. In Objective 2, first, we separately estimated the proportion of valproate users with a record of a pregnancy test within the 90 days i) before and ii) after the date of valproate prescribing or dispensing per month. We estimated the change in level and trend in these proportions after the implementation of the 2018 EU RMMs. Second, we estimated the proportion of valproate users with a record of contraceptive (prescribed or dispensed with a prescription, or identified through medical events or procedures records) in 90-days before the prescription, or prescribed/dispensed during a contraceptive episode. We then estimated the change in level and trend in this proportion after the implementation of the 2018 EU intervention, using an ITS analysis design. In Objective 3, we estimated the incidence of new pregnancies during a period of valproate use per month and the change in level and trend in this rate after the implementation of the 2018 EU intervention, using an ITS analysis design. In Objective 4, we estimated the rates of alternative medication prescriptions/dispensings for the indications epilepsy, bipolar disorder, and migraine among valproate users and the rate of switching from valproate to an alternative medicine per month. Then, the change in trend of switches from valproate to alternative medications before and after the implementation of the 2018 EU intervention was estimated, using an ITS analysis design. In Objective 5, evidence generated from Objectives 1-4, weighed by the strengths and limitations of the analyses, was used to draw conclusions on the effectiveness of the RMMs, per country and across European countries included in the study. Results Objective 1: There were 69,533 valproate users out of a total of 9,699,371 female subjects of childbearing age from the five participating centres during the study period. The median follow-up time of the study population ranged between 3.5-10.0 years and the mean age at the start of follow-up was always ≥30 years in different centres. The monthly incidence rate of valproate use ranged between 0.01-0.47 per 1000 persons months across databases and the prevalence rate ranged between 1.2-7.7 per 1000 female subjects. While the observed rates were similar for DNR, PHARMO, BIFAP and CPRD, the rates of prevalent use were much higher in ARS Tuscany. We observed a statistically significant declining trend in prevalent use of valproates in all countries/regions, for which an ITS analysis could be performed, but no significant decreasing trend in incidence rates after the 2018 RMMs compared to the period before. The monthly rate of valproate discontinuers ranged between 1-8% across all databases, and in no database we observed a significant increase in trend or level of valproate discontinuation after the 2018 intervention compared to time prior. Objective 2: We included 69,533 female valproate users from the five participating centres during the study period, with a median follow-up time between 4.4-11.0 years and the mean age at the start of follow-up ≥34 years. Due to the limited data on pregnancy tests from all databases, modelling of any trend change in proportion of valproate prescriptions or dispensings with an adherent pregnancy test before versus after 2018 RMMs was not possible. The rate of recorded contraceptive coverage at the start of valproate treatment was low across all centres, as only 0.5-23% of valproate prescriptions/dispensings each month were accompanied by a contraceptive prescription in 90-days before, and only between 0.5-25% of new valproate treatment episode had started during contraceptive use. There was no increasing trend in compliant valproate prescriptions/ dispensings with a contraceptive coverage after the 2018 RMMs across the studied databases, and the only increase in level was observed in PHARMO. Objective 3: We included 69,533 female valproate users from the five participating centres during study period, with a median follow-up time between 4.4-11.0 years and the mean age at the start of follow-up ≥34 years. In general, we observed a substantial number of concurrent new valproate prescriptions/dispensings during a pregnancy time window in ARS Tuscany (386 pre- and 40 post 2018 intervention), BIFAP (330 pre and 20 post) and CPRD (204 pre and 56 post), while there were fewer concurrent events in PHARMO (27 pre and 0 post). However, the rates of concurrent events declined for most databases after the 2018 intervention. There was no data on pregnancy counts available from DNR. Objective 4: We included 69,533 female valproate users from the five participating centres during study period, with a median follow-up time between 4.4-11.0 years and the mean age at the start of follow-up ≥34 years. We found an increasing trend in rates of alternative medicine use for epilepsy and bipolar diseases indications of valproates across the study period in most databases (i.e., DNR, ARS Tuscany, PHARMO and CPRD), while the rates for migraine were mostly steady. The monthly rate of switch from a valproate to an alternative medication was similar across all DAPs and ranged between 1-8%. Running an ITS analysis was not possible for most of the included databases due to the low frequency of switching, but there was a significant increase in trend in switching rates from valproates to alternative medicine after the 2018 RMMs in ARS Tuscany. Objective 5: We found a generally declining trend in prevalence rate of valproate use after the 2018 RMMs in almost all databases (Objective 1), but also no increasing trend in compliant valproate prescriptions/dispensings with a contraceptive coverage (Objective 2). There was a substantial number of occurrences of pregnancy events (as the final endpoint) concurrently with valproate exposure across most included databases, but the rates declined after 2018 (Objective 3). Furthermore, we observed a significant increase in switching rates from valproates to alternative medications only in few regions (such as ARS Tuscany) (Objective 4). Noteworthy, these findings should be interpreted in context of the limitations that we faced, such as an inability to investigate some objectives due to limited data availability on pregnancy test or over-the-counter use of some contraceptives, and the occurrence of COVID-19 pandemic, which has shortened and impacted our post-intervention period and limited our ability to run ITS analyses for some objectives and some databases. Conclusions Objective 1: We observed declining trends in prevalent use of valproates after the 2018 RMMs across all databases. However, there were no declining trends in incidence rate of valproates in none of databases. The rate of discontinuation of valproates was not affected by the 2018 RMMs. Objective 2: We found in general low rates of recorded adherent contraceptive coverage with valproate use across all studied regions/countries, and there was no increased trend in compliant valproate prescriptions/dispensings with a contraceptive coverage after the 2018 RMMs compared to time prior. Due to limited data availability, rates of adherent pregnancy tests and the trend change after the intervention could not be studied. Objective 3: Despite the declining rates after the 2018 intervention, high counts and rates of concurrent pregnancy events with a valproate prescription/dispensing were observed across most studied countries/regions. Objective 4: Although the trend in alternative medication use for most indications of valproates (epilepsy and bipolar disorder) was increasing during the study period, the only significant increase in trend in switching rates from valproates to alternative medications after the 2018 RMMs was observed in ARS Tuscany. Objective 5: Based on the findings on various objectives in this study, we can conclude that there was a small impact of the 2018 RMMs on valproate use and prescribing in the studied European countries/regions. Considering the limitations of this study (such as not studying all PPP elements, the included databases had important limitations, and the study period after 2018 intervention was rather short), the results of other currently ongoing studies are needed to have a clearer picture of the appropriate implementation of 2018 RMMs on valproate use in Europe., The research leading to these results was conducted as part of the activities of the EU PE&PV (Pharmacoepidemiology and Pharmacovigilance) Research Network which is a public academic partnership coordinated by the Utrecht University, the Netherlands. The project has received support from the European Medicines Agency under the Framework service contract nr EMA/2018/28/PE. The content of this paper expresses the opinion of the authors and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties.

Published
2022
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14. Hydroxyzine Initiation Following Drug Safety Advisories on Cardiac Arrhythmias in the UK and Canada: A Longitudinal Cohort Study

Author

Morrow, Richard L, Mintzes, Barbara, Souverein, Patrick C, Hallgreen, Christine E, Ahmed, Bilal, Roughead, Elizabeth E, De Bruin, Marie L, Kristiansen, Sarah Brøgger, Lexchin, Joel, Kemp-Casey, Anna, Sketris, Ingrid, Mangin, Dee, Pearson, Sallie-Anne, Puil, Lorri, Lopert, Ruth, Bero, Lisa, Gnjidic, Danijela, Sarpatwari, Ameet, Dormuth, Colin R, Morrow, Richard L, Mintzes, Barbara, Souverein, Patrick C, Hallgreen, Christine E, Ahmed, Bilal, Roughead, Elizabeth E, De Bruin, Marie L, Kristiansen, Sarah Brøgger, Lexchin, Joel, Kemp-Casey, Anna, Sketris, Ingrid, Mangin, Dee, Pearson, Sallie-Anne, Puil, Lorri, Lopert, Ruth, Bero, Lisa, Gnjidic, Danijela, Sarpatwari, Ameet, and Dormuth, Colin R

Abstract

INTRODUCTION: Regulatory advisories on hydroxyzine and risk of QT prolongation and Torsade de pointes (TdP) were issued in the UK in April 2015 and Canada in June 2016. We hypothesized patients with risk factors for QT prolongation and TdP, compared with those without risk factors, would be less likely to initiate hydroxyzine in the UK and in British Columbia (BC), Canada, following advisories.METHODS: We conducted a longitudinal study with repeated measures, and evaluated hydroxyzine initiation in a UK cohort and a concurrent BC control cohort (April 2013-March 2016) as well as in a BC advisory cohort (June 2014-May 2017).RESULTS: This study included 247,665 patients in the UK cohort, 297,147 patients in the BC control cohort, and 303,653 patients in the BC advisory cohort. Over a 12-month post-advisory period, hydroxyzine initiation decreased by 21% in the UK (rate ratio 0.79, 95% confidence interval 0.66-0.96) relative to the expected level of initiation based on the pre-advisory trend. Hydroxyzine initiation did not change in the BC control cohort or following the Canadian advisory in the BC advisory cohort. The decrease in hydroxyzine initiation in the UK in the 12 months after the advisories was not significantly different for patients with risk factors compared with those without risk factors.CONCLUSION: Hydroxyzine initiation decreased in the UK, but not in BC, in the 12 months following safety advisories. The decrease in hydroxyzine initiation in the UK was not significantly different for patients with versus without risk factors for QT prolongation and TdP.

Published
2022

15. Investigation of the potential association between the use of fluoxetine and occurrence of acute pancreatitis: a Danish register-based cohort study

Author

Aakjær, Mia, Kristiansen, Sarah Brøgger, Pape, Kathrine, Sessa, Maurizio, Dalhoff, Kim Peder, De Bruin, Marie Louise, Andersen, Morten, Aakjær, Mia, Kristiansen, Sarah Brøgger, Pape, Kathrine, Sessa, Maurizio, Dalhoff, Kim Peder, De Bruin, Marie Louise, and Andersen, Morten

Abstract

BACKGROUND: There is currently conflicting evidence of the association between the use of selective serotonin reuptake inhibitors (SSRIs) and acute pancreatitis. The SSRI fluoxetine has been suspected to be the driver of this serious outcome. Therefore, this study aims to investigate the potential association between fluoxetine use and the occurrence of acute pancreatitis.METHODS: We conducted a nationwide cohort study using Danish register-based data from 1996 to 2016. The exposed group were new users of fluoxetine (1-year washout). The control subjects were new users of citalopram or SSRIs, excluding fluoxetine. The outcome was an incident diagnosis of acute pancreatitis with a 5-year washout. We used an intention-to-treat approach following patients for a maximum of 6 months. Cox regression analyses were performed, estimating hazard ratios (HRs) and 95% confidence intervals (CIs) adjusted for age/sex, comorbidities and co-medications, using propensity score adjustment and matching.RESULTS: In the propensity score-matched analyses, 61 783 fluoxetine users were included. The incidence rates among users of fluoxetine and other SSRIs were 5.33 (3.05-8.66) and 5.36 (3.06-8.70) per 10 000 person-years, respectively. No increased risk of acute pancreatitis was identified following fluoxetine exposure compared with either citalopram [HR 1.00, 95% CI 0.50-2.00) or other SSRIs (0.76, 0.40-1.46).CONCLUSIONS: Fluoxetine use was not associated with an increased risk of acute pancreatitis compared with citalopram or other SSRIs. The absolute risk of acute pancreatitis was low and did not vary between different SSRIs. Further research is needed to determine whether there is a class effect on the risk of acute pancreatitis.

Published
2022

16. Hydroxyzine Initiation Following Drug Safety Advisories on Cardiac Arrhythmias in the UK and Canada: A Longitudinal Cohort Study

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Morrow, Richard L, Mintzes, Barbara, Souverein, Patrick C, Hallgreen, Christine E, Ahmed, Bilal, Roughead, Elizabeth E, De Bruin, Marie L, Kristiansen, Sarah Brøgger, Lexchin, Joel, Kemp-Casey, Anna, Sketris, Ingrid, Mangin, Dee, Pearson, Sallie-Anne, Puil, Lorri, Lopert, Ruth, Bero, Lisa, Gnjidic, Danijela, Sarpatwari, Ameet, Dormuth, Colin R, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Morrow, Richard L, Mintzes, Barbara, Souverein, Patrick C, Hallgreen, Christine E, Ahmed, Bilal, Roughead, Elizabeth E, De Bruin, Marie L, Kristiansen, Sarah Brøgger, Lexchin, Joel, Kemp-Casey, Anna, Sketris, Ingrid, Mangin, Dee, Pearson, Sallie-Anne, Puil, Lorri, Lopert, Ruth, Bero, Lisa, Gnjidic, Danijela, Sarpatwari, Ameet, and Dormuth, Colin R

Published
2022

17. Investigation of the potential association between the use of fluoxetine and occurrence of acute pancreatitis: a Danish register-based cohort study

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Aakjær, Mia, Kristiansen, Sarah Brøgger, Pape, Kathrine, Sessa, Maurizio, Dalhoff, Kim Peder, De Bruin, Marie Louise, Andersen, Morten, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, Aakjær, Mia, Kristiansen, Sarah Brøgger, Pape, Kathrine, Sessa, Maurizio, Dalhoff, Kim Peder, De Bruin, Marie Louise, and Andersen, Morten

Published
2022

18. Investigation of the potential association between the use of fluoxetine and occurrence of acute pancreatitis:a Danish register-based cohort study

Author

Aakjær, Mia, Kristiansen, Sarah Brøgger, Pape, Kathrine, Sessa, Maurizio, Dalhoff, Kim Peder, De Bruin, Marie Louise, Andersen, Morten, Aakjær, Mia, Kristiansen, Sarah Brøgger, Pape, Kathrine, Sessa, Maurizio, Dalhoff, Kim Peder, De Bruin, Marie Louise, and Andersen, Morten

Abstract

BACKGROUND: There is currently conflicting evidence of the association between the use of selective serotonin reuptake inhibitors (SSRIs) and acute pancreatitis. The SSRI fluoxetine has been suspected to be the driver of this serious outcome. Therefore, this study aims to investigate the potential association between fluoxetine use and the occurrence of acute pancreatitis.METHODS: We conducted a nationwide cohort study using Danish register-based data from 1996 to 2016. The exposed group were new users of fluoxetine (1-year washout). The control subjects were new users of citalopram or SSRIs, excluding fluoxetine. The outcome was an incident diagnosis of acute pancreatitis with a 5-year washout. We used an intention-to-treat approach following patients for a maximum of 6 months. Cox regression analyses were performed, estimating hazard ratios (HRs) and 95% confidence intervals (CIs) adjusted for age/sex, comorbidities and co-medications, using propensity score adjustment and matching.RESULTS: In the propensity score-matched analyses, 61 783 fluoxetine users were included. The incidence rates among users of fluoxetine and other SSRIs were 5.33 (3.05-8.66) and 5.36 (3.06-8.70) per 10 000 person-years, respectively. No increased risk of acute pancreatitis was identified following fluoxetine exposure compared with either citalopram [HR 1.00, 95% CI 0.50-2.00) or other SSRIs (0.76, 0.40-1.46).CONCLUSIONS: Fluoxetine use was not associated with an increased risk of acute pancreatitis compared with citalopram or other SSRIs. The absolute risk of acute pancreatitis was low and did not vary between different SSRIs. Further research is needed to determine whether there is a class effect on the risk of acute pancreatitis.

Published
2022

19. Hydroxyzine Initiation Following Drug Safety Advisories on Cardiac Arrhythmias in the UK and Canada:A Longitudinal Cohort Study

Author

Morrow, Richard L., Mintzes, Barbara, Souverein, Patrick C., Hallgreen, Christine E., Ahmed, Bilal, Roughead, Elizabeth E., De Bruin, Marie L., Kristiansen, Sarah Brøgger, Lexchin, Joel, Kemp-Casey, Anna, Sketris, Ingrid, Mangin, Dee, Pearson, Sallie Anne, Puil, Lorri, Lopert, Ruth, Bero, Lisa, Gnjidic, Danijela, Sarpatwari, Ameet, Dormuth, Colin R., Morrow, Richard L., Mintzes, Barbara, Souverein, Patrick C., Hallgreen, Christine E., Ahmed, Bilal, Roughead, Elizabeth E., De Bruin, Marie L., Kristiansen, Sarah Brøgger, Lexchin, Joel, Kemp-Casey, Anna, Sketris, Ingrid, Mangin, Dee, Pearson, Sallie Anne, Puil, Lorri, Lopert, Ruth, Bero, Lisa, Gnjidic, Danijela, Sarpatwari, Ameet, and Dormuth, Colin R.

Abstract

Introduction: Regulatory advisories on hydroxyzine and risk of QT prolongation and Torsade de pointes (TdP) were issued in the UK in April 2015 and Canada in June 2016. We hypothesized patients with risk factors for QT prolongation and TdP, compared with those without risk factors, would be less likely to initiate hydroxyzine in the UK and in British Columbia (BC), Canada, following advisories. Methods: We conducted a longitudinal study with repeated measures, and evaluated hydroxyzine initiation in a UK cohort and a concurrent BC control cohort (April 2013–March 2016) as well as in a BC advisory cohort (June 2014–May 2017). Results: This study included 247,665 patients in the UK cohort, 297,147 patients in the BC control cohort, and 303,653 patients in the BC advisory cohort. Over a 12-month post-advisory period, hydroxyzine initiation decreased by 21% in the UK (rate ratio 0.79, 95% confidence interval 0.66–0.96) relative to the expected level of initiation based on the pre-advisory trend. Hydroxyzine initiation did not change in the BC control cohort or following the Canadian advisory in the BC advisory cohort. The decrease in hydroxyzine initiation in the UK in the 12 months after the advisories was not significantly different for patients with risk factors compared with those without risk factors. Conclusion: Hydroxyzine initiation decreased in the UK, but not in BC, in the 12 months following safety advisories. The decrease in hydroxyzine initiation in the UK was not significantly different for patients with versus without risk factors for QT prolongation and TdP.

Published
2022

22. Role of pannexin and adenosine triphosphate (ATP) following myocardial ischemia/reperfusion

Author

Kristiansen, Sarah Brøgger, Skovsted, Gry Freja, Berchtold, Lukas Adrian, Radziwon-Balicka, Aneta, Dreisig, Karin, Edvinsson, Lars, Sheykhzade, Majid, Haanes, Kristian Agmund, Kristiansen, Sarah Brøgger, Skovsted, Gry Freja, Berchtold, Lukas Adrian, Radziwon-Balicka, Aneta, Dreisig, Karin, Edvinsson, Lars, Sheykhzade, Majid, and Haanes, Kristian Agmund

Abstract

OBJECTIVES: The purinergic system has not been investigated in detail following ischemia/reperfusion (I/R) injury in the heart. In the present study we focus on both release and response to extracellular adenosine triphosphate (ATP). Pannexin (Panx) channels have been shown to be involved in ATP release from myocytes and can activate P2X1 and P2Y2 receptors on the coronary artery.DESIGN: We applied a well characterized I/R model in rats, with 24 hours of reperfusion. Panx expression in the myocardial tissue was measured with quantitative polymerase chain reaction (qPCR) and flow cytometry. ATP release was detected in situ using luminescence and the vascular response to nucleotides determined in a wire myograph.RESULTS: Here we show that Panx expression is increased after experimental myocardial I/R, leading to an increase in extracellular ATP release, which could be inhibited by probenecid. Functional studies revealed that the P2Y2 receptor dependent contraction is reduced in the coronary artery after I/R, which might be a response to the increased ATP levels.CONCLUSION: We therefore, conclude that the regulation of the arterial purinergic system minimizes coronary contractions following ischemia.

Published
2018

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