Bakker, Roberto

Mulder, Hans

Ruhé, Henricus

Seldenrijk, Adrie

Simoons, Mirjam

van Roon, Eric

ARTS repository - University of Groningen

   University of GroningenAuthors' Response to Braillon's Comment on: "Limited Evidence for Risk Factors forProarrhythmia and Sudden Cardiac Death in Patients Using AntidepressantsSimoons, Mirjam; Seldenrijk, Adrie; Mulder, Hans; van Roon, Eric; Bakker, Roberto; Ruhé,HenricusPublished in:Drug SafetyDOI:10.1007/s40264-018-0716-5IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite fromit. Please check the document version below.Document VersionPublisher's PDF, also known as Version of recordPublication date:2018Link to publication in University of Groningen/UMCG research databaseCitation for published version (APA):Simoons, M., Seldenrijk, A., Mulder, H., van Roon, E., Bakker, R., & Ruhé, H. (2018). Authors' Response toBraillon's Comment on: "Limited Evidence for Risk Factors for Proarrhythmia and Sudden Cardiac Death inPatients Using Antidepressants: Dutch Consensus on ECG Monitoring". Drug Safety, 41(12), 1417-1418.Advance online publication. https://doi.org/10.1007/s40264-018-0716-5CopyrightOther than for strictly personal use, it is not permitted to download or to forward/distribute the text or part of it without the consent of theauthor(s) and/or copyright holder(s), unless the work is under an open content license (like Creative Commons).The publication may also be distributed here under the terms of Article 25fa of the Dutch Copyright Act, indicated by the “Taverne” license.More information can be found on the University of Groningen website: https://www.rug.nl/library/open-access/self-archiving-pure/taverne-amendment.Take-down policyIf you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediatelyand investigate your claim.Downloaded from the University of Groningen/UMCG research database (Pure): http://www.rug.nl/research/portal. For technical reasons thenumber of authors shown on this cover page is limited to 10 maximum.Vol.:(0123456789)Drug Safety (2018) 41:1417–1418 https://doi.org/10.1007/s40264-018-0716-5LETTER TO THE EDITORAuthors’ Response to Braillon’s Comment on: “Limited Evidence for Risk Factors for Proarrhythmia and Sudden Cardiac Death in Patients Using Antidepressants: Dutch Consensus on ECG Monitoring”Mirjam Simoons1,2,3  · Adrie Seldenrijk2,4 · Hans Mulder1,5 · Eric van Roon3,6 · Roberto Bakker7,8 · Henricus Ruhé2,9,10 Published online: 17 August 2018 © Springer Nature Switzerland AG 2018We thank Dr. Braillon for his comments on our article [1]. Dr. Braillon questions whether we should minimize the risk of proarrhythmia and sudden cardiac death in rela-tion to antidepressants with recommendations for electro-cardiogram monitoring or avoid the use of antidepressants all together and mainly treat patients with depression with psychotherapy [2]. We agree with Dr. Braillon that psycho-therapy (cognitive behavioral therapy) is an alternative first-line treatment option for depression with at least better and prolonged effects regarding relapse prevention relative to antidepressants [3–5]. However, the aim of our article was to aid physicians and patients who have collaboratively decided to start antidepressant therapy to treat depression either as monotherapy or in combination with psychotherapy [1, 6]. We describe a set of recommendations for estimating and minimizing the risk of proarrhythmia and sudden cardiac death after the choice for pharmacological therapy above other treatment options has been made [1].For decades, there has been a debate about the efficacy, effectiveness, and benefit-harm ratio of antidepressants. A recent systematic review and network analysis that was not yet available when Prescrire published its list of drugs to avoid in 2017 [7] represents the most comprehensive analysis of the evidence base for antidepressant efficacy and acceptability ever performed [8]. Based on 552 trials and over 116,000 participants, Cipriani et al. found that all 21 antidepressants included in the meta-analysis were more efficacious than placebo in adults with major depres-sive disorder, while few differences were found between the antidepressants and placebo when tolerability was con-cerned [8]. In fact, treatment with antidepressants can be lifesaving. Patients with major depressive disorder more often die from suicide than from proarrhythmia or sudden cardiac death. Although the risk of intentional overdosing as a consequence of psychiatric disease is always present, the literature currently available shows that adults aged over 25 years treated with any class of antidepressant have a lower risk of suicidality compared with placebo [9, 10]. We agree with Dr. Braillon that risks associated with any drug This reply refers to the article available at https ://doi.org/10.1007/s4026 4-018-0714-7. * Henricus Ruhé  eric.ruhe@radboudumc.nl1 Department of Clinical Pharmacy, Wilhelmina Hospital Assen, Assen, The Netherlands2 Department of Psychiatry, Radboudumc, PO-Box 9101, 6500 HB Nijmegen, The Netherlands3 Unit of Pharmacotherapy, Epidemiology and-Economics, Department of Pharmacy, University of Groningen, Groningen, The Netherlands4 Department of Research and Innovation, GGZ InGeest, Amsterdam, The Netherlands5 Psychiatric Hospital GGZ Drenthe, Assen, The Netherlands6 Department of Clinical Pharmacy and Clinical Pharmacology, Medical Centre Leeuwarden, Leeuwarden, The Netherlands7 Psychiatric Centre GGz Centraal, Amersfoort, The Netherlands8 Department of Psychiatry and Psychology, South Limburg Mental Health and Teaching Network, Maastricht University Medical Centre, Maastricht, The Netherlands9 Department of Psychiatry, Warneford Hospital, University of Oxford, Oxford, UK10 Department of Psychiatry, Radboudumc, Nijmegen, The Netherlands1418 M. Simoons et al.could be prevented by avoiding such agents and consider-ing alternatives (e.g., psychotherapy) instead. Considering the data from the aforementioned meta-analyses, however, the suggested market withdrawal for antidepressants such as citalopram, escitalopram, and venlafaxine [7] is, in our opinion, too far reaching.Once the choice for antidepressant therapy has been made, in our opinion, it is important to minimize the risk of proarrhythmia and sudden cardiac death. Currently, the only way to achieve risk minimization with respect to these adverse effects of antidepressants is to monitor the electro-cardiogram based on risk factors such as older age, female sex, or aberrant potassium levels. We provide clear and read-ily applicable recommendations for performing electrocar-diogram screening and monitoring in daily clinical practice, thereby meeting a need of clinicians that we identified.We hope we were able to clarify the issues raised by Dr. Braillon and would like to thank him again for his reflections on our work.Compliance with Ethical Standards Funding No specific funding was received for this letter. The original project was funded by the Dutch Network for Quality Development in Mental Health Care (Grants P140019 and P140040 to Henricus Ruhé and Roberto Bakker). This organization had no influence on the content of the study, the original manuscript, or this letter.Conflict of interest Henricus Ruhé obtained an Investigator-Initiated Trial grant and speaking fees from Lundbeck BV, which are not related to the current work. Mirjam Simoons, Adrie Seldenrijk, Hans Mulder, Eric van Roon, and Roberto Bakker have no conflicts of interest that are directly relevant to the contents of the study, the original manu-script, or this letter.Ethics approval Ethics approval was not applicable for this letter.Patient consent Patient consent was not applicable for this letter.References 1. Simoons M, Seldenrijk A, Mulder H, Birkenhager T, Groothedde-Kuyvenhoven M, Kok R, et al. Limited evidence for risk factors for proarrhythmia and sudden cardiac death in patients using anti-depressants: Dutch Consensus on ECG Monitoring. Drug Saf. 2018;41:655–64. 2. Braillon A. Comment on: “Limited evidence for risk factors for proarrhythmia and sudden cardiac death in patients using anti-depressants: Dutch Consensus on ECG Monitoring”. Drug Saf. 2018. https ://doi.org/10.1007/s4026 4-018-0714-7. 3. Spijker J, Bockting CLH, Meeuwissen JAC, Vliet van IM, Emmelkamp PMG, Hermens MLM, et  al. Multidisciplinary guideline depression (third revision) [in Dutch]. 2013. https ://www.ggzri chtli jnen.nl/depre ssie. Accessed 19 Jul 2018. 4. National Institute for Health and Care Excellence. Depression in adults: recognition and management (CG 90). 2009. https ://www.nice.org.uk/guida nce/cg90. Accessed 19 Jul 2018. 5. American Psychiatric Association. Practice guideline for the treat-ment of patients with major depressive disorder. 2010. http://psych iatry onlin e.org/pb/asset s/raw/sitew ide/pract ice_guide lines /guide lines /mdd.pdf. Accessed 19 Jul 2018. 6. Cuijpers P, Sijbrandij M, Koole SL, Andersson G, Beekman AT, Reynolds CF 3rd. Adding psychotherapy to antidepressant medi-cation in depression and anxiety disorders: a meta-analysis. World Psychiatry. 2014;13:56–67. 7. Prescrire. Towards better patient care: drugs to avoid in 2017. Rev Prescrire. 2017;37:137–48. 8. Cipriani A, Furukawa TA, Salanti G, Chaimani A, Atkinson LZ, Ogawa Y, et al. Comparative efficacy and acceptability of 21 antidepressant drugs for the acute treatment of adults with major depressive disorder: a systematic review and network meta-analysis. Lancet. 2018;391:1357–66. 9. Gibbons RD, Brown CH, Hur K, Davis J, Mann JJ. Suicidal thoughts and behavior with antidepressant treatment: reanalysis of the randomized placebo-controlled studies of fluoxetine and venlafaxine. Arch Gen Psychiatry. 2012;69:580–7. 10. Stone M, Laughren T, Jones ML, Levenson M, Holland PC, Hughes a, et al. Risk of suicidality in clinical trials of antidepres-sants in adults: analysis of proprietary data submitted to US Food and Drug Administration. BMJ. 2009;339:b2880.

English

Authors' Response to Braillon's Comment on: "Limited Evidence for Risk Factors for Proarrhythmia and Sudden Cardiac Death in Patients Using Antidepressants:Dutch Consensus on ECG Monitoring"

Dissertations of the University of Groningen

Proceedings - University of Groningen

   University of GroningenAuthors' Response to Braillon's Comment on: "Limited Evidence for Risk Factors forProarrhythmia and Sudden Cardiac Death in Patients Using AntidepressantsSimoons, Mirjam; Seldenrijk, Adrie; Mulder, Hans; van Roon, Eric; Bakker, Roberto; Ruhé,HenricusPublished in:Drug SafetyDOI:10.1007/s40264-018-0716-5IMPORTANT NOTE: You are advised to consult the publisher's version (publisher's PDF) if you wish to cite fromit. Please check the document version below.Document VersionPublisher's PDF, also known as Version of recordPublication date:2018Link to publication in University of Groningen/UMCG research databaseCitation for published version (APA):Simoons, M., Seldenrijk, A., Mulder, H., van Roon, E., Bakker, R., & Ruhé, H. (2018). Authors' Response toBraillon's Comment on: "Limited Evidence for Risk Factors for Proarrhythmia and Sudden Cardiac Death inPatients Using Antidepressants: Dutch Consensus on ECG Monitoring". Drug Safety, 41(12), 1417-1418.https://doi.org/10.1007/s40264-018-0716-5CopyrightOther than for strictly personal use, it is not permitted to download or to forward/distribute the text or part of it without the consent of theauthor(s) and/or copyright holder(s), unless the work is under an open content license (like Creative Commons).The publication may also be distributed here under the terms of Article 25fa of the Dutch Copyright Act, indicated by the “Taverne” license.More information can be found on the University of Groningen website: https://www.rug.nl/library/open-access/self-archiving-pure/taverne-amendment.Take-down policyIf you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediatelyand investigate your claim.Downloaded from the University of Groningen/UMCG research database (Pure): http://www.rug.nl/research/portal. For technical reasons thenumber of authors shown on this cover page is limited to 10 maximum.Vol.:(0123456789)Drug Safety (2018) 41:1417–1418 https://doi.org/10.1007/s40264-018-0716-5LETTER TO THE EDITORAuthors’ Response to Braillon’s Comment on: “Limited Evidence for Risk Factors for Proarrhythmia and Sudden Cardiac Death in Patients Using Antidepressants: Dutch Consensus on ECG Monitoring”Mirjam Simoons1,2,3  · Adrie Seldenrijk2,4 · Hans Mulder1,5 · Eric van Roon3,6 · Roberto Bakker7,8 · Henricus Ruhé2,9,10 Published online: 17 August 2018 © Springer Nature Switzerland AG 2018We thank Dr. Braillon for his comments on our article [1]. Dr. Braillon questions whether we should minimize the risk of proarrhythmia and sudden cardiac death in rela-tion to antidepressants with recommendations for electro-cardiogram monitoring or avoid the use of antidepressants all together and mainly treat patients with depression with psychotherapy [2]. We agree with Dr. Braillon that psycho-therapy (cognitive behavioral therapy) is an alternative first-line treatment option for depression with at least better and prolonged effects regarding relapse prevention relative to antidepressants [3–5]. However, the aim of our article was to aid physicians and patients who have collaboratively decided to start antidepressant therapy to treat depression either as monotherapy or in combination with psychotherapy [1, 6]. We describe a set of recommendations for estimating and minimizing the risk of proarrhythmia and sudden cardiac death after the choice for pharmacological therapy above other treatment options has been made [1].For decades, there has been a debate about the efficacy, effectiveness, and benefit-harm ratio of antidepressants. A recent systematic review and network analysis that was not yet available when Prescrire published its list of drugs to avoid in 2017 [7] represents the most comprehensive analysis of the evidence base for antidepressant efficacy and acceptability ever performed [8]. Based on 552 trials and over 116,000 participants, Cipriani et al. found that all 21 antidepressants included in the meta-analysis were more efficacious than placebo in adults with major depres-sive disorder, while few differences were found between the antidepressants and placebo when tolerability was con-cerned [8]. In fact, treatment with antidepressants can be lifesaving. Patients with major depressive disorder more often die from suicide than from proarrhythmia or sudden cardiac death. Although the risk of intentional overdosing as a consequence of psychiatric disease is always present, the literature currently available shows that adults aged over 25 years treated with any class of antidepressant have a lower risk of suicidality compared with placebo [9, 10]. We agree with Dr. Braillon that risks associated with any drug This reply refers to the article available at https ://doi.org/10.1007/s4026 4-018-0714-7. * Henricus Ruhé  eric.ruhe@radboudumc.nl1 Department of Clinical Pharmacy, Wilhelmina Hospital Assen, Assen, The Netherlands2 Department of Psychiatry, Radboudumc, PO-Box 9101, 6500 HB Nijmegen, The Netherlands3 Unit of Pharmacotherapy, Epidemiology and-Economics, Department of Pharmacy, University of Groningen, Groningen, The Netherlands4 Department of Research and Innovation, GGZ InGeest, Amsterdam, The Netherlands5 Psychiatric Hospital GGZ Drenthe, Assen, The Netherlands6 Department of Clinical Pharmacy and Clinical Pharmacology, Medical Centre Leeuwarden, Leeuwarden, The Netherlands7 Psychiatric Centre GGz Centraal, Amersfoort, The Netherlands8 Department of Psychiatry and Psychology, South Limburg Mental Health and Teaching Network, Maastricht University Medical Centre, Maastricht, The Netherlands9 Department of Psychiatry, Warneford Hospital, University of Oxford, Oxford, UK10 Department of Psychiatry, Radboudumc, Nijmegen, The Netherlands1418 M. Simoons et al.could be prevented by avoiding such agents and consider-ing alternatives (e.g., psychotherapy) instead. Considering the data from the aforementioned meta-analyses, however, the suggested market withdrawal for antidepressants such as citalopram, escitalopram, and venlafaxine [7] is, in our opinion, too far reaching.Once the choice for antidepressant therapy has been made, in our opinion, it is important to minimize the risk of proarrhythmia and sudden cardiac death. Currently, the only way to achieve risk minimization with respect to these adverse effects of antidepressants is to monitor the electro-cardiogram based on risk factors such as older age, female sex, or aberrant potassium levels. We provide clear and read-ily applicable recommendations for performing electrocar-diogram screening and monitoring in daily clinical practice, thereby meeting a need of clinicians that we identified.We hope we were able to clarify the issues raised by Dr. Braillon and would like to thank him again for his reflections on our work.Compliance with Ethical Standards Funding No specific funding was received for this letter. The original project was funded by the Dutch Network for Quality Development in Mental Health Care (Grants P140019 and P140040 to Henricus Ruhé and Roberto Bakker). This organization had no influence on the content of the study, the original manuscript, or this letter.Conflict of interest Henricus Ruhé obtained an Investigator-Initiated Trial grant and speaking fees from Lundbeck BV, which are not related to the current work. Mirjam Simoons, Adrie Seldenrijk, Hans Mulder, Eric van Roon, and Roberto Bakker have no conflicts of interest that are directly relevant to the contents of the study, the original manu-script, or this letter.Ethics approval Ethics approval was not applicable for this letter.Patient consent Patient consent was not applicable for this letter.References 1. Simoons M, Seldenrijk A, Mulder H, Birkenhager T, Groothedde-Kuyvenhoven M, Kok R, et al. Limited evidence for risk factors for proarrhythmia and sudden cardiac death in patients using anti-depressants: Dutch Consensus on ECG Monitoring. Drug Saf. 2018;41:655–64. 2. Braillon A. Comment on: “Limited evidence for risk factors for proarrhythmia and sudden cardiac death in patients using anti-depressants: Dutch Consensus on ECG Monitoring”. Drug Saf. 2018. https ://doi.org/10.1007/s4026 4-018-0714-7. 3. Spijker J, Bockting CLH, Meeuwissen JAC, Vliet van IM, Emmelkamp PMG, Hermens MLM, et  al. Multidisciplinary guideline depression (third revision) [in Dutch]. 2013. https ://www.ggzri chtli jnen.nl/depre ssie. Accessed 19 Jul 2018. 4. National Institute for Health and Care Excellence. Depression in adults: recognition and management (CG 90). 2009. https ://www.nice.org.uk/guida nce/cg90. Accessed 19 Jul 2018. 5. American Psychiatric Association. Practice guideline for the treat-ment of patients with major depressive disorder. 2010. http://psych iatry onlin e.org/pb/asset s/raw/sitew ide/pract ice_guide lines /guide lines /mdd.pdf. Accessed 19 Jul 2018. 6. Cuijpers P, Sijbrandij M, Koole SL, Andersson G, Beekman AT, Reynolds CF 3rd. Adding psychotherapy to antidepressant medi-cation in depression and anxiety disorders: a meta-analysis. World Psychiatry. 2014;13:56–67. 7. Prescrire. Towards better patient care: drugs to avoid in 2017. Rev Prescrire. 2017;37:137–48. 8. Cipriani A, Furukawa TA, Salanti G, Chaimani A, Atkinson LZ, Ogawa Y, et al. Comparative efficacy and acceptability of 21 antidepressant drugs for the acute treatment of adults with major depressive disorder: a systematic review and network meta-analysis. Lancet. 2018;391:1357–66. 9. Gibbons RD, Brown CH, Hur K, Davis J, Mann JJ. Suicidal thoughts and behavior with antidepressant treatment: reanalysis of the randomized placebo-controlled studies of fluoxetine and venlafaxine. Arch Gen Psychiatry. 2012;69:580–7. 10. Stone M, Laughren T, Jones ML, Levenson M, Holland PC, Hughes a, et al. Risk of suicidality in clinical trials of antidepres-sants in adults: analysis of proprietary data submitted to US Food and Drug Administration. BMJ. 2009;339:b2880.

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Authors' Response to Braillon's Comment on: "Limited Evidence for Risk Factors for Proarrhythmia and Sudden Cardiac Death in Patients Using Antidepressants: Dutch Consensus on ECG Monitoring"

Authors' Response to Braillon's Comment on: "Limited Evidence for Risk Factors for Proarrhythmia and Sudden Cardiac Death in Patients Using Antidepressants:Dutch Consensus on ECG Monitoring"

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