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Drug Use and Torsades De Pointes Cardiac Arrhythmias in Sweden: a Nationwide Register-­Based Cohort Study

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Drug Use and Torsades De Pointes Cardiac Arrhythmias in Sweden: a Nationwide Register-­Based Cohort Study Open access Original research BMJ Open: first published as 10.1136/bmjopen-2019-034560 on 12 March 2020. Downloaded from Drug use and torsades de pointes cardiac arrhythmias in Sweden: a nationwide register- based cohort study Bengt Danielsson,1 Julius Collin,1 Anastasia Nyman,1 Annica Bergendal,1 Natalia Borg,1 Maria State,1 Lennart Bergfeldt,2 Johan Fastbom 1 To cite: Danielsson B, Collin J, ABSTRACT Strengths and limitations of this study Nyman A, et al. Drug use and Objective To study the occurrence of torsades de pointes torsades de pointes cardiac (TdP) ventricular tachycardia in relation to use of drugs ► This study used individual- based data from nation- arrhythmias in Sweden: a labelled with TdP risk, using two nationwide Swedish nationwide register- based wide registers on inpatient diagnoses and drug dis- registers. cohort study. BMJ Open pensations from pharmacies, making it possible to Design Prospective register- based cohort study. 2020;10:e034560. doi:10.1136/ estimate the incidence of TdP per 100 000 users of Setting Entire Sweden. bmjopen-2019-034560 prescribed individual drugs labelled with torsades Participants Persons aged ≥18 years prescribed and de pointes (TdP) risk. ► Prepublication history for dispensed any drug classified with TdP risk during ► To our knowledge, the study is, so far, the largest this paper is available online. 2006–2017, according to CredibleMeds. Persons with a To view these files, please visit in terms of number of patients with TdP diagnosis. registered TdP diagnosis during the study period, using the journal online (http:// dx. doi. ► One limitation is that the data on drug use do not in- drugs labelled with known (TdP 1), possible (TdP 2) org/ 10. 1136/ bmjopen- 2019- clude information about drug treatment at hospitals. 034560). or conditional (TdP 3) risk at the incident of TdP were examined. Received 01 October 2019 Primary outcome measures Occurrence of TdP in Revised 30 January 2020 relation to exposure rates for individual drugs with TdP scenario, sudden cardiac death. Symptoms Accepted 12 February 2020 risk. may, however, vary from dizziness, syncope Secondary outcome measures Concurrent use of and seizures to cardiac arrest/sudden death. more than one TdP- labelled drug in a person with a TdP Prolongation of the corrected QT interval diagnosis. (QTc) on the ECG may predispose to TdP, Results During the study period, 410 TdP cases using together known as long QT syndrome (LQTS). http://bmjopen.bmj.com/ drugs with TdP risk labels at the incident were registered; LQTS can be congenital or acquired.1 2 Drugs 205 women and 205 men, mean age 74.0 and 71.5 years, respectively. Antidepressants dominated (129/410, 30%), in most therapeutic groups, including several followed by antiarrhythmics (17%). Diuretics and gastric widely used antidepressant and antipsychotic acid- secretion inhibitors, with TdP risk related to induction drugs, have been shown to be associated with of hypokalaemia or hypomagnesaemia, were used in 56% an increased risk of acquired LQTS, mainly and 32% of the 410 TdP cases, respectively. Among the due to blockade of one of the cardiac potas- most used antidepressants, citalopram with known TdP 1 sium channels expressed by the hERG gene. risk was associated with both a higher absolute number This results in inhibition of a major repolar- on September 30, 2021 by guest. Protected copyright. and incidence of TdP per 100 000 users (two to four ising potassium current, IKr. According to the times), compared with mirtazapine with possible (TdP 2), CredibleMeds classification system,3 which is © Author(s) (or their and sertraline with conditional (TdP 3) risk. Multiple risk updated regularly by an expert panel, drugs factors, including advanced age, cardiovascular disease employer(s)) 2020. Re- use that can prolong the QTc interval have permitted under CC BY-NC. No and treatment with more than one TdP- classified drug, commercial re- use. See rights were frequently observed. different propensities to cause TdP (see the and permissions. Published by Conclusions Antidepressants followed by antiarrhythmics Methods section). BMJ. dominated among TdP risk drugs used by adults with TdP During the past decades, safety signals for 1 Department of Analysis, diagnosis, the majority being ≥65 years. TdP risk class QTc prolongation and TdP have resulted Swedish National Board of and concomitant medication should be considered when in the withdrawal from the market of some Health and Welfare, Stockholm, prescribing antidepressants to older patients. psychotropic drugs that block the hERG Sweden 4 2Department of Molecular and channel (eg, sertindole or thioridazine ) or 5 6 Clinical Medicine, University of a restriction in their use (eg, citalopram Gothenburg, Goteborg, Sweden INTRODUCTION and haloperidol7) in many countries. Several Torsades de pointes (TdP) ventricular tachy- studies also indicate that the risk of drug- Correspondence to Dr Johan Fastbom; cardia is a rare but life- threatening condition induced TdP is particularly relevant in johan. fastbom@ socialstyrelsen. that can deteriorate into ventricular fibrilla- combination with other patient-specific risk se tion and cardiac arrest and, in the worst case factors, such as age, cardiovascular diseases, Danielsson B, et al. BMJ Open 2020;10:e034560. doi:10.1136/bmjopen-2019-034560 1 Open access BMJ Open: first published as 10.1136/bmjopen-2019-034560 on 12 March 2020. Downloaded from electrolyte disturbances or simultaneous use of drugs analyses. In the following text and tables, this is labelled increasing the risk of TdP.3 4 8–12 as ‘use’. All drugs classified with risk of TdP according Previous studies have indicated that TdP is under- to CredibleMeds3 (http://www. crediblemeds. org, 31 reported. One reason is that accurate diagnosis requires October 2018) were examined: TdP 1=known risk of ECG recording during the event. Another reason is that TdP (list 1), TdP 2=possible risk of TdP (list 2) and TdP a sizeable proportion of patients with TdP will not survive 3=conditional risk of TdP (list 3). the ventricular arrhythmia. All- cause death, adjusted for a The number of users of individual drugs within a certain number of potential comorbidity confounders, has there- therapeutic group varies considerably, as well as between fore been used as a proxy for studying risks of using TdP- various age groups. We therefore estimated the incidence classified antipsychotics13–15or antidepressants16 17 in the of TdP per 100 000 users of individual TdP- labelled drugs elderly. in persons aged ≥65 years (definition of older adults in Case report studies provide unique information about Sweden) and in individuals aged 18–64 years, during the the link between TdP- classified drugs and TdP. However, whole study period. Here a user of a drug was defined as until now, these studies have been relatively small and a person to whom the pharmacy had dispensed the drug have not allowed comparisons of TdP risk between drugs, at least once during the study period. as they have not taken drug exposure rates into account.9 Therefore the main objective of this study, based on Additional risk factors for TdP Swedish national registries, was to investigate occurrence As mentioned in the Introduction section, several case of TdP in relation to exposure rates (incidence of TdP report studies suggest that the risk of drug-induced TdP is per 100 000 users of a TdP- classified drug) for individual particularly relevant in combination with other important drugs with TdP risk, in persons aged 18–64 and ≥65 years. patient- specific risk factors, in particular genetic suscepti- The second aim was to study the concomitant use of bility (LQTS mutations), cardiovascular disease, electro- more than one TdP- labelled drug in a person with a TdP lyte disturbances (hypokalaemia and hypomagnesaemia), diagnosis. or simultaneous use of two or more drugs which increase the risk of TdP.3 4 8–10 By using data from SPDR, it has been possible to study the occurrence of some major METHODS established contributing risk factors, in each individual Study population and registers at the incident of TdP, as follows: (1) concomitant use This was a cohort study. The study population comprised of more than one TdP- classified drug, (2) treatment with all individuals above the age of 18 years who had been diuretics which may cause hypokalaemia and hypomag- prescribed and dispensed any drug classified with TdP nesaemia, (3) treatment with acid-secretion inhibitors risk according to CredibleMeds, from 1 January 2006 to (proton pump inhibitors and H2- receptor antagonists) http://bmjopen.bmj.com/ 31 December 2017. The study was based on data from which may cause hypomagnesaemia and (4) use of drugs two Swedish registers linked by the personal identifica- against cardiovascular disease (Anatomical, Therapeutic, tion number: the Swedish Patient Register (SPR) and Chemical (ATC) code C). the Swedish Prescribed Drug Register (SPDR). These registers are administered by the Swedish National Board of Health and Welfare, an authority under the Swedish PATIENT AND PUBLIC INVOLVEMENT (PPI) Ministry of Health and Social Affairs. The collection of This study was based on data from Swedish healthcare register data is governed by Swedish legislation, and it registers. We did not directly include PPI in this study, on September 30, 2021 by guest. Protected copyright. is mandatory for Swedish healthcare and pharmacies to but the registers used in the study are developed with report the data.
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