The Lancet



SUPPLEMENTARY MATERIALAPPENDICES: ProcedureProcedure codeMRI scans of the brainUXMA00-99CT scans of the brainUXCA00-99Appendix 1: Information on CT or MRI scans of the brain obtained from the Danish National Patient RegisterDiseaseICD-10 codesIntracerebral haemorrhage (ICH)I61Ischaemic stroke (IS)I63Unspecified strokeI64Appendix 2: Information on stroke obtained from the Danish National Patient RegisterStatinsATC codesSimvastatinC10AA01/B04AB01aLovastatinC10AA02/B04AB02PravastatinC10AA03/B04AB03FluvastatinC10AA04/B04AB04AtorvastatinC10AA05CerivastatinC10AA06RosuvastatinC10AA07Appendix 3: Information on prescriptions redeemed for statins obtained from the Danish National Prescription RegisteraBefore 1997, statins were classified by ATC codes B04AB and hereafter by ATC codes C10AA.Hydrophilic statins included pravastatin and rosuvastatin. Lipophilic statins included atorvastatin, fluvastatin, lovastatin, cerivastatin and simvastatin.Educationa > 15 years10-15 years< 10 yearsIncome bHighMediumLowCohabitation statusLiving with a partner Married Registered partnership CohabitationLiving aloneAppendix 4: Information on sociodemographic factors obtained from Statistics Denmark and the Civil Registration SystemaEducational level was classified according to the UNESCO classification as low (≤10 years), medium (11–15 years) and high education (>15 years).bIncome was defined as the net income for an individual (ie income after taxes and interest rates) and divided into low, medium and high income.CategoryCoding definitionDiagnoses codes (ICD-10)Diagnosis time frameDrug codes (ATC)Prescription time frameCirculatory systemHypertensionaDiagnosis I10-I13, I15Since 1995Ischaemic heart diseaseDiagnosis AND/OR prescriptions for antianginal drugI20-I25Since 1995C01DATwice last yearAtrial fibrillationDiagnosisI48Since 1995Congestive heart failureDiagnosisI50Since 1995Peripheral artery occlusive diseasesDiagnosisI70-I74Since 1995Cerebrovascular diseasebDiagnosisI60, I62, I69Since 1995Endocrine systemDiabetes mellitusDiagnosis AND/OR prescription of antidiabeticsE10-E14Since 1995A10A, A10BTwice last yearPulmonary system Chronic obstructive pulmonary diseasePrescriptions for obstructive airway disease drugsR03Twice last yearGastrointestinal systemChronic liver diseaseDiagnosisB16-B19, K70-K74, K766, I85Since 1995Haematological systemCoagulation defectscDiagnosisD66-D69Since 1995AnaemiasDiagnosisD50-D53, D55-D61, D63-D64Last two yearsCancersCancerDiagnosisC00-C43, C45-C97Last five yearsNeurological systemEpilepsydDiagnosis AND prescriptions of anti-epilepticsG40-G41Since 1995N03Twice last yearParkinson’s diseaseDiagnosisG20-G22Since 1995Mental health conditionsMood, stress or anxiety-related disorderDiagnosisF32-F34, F40-F48Last two yearsAlcohol problemsDiagnosisF101-F109Last two yearsSubstance abuseDiagnosisF11-F16, F18-F19Last two yearsBipolar affective disorderDiagnosis AND/OR prescriptions of lithium saltsF30-F31Since 1995N05ANTwice last yearSchizophrenia or schizoaffective disorderDiagnosisF20, F25Since 1995DementiaDiagnosis AND/OR prescriptions for antidementia drugsF00-F03, F051, G30Since 1995N06DTwice last yearAppendix 5: Information on comorbidity by the Multimorbidity IndexPEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QcmlvcjwvQXV0aG9yPjxZZWFyPjIwMTY8L1llYXI+PFJl

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ADDIN EN.CITE.DATA obtained from the Danish National Patient RegisteraModified from original index by excluding prescriptions for antihypertensive drugs from the definition of this category.bModified from original index by excluding stroke diagnoses (ie ICH and IS=I61+I63+I64) from the definition of the category ‘Stroke’ (now renamed ‘cerebrovascular disease’). cModified from original index by adding a new category including coagulation defects.dModified from the original index by including epilepsy diagnoses only in the definition of the category ‘Epilepsy’.Drug categoryDrug nameATC codesAntithrombotic agentsAntiplatelet agentsAcetylsalicylic acidB01AC06, B01AC30DipyridamoleB01AC07ClopidogrelB01AC04Other APD (Prasugrel and Ticagrelor)B01AC22, B01AC24Anticoagulant agents Vitamin K antagonistsVitamin K antagonistsB01AA Direct oral anticoagulants (DOAC)Dabigatran etexilateB01AE07Rivaroxaban B01AF01 ApixabanB01AF02 Antihypertensive agentsAntihypertensivesC02DiureticsC03Peripheral vasodilatorsC04Beta blockersC07Calcium channel blockersC08Agents acting on the renin-angiotensin systemC09Other selected agents that may influence risk of strokeNon-steroidal anti-inflammatory drugs (NSAID) Butylpyrazolidines, acetic acid derivatives, oxicams, propionic acid derivatives, coxibs, nabumetoneM01AA-M01AH, M01AX01Systemic glucocoticoidsBetamethasone, methylprednisolone, prednisolone, prednisone, triamcinolone, hydrocortisoneH02AB01,H02AB04, H02AB06-09Selective serotonin reuptake inhibitors (SSRI) Zimeldine, fluoxetine, citalopram, paroxetine, sertraline, alaproclate, fluvoxamine, etoperidone, escitalopramN06AB02-10Appendix 6: Information on prescriptions redeemed for selected agents that may influence the risk of stroke obtained from the Danish National Prescription RegisterTABLESCriteriaCovariateMatching tolerance1Calendar periodStatin users were matched with non-users on the date of initiation to guarantee perfect alignment for calendar period.2 SexStatin users were matched with non-users who were of same sex.3AgeStatin users were matched with non-users who had same birthday (+/- 1 month). If less than 5 such non-users were found, the search was expanded by 1 month in either direction (ie +/- 2 months in total). This process was repeated a maximum of 10 times until at least 5 candidates were found.4Propensity scoreaAmong all non-users who fulfilled criteria 1-3, the 5 non-users with the most similar propensity scoreb on date of initiation, were selected.Supplementary Table 1: Matching procedures for the studyaThe propensity score (PS) included information on cohabitation status, income, education and comorbidities (ie hypertension, atrial fibrillation, ischaemic heart disease, congestive heart failure, peripheral artery occlusive disease, cerebrovascular disease, diabetes, chronic obstructive pulmonary disease, chronic liver disease, coagulation defects, anaemia, cancer, epilepsy, Parkinson’s disease, mood, stress or anxiety-related disorder, alcohol problems, substance abuse, bipolar affective disorder, schizophrenia/schizoaffective disorder, and dementia).bThe similarity between the PS of users and non-users varied. For instance, for individuals aged 95 years using statins, the matching to 5 non-users with the same PS was less likely compared to among individuals aged 75 years.CountsContributed timePatternsa NobP (%)CP (%)Mean (days)Total (1000 PY)P (%)CP (%)Non-usersN2,684,83893.5693.561,459.4 10,727.896.3996.39NSQN159,6785.5699.12819.4 358.23.2299.60NSQNSQN21,5040.7599.87653.7 38.50.3599.95NSQNSQNSQN3,1570.1199.98537.0 4.60.0499.99NSQNSQNSQNSQN4870.02100.00569.0 0.80.01100.00NSQNSQNSQNSQNSQN910.00100.00586.5 0.10.00100.00Statin usersNS490,81085.5285.521,419.7 1,907.891.2091.20NSQNS69,80712.1697.68841.6160.87.6998.89NSQNSQNS11,1221.9499.62653.619.90.9599.84NSQNSQNSQNS1,8360.3299.94590.53.00.1499.98NSQNSQNSQNSQNS3070.0599.99422.20.40.02100.00NSQNSQNSQNSQNSQNS390.01100.00448.50.00.00100.00Supplementary Table 2: Frequency tabulations on patterns of exposuresa Patterns of exposure status at day of statin initiation: N: non-use, S: statin initiation, Q: quarantine.b Number of non-users/statin users included in the analyses of the study (which do not represent the number of unique individuals).Abbreviations: P: proportion; CP: cumulative proportion; PY: person years.Age category(years)ICH events among statin users(No (%))50-5460 (4.3)55-59109 (7.7)60-64191 (13.6)65-69251 (17.8)70-74294 (20.9)75-79257 (18.2)80-84163 (11.6)85-8969 (4.9)90-10015 (1.0)Total1,409 (100)Supplementary Table 3: Age distribution on ICH events among statin usersFIGURESSupplementary Figure 1A: Adjusted HRs and 95% CIs for the risk of intracerebral haemorrhage for statin users compared to non-users plotted as a function of time since index date, evaluated by demographic and socioeconomic factorsAbbreviations: aHR: adjusted hazard ratio; CI: confidence interval.Supplementary Figure 1B: Adjusted HRs and 95% CIs for the risk of intracerebral haemorrhage for statin users compared to non-users plotted as a function of time since index date, evaluated by comorbidity and number of statin initiationsAbbreviations: aHR: adjusted hazard ratio; CI: confidence interval; Other circulatory: Other circulatory disorders; Other physical: Other physical disorders; Neurological or mental: neurological or mental disorders; Nos of initiations: number of statin initiations.Other circulatory disorders included ischaemic heart disease, congestive heart failure, peripheral occlusive artery disease, and cerebrovascular disease. Other physical disorders included diabetes, chronic obstructive pulmonary disease, chronic liver disease, coagulation defects, anaemia, and cancer. Neurological and mental disorders included epilepsy, Parkinson’s disease, mood, stress and anxiety-related disorder, alcohol problems, substance abuse, bipolar affective disorder, schizophrenia/schizoaffective disorder, and dementia.Some values for the plots on neurological or mental disorders were not displayed in case of less than five events due to privacy concerns.Supplementary Figure 2: Adjusted HRs and 95% CIs for the risk of intracerebral haemorrhage and ischaemic stroke for statin users compared to non-users plotted as a function of time since index date, evaluated for all stroke diagnoses regardless of primary/secondary diagnoses, types of contacts, and execution of brain scansAbbreviations: aHR: adjusted hazard ratio; CI: confidence interval.Supplementary Figure 3: Adjusted HRs and 95% CIs for the risk of intracerebral haemorrhage and ischaemic stroke for statin users compared to non-users plotted as a function of time since index date, evaluated for the most recent follow-up period (2009-2013)Abbreviations: aHR: adjusted hazard ratio; CI: confidence interval.Supplementary Figure 4: Adjusted HRs and 95% CIs for the risk of intracerebral haemorrhage for statin users compared to non-users plotted as a function of time since index date, evaluated for varying lengths of carryover periodsAbbreviations: aHR: adjusted hazard ratio; CI: confidence intervalSupplementary Figure 5: Adjusted HRs and 95% CIs for the risk of intracerebral haemorrhage for statin users compared to non-users plotted as a function of time since index date, evaluated for varying lengths of grace periodsaaAn individual was considered to be ‘user’ for the number of days corresponding to the number of redeemed pills + a grace period of 0%, 20%, 33% (main analysis) and 50%, to include some leeway when refilling prescriptions.Abbreviations: aHR: adjusted hazard ratio; CI: confidence interval. ................
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