contents · supplementary material 8. propensity score adjusted rate ratios of all outcomes without...
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Appendix: Cardiovascular outcomes associated with use of
clarithromycin: population based study
Contents Supplementary material 1: ICD-9 and ICD-10 codes for outcomes identification ...................................... 2
Supplementary material 2. Helicobacter pylori eradication therapy regimen containing clarithromycin
with appropriate doses ................................................................................................................................ 3
Supplementary material 3. List of covariates included in Propensity Score with ICD codes ...................... 4
Supplementary material 4. Distribution of propensity scores in 20 strata *† .............................................. 6
Supplementary material 5. Number of prescriptions for out-patient Helicobacter pylori treatment
containing-clarithromycin from 2003-2012 ................................................................................................ 7
Supplementary material 6. Baseline characteristics of trimmed cohort at index date in cohort analysis ..... 8
Supplementary material 7. Propensity score distributions before and after propensity score trimming .... 10
Supplementary material 8. Propensity score adjusted rate ratios of all outcomes without trimming band 11
Supplementary material 9. Rate ratios of all outcomes for current and recent use of clarithromycin versus
amoxicillin in sensitivity analysis ............................................................................................................. 15
Supplementary material 10. Subgroup analysis of risk of cardiovascular outcomes associated with current
use of clarithromycin versus amoxicillin .................................................................................................. 17
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Supplementary material 1: ICD-9 and ICD-10 codes for outcomes identification
ICD-9 Codes
Myocardial Infarction 410
Arrhythmia 426.82, 427.0, 427.1, 427.2, 427.41, 427.42, 427.5, 427.60
Stroke 430, 431, 432, 433.01, 433.11, 433.21, 433.31, 433.81, 433.91, 434,
436, 437.0, 437.1
ICD-10 Codes
Cardiac death I11, I13, I20-25, I27, I30-52
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Supplementary material 2. Helicobacter pylori eradication therapy regimen containing
clarithromycin with appropriate doses
Co-prescription of two antibiotics and one of the proton pump inhibitors:
Clarithromycin 500mg bd Amoxicillin 1000mg bd Esomeprazole 20mg bd
Lansoprazole 30mg bd
Omeprazole 20mg bd
Pantoprazole 40mg bd
Rabeprazole 20mg bd
Clarithromycin 250mg bd Metronidazole 400mg bd Esomeprazole 20mg bd
Lansoprazole 30mg bd
Omeprazole 20mg bd
Pantoprazole 40mg bd
Rabeprazole 20mg bd
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Supplementary material 3. List of covariates included in Propensity Score with ICD codes
Parameters
Demographic factors
Calendar month at exposure
Medical history ICD9 Codes
Respiratory related disease
Chronic obstructive pulmonary disease or related 490-492, 494, 496
Endocrine and metabolic disorders
Obesity 278.0
Hyperlipidaemia 272.0-272.2, 272.4
Diabetes and related complications 249, 250
Thyroid disorders 242-244
Cardiovascular related disease
Hypertensive diseases 401-405
Coronary heart disease 410, 411, 412, 413, 414, 429.71, 429.79
Cerebrovascular diseases 430-437
Arterial disease 433.00, 433.10, 433.20, 433.30, 433.80, 433.90,
440-445, 447, 557
Cardiomyopathy 425
Heart failure 402.01, 402.11, 402.91, 404.01, 404.03, 404.11,
404.13, 404.91, 404.93, 428
Valve disorders 424
Arrhythmia and conduction disorders 426-427
Renal disease
Hypertensive renal disease 403-404
Renal failure 584-586
Liver disease
Esophageal varices 456.0, 456.1, 456.2
Hepatic failure, liver fibrosis and cirrhosis 570, 571
Psychiatric disease
Schizophrenia and psychosis 295, 297, 298.3, 298.4, 298.8, 298.9
Bipolar disorder 296.0, 296.1, 296.4-296.7, 296.80, 296.81
296.89
Depression 296.2, 296.3, 296.82, 298.0, 300.4, 311
Prescription drug used in past year
ARB/ACE-I
Calcium channel blockers
Loop diuretics
Other diuretics
Beta-blockers
Anti-arrhythmics class I and II
Digoxin
Nitrates
Platelet inhibitors
Anticoagulants
Peripheral vasodilator
Lipid lowering drugs
Insulin
Oral hypoglycemic agent
Antidepressants
Antipsychotics
Oral corticosteroids
NSAIDS
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PPI/H-2 blocker
Number of drugs used
Health care use
Number of outpatients visits in past year
Number of inpatient stays in past year
Number of emergency visits in past year
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Supplementary material 4. Distribution of propensity scores in 20 strata *†
Propensity
score
Clarithromycin users Amoxicillin users
N (%) Myocardial infarction (%) N (%) Myocardial infarction (%)
1 2356 (2.2) 13 (3.5) 13 984 (6.4) 61 (6.8)
2 3284 (3.0) 9 (2.5) 13 055 (6.0) 67 (7.5)
3 3061 (2.8) 18 (4.9) 13 278 (6.1) 85 (9.5)
4 2914 (2.7) 8 (2.2) 13 425 (6.2) 66 (7.4)
5 3074 (2.8) 18 (4.9) 14 344 (6.6) 46 (5.2)
6 2557 (2.4) 9 (2.5) 12 733 (5.9) 40 (4.5)
7 2677 (2.5) 5 (1.4) 13 669 (6.3) 41 (4.6)
8 2925 (2.7) 8 (2.2) 14 165 (6.5) 36 (4.0)
9 2745 (2.5) 7 (1.9) 12 806 (5.9) 35 (3.9)
10 4075 (3.7) 8 (2.2) 12 282 (5.6) 40 (4.5)
11 4935 (4.5) 13 (3.5) 11 638 (5.3) 39 (4.4)
12 6455 (5.9) 16 (4.4) 9634 (4.4) 21 (2.4)
13 5930 (5.4) 7 (1.9) 10 408 (4.8) 39 (4.4)
14 5838 (5.4) 21 (5.7) 10 500 (4.8) 49 (5.5)
15 6414 (5.9) 30 (8.2) 9925 (4.6) 40 (4.5)
16 7612 (7.0) 47 (12.8) 8727 (4.0) 53 (5.9)
17 8860 (8.1) 32 (8.7) 7479 (3.4) 53 (5.9)
18 10 520 (9.7) 32 (8.7) 5819 (2.7) 24 (2.7)
19 11 921 (10.9) 32 (8.7) 4418 (2.0) 27 (3.0)
20 10 835 (9.9) 34 (9.3) 5504 (2.5) 30 (3.4)
* 1 indicates smallest probability of receiving clarithromycin; 20 indicates highest probability of
receiving clarithromycin †Value in (%) was corrected to 1 decimal place
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Supplementary material 5. Number of prescriptions for out-patient Helicobacter pylori
treatment containing-clarithromycin from 2003-2012
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Supplementary material 6. Baseline characteristics of trimmed cohort at index date in
cohort analysis. Values are numbers (percentages) unless stated otherwise
Characteristics Clarithromycin users
(n=95 797)
Amoxicillin users
(n=198 305)
Median age (years) 59.0 60.0
Men 49 652 (51.8) 104 050 (52.5)
Calendar month at exposure
January 8247 (8.6) 17 928 (9.0)
February 8025 (8.4) 16 686 (8.4)
March 8996 (9.4) 18 885 (9.5)
April 8293 (8.7) 17 140 (8.6)
May 8269 (8.6) 17 268 (8.7)
June 7897 (8.2) 16 592 (8.4)
July 8023 (8.4) 16 469 (8.3)
August 8009 (8.4) 16 131 (8.1)
September 7452 (7.8) 15 425 (7.8)
October 7449 (7.8) 15 047 (7.6)
November 7401 (7.7) 15 008 (7.6)
December 7736 (8.1) 15 726 (7.9)
Medical history:
Chronic obstructive pulmonary disease 4324 (4.5) 5739 (2.9)
Obesity 231 (0.2) 351 (0.2)
Diabetes 8566 (8.9) 14 416 (7.3)
Thyroid disorders 1511 (1.6) 3002 (1.5)
Hyperlipidaemia 3567 (3.7) 5849 (3.0)
Hypertensive diseases 14 290 (14.9) 24 328 (12.3)
Coronary heart disease 6581 (6.9) 10 429 (5.3)
Cerebrovascular diseases 6981 (7.3) 11 459 (5.8)
Arterial disease 1666 (1.7) 2540 (1.3)
Cardiomyopathy 293 (0.3) 461 (0.2)
Heart failure 4078 (4.3) 5724 (2.9)
Valve disorders 537 (0.6) 997 (0.5)
Arrhythmia and conduction disorders 4999 (5.2) 8731 (4.4)
Hypertensive renal disease 296 (0.3) 383 (0.2)
Renal failure 1928 (2.0) 2581 (1.3)
Oesophageal varices 133 (0.1) 133 (0.1)
Hepatic failure, liver fibrosis and cirrhosis 1075 (1.1) 1472 (0.7)
Schizophrenia, delusional disorders and
psychosis
1739 (1.8) 3775 (1.9)
Bipolar disorder 190 (0.2) 429 (0.2)
Depression 2569 (2.7) 4720 (2.4)
Prescription in past year:
Angiotensin receptor blocker/angiotensin
converting enzyme inhibitor
13 791 (14.4) 24 758 (12.5)
Calcium channel blockers 18 619 (19.4) 35 205 (17.8)
Loop diuretics 7290 (7.6) 10 189 (5.1)
Other diuretics 7617 (8.0) 15 103 (7.6)
β blockers 16 658 (17.4) 31 485 (15.9)
Anti-arrhythmics class I and II 937 (1.0) 1380 (0.7)
Digoxin 2044 (2.1) 3203 (1.6)
Nitrates 7942 (8.3) 12 008 (6.1)
Platelet inhibitors 14 871 (15.5) 24 069 (12.1)
Anticoagulants 2977 (3.1) 4920 (2.5)
Peripheral vasodilators 775 (0.8) 1258 (0.6)
Lipid lowering drugs 8288 (8.7) 14 468 (7.3)
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Insulin 2611 (2.7) 3629 (1.8)
Oral hypoglycemic agent 11 080 (11.6) 21 012 (10.6)
Antidepressants 4549 (4.8) 8091 (4.1)
Antipsychotics 3496 (3.7) 6598 (3.3)
Oral corticosteroids 6516 (6.8) 7796 (3.9)
Non-steroidal anti-inflammatory drugs 15 728 (16.4) 27 527 (13.9)
Proton pump inhibitors/H2 receptor
blockers
45 043 (47.0) 38 840 (19.6)
Median No (interquartile range) of
prescriptions used in past year
14 (4-38) 11 (2-29)
Health care use in past year:
Median No (interquartile range) of
outpatient visits
5 (1-10) 4 (1-9)
Median No (interquartile range) of
inpatient stays
1 (0-1) 0 (0-1)
Median No (interquartile range) of
emergency department visits
1 (0-2) 0 (0-1)
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Supplementary material 7. Propensity score distributions before and after propensity score
trimming
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Supplementary material 8. Propensity score adjusted rate ratios of all outcomes without
trimming band
Outcomes by treatment
duration No of patients No of events
Rate ratio
(95% CI)
Myocardial infarction*
Day 1-14
Clarithromycin 102 514 132
3.57
(2.78 to 4.57)
Amoxicillin 204 851 149 ---
Day 15-30
Clarithromycin 70 184 11
1.00
(0.48 to 2.08)
Amoxicillin 200 766 34 ---
Day 31-90
Clarithromycin 67 707 23
1.11
(0.67 to 1.86)
Amoxicillin 193 518 67 ---
Day 91-365
Clarithromycin 63 155 67
0.94
(0.70 to 1.27)
Amoxicillin 180 518 221 ---
Day 366-730
Clarithromycin 53 614 72
1.17
(0.88 to 1.57)
Amoxicillin 153 423 223 ---
Day 731-1095
Clarithromycin 46 586 62
1.03
(0.75 to 1.42)
Amoxicillin 130 661 198 ---
Arrhythmia*
Day 1-14
Clarithromycin 107 200 23
2.30
(1.30 to 4.09)
Amoxicillin 214 217 33 ---
Day 15-30
Clarithromycin 72 574 7
0.81
(0.33 to 1.97)
Amoxicillin 209 862 27 ---
Day 31-90
Clarithromycin 69 933 17
0.79
(0.45 to 1.40)
Amoxicillin 202 070 66 ---
Day 91-365
Clarithromycin 65 072 41
1.10
(0.74 to 1.63)
Amoxicillin 188 108 110 ---
Day 366-730
Clarithromycin 55 081 36 1.13
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(0.74 to 1.72)
Amoxicillin 159 545 100 ---
Day 731-1095
Clarithromycin 47 788 28
1.14
(0.70 to 1.83)
Amoxicillin 135 503 81 ---
Stroke*
Day 1-14
Clarithromycin 90 225 63
1.13
(0.83 to 1.54)
Amoxicillin 180 320 176 ---
Day 15-30
Clarithromycin 63 829 21
1.13
(0.66 to 1.94)
Amoxicillin 177 169 61 ---
Day 31-90
Clarithromycin 61 804 79
1.33
(0.99 to 1.78)
Amoxicillin 171 154 176 ---
Day 91-365
Clarithromycin 57 983 178
1.04
(0.87 to 1.25)
Amoxicillin 160 202 573 ---
Day 366-730
Clarithromycin 49 616 177
1.12
(0.93 to 1.34)
Amoxicillin 137 147 555 ---
Day 731-1095
Clarithromycin 43 398 172
1.16
(0.96 to 1.40)
Amoxicillin 117 677 524 ---
All-cause mortality*
Day 1-14
Clarithromycin 108 988 1948
1.72
(1.61 to 1.83)
Amoxicillin 217 788 2562 ---
Day 15-30
Clarithromycin 73 526 569
0.89
(0.80 to 0.99)
Amoxicillin 213 275 1611 ---
Day 31-90
Clarithromycin 70 820 659
0.68
(0.62 to 0.75)
Amoxicillin 205 313 2283 ---
Day 91-365
Clarithromycin 65 875 836
0.89
(0.82 to 0.97)
Amoxicillin 191 066 2563 ---
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Day 366-730
Clarithromycin 55 750 505
0.99
(0.89 to 1.11)
Amoxicillin 161 948 1544 ---
Day 731-1095
Clarithromycin 48 329 283
0.98
(0.84 to 1.13)
Amoxicillin 137 512 954 ---
Cardiac mortality†
Day 1-14
Clarithromycin 108 988 201
1.71
(1.41 to 2.06)
Amoxicillin 217 788 315 ---
Day 15-30
Clarithromycin 73 526 55
1.30
(0.94 to 1.80)
Amoxicillin 213 275 152 ---
Day 31-90
Clarithromycin 70 820 54
0.78
(0.57 to 1.07)
Amoxicillin 205 313 219 ---
Day 91-365
Clarithromycin 65 875 84
0.86
(0.66 to 1.11)
Amoxicillin 191 066 313 ---
Day 366-730
Clarithromycin 55 750 53
0.96
(0.70 to 1.33)
Amoxicillin 161 948 210 ---
Day 731-1095
Clarithromycin 48 329 35
0.77
(0.52 to 1.14)
Amoxicillin 137 512 160 ---
Non-cardiac mortality*
Day 1-14
Clarithromycin 108 988 1687
1.79
(1.67 to 1.92)
Amoxicillin 217 788 2067 ---
Day 15-30
Clarithromycin 73 526 490
0.89
(0.79 to 0.99)
Amoxicillin 213 275 1335 ---
Day 31-90
Clarithromycin 70 820 555
0.69
(0.62 to 0.76)
Amoxicillin 205 313 1808 ---
Day 91-365
Clarithromycin 65 875 655 0.92
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(0.83 to 1.01)
Amoxicillin 191 066 1799 ---
Day 366-730
Clarithromycin 55 750 387
1.05
(0.92 to 1.20)
Amoxicillin 161 948 1052 ---
Day 731-1095
Clarithromycin 48 329 195
1.04
(0.87 to 1.25)
Amoxicillin 137 512 592 ---
Days 1-14=current use; days 15-30=recent use; days 31-1095=past use.
* Analysis with adjustment for age, sex and propensity score †
Analysis with adjustment for age, sex, history of myocardial infarction and arrhythmia, and propensity score
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Supplementary material 9. Rate ratios of all outcomes for current and recent use of
clarithromycin versus amoxicillin in sensitivity analysis
Before PS adjustment
Propensity scores
trimming 1st & 20th strata
Propensity scores
without trimming strata
Outcomes by
treatment duration
Rate ratio*
(95% CI)
Rate ratio‡
(95% CI)
Rate ratio‡
(95% CI)
Myocardial infarction
Day 1-7
Clarithromycin
2.51
(1.95 to 3.22)
3.47
(2.63 to 4.57)
3.34
(2.56 to 4.34)
Amoxicillin --- --- ---
Day 8-30
Clarithromycin
1.63
(1.01 to 2.64)
1.50
(0.82 to 2.73)
1.54
(0.92 to 2.58)
Amoxicillin --- --- ---
Outcomes by
treatment duration
Rate ratio*
(95% CI)
Rate ratio‡
(95% CI)
Rate ratio‡
(95% CI)
Arrhythmia
Day 1-7
Clarithromycin
2.96
(1.57 to 5.60)
3.52
(1.71 to 7.23)
3.41
(1.73 to 6.73)
Amoxicillin --- --- ---
Day 8-30
Clarithromycin
0.88
(0.44 to 1.76)
0.77
(0.35 to 1.72)
0.76
(0.36 to 1.58)
Amoxicillin --- --- ---
Outcomes by
treatment duration
Rate ratio*
(95% CI)
Rate ratio‡
(95% CI)
Rate ratio‡
(95% CI)
Stroke
Day 1-7
Clarithromycin
0.93
(0.67 to 1.29)
1.04
(0.72 to 1.50)
1.06
(0.75 to 1.49)
Amoxicillin --- --- ---
Day 8-30
Clarithromycin
1.22
(0.82 to 1.80)
1.11
(0.71 to 1.75)
1.10
(0.72 to 1.69)
Amoxicillin --- --- ---
Outcomes by
treatment duration
Rate ratio*
(95% CI)
Rate ratio‡
(95% CI)
Rate ratio‡
(95% CI)
All-cause mortality
Day 1-7
Clarithromycin
2.67
(2.48 to 2.88)
2.23
(2.04 to 2.43)
1.98
(1.83 to 2.15)
Amoxicillin --- --- ---
Day 8-30
Clarithromycin
1.58
(1.47 to 1.69)
1.17
(1.07 to 1.27)
1.04
(0.96 to 1.12)
Amoxicillin --- --- ---
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Outcomes by
treatment duration
Rate ratio†
(95% CI)
Rate ratioa
(95% CI)
Rate ratioa
(95% CI)
Cardiac mortality
Day 1-7
Clarithromycin
1.83
(1.48 to 2.26)
1.62
(1.27 to 2.07)
1.62
(1.29 to 2.03)
Amoxicillin --- --- ---
Day 8-30
Clarithromycin
1.62
(1.29 to 2.03)
1.47
(1.13 to 1.92)
1.44
(1.13 to 1.83)
Amoxicillin --- --- ---
Outcomes by
treatment duration
Rate ratio*
(95% CI)
Rate ratio‡
(95% CI)
Rate ratio‡
(95% CI)
Non-cardiac mortality
Day 1-7
Clarithromycin
2.91
(2.68 to 3.15)
2.42
(2.20 to 2.67)
2.10
(1.93 to 2.30)
Amoxicillin --- --- ---
Day 8-30
Clarithromycin
1.64
(1.52 to 1.77)
1.20
(1.09 to 1.31)
1.04
(0.96 to 1.13)
Amoxicillin --- --- ---
Days 1-7=current use; days 8-30=recent use.
* Analysis with initial adjustment for age, sex † Analysis with initial adjustment for age, sex and history of myocardial infarction and arrhythmia
‡ Analysis with full adjustment for age, sex, and propensity score
a Analysis with full adjustment for age, sex, and history of myocardial infarction and arrhythmia and propensity
score
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Supplementary material 10. Subgroup analysis of risk of cardiovascular outcomes
associated with current use of clarithromycin versus amoxicillin Rate ratio
(95%CI)*
Absolute risk difference per 1000
(95%CI)*
Cardiac death
Sex
Male 1.71 (1.31 to 2.23) 1.15 (0.50 to 1.98)
Female 1.62 (1.16 to 2.25) 0.75 (0.19 to 1.51)
Age
18-64 2.13 (1.07 to 4.23) 0.20 (0.01 to 0.57)
65-74 1.73 (1.05 to 2.84) 0.87 (0.06 to 2.19)
75+ 1.60 (1.25 to 2.03) 2.63 (1.10 to 4.52)
History of hypertensive diseases
No 1.53 (1.17 to 1.99) 0.57 (0.18 to 1.07)
Yes 1.90 (1.37 to 2.65) 3.47 (1.43 to 6.36)
History of diabetes mellitus
No 1.57 (1.24 to 1.99) 0.71 (0.30 to 1.24)
Yes 2.03 (1.32 to 3.12) 3.71 (1.15 to 7.63)
Myocardial infarction
Sex
Male 3.64 (2.57 to 5.15) 2.13 (1.27 to 3.35)
Female 3.74 (2.51 to 5.56) 1.68 (0.93 to 2.79)
Age
18-64 5.11 (2.63 to 9.90) 0.63 (0.25 to 1.37)
65-74 2.14 (1.19 to 3.86) 1.15 (0.19 to 2.89)
75+ 4.00 (2.89 to 5.54) 5.77 (3.63 to 8.73)
History of hypertensive diseases
No 3.78 (2.73 to 5.23) 1.51 (0.94 to 2.29)
Yes 3.32 (2.15 to 5.12) 4.78 (2.37 to 8.49)
History of diabetes mellitus
No 3.76 (2.79 to 5.07) 1.65 (1.07 to 2.43)
Yes 3.12 (1.82 to 5.35) 4.95 (1.91 to 10.15)
Arrhythmia
Sex
Male 2.40 (1.17 to 4.91) 0.30 (0.04 to 0.85)
Female 1.92 (0.64 to 5.75) 0.09 (-0.04 to 0.46)
Age
18-64 3.99 (1.10 to 14.50) 0.13 (0.00† to 0.60)
65-74 2.21 (0.53 to 9.32) 0.18 (-0.07 to 1.27)
75+ 1.92 (0.89 to 4.13) 0.40 (-0.05 to 1.36)
History of hypertensive diseases
No 2.58 (1.26 to 5.27) 0.20 (0.03 to 0.55)
Yes 1.61 (0.55 to 4.75) 0.24 (-0.17 to 1.45)
History of diabetes mellitus
No 2.49 (1.29 to 4.81) 0.21 (0.04 to 0.53)
Yes 1.25 (0.29 to 5.36) 0.11 (-0.31 to 1.89)
*Adjusted for propensity score with trimming 1st and 20
th strata
† Value was 0.004 when corrected to 3 decimal places.
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