On-Line Supplement. Risks of pneumonia in asthmatic patients taking inhaled corticosteroids
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1 On-Line Supplement Risks of pneumonia in asthmatic patients taking inhaled corticosteroids Paul M. O Byrne, Soren Pedersen, Lars-Göran Carlsson, Finn Radner,Anders Thorén Stefan Peterson, Pierre Ernst, Samy Suissa.
2 Additional Analysis As a complementary analysis the overall relative risk (RR) using a Mantel Haenszel (MH) approach stratified by study and adjusted for treatment exposure was calculated. This provided the pooled MH RR and 95% confidence intervals (CI) for pneumonia AE and SAE. For the visual assessment of the risk over all individual studies, a descriptive 95% credibility interval for the RR was provided using the method of Barker and Cadwell (1) with an uninformative uniform prior; the median of the posterior distribution was used to provide a point estimate for the RR, allowing presentation of studies with no event. These Bayesian risk estimates and credibility intervals are presented in forest plots, together with the pooled MH RR and its 95% CI for pneumonia AE and SAE. Reference (1) Barker L, Cadwell BL. An analysis of eight 95 per cent confidence intervals for a ratio of Poisson parameters when events are rare. Stat Med 2008; 27:
3 Table E1 Double-blind placebo-controlled trials included in the primary analysis Studycode Duration Age min Age max exposure (1000 treatment years) ICS Non-ICS ICS Non-ICS daily delivered doses of budesonide* (μg) Comparison Budesonide pmdi trials months BUD CFC vs PLA months BUD CFC vs PLA Budesonide Turbuhaler trials months BUD TBH vs PLA months BUD TBH vs PLA months BUD TBH vs PLA months ;320;640;1280 BUD TBH vs PLA months ;320 BUD TBH vs PLA months ;320;640 BUD TBH vs PLA months ;640 BUD TBH vs PLA months BUD TBH vs PLA vs Sodium cromoglicate (N=15, excluded) months BUD TBH vs PLA months ;160 BUD TBH vs PLA SD months ;320 BUD TBH vs PLA SD ** 12 months of 36 months (children 160) BUD TBH vs PLA on top of regular asthma treatment SD months BUD TBH vs PLA SD months BUD TBH vs PLA SD months ;320 BUD TBH vs PLA SD months ;640 BUD TBH vs PLA SD months ;640 BUD TBH vs PLA
4 Table E1 Double-blind placebo-controlled trials included in the primary analysis Studycode Duration Age min Age max exposure (1000 treatment years) ICS Non-ICS ICS Non-ICS daily delivered doses of budesonide* (μg) Comparison Budesonide nebulizing suspension trials *** 3 months ,500;1000 BUD NEB vs PLA months ;1000;2000 BUD NEB vs PLA *** 3 months ,500;1000 BUD NEB vs PLA Budesonide/formoterol pmdi trials SD months /18; 320 SD months /18; 640; SD months /9; 320 Formoterol Turbuhaler trials SD months plus 9; 160 vs FORM TBH (18μg) vs PLA BUD/FORM HFA vs [BUD HFA plus FORM TBH]vs BUD HFA vs FORM TBH (18μg) vs PLA vs PLA BUD TBH vs [BUD TBH plus FORM TBH] vs PLA *Delivered doses of 80, 160, 320, 640 or 1280 µg correspond to metered doses of 100, 200, 400, 800 and 1600 µg of budesonide ** Only data from the first 12 months have been included in the analysis *** Patients aged 3 years and younger have been removed from the dataset and have thus not been counted
5 Table E2 Double-blind controlled trials included in the supplementary analysis Studycode Duration Age min Age max Budeso nide Comparat or exposure (1000 treatment years) Budesoni de Compara tor daily delivered doses of budesonide (μg) Comparison Budesonide pmdi trials months BUD CFC vs PLA months BUD CFC vs PLA Budesonide Turbuhaler trials months BUD TBH vs PLA months BUD TBH vs PLA months BUD TBH vs PLA months BUD TBH vs BUD TBH months vs 640 BUD TBH vs BUD TBH months ;320;640;1280 BUD TBH vs PLA months ;320 BUD TBH vs PLA months ;320;640 BUD TBH vs PLA months ;640 BUD TBH vs PLA months months (of 18 months) dose titration months BUD TBH vs Sodium cromoglicate BUD TBH dose titration (openlabel vs Sodium cromoglicate N=64) BUD TBH vs PLA (N=15) (vs Sodium cromoglicate N=15) months BUD TBH vs PLA months ;160 BUD TBH vs PLA months ;320 BUD TBH vs BUD TBH BN-00P months BUD TBH vs FLUT SD months ;320 BUD TBH vs PLA
6 Table E2 Double-blind controlled trials included in the supplementary analysis Studycode Duration Age min SD SD months (of 17 months) 12 months of 36 months Age max Budeso nide Comparat or exposure (1000 treatment years) Budesoni de Compara tor daily delivered doses of budesonide (μg) Comparison ;2560 BUD TBH vs BUD_TBH (children 160) BUD TBH vs PLA on top of regular asthma treatment SD months ;960 BUD TBH vs BUD TBH SD months BUD TBH vs PLA SD months BUD TBH vs PLA SD months ;320 BUD TBH vs PLA SD months ;640 BUD TBH vs PLA SD months ;640 BUD TBH vs PLA Budesonide nebulizing suspension trials months ,500;1000 BUD NEB vs PLA months ;1000;2000 BUD NEB vs PLA months ,500;1000 BUD NEB vs PLA SD months Budesonide/formoterol pmdi trials D5896C00001 SD months 3 months ;1000;2000; 4000; /9;320/9; 320/18; /18 vs 640 SD months /18 vs 320 SD months /18; 320 SD months /18; 640; BUD NEB vs PBUD TBH BUD/FORM HFA vs BUD/FORM TBH vs BUD CFC BUD/FORM HFA vs BUD/FORM TBH vs BUD CFC vs FORM TBH (18μg) vs PLA BUD/FORM HFA vs [BUD HFA plus FORM TBH]vs BUD HFA vs FORM TBH (18μg) vs PLA
7 Table E2 Double-blind controlled trials included in the supplementary analysis Studycode Duration Age min Age max Budeso nide Comparat or exposure (1000 treatment years) Budesoni de Compara tor daily delivered doses of budesonide (μg) SD months /18;160 Comparison vs FORM TBH SD months /18;160/9, 160 SD months /9; 320 SD months Budesonide/formoterol Turbuhaler trials 640/18; 1280/36;1280 D5890C months /18 vs PLA BUD/FORM TBH vs FLUT/SALM SD months /9 vs 320 BUD/FORM TBH vs BUD TBH SD months /18 vs 640 BUD/FORM TBH vs BUD TBH SD months /18 vs 320 BUD/FORM TBH vs BUD TBH SD months /9 BUD/FORM TBH vs FLUT SD months /9 vs 160 BUD/FORM TBH vs BUD TBH SD months /9 vs 320 BUD/FORM TBH vs BUD TBH SD months SD months SD months SD months /9 (SMART) vs /9 (SMART) vs /9 (SMART) vs 160/9 vs /18; ind dose BUD/FORM TBH vs BUD TBH BUD/FORM TBH vs BUD TBH BUD/FORM TBH vs BUD TBH BUD/FORM TBH vs FLUT/SALM SD months /18 vs 320 BUD/FORM TBH vs BUD TBH SD months /36;1280 BUD/FORM TBH vs BUD TBH SD months /9 vs 320
8 Table E2 Double-blind controlled trials included in the supplementary analysis Studycode Duration Age min Age max SD months SD months Formoterol Turbuhaler trials Budeso nide Comparat or exposure (1000 treatment years) Budesoni de Compara tor months daily delivered doses of budesonide (μg) 320/9 (SMART) vs 320/9 320/9 (SMART) vs 640/ ; 160; ; months ; 640 SD months ; 160 RofleponideTurbuhaler trials Comparison BUD/FORM TBH vs BUD/FORM TBH BUD/FORM TBH vs BUD/FORM TBH vs FLUT/SALM BUD TBH vs [BUD TBH plus FORM TBH] BUD TBH vs [BUD TBH plus FORM TBH] BUD TBH vs [BUD TBH plus FORM TBH] vs PLA SD months ;960 Rofleponide TBH vs BUD TBH
9 Table E3 Reporting of pneumonia as AE and SAE in the double-blind controlled trials included in the supplementary analysis Subgroup on budesonide Exposure on budesonide in TTY (%) of patients reporting pneumonia AEs on budesonide (%) of patients reporting pneumonia SAEs on budesonide All trials excluding START (0.68%) 49 (0.16%) START alone (0.91%) 8 (0.22%) Patients aged 4-11years (1.12%) 11 (0.23%) Patients aged years (0.63%) 46 (0.16%) All trials (0.70%) 57 (0.17%)
10 Table E4 Reporting of pneumonia AEs in trials comparing high-dose and low-dose budesonide Studycode on HIGH BUD on LOW BUD Exposure on HIGH BUD (TTY) Exposure on LOW BUD (TTY) (%) of patients reporting pneumonia AEs HIGH BUD LOW BUD HR (95% CI) Rate per TTY (%) of patients reporting pneumonia AEs % % % % % % % % % % % % % % % % % % % % 38.9 SD % % 0.0 SD % % 0.0 SD % % 10.0 SD % % All trials % % (0.43;1.78) Rate per TTY
11 Studycode Reporting of pneumonia SAEs in trials comparing high-dose and low-dose budesonide on HIGH BUD on LOW BUD reporting pneumonia SAEs HIGH BUD LOW BUD SD SD SD SD reporting pneumonia SAEs All trials % %
12 Table E5 Reporting of pneumonia AEs in trials comparing budesonide and fluticasone Studycode on BUD on FLUT Exposure on BUD (TTY) Exposure on FLUT (TTY) (%) of patients reporting pneumonia AEs BUD FLUT HR (95% CI) Rate per TTY (%) of patients reporting pneumonia AEs BN-00P % % 0.0 D5890C % % 12.9 SD % % 0.0 SD % % 50.7 SD % % 15.8 All trials % % (0.58;1.75) Rate per TTY Studycode Reporting of pneumonia SAEs in trials comparing budesonide and fluticasone on BUD on FLUT (%) of patients reporting pneumonia SAEs BUD FLUT (%) of patients reporting pneumonia SAEs BN-00P % 0 0.0% D5890C % % SD % 0 0.0% SD % 0 0.0% SD % % All trials % %
13 Table E6 Statistical analysis of time to first pneumonia, sex and race as separate factors Variable Contrast Event/N Ratio 95% C.I. P-value Factor test Sex F vs M 101/15089 vs 134/ Race Black vs Cauc 2/899 vs 175/ Oriental vs Cauc 34/3602 vs 175/ Other* vs Cauc 11/1788 vs 175/ Missing **vs Cauc 13/3526 vs 175/ * Other race than caucasian, black or oriental ** Note that a total of 3526 patients were classified with a missing code. The latter group was mainly from older studies where the race had not been collected.
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