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Published in: BMC Medical Research Methodology 1/2013

Open Access 01-12-2013 | Research article

Proton pump inhibitors and the risk of pneumonia: a comparison of cohort and self-controlled case series designs

Authors: Emmae N Ramsay, Nicole L Pratt, Philip Ryan, Elizabeth E Roughead

Published in: BMC Medical Research Methodology | Issue 1/2013

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Abstract

Background

To compare the results of a new-user cohort study design and the self-controlled case series (SCCS) design using the risk of hospitalisation for pneumonia in those dispensed proton pump inhibitors compared to those unexposed as a case study.

Methods

The Australian Government Department of Veterans’ Affairs administrative claims database was used. Exposure to proton pump inhibitors and hospitalisations for pneumonia were identified over a 4 year study period 01 Jul 2007 -30 Jun 2011. The same inclusion and exclusion criteria were applied to both studies, however, the SCCS study included subjects with a least one hospitalisation for pneumonia.

Results

There were 105,467 subjects included in the cohort study and 6775 in the SCCS. Both studies showed an increased risk of hospitalisations for pneumonia in the three defined risk periods following initiation of proton pump inhibitors compared to baseline. With the highest risk in the first 1 to 7 days (Cohort RR, 3.24; 95% CI (2.50, 4.19): SCCS: RR, 3.07; 95% CI (2.69, 3.50)).

Conclusions

This study has shown that the self-controlled case series method produces similar risk estimates to a new-users cohort study design when applied to the association of proton pump inhibitors and pneumonia. Exposure to a proton pump inhibitor increases the likelihood of being admitted to hospital for pneumonia, with the risk highest in the first week of treatment.
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Literature
1.
go back to reference Suissa S, Delaney J: The case-crossover study design in pharmacoepidemiology. Stat Methods Med Res. 2009, 18: 53-65. 10.1177/0962280208092346.CrossRefPubMed Suissa S, Delaney J: The case-crossover study design in pharmacoepidemiology. Stat Methods Med Res. 2009, 18: 53-65. 10.1177/0962280208092346.CrossRefPubMed
2.
go back to reference Whitaker HJ, Farrington CP, Spiessens B, Musonda P: Tutorial in Biostatistics: the self-controlled case series method. Stat Med. 2006, 25 (10): 1768-1797. 10.1002/sim.2302.CrossRefPubMed Whitaker HJ, Farrington CP, Spiessens B, Musonda P: Tutorial in Biostatistics: the self-controlled case series method. Stat Med. 2006, 25 (10): 1768-1797. 10.1002/sim.2302.CrossRefPubMed
3.
go back to reference Whitaker HJ, Hocine MN, Farrington CP: The methodology of self-controlled case series studies. Stat Methods Med Res. 2009, 18: 7-26. 10.1177/0962280208092342.CrossRefPubMed Whitaker HJ, Hocine MN, Farrington CP: The methodology of self-controlled case series studies. Stat Methods Med Res. 2009, 18: 7-26. 10.1177/0962280208092342.CrossRefPubMed
4.
go back to reference Glanz J, McClure D, Xu S, Hambidge S, Lee M, Kolczak M, et al: Four different study designs to evaluate vaccine safety were equally validated with contrasting limitations. JCE. 2006, 59: 808-818.PubMed Glanz J, McClure D, Xu S, Hambidge S, Lee M, Kolczak M, et al: Four different study designs to evaluate vaccine safety were equally validated with contrasting limitations. JCE. 2006, 59: 808-818.PubMed
5.
go back to reference Hippisley-Cox J: Unintended effects of statins in men and women in England and Wales: population based cohort study using the QResearch database. BMJ. 2010, 340: c2197-10.1136/bmj.c2197.CrossRefPubMedPubMedCentral Hippisley-Cox J: Unintended effects of statins in men and women in England and Wales: population based cohort study using the QResearch database. BMJ. 2010, 340: c2197-10.1136/bmj.c2197.CrossRefPubMedPubMedCentral
6.
go back to reference Gulmez S, Holm A, Frederiksen H, Jensen T, Pedersen C, Hallas J: Use of proton pump inhibitors and the risk of community-acquired pneumonia: a population-based case–control study. Arch Intern Med. 2007, 167 (9): 950-955. 10.1001/archinte.167.9.950.CrossRefPubMed Gulmez S, Holm A, Frederiksen H, Jensen T, Pedersen C, Hallas J: Use of proton pump inhibitors and the risk of community-acquired pneumonia: a population-based case–control study. Arch Intern Med. 2007, 167 (9): 950-955. 10.1001/archinte.167.9.950.CrossRefPubMed
7.
go back to reference Laheij R, Sturkenboom M, Hassing R, Dieleman J, Stricker B, Jansen J: Risk of community-acquired pneumonia and use of gastric acid-suppressive drugs. JAMA. 2004, 292 (16): 1955-1960. 10.1001/jama.292.16.1955.CrossRefPubMed Laheij R, Sturkenboom M, Hassing R, Dieleman J, Stricker B, Jansen J: Risk of community-acquired pneumonia and use of gastric acid-suppressive drugs. JAMA. 2004, 292 (16): 1955-1960. 10.1001/jama.292.16.1955.CrossRefPubMed
8.
go back to reference Eom C-S, Jeon C, Lim J-W, Cho E-G, Park SM, Lee K-S: Use of acid-suppressive drugs and risk of pneumonia: systematic review and meta-analysis. CMAJ. 2011, 183 (3): 310-319.CrossRefPubMedPubMedCentral Eom C-S, Jeon C, Lim J-W, Cho E-G, Park SM, Lee K-S: Use of acid-suppressive drugs and risk of pneumonia: systematic review and meta-analysis. CMAJ. 2011, 183 (3): 310-319.CrossRefPubMedPubMedCentral
9.
go back to reference Gadzhanova SV, Roughead EE, Mackson JM: Initiation and duration of proton pump inhibitors in the Australian veteran population. Intern Med J. 2012, 42 (E68): 73- Gadzhanova SV, Roughead EE, Mackson JM: Initiation and duration of proton pump inhibitors in the Australian veteran population. Intern Med J. 2012, 42 (E68): 73-
10.
go back to reference Suissa S: Immortal time bias in pharmacoepidemiology. Am J Epidemiol. 2008, 167 (4): 492-9. 10.1093/aje/kwm324.CrossRefPubMed Suissa S: Immortal time bias in pharmacoepidemiology. Am J Epidemiol. 2008, 167 (4): 492-9. 10.1093/aje/kwm324.CrossRefPubMed
11.
go back to reference Australian Bureau of Statistics (ABS): Socio-economic indexes for areas, Australia, 2001 ABS cat. no. 2039.0. Information paper: census of population and housing. 2003, Canberra: ABS Australian Bureau of Statistics (ABS): Socio-economic indexes for areas, Australia, 2001 ABS cat. no. 2039.0. Information paper: census of population and housing. 2003, Canberra: ABS
12.
go back to reference Sloan KL, Sales AE, Liu CF, Fishman P, Nichol P, Suzuki NT, et al: Construction and characteristics of the RxRisk-V: a VA-adapted pharmacy-based case-mix instrument. Med Care. 2003, 41 (6): 761-74. PubMed PMID: 12773842PubMed Sloan KL, Sales AE, Liu CF, Fishman P, Nichol P, Suzuki NT, et al: Construction and characteristics of the RxRisk-V: a VA-adapted pharmacy-based case-mix instrument. Med Care. 2003, 41 (6): 761-74. PubMed PMID: 12773842PubMed
13.
go back to reference Thomas L, Culley E, Gladowski P, Goff V, Fong J, Marche S: Longitudinal analysis of the costs associated with inpatient initiation and subsequent outpatient continuation of proton pump inhibitor therapy for stress ulcer prophylaxis in a large managed care organisation. J Manag Care Pharm. 2010, 16 (2): 122-29.PubMed Thomas L, Culley E, Gladowski P, Goff V, Fong J, Marche S: Longitudinal analysis of the costs associated with inpatient initiation and subsequent outpatient continuation of proton pump inhibitor therapy for stress ulcer prophylaxis in a large managed care organisation. J Manag Care Pharm. 2010, 16 (2): 122-29.PubMed
14.
go back to reference Zink DA, Pohlman M, Barnes M, Cannon ME: Long-term use of acid suppression started inappropriately during hospitalization. Aliment Pharmacol Ther. 2005, 21: 1203-9. 10.1111/j.1365-2036.2005.02454.x.CrossRefPubMed Zink DA, Pohlman M, Barnes M, Cannon ME: Long-term use of acid suppression started inappropriately during hospitalization. Aliment Pharmacol Ther. 2005, 21: 1203-9. 10.1111/j.1365-2036.2005.02454.x.CrossRefPubMed
15.
go back to reference Farrington C, Whitaker H: Semiparametric analysis of case series data. Appl Statist. 2006, 55(Part 5): 553-94. Farrington C, Whitaker H: Semiparametric analysis of case series data. Appl Statist. 2006, 55(Part 5): 553-94.
16.
go back to reference Farrington C, Anaya K, Whitaker HJ, Hocine M, Douglas I, Smeeth L: Self-controlled case series analysis with event-dependent observation periods. American Journal of Statistical Association. 2011, 106 (494): 417-26. 10.1198/jasa.2011.ap10108.CrossRef Farrington C, Anaya K, Whitaker HJ, Hocine M, Douglas I, Smeeth L: Self-controlled case series analysis with event-dependent observation periods. American Journal of Statistical Association. 2011, 106 (494): 417-26. 10.1198/jasa.2011.ap10108.CrossRef
17.
go back to reference Farrington CP, Whitaker HJ, Hocine MN: Case series analysis for censored, perturbed or curtailed post-event exposures. Biostatistics. 2009, 10 (1): 3-16.CrossRefPubMed Farrington CP, Whitaker HJ, Hocine MN: Case series analysis for censored, perturbed or curtailed post-event exposures. Biostatistics. 2009, 10 (1): 3-16.CrossRefPubMed
18.
go back to reference Laheij RJ, Van Ijzendoorn MC, Janssen MJ, Jansen JB: Gastric acid-suppressive therapy and community-acquired respiratory infections. Aliment Pharmacol Ther. 2003, 18 (8): 847-51. 10.1046/j.1365-2036.2003.01744.x. PubMed PMID: 14535879CrossRefPubMed Laheij RJ, Van Ijzendoorn MC, Janssen MJ, Jansen JB: Gastric acid-suppressive therapy and community-acquired respiratory infections. Aliment Pharmacol Ther. 2003, 18 (8): 847-51. 10.1046/j.1365-2036.2003.01744.x. PubMed PMID: 14535879CrossRefPubMed
19.
go back to reference Gulmez SE, Holm A, Frederiksen H, Jensen TG, Pedersen C, Hallas J: Use of proton pump inhibitors and the risk of community-acquired pneumonia: a population-based case–control study. Arch Intern Med. 2007, 167 (9): 950-5. 10.1001/archinte.167.9.950. PubMed PMID: 17502537CrossRefPubMed Gulmez SE, Holm A, Frederiksen H, Jensen TG, Pedersen C, Hallas J: Use of proton pump inhibitors and the risk of community-acquired pneumonia: a population-based case–control study. Arch Intern Med. 2007, 167 (9): 950-5. 10.1001/archinte.167.9.950. PubMed PMID: 17502537CrossRefPubMed
Metadata
Title
Proton pump inhibitors and the risk of pneumonia: a comparison of cohort and self-controlled case series designs
Authors
Emmae N Ramsay
Nicole L Pratt
Philip Ryan
Elizabeth E Roughead
Publication date
01-12-2013
Publisher
BioMed Central
Published in
BMC Medical Research Methodology / Issue 1/2013
Electronic ISSN: 1471-2288
DOI
https://doi.org/10.1186/1471-2288-13-82

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