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All Studies   Meta Analysis       

Proton Pump Inhibitor Use and Risk of Serious Infections in Young Children

Lassalle et al., JAMA Pediatrics, doi:10.1001/jamapediatrics.2023.2900
Oct 2023  
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PPIs for COVID-19
1st treatment shown to increase risk in September 2020, now with p = 0.00000012 from 39 studies.
5,100+ studies for 112 treatments. c19early.org
Analysis of 1.2 million children in France showing increased risk of serious infection with proton pump inhibitor (PPI) use. PPI exposure was associated with higher risk of infections in the digestive tract, ear/nose/throat, lower respiratory tract, kidney/urinary tract, and nervous system.
Lassalle et al., 1 Oct 2023, retrospective, France, peer-reviewed, 3 authors. Contact: lassalle@ansm.sante.fr.
This PaperPPIsAll
Proton Pump Inhibitor Use and Risk of Serious Infections in Young Children
PharmD Marion Lassalle, PhD Mahmoud Zureik, MD, PhD Rosemary Dray-Spira
JAMA Pediatrics, doi:10.1001/jamapediatrics.2023.2900
IMPORTANCE Proton pump inhibitor (PPI) use may lead to infections through alteration of the microbiota or direct action on the immune system. However, only a few studies were conducted in children, with conflicting results. OBJECTIVE To assess the associations between PPI use and serious infections in children, overall and by infection site and pathogen. DESIGN, SETTING, AND PARTICIPANTS This nationwide cohort study was based on the Mother-Child EPI-MERES Register built from the French Health Data System (SNDS). We included all children born between January 1, 2010, and December 31, 2018, who received a treatment for gastroesophageal reflux disease or other gastric acid-related disorders, namely PPIs, histamine 2 receptor antagonists, or antacids/alginate. The index date was defined as the first date any of these medications was dispensed. Children were followed up until admission to the hospital for serious infection, loss of follow-up, death, or December 31, 2019. EXPOSURE PPI exposure over time. MAIN OUTCOMES AND MEASURES Associations between serious infections and PPI use were estimated by adjusted hazard ratios (aHRs) and 95% CIs using Cox models. PPI use was introduced as time-varying. A 30-day lag was applied to minimize reverse causality. Models were adjusted for sociodemographic data, pregnancy characteristics, child comorbidities, and health care utilization. RESULTS The study population comprised 1 262 424 children (median [IQR] follow-up, 3.8 [1.8-6.2] years), including 606 645 who received PPI (323 852 male [53.4%]; median [IQR] age at index date, 88 [44-282] days) and 655 779 who did not receive PPI (342 454 male [52.2%]; median [IQR] age, 82 [44-172] days). PPI exposure was associated with an increased risk of serious infections overall (aHR, 1.34; 95% CI, 1.32-1.36). Increased risks were also observed for infections in the digestive tract (aHR, 1.52; 95% CI, 1.48-1.55); ear, nose, and throat sphere (aHR, 1.47; 95% CI, 1.41-1.52); lower respiratory tract (aHR, 1.22; 95% CI, 1.19-1.25); kidneys or urinary tract (aHR, 1.20; 95% CI, 1.15-1.25); and nervous system (aHR, 1.31; 95% CI, 1.11-1.54) and for both bacterial (aHR, 1.56; 95% CI, 1.50-1.63) and viral infections (aHR, 1.30; 95% CI, 1.28-1.33). CONCLUSIONS AND RELEVANCE In this study, PPI use was associated with increased risks of serious infections in young children. Proton pump inhibitors should not be used without a clear indication in this population.
Conflict of Interest Disclosures: None reported. Data Sharing Statement: See Supplement 2.
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Children were followed up until admission ' 'to the hospital for serious infection, loss of follow-up, death, or December 31, ' '2019.</jats:p></jats:sec><jats:sec ' 'id="ab-poi230045-7"><jats:title>Exposure</jats:title><jats:p>PPI exposure over ' 'time.</jats:p></jats:sec><jats:sec id="ab-poi230045-8"><jats:title>Main Outcomes and ' 'Measures</jats:title><jats:p>Associations between serious infections and PPI use were ' 'estimated by adjusted hazard ratios (aHRs) and 95% CIs using Cox models. PPI use was ' 'introduced as time-varying. A 30-day lag was applied to minimize reverse causality. Models ' 'were adjusted for sociodemographic data, pregnancy characteristics, child comorbidities, and ' 'health care utilization.</jats:p></jats:sec><jats:sec ' 'id="ab-poi230045-9"><jats:title>Results</jats:title><jats:p>The study population comprised ' '1\u202f262\u202f424 children (median [IQR] follow-up, 3.8 [1.8-6.2] years), including ' '606\u202f645 who received PPI (323\u202f852 male [53.4%]; median [IQR] age at index date, 88 ' '[44-282] days) and 655\u202f779 who did not receive PPI (342\u202f454 male [52.2%]; median ' '[IQR] age, 82 [44-172] days). PPI exposure was associated with an increased risk of serious ' 'infections overall (aHR, 1.34; 95% CI, 1.32-1.36). Increased risks were also observed for ' 'infections in the digestive tract (aHR, 1.52; 95% CI, 1.48-1.55); ear, nose, and throat ' 'sphere (aHR, 1.47; 95% CI, 1.41-1.52); lower respiratory tract (aHR, 1.22; 95% CI, ' '1.19-1.25); kidneys or urinary tract (aHR, 1.20; 95% CI, 1.15-1.25); and nervous system (aHR, ' '1.31; 95% CI, 1.11-1.54) and for both bacterial (aHR, 1.56; 95% CI, 1.50-1.63) and viral ' 'infections (aHR, 1.30; 95% CI, 1.28-1.33).</jats:p></jats:sec><jats:sec ' 'id="ab-poi230045-10"><jats:title>Conclusions and Relevance</jats:title><jats:p>In this study, ' 'PPI use was associated with increased risks of serious infections in young children. 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thiopurines and anti-tumor necrosis ' 'factor.', 'volume': '20', 'author': 'Meyer', 'year': '2022', 'journal-title': 'Clin Gastroenterol Hepatol'}, { 'issue': '9', 'key': 'poi230045r17', 'doi-asserted-by': 'publisher', 'first-page': '1480', 'DOI': '10.1111/apt.v52.9', 'article-title': 'Pregnancy in women with inflammatory bowel disease: a French nationwide ' 'study 2010-2018.', 'volume': '52', 'author': 'Meyer', 'year': '2020', 'journal-title': 'Aliment Pharmacol Ther'}, { 'issue': '1', 'key': 'poi230045r18', 'doi-asserted-by': 'publisher', 'first-page': '27', 'DOI': '10.5009/gnl15502', 'article-title': '25 Years of proton pump inhibitors: a comprehensive review.', 'volume': '11', 'author': 'Strand', 'year': '2017', 'journal-title': 'Gut Liver'}, { 'key': 'poi230045r19', 'doi-asserted-by': 'publisher', 'DOI': '10.1136/bmj-2021-069211', 'article-title': 'Reduce unnecessary use of proton pump inhibitors.', 'volume': '379', 'author': 'Farrell', 'year': '2022', 'journal-title': 'BMJ'}, { 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'author': 'Yang', 'year': '2022', 'journal-title': 'J Pediatr'}, { 'key': 'poi230045r23', 'doi-asserted-by': 'publisher', 'DOI': '10.1177/1756284819853790', 'article-title': 'Burden of drug use for gastrointestinal symptoms and functional ' 'gastrointestinal disorders in France: a national study using ' 'reimbursement data for 57 million inhabitants.', 'volume': '12', 'author': 'Tuppin', 'year': '2019', 'journal-title': 'Therap Adv Gastroenterol'}, { 'issue': '6', 'key': 'poi230045r24', 'doi-asserted-by': 'publisher', 'first-page': '602', 'DOI': '10.1001/jama.2018.21554', 'article-title': 'Using the E-value to assess the potential effect of unmeasured ' 'confounding in observational studies.', 'volume': '321', 'author': 'Haneuse', 'year': '2019', 'journal-title': 'JAMA'}, { 'issue': '4', 'key': 'poi230045r25', 'doi-asserted-by': 'publisher', 'first-page': '268', 'DOI': '10.7326/M16-2607', 'article-title': 'Sensitivity analysis in observational research: introducing the ' 'E-value.', 'volume': '167', 'author': 'VanderWeele', 'year': '2017', 'journal-title': 'Ann Intern Med'}, { 'issue': '3', 'key': 'poi230045r26', 'doi-asserted-by': 'publisher', 'first-page': '383', 'DOI': '10.1097/EDE.0b013e3181d61eeb', 'article-title': 'Negative controls: a tool for detecting confounding and bias in ' 'observational studies.', 'volume': '21', 'author': 'Lipsitch', 'year': '2010', 'journal-title': 'Epidemiology'}, { 'issue': '8', 'key': 'poi230045r27', 'doi-asserted-by': 'publisher', 'first-page': '1531', 'DOI': '10.1111/apa.v109.8', 'article-title': 'The effects of proton pump inhibitors on the microbiome in young ' 'children.', 'volume': '109', 'author': 'Levy', 'year': '2020', 'journal-title': 'Acta Paediatr'}, { 'issue': '2', 'key': 'poi230045r28', 'doi-asserted-by': 'publisher', 'first-page': '495', 'DOI': '10.1053/j.gastro.2020.08.065', 'article-title': 'Childhood development and the microbiome: the intestinal microbiota in ' 'maintenance of health and development of disease during childhood ' 'development.', 'volume': '160', 'author': 'Ronan', 'year': '2021', 'journal-title': 'Gastroenterology'}, { 'issue': '4', 'key': 'poi230045r29', 'doi-asserted-by': 'publisher', 'first-page': '706', 'DOI': '10.1053/j.gastro.2017.01.031', 'article-title': 'The risks and benefits of long-term use of proton pump inhibitors: ' 'expert review and best practice advice from the American ' 'Gastroenterological Association.', 'volume': '152', 'author': 'Freedberg', 'year': '2017', 'journal-title': 'Gastroenterology'}, { 'issue': '1', 'key': 'poi230045r30', 'doi-asserted-by': 'publisher', 'first-page': '55', 'DOI': '10.1038/nrmicro.2016.142', 'article-title': 'Emerging pathogenic links between microbiota and the gut-lung axis.', 'volume': '15', 'author': 'Budden', 'year': '2017', 'journal-title': 'Nat Rev Microbiol'}, { 'issue': '4', 'key': 'poi230045r31', 'doi-asserted-by': 'publisher', 'first-page': '420', 'DOI': '10.1017/ice.2019.23', 'article-title': 'Risk factors for Clostridium difficile infection in pediatric ' 'inpatients: a meta-analysis and systematic review.', 'volume': '40', 'author': 'Anjewierden', 'year': '2019', 'journal-title': 'Infect Control Hosp Epidemiol'}, { 'issue': '1', 'key': 'poi230045r32', 'doi-asserted-by': 'publisher', 'first-page': '84', 'DOI': '10.1007/s00535-017-1369-3', 'article-title': 'Magnitude and direction of the association between Clostridium ' 'difficile infection and proton pump inhibitors in adults and pediatric ' 'patients: a systematic review and meta-analysis.', 'volume': '53', 'author': 'Oshima', 'year': '2018', 'journal-title': 'J Gastroenterol'}, { 'issue': '4', 'key': 'poi230045r33', 'doi-asserted-by': 'publisher', 'DOI': '10.1183/13993003.03229-2020', 'article-title': 'The risk of community-acquired pneumonia in children using gastric acid ' 'suppressants.', 'volume': '58', 'author': 'van der Sande', 'year': '2021', 'journal-title': 'Eur Respir J'}, { 'issue': '3', 'key': 'poi230045r34', 'doi-asserted-by': 'publisher', 'first-page': '335', 'DOI': '10.1097/MPG.0000000000001984', 'article-title': 'Proton pump inhibitors and infant pneumonia/other lower respiratory ' 'tract infections: national nested case-control study.', 'volume': '67', 'author': 'Blank', 'year': '2018', 'journal-title': 'J Pediatr Gastroenterol Nutr'}, { 'issue': '9', 'key': 'poi230045r35', 'doi-asserted-by': 'publisher', 'DOI': '10.3390/jcm7090252', 'article-title': 'Association between proton pump inhibitor use and CNS infection risk: a ' 'retrospective cohort study.', 'volume': '7', 'author': 'Hung', 'year': '2018', 'journal-title': 'J Clin Med'}, { 'issue': '11', 'key': 'poi230045r36', 'doi-asserted-by': 'publisher', 'first-page': '1027', 'DOI': '10.1007/s40266-019-00704-6', 'article-title': 'Proton pump inhibitors and infection-related hospitalizations among ' 'residents of long-term care facilities: a case-control study.', 'volume': '36', 'author': 'Wang', 'year': '2019', 'journal-title': 'Drugs Aging'}, { 'issue': '2', 'key': 'poi230045r37', 'doi-asserted-by': 'publisher', 'first-page': '223', 'DOI': '10.1007/s11606-012-2211-5', 'article-title': 'Confounding in the association of proton pump inhibitor use with risk ' 'of community-acquired pneumonia.', 'volume': '28', 'author': 'Jena', 'year': '2013', 'journal-title': 'J Gen Intern Med'}, { 'issue': '11', 'key': 'poi230045r38', 'doi-asserted-by': 'publisher', 'DOI': '10.1002/14651858.CD008550.pub2', 'article-title': 'Pharmacological treatment of children with gastro-oesophageal reflux.', 'volume': '2014', 'author': 'Tighe', 'year': '2014', 'journal-title': 'Cochrane Database Syst Rev'}, { 'issue': '7', 'key': 'poi230045r39', 'doi-asserted-by': 'publisher', 'first-page': '785', 'DOI': '10.1002/pds.v25.7', 'article-title': 'Positive predictive values of selected hospital discharge diagnoses to ' 'identify infections responsible for hospitalization in the French ' 'national hospital database.', 'volume': '25', 'author': 'Sahli', 'year': '2016', 'journal-title': 'Pharmacoepidemiol Drug Saf'}, { 'issue': '23', 'key': 'poi230045r40', 'doi-asserted-by': 'publisher', 'first-page': '2462', 'DOI': '10.1001/jama.2011.822', 'article-title': 'Surveillance bias in outcomes reporting.', 'volume': '305', 'author': 'Haut', 'year': '2011', 'journal-title': 'JAMA'}, { 'issue': '3', 'key': 'poi230045r41', 'doi-asserted-by': 'publisher', 'first-page': '767', 'DOI': '10.1016/j.jpeds.2014.11.030', 'article-title': 'No effect of proton pump inhibitors on crying and irritability in ' 'infants: systematic review of randomized controlled trials.', 'volume': '166', 'author': 'Gieruszczak-Bialek', 'year': '2015', 'journal-title': 'J Pediatr'}, { 'issue': '11', 'key': 'poi230045r42', 'doi-asserted-by': 'publisher', 'DOI': '10.1371/journal.pmed.1003429', 'article-title': 'Mode of birth and risk of infection-related hospitalisation in ' 'childhood: a population cohort study of 7.17 million births from 4 ' 'high-income countries.', 'volume': '17', 'author': 'Miller', 'year': '2020', 'journal-title': 'PLoS Med'}, { 'issue': '3', 'key': 'poi230045r43', 'doi-asserted-by': 'publisher', 'first-page': '449', 'DOI': '10.1007/s00228-019-02810-1', 'article-title': 'Use of proton pump inhibitors in adults in France: a nationwide drug ' 'utilization study.', 'volume': '76', 'author': 'Lassalle', 'year': '2020', 'journal-title': 'Eur J Clin Pharmacol'}], 'container-title': 'JAMA Pediatrics', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://jamanetwork.com/journals/jamapediatrics/articlepdf/2808367/jamapediatrics_lassalle_2023_oi_230045_1695847051.54709.pdf', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2023, 10, 2]], 'date-time': '2023-10-02T15:02:59Z', 'timestamp': 1696258979000}, 'score': 1, 'resource': {'primary': {'URL': 'https://jamanetwork.com/journals/jamapediatrics/fullarticle/2808367'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2023, 10, 1]]}, 'references-count': 43, 'journal-issue': {'issue': '10', 'published-print': {'date-parts': [[2023, 10, 1]]}}, 'URL': 'http://dx.doi.org/10.1001/jamapediatrics.2023.2900', 'relation': {}, 'ISSN': ['2168-6203'], 'subject': [], 'container-title-short': 'JAMA Pediatr', 'published': {'date-parts': [[2023, 10, 1]]}}
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