Proton pump inhibitors for infants in three Scandinavian countries increased from 2007 to 2020 despite international recommendations

Lyamouri, Miriam; Mårild, Karl; Nielsen, Rasmus Gaardskær; Størdal, Ketil

doi:10.1111/apa.16491

Cited by 8 publications

(9 citation statements)

References 28 publications

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“…The use of PPIs in infants (<1 year) is in general not recommended by the international guidelines ( 4 , 8 ), and not approved for use before 1 year in the Scandinavian countries and European Union ( 13 – 16 ). For those reasons, infant PPI use was not examined in this study, but dealt with in another separate study ( 17 ).…”

Section: Methodsmentioning

confidence: 99%

Use of proton pump inhibitors in scandinavian children and adolescents: An observational study

Closs

Mårild²,

Nielsen³

et al. 2023

Front. Pediatr.

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AimsTo examine the use of proton pump inhibitors (PPIs) in Scandinavian children with focus on the geographical variation, temporal changes and possible contributing factors to observed changes.MethodsAn observational population-based study of children and adolescents (1-17 years) in Norway, Sweden, and Denmark during the period 2007-2020. Information concerning dispensed PPIs was obtained from the national prescription databases of each country and presented as means per 1,000 children for each country and calendar year in four age categories (1-4, 5-9, 10-13 and 14-17 years).ResultsIn 2007, the PPI use in children was similar across Scandinavian countries. An increased PPI use was observed in all countries during the study period, with gradually increasing differences between the countries. In general, Norway showed both the largest total increase and the largest increase in each age category compared to Sweden and Denmark. In 2020 Norwegian children showed, on average, a 59% higher PPI use compared to Swedish children and a more than double the overall dispensation rate than Denmark. In Denmark there was a 19% reduction in dispensed PPIs from 2015 to 2020.ConclusionDespite being countries with similar health care systems and without indications of increased incidence of gastroesophageal reflux disease (GERD), we observed considerable geographical variation and temporal changes of PPI use in children. Although this study did not contain data on the indication for PPI use, these large differences across countries and time may indicate a current overtreatment.

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Section: Methodsmentioning

confidence: 99%

Use of proton pump inhibitors in scandinavian children and adolescents: An observational study

Closs

Mårild²,

Nielsen³

et al. 2023

Front. Pediatr.

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“…Following the results of the principal component analysis performed during the validation study, some answers have been grouped in four topics, namely behavior and communication (items no. 3,5,8,13,16,18,21,22,24,32,33), ability to remain alone (items no. 7, 10, 15,17,23), family environment (items no.…”

Section: Data and Statistical Analysismentioning

confidence: 99%

“…Together, this leads to numerous changes in infant formula, the use of over-thecounter medications, an over-prescription of drugs despite recommendations regarding their uselessness, and therefore an increase in healthcare costs (13,15,18). In particular, despite their lack of efficacy in this indication, proton pump inhibitors are increasingly used in infants presenting with unexplained regurgitation or crying, restlessness and irritability that define colic (19)(20)(21)(22).…”

Section: Introductionmentioning

confidence: 99%

Effectiveness of a starch thickened infant formula with reduced lactose content, probiotics and prebiotics on quality of life and clinical outcome in infants with regurgitation and/or colic

et al. 2023

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BackgroundRegurgitation and colic are quite common in young infants, leading to a reduced quality of life (QoL) and to parental distress. Their management is challenging and aims to effectively reassure and relieve symptoms. This study aimed to assess the effectiveness over 30 days of a starch thickened formula with a reduced lactose content, Limosilactobacillus reuteri (Lactobacillus reuteri) DSM 17938 and FOS/GOS.MethodsA real-world prospective multicenter experimental study was conducted in a before-after design within subject. Full term infants 0−5 months with regurgitation or colic or both symptoms and without intercurrent illness were included after parental informed consent and received the studied formula. The primary endpoint was the improvement in QoL using the QUALIN infant’s questionnaire. Secondary endpoints were the symptoms outcome and the formula tolerance.ResultsOf the 101 infants included (age: 6.2 ± 4.3 weeks), 33 had regurgitation, 34 colic and 34 had both. At D30, the QoL score was improved in 75% of infants in per protocol analysis (n = 68; +8.2 ± 13.7; p < 0.001), more in those with colic or both symptoms. Meanwhile, in intention to treat analysis (all p < 0.001), the daily number of regurgitations decreased by 61% and the weekly number of days with colic by 63% while the daily cumulative duration of crying decreased by 82 ± 106 mn. These improvements were observed within the first week by 89 and 76% of parents, respectively.ConclusionThe study formula associated with reassurance is shown to be quickly effective in the management of infant’s regurgitation or/and colic in routine clinical practice.Clinical trial registrationhttps://clinicaltrials.gov/, identifier NCT04462640.

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“…In France, 6.1% of children younger than 2 years used PPIs in 2019, up from 3.6% in 2010 . In the first year of life, prevalence of PPI use increased from 2.4% to 5.2% between 2005 and 2012 in New Zealand, while prescription rates were 1.9% in Sweden, 2.3% in Norway, and 4.6% in Denmark in 2020, a 3- to 5-fold increase since 2000 …”

Section: Introductionmentioning

confidence: 99%

“…4 In the first year of life, prevalence of PPI use increased from 2.4% to 5.2% between 2005 and 2012 in New Zealand, 5 while prescription rates were 1.9% in Sweden, 2.3% in Norway, and 4.6% in Denmark in 2020, a 3-to 5-fold increase since 2000. 6,7 PPI use has been associated with bone fractures, 8 acute kidney injury, 9 allergy, 10 asthma, 11 and inflammatory bowel diseases 12 in children. They are also suspected of leading to infections 13 through pH modification or direct action on the immune system.…”

mentioning

confidence: 99%

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

Lassalle¹,

Zureik

Dray‐Spira³

2023

JAMA Pediatr

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ImportanceProton 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.ObjectiveTo assess the associations between PPI use and serious infections in children, overall and by infection site and pathogen.Design, Setting, and ParticipantsThis 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.ExposurePPI exposure over time.Main Outcomes and MeasuresAssociations 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.ResultsThe 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 RelevanceIn 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.

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Proton pump inhibitors for infants in three Scandinavian countries increased from 2007 to 2020 despite international recommendations

Cited by 8 publications

References 28 publications

Use of proton pump inhibitors in scandinavian children and adolescents: An observational study

Use of proton pump inhibitors in scandinavian children and adolescents: An observational study

Effectiveness of a starch thickened infant formula with reduced lactose content, probiotics and prebiotics on quality of life and clinical outcome in infants with regurgitation and/or colic

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

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