Effect of on-demand vs continuous prescription of proton pump inhibitors on symptom burden and quality of life: results of a real-world randomized controlled trial in primary care patients with gastroesophageal reflux disease

Anna Andreasson; Lars Agréus; Nikolaos Mastellos; Grzegorz Bliźniuk; Dorota Waśko-Czopnik; Agapi Angelaki; Eirini Theodosaki; Christos Lionis; Karin Hek; Robert Verheij; Ellen Wright; Stevo Durbaba; Jean Muris; Piotr Bródka; Stanislaw Saganowski; Jean-Francois Ethiér; Vasa Curcin; Brendan Delaney

doi:10.1080/07853890.2024.2354683

Effect of on-demand vs continuous prescription of proton pump inhibitors on symptom burden and quality of life: results of a real-world randomized controlled trial in primary care patients with gastroesophageal reflux disease

Anna Andreasson^*, Lars Agréus, Nikolaos Mastellos, Grzegorz Bliźniuk, Dorota Waśko-Czopnik, Agapi Angelaki, Eirini Theodosaki, Christos Lionis, Karin Hek, Robert Verheij, Ellen Wright, Stevo Durbaba, Jean Muris, Piotr Bródka, Stanislaw Saganowski, Jean-Francois Ethiér, Vasa Curcin, Brendan Delaney

^*Corresponding author for this work

School of Psychological Sciences

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Abstract

Objectives: This study aimed to assess the impact of on-demand versus continuous prescribing of proton pump inhibitors (PPIs) on symptom burden and health-related quality of life in patients with gastroesophageal reflux disease (GERD) presenting to primary care. Methods: Thirty-six primary care centres across Europe enrolled adult GERD patients from electronic health records. Participants were randomised to on-demand or continuous PPI prescriptions and were followed for 8 weeks. PPI intake, symptom burden, and quality of life were compared between the two groups using mixed-effect regression analyses. Spearman’s correlation was used to assess the association between changes in PPI dose and patient-reported outcomes. Results: A total of 488 patients (median age 51 years, 58% women) completed the initial visit, with 360 attending the follow-up visit. There was no significant difference in PPI use between the continuous and on-demand prescription groups (b=.57, 95%CI:0.40-1.53), although PPI use increased in both groups (b = 1.33, 95%CI:0.65 − 2.01). Advice on prescribing strategy did not significantly affect patient-reported outcomes. Both symptom burden (Reflux Disease Questionnaire, b=-0.61, 95%CI:-0.73 − -0.49) and quality of life (12-item Short Form Survey physical score b = 3.31, 95%CI:2.17 − 4.45) improved from baseline to follow-up in both groups. Increased PPI intake correlated with reduced reflux symptoms (n = 347, ρ=-0.12, p = 0.02) and improved quality of life (n = 217, ρ = 0.16, p = 0.02). Conclusion: In real-world settings, both continuous and on-demand PPI prescriptions resulted in similar increases in PPI consumption with no difference in treatment effects. Achieving an adequate PPI dose to alleviate reflux symptom burden improves quality of life in GERD patients. EudraCT number 2014-001314-25.

Original language	English
Article number	2354683
Pages (from-to)	1-9
Number of pages	9
Journal	Annals of Medicine
Volume	56
Issue number	1
DOIs	https://doi.org/10.1080/07853890.2024.2354683
Publication status	Published - Dec 2024

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Copyright the Author(s) 2024. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

Keywords

continuous use
gastroesophageal reflux disease
on-demand use
proton pump inhibitors
quality of life
randomized controlled trial
self-rated health

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Andreasson, A., Agréus, L., Mastellos, N., Bliźniuk, G., Waśko-Czopnik, D., Angelaki, A., Theodosaki, E., Lionis, C., Hek, K., Verheij, R., Wright, E., Durbaba, S., Muris, J., Bródka, P., Saganowski, S., Ethiér, J.-F., Curcin, V., & Delaney, B. (2024). Effect of on-demand vs continuous prescription of proton pump inhibitors on symptom burden and quality of life: results of a real-world randomized controlled trial in primary care patients with gastroesophageal reflux disease. Annals of Medicine, 56(1), 1-9. Article 2354683. https://doi.org/10.1080/07853890.2024.2354683

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title = "Effect of on-demand vs continuous prescription of proton pump inhibitors on symptom burden and quality of life: results of a real-world randomized controlled trial in primary care patients with gastroesophageal reflux disease",

abstract = "Objectives: This study aimed to assess the impact of on-demand versus continuous prescribing of proton pump inhibitors (PPIs) on symptom burden and health-related quality of life in patients with gastroesophageal reflux disease (GERD) presenting to primary care. Methods: Thirty-six primary care centres across Europe enrolled adult GERD patients from electronic health records. Participants were randomised to on-demand or continuous PPI prescriptions and were followed for 8 weeks. PPI intake, symptom burden, and quality of life were compared between the two groups using mixed-effect regression analyses. Spearman{\textquoteright}s correlation was used to assess the association between changes in PPI dose and patient-reported outcomes. Results: A total of 488 patients (median age 51 years, 58\% women) completed the initial visit, with 360 attending the follow-up visit. There was no significant difference in PPI use between the continuous and on-demand prescription groups (b=.57, 95\%CI:0.40-1.53), although PPI use increased in both groups (b = 1.33, 95\%CI:0.65 − 2.01). Advice on prescribing strategy did not significantly affect patient-reported outcomes. Both symptom burden (Reflux Disease Questionnaire, b=-0.61, 95\%CI:-0.73 − -0.49) and quality of life (12-item Short Form Survey physical score b = 3.31, 95\%CI:2.17 − 4.45) improved from baseline to follow-up in both groups. Increased PPI intake correlated with reduced reflux symptoms (n = 347, ρ=-0.12, p = 0.02) and improved quality of life (n = 217, ρ = 0.16, p = 0.02). Conclusion: In real-world settings, both continuous and on-demand PPI prescriptions resulted in similar increases in PPI consumption with no difference in treatment effects. Achieving an adequate PPI dose to alleviate reflux symptom burden improves quality of life in GERD patients. EudraCT number 2014-001314-25.",

keywords = "continuous use, gastroesophageal reflux disease, on-demand use, proton pump inhibitors, quality of life, randomized controlled trial, self-rated health",

author = "Anna Andreasson and Lars Agr{\'e}us and Nikolaos Mastellos and Grzegorz Bli{\'z}niuk and Dorota Wa{\'s}ko-Czopnik and Agapi Angelaki and Eirini Theodosaki and Christos Lionis and Karin Hek and Robert Verheij and Ellen Wright and Stevo Durbaba and Jean Muris and Piotr Br{\'o}dka and Stanislaw Saganowski and Jean-Francois Ethi{\'e}r and Vasa Curcin and Brendan Delaney",

note = "Copyright the Author(s) 2024. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.",

year = "2024",

month = dec,

doi = "10.1080/07853890.2024.2354683",

language = "English",

volume = "56",

pages = "1--9",

journal = "Annals of Medicine",

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Andreasson, A, Agréus, L, Mastellos, N, Bliźniuk, G, Waśko-Czopnik, D, Angelaki, A, Theodosaki, E, Lionis, C, Hek, K, Verheij, R, Wright, E, Durbaba, S, Muris, J, Bródka, P, Saganowski, S, Ethiér, J-F, Curcin, V & Delaney, B 2024, 'Effect of on-demand vs continuous prescription of proton pump inhibitors on symptom burden and quality of life: results of a real-world randomized controlled trial in primary care patients with gastroesophageal reflux disease', Annals of Medicine, vol. 56, no. 1, 2354683, pp. 1-9. https://doi.org/10.1080/07853890.2024.2354683

Effect of on-demand vs continuous prescription of proton pump inhibitors on symptom burden and quality of life: results of a real-world randomized controlled trial in primary care patients with gastroesophageal reflux disease. / Andreasson, Anna; Agréus, Lars; Mastellos, Nikolaos et al.
In: Annals of Medicine, Vol. 56, No. 1, 2354683, 12.2024, p. 1-9.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Effect of on-demand vs continuous prescription of proton pump inhibitors on symptom burden and quality of life

T2 - results of a real-world randomized controlled trial in primary care patients with gastroesophageal reflux disease

AU - Andreasson, Anna

AU - Agréus, Lars

AU - Mastellos, Nikolaos

AU - Bliźniuk, Grzegorz

AU - Waśko-Czopnik, Dorota

AU - Angelaki, Agapi

AU - Theodosaki, Eirini

AU - Lionis, Christos

AU - Hek, Karin

AU - Verheij, Robert

AU - Wright, Ellen

AU - Durbaba, Stevo

AU - Muris, Jean

AU - Bródka, Piotr

AU - Saganowski, Stanislaw

AU - Ethiér, Jean-Francois

AU - Curcin, Vasa

AU - Delaney, Brendan

N1 - Copyright the Author(s) 2024. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

PY - 2024/12

Y1 - 2024/12

N2 - Objectives: This study aimed to assess the impact of on-demand versus continuous prescribing of proton pump inhibitors (PPIs) on symptom burden and health-related quality of life in patients with gastroesophageal reflux disease (GERD) presenting to primary care. Methods: Thirty-six primary care centres across Europe enrolled adult GERD patients from electronic health records. Participants were randomised to on-demand or continuous PPI prescriptions and were followed for 8 weeks. PPI intake, symptom burden, and quality of life were compared between the two groups using mixed-effect regression analyses. Spearman’s correlation was used to assess the association between changes in PPI dose and patient-reported outcomes. Results: A total of 488 patients (median age 51 years, 58% women) completed the initial visit, with 360 attending the follow-up visit. There was no significant difference in PPI use between the continuous and on-demand prescription groups (b=.57, 95%CI:0.40-1.53), although PPI use increased in both groups (b = 1.33, 95%CI:0.65 − 2.01). Advice on prescribing strategy did not significantly affect patient-reported outcomes. Both symptom burden (Reflux Disease Questionnaire, b=-0.61, 95%CI:-0.73 − -0.49) and quality of life (12-item Short Form Survey physical score b = 3.31, 95%CI:2.17 − 4.45) improved from baseline to follow-up in both groups. Increased PPI intake correlated with reduced reflux symptoms (n = 347, ρ=-0.12, p = 0.02) and improved quality of life (n = 217, ρ = 0.16, p = 0.02). Conclusion: In real-world settings, both continuous and on-demand PPI prescriptions resulted in similar increases in PPI consumption with no difference in treatment effects. Achieving an adequate PPI dose to alleviate reflux symptom burden improves quality of life in GERD patients. EudraCT number 2014-001314-25.

AB - Objectives: This study aimed to assess the impact of on-demand versus continuous prescribing of proton pump inhibitors (PPIs) on symptom burden and health-related quality of life in patients with gastroesophageal reflux disease (GERD) presenting to primary care. Methods: Thirty-six primary care centres across Europe enrolled adult GERD patients from electronic health records. Participants were randomised to on-demand or continuous PPI prescriptions and were followed for 8 weeks. PPI intake, symptom burden, and quality of life were compared between the two groups using mixed-effect regression analyses. Spearman’s correlation was used to assess the association between changes in PPI dose and patient-reported outcomes. Results: A total of 488 patients (median age 51 years, 58% women) completed the initial visit, with 360 attending the follow-up visit. There was no significant difference in PPI use between the continuous and on-demand prescription groups (b=.57, 95%CI:0.40-1.53), although PPI use increased in both groups (b = 1.33, 95%CI:0.65 − 2.01). Advice on prescribing strategy did not significantly affect patient-reported outcomes. Both symptom burden (Reflux Disease Questionnaire, b=-0.61, 95%CI:-0.73 − -0.49) and quality of life (12-item Short Form Survey physical score b = 3.31, 95%CI:2.17 − 4.45) improved from baseline to follow-up in both groups. Increased PPI intake correlated with reduced reflux symptoms (n = 347, ρ=-0.12, p = 0.02) and improved quality of life (n = 217, ρ = 0.16, p = 0.02). Conclusion: In real-world settings, both continuous and on-demand PPI prescriptions resulted in similar increases in PPI consumption with no difference in treatment effects. Achieving an adequate PPI dose to alleviate reflux symptom burden improves quality of life in GERD patients. EudraCT number 2014-001314-25.

KW - continuous use

KW - gastroesophageal reflux disease

KW - on-demand use

KW - proton pump inhibitors

KW - quality of life

KW - randomized controlled trial

KW - self-rated health

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Andreasson A, Agréus L, Mastellos N, Bliźniuk G, Waśko-Czopnik D, Angelaki A et al. Effect of on-demand vs continuous prescription of proton pump inhibitors on symptom burden and quality of life: results of a real-world randomized controlled trial in primary care patients with gastroesophageal reflux disease. Annals of Medicine. 2024 Dec;56(1):1-9. 2354683. doi: 10.1080/07853890.2024.2354683

Effect of on-demand vs continuous prescription of proton pump inhibitors on symptom burden and quality of life: results of a real-world randomized controlled trial in primary care patients with gastroesophageal reflux disease

Abstract

Bibliographical note

Keywords

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