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NSAIDs prescription use and subsequent risk of upper gastrointestinal bleeding: a time-trend analysis

A. Bedene1, E.L. van Dorp1, F.R. Rosendaal1, A. Dahan1, W.M. Lijfering1

1Leiden University Medical Center, Leiden, Netherlands

Abstract Number: PB0436

Meeting: ISTH 2021 Congress

Theme: Hemophilia and Rare Bleeding Disorders » Acquired Hemorrhagic Coagulation Disorders

Background: The prevalence of nonsteroidal anti-inflammatory drugs (NSAIDs) prescriptions has decreased since 2013 in the Netherlands following the advice of postoperative pain prescription guidelines.

Aims: We aimed to investigate whether the incidence of upper gastrointestinal bleeding—one of the adverse events of NSAIDs use— has decreased between 2013-2018 in a nation-wide population study.

Methods: We investigated individual patient data of 17 million residents of the Netherlands, from  national statistics on medication prescription, hospital admission and mortality between 2013 and 2018. The cumulative incidence of severe upper gastrointestinal bleeding (either fatal or requiring hospital admission) over two calendar years’ time was calculated and the relative risk of severe upper gastrointestinal bleeding was compared between 2018-2017, 2016-2015 and 2014-2013 (reference cohort). Demographic differences were adjusted with logistic regression.

Results: The cumulative incidence of severe upper gastrointestinal bleeding did not decrease throughout the study period (Table 1). A similar result was shown when the analysis was restricted to those who did not receive NSAIDs or antithrombotic agents prescription (age- and sex-adjusted odds ratio, 1.29 [95% CI, 1.26-1.32], comparing 2017-2018 with 2013-2014) (Table 1). In a post hoc analysis we observed that the risk of severe upper gastrointestinal bleeding was higher in men than in women in all age groups, except in the young, where women had a 1.5-1.9 fold higher risk than men (Figure 1). The latter suggests an over-the-counter of NSAIDs use, since their use is far more prevalent in young women than men due to alleviate menstrual pain.

Year No. Total No. Cumulative incidence, per
100,000 inhabitants (95% CI)
Odds ratio
 (95% CI)
Odds ratio
 (95% CI)*
Incident upper
gastrointestinal
bleeding
2013-2014 34071 17112982 199.09 (196.99-201.22) 1.00 (reference) 1.00 (reference)
2015-2016 42732 17269164 247.45 (245.11-249.80) 1.24 (1.23-1.26) 1.21 (1.20-1.23)
2017-2018 45516 17473459 260.49 (258.11-262.89) 1.31 (1.29-1.33) 1.25 (1.24-1.27)
Incident upper gastrointestinal bleeding
in those without prescription for NSAIDs 
2013-2014 23029 13018126 176.90 (174.63-179.20) 1.00 (reference) 1.00 (reference)
2015-2016 29562 13362796 221.23 (218.72-223.76) 1.25 (1.23-1.27) 1.21 (1.19-1.23)
2017-2018 32503 13737729 236.60 (234.04-239.18) 1.34 (1.32-1.36) 1.26 (1.24-1.28)
Incident upper gastrointestinal bleeding 
in those without either prescription for 
NSAIDs nor antithrombotic agents 
2013-2014

10837 11678227 92.80 (91.07-94.56) 1.00 (reference) 1.00 (reference)
2015-2016 14062 11935659 117.82 (115.88-119.78) 1.27 (1.24-1.30) 1.24 (1.21-1.27)
2017-2018 15338 12229473 125.42 (123.45-127.42) 1.35 (1.32-1.39) 1.29 (1.26-1.32)

Figure 1. An annual time-trend analysis of incident upper gastrointestinal bleeding in three different clinical scenarios stratified by age and sex, the Netherlands, from 2013 to 2018 Figure shows crude relative risk of women vs men of upper gastrointestinal bleeding per calendar year in four different scenarios: A) total population, B) individuals who did not receive a prescription for NSAIDs nor antithrombotic agents, C) individuals without competing risks, which was defined as having received a prescription for NSAIDs (ATC code: M01A), antithrombotic agents (B01A), anticancer medication (L01, L02), systemic corticosteroids (H02A, H02B), drugs for stomach-acid related disorders (A02A, A02B, A02X), antidepressants (N06A), antihypertensives (C02, C03, C07, C08, C09), antidiabetic medication (A10).defined as having received a prescription for NSAIDs (ATC code: M01A), antithrombotic agents (B01A), anticancer medication (L01, L02), systemic corticosteroids (H02A, H02B), drugs for stomach-acid related disorders (A02A, A02B, A02X), antidepressants (N06A), antihypertensives (C02, C03, C07, C08, C09), antidiabetic medication (A10).

Table 1. Risk of incident upper gastrointestinal bleeding, the Netherlands, cohorts 2013-2014, 2015-2016, and 2017-2018. Abbreviations: CI, confidence interval; NSAIDs, nonsteroidal anti-inflammatory drugs. All medications were identified through prescription reimbursement data, based on their ATC codes. Upper gastrointestinal bleeding cases were identified based on ICD-10CM codes in the hospital admission and death registry per two calendar years. *adjusted for: age (categorized), and sex

Conclusions: The decrease in the prevalence of NSAIDs prescriptions has not led to a decrease in the incidence of severe upper gastrointestinal bleeding.

To cite this abstract in AMA style:

Bedene A, van Dorp EL, Rosendaal FR, Dahan A, Lijfering WM. NSAIDs prescription use and subsequent risk of upper gastrointestinal bleeding: a time-trend analysis [abstract]. Res Pract Thromb Haemost. 2021; 5 (Suppl 2). https://abstracts.isth.org/abstract/nsaids-prescription-use-and-subsequent-risk-of-upper-gastrointestinal-bleeding-a-time-trend-analysis/. Accessed May 16, 2022.

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