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KMID : 1011320200120010020
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Journal of Pharmacoepidemiology and Risk Management
2020 Volume.12 No. 1 p.20 ~ p.28
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Association of Statin Therapy with Risk of Peptic Ulcer Disease: A Nested Case-Control Study Using National Insurance Health Service Database
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Kim Ki-Jin
Jung Min-Ji
Lee Suk-Hyang
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Abstract
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Objective: Statins reduce cholesterol in patients with dyslipidemia. Statins also has been found to play a protective role
in bacterial infections such as peptic ulcer disease (PUD) with Helicobacter pylori. It is necessary to study to find out
whether statin use actually reduces PUD using a real world data. This study aimed to investigate the risk of PUD in
patients with and without statin.
Methods: We conducted a nested case-control study for PUD patients with dyslipidemia
using the National Health Insurance Service-National Sample Cohort (NHIS-NSC) data (2002-2013). The index date was
defined as the first diagnosis of PUD during the index period between 2010 and 2013. For each case of PUD, one
control of hyperlipidemia patient without PUD was selected by 1:1 random sampling according to sex and age. Crude
and adjusted odds ratio (aOR) associated with the risk of PUD were estimated using logistic regression models.
Results: Total 355,083 patients with dyslipidemia were extracted. For case-control groups, 8,968 (27.96%) of 32,077 patients
with PUD and 6,242 (20.75%) of 30,081 patients without PUD had taken statin. The crude odds ratio was 1.48 (95%
CI 1.43-1.54, p＜0.0001) and aOR was 1.45 (95% CI 1.40-1.51, p＜0.0001) for association of statin and PUD.
Conclusion: In this nested case-control study using the NHIS-NSC data, statins did not have effects on prevention of
PUD. With the possible selection bias and confounding factors in this study design using the claim database, odds of
PUD was increased by 45% with statin use in patients with dyslipidemia in Korea.
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KEYWORD
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Peptic ulcer disease (PUD), Statin, Nested case-control study, Real world data
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