Effect of Dipeptidyl-4 Inhibitors in Reducing Stroke Severity, From HIRA Database

Study Overview
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Brief Summary
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The goal of this observational study is to compare severity and mortality rates of acute cerebral infarction(requiring thrombolysis or endovascular recanalization) depending on the type of oral antidiabetic drug taken before the onset of cerebral infarction. Researchers will compare the group that used DPP-4 inhibitors as anti-diabetic drugs before cerebral infarction and the group that did not use them to see the effect of DPP-4 inhibitors in reducing severity of cerebral infarction.

Detailed Description
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This is a retrospective study to see the effects of reducing the severity of cerebral infarction(requiring thrombolysis or endovascular recanalization) of DPP-4 inhibitors by comparing the survival rate after acute cerebral infarction hospitalization, discharge rate to home, and medical cost. A. Severity of cerebral infarction and poor prognosis is mainly associated with hyperglycemia caused by diabetes, which increases the Infarction volume and hemorrhagic trasformation. B. However, the effect of loergin blood glucose on reducing the Infarction volume and improving prognosis of cerebral infarction has not been proven. C. Preclinical studies have demonstrated a anti-stroke effect that reduces the Infarction volume using certain anti-diabetic drugs. D. Therefore, there is a possibility that certain anti-diabetic drugs may reduce the severity of cerebral infarction as a class effect in addition to the effect of blood sugar control. E. This is particularly likely to exist in the DPP-4 inhibitor family identified through preclinical studies.

Official Title
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Effect of Dipeptidyl-4 Inhibitors in Reducing Stroke Severity, From the Health Insurance Review and Assessment Service Database

Conditions
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Cerebral Infarction, Infarction, Brain, Dipeptidyl-Peptidase IV Inhibitors

Intervention / Treatment
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* Drug: Dipeptidyl peptidase-4 inhibitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with acute cerebral infarction who underwent thrombolysis or endovascular recanalization in Korea between 2014 and 2021 Those who have been previously diagnosed with diabetes and are taking oral anti-diabetic drugs Adult (over 19 years of age) The definition of antidiabetic drug use is defined as a case in which an antidiabetic drug was prescribed for at least 2 months before stroke and the duration of treatment for stroke coincided with the prescribed duration of the drug. Exclusion Criteria: Patients taking insulin to control diabetes

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DPP4i<br>used DPP-4 inhibitors as anti-diabetic drugs before cerebral infarction(requiring thrombolysis or endovascular recanalization) Combination therpay is acceptable. | Drug: Dipeptidyl peptidase-4 inhibitor<br>* The definition of antidiabetic drug use is defined as a case in which an antidiabetic drug was prescribed for at least 2 months before stroke and the duration of treatment for stroke coincided with the prescribed duration of the drug.<br>* Other names: Suganon Tab;|
| except DPP4i<br>patients that did not use DPP-4 inhibitors as anti-diabetic drugs before cerebral infarction(requiring thrombolysis or endovascular recanalization) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year survival rate | The survival rates of the DPP-4 inhibitor group and the non-use group are compared 1 year after the onset of severe stroke. | Check the data one year after the onset of stroke. | 
| 90-day survival rate | The survival rates of the DPP-4 inhibitor group and the non-use group are compared 90-day after the onset of severe stroke. | Check the data 90-day after the onset of stroke. | 
| re-hospitalization | The re-hospitalization rates of the DPP-4 inhibitor group and the non-use group are compared after the onset of severe stroke. | 1 year after discharge the stroke treatment. | 
| frequency of cerebral hemorrhage | The frequency of cerebral hemorrhage rates of the DPP-4 inhibitor group and the non-use group are compared after the onset of severe stroke. | Hospitalization period and 1 year after discharge the stroke treatment. | 
| Rate of Intensive care unit treatment | The Intensive care unit treatment rate of the DPP-4 inhibitor group and the non-use group are compared. | Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke. | 
| Duration of Intensive care unit | The duration of Intensive care unit of the DPP-4 inhibitor group and the non-use group are compared. | Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke. | 
| Rate of Stroke care unit treatment | The Stroke care unit treatment rate of the DPP-4 inhibitor group and the non-use group are compared. | Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke. | 
| Duration of Stroke care unit | The duration of Stroke care unit of the DPP-4 inhibitor group and the non-use group are compared. | Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke. | 
| tracheal intubation period | The tracheal intubation period of the DPP-4 inhibitor group and the non-use group are compared. | Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke. | 
| total hospitalization days | The total hospitalization days of the DPP-4 inhibitor group and the non-use group are compared. | Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke. | 
| medical expenses incurred at the time of hospitalization | The medical expenses incurred at the time of hospitalization of the DPP-4 inhibitor group and the non-use group are compared. | Hospitalization period is expected to be up to three months. It is not possible to accurately estimate the period of hospitalization due to severe stroke. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Home discharge rate | The Home discharge rate of the DPP-4 inhibitor group and the non-use group are compared. | At the end of discharge from stroke treatment. | 
| medical expenses after discharge from hospital | The medical expenses after discharge from hospital of the DPP-4 inhibitor group and the non-use group are compared. | 1 year after discharge the stroke treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dipeptidyl-Peptidase IV Inhibitors, Antidiabetic Drug