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The purpose of this study is
A cohort study with a nested case control analysis on the association between acid-suppressing drugs and seizures using THIN database in the UK
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients newly prescribed PPI | All patients newly prescribed PPI |
| |
| All patients newly prescribed H2RA | All patients newly prescribed H2RA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risk of seizure | Drug | Patients newly prescribed PPI and H2RA, respectively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of seizure in the general population and stratified by epilepsy status. | Participants will be followed for the duration of the study period 1 January 2005-31 December 2011, an expected average of 3 years. | |
| Follow-up of safety outcomes: First recorded entry of seizure. | Participants will be followed for the duration of the study period 1 January 2005-31 December 2011, an expected average of 3 years. |
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Inclusion Criteria:
Exclusion Criteria:
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All individuals aged 20-84 years from 1 January 2005 to 31 December 2011, who have been enrolled with their primary care physician for at least 2 years and have a computerized prescription history of at least 1 year. Patients will have to be free of acid-suppressing drugs (PPI or H2RA) for at least one year, and never have a diagnosis of cancer, alcohol abuse or alcohol-related disease, or drug abuse.
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| Name | Affiliation | Role |
|---|---|---|
| Luis a Garcia Rodriguez, MD | CEIFE (Centro Espanol de Investigacion Farmacoepidemiologica - Spanish Centre for Pharmacoepidemiologic Research ) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Madrid | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27450309 | Background | Saez ME, Gonzalez-Perez A, Gaist D, Johansson S, Nagy P, Garcia Rodriguez LA. Risk of seizure associated with use of acid-suppressive drugs: An observational cohort study. Epilepsy Behav. 2016 Sep;62:72-80. doi: 10.1016/j.yebeh.2016.06.039. Epub 2016 Jul 21. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Study Report Synopsis | Study Protocol | View IPD |
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| ID | Term |
|---|---|
| D012640 | Seizures |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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D9612N00017_Seizure_Study_report_synopsis_FINAL_redacted |