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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
| University of Pennsylvania | OTHER |
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The purpose of this study is to compare the incidence of hospitalization with acute liver failure among patients with type 2 diabetes who are new users of Saxagliptin and those who are new users of other oral antidiabetic drugs.
Prospectively designed retrospective database study. This study will be conducted using administrative claims data and electronic medical records that are collected as part of routine clinical practice
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients exposed to Saxagliptin | |||
| Patients exposed to oral antidiabetic drugs (not Saxagliptin) |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants hospitalized with a diagnosis of acute liver failure | 18-months | |
| Number of participants hospitalized with a diagnosis of acute liver failure | 36-months | |
| Number of participants hospitalized with a diagnosis of acute liver failure | 54-months |
| Measure | Description | Time Frame |
|---|---|---|
| Deaths due to acute liver failure | 18, 36 and 54 months | |
| Hospitalizations with acute liver failure and/or death due to acute liver failure | 18, 36 and 54 months | |
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Inclusion Criteria:
Exclusion Criteria:
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This study will be carried out using databases containing administrative claims data (HealthCore Integrated Research DatabaseSM (HIRD) and Medicare in the U.S.) and electronic medical records (General Practice Research Database (GPRD) and The Health Improvement Network (THIN) in the UK). The US population includes patients from health plans in the northeast, southeastern, mid-Atlantic, central, mid-western, and western regions (HIRD) as well as US citizens 65 years of age and older (Medicare). The UK population includes patients seeking medical care from general practitioners (GPRD and THIN)
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28878934 | Derived | Lo Re V, Carbonari DM, Saine ME, Newcomb CW, Roy JA, Liu Q, Wu Q, Cardillo S, Haynes K, Kimmel SE, Reese PP, Margolis DJ, Apter AJ, Reddy KR, Hennessy S, Bhullar H, Gallagher AM, Esposito DB, Strom BL. Postauthorization safety study of the DPP-4 inhibitor saxagliptin: a large-scale multinational family of cohort studies of five outcomes. BMJ Open Diabetes Res Care. 2017 Jul 31;5(1):e000400. doi: 10.1136/bmjdrc-2017-000400. eCollection 2017. | |
| 25889498 |
| Label | URL |
|---|---|
| CSR Synopsis | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Hospitalizations with acute liver injury |
| 18, 36 and 54 months |
| Derived |
| Saine ME, Carbonari DM, Newcomb CW, Nezamzadeh MS, Haynes K, Roy JA, Cardillo S, Hennessy S, Holick CN, Esposito DB, Gallagher AM, Bhullar H, Strom BL, Lo Re V 3rd. Determinants of saxagliptin use among patients with type 2 diabetes mellitus treated with oral anti-diabetic drugs. BMC Pharmacol Toxicol. 2015 Apr 2;16:8. doi: 10.1186/s40360-015-0007-z. |
| D004700 | Endocrine System Diseases |