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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 hospitalization for severe hypersensitivity and cutaneous reactions 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 |
|---|---|---|
| Hospitalizations with any hypersensitivity reaction, including anaphylaxis, angioedema, generalized urticaria, SJS, TEN, and other severe skin reactions (i.e., acute generalized exanthematous pustulosis and drug rash with eosinophilia/systemic symptoms) | 12-months | |
| Hospitalizations with any hypersensitivity reaction, including anaphylaxis, angioedema, generalized urticaria, SJS, TEN, and other severe skin reactions (i.e., acute generalized exanthematous pustulosis and drug rash with eosinophilia/systemic symptoms) | 18-months | |
| Hospitalizations with any hypersensitivity reaction, including anaphylaxis, angioedema, generalized urticaria, SJS, TEN, and other severe skin reactions (i.e., acute generalized exanthematous pustulosis and drug rash with eosinophilia/systemic symptoms) | 36-months | |
| Hospitalizations with any hypersensitivity reaction, including anaphylaxis, angioedema, generalized urticaria, SJS, TEN, and other severe skin reactions (i.e., acute generalized exanthematous pustulosis and drug rash with eosinophilia/systemic symptoms) | 54-months |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalized for anaphylaxis | 12-months | |
| Hospitalized for anaphylaxis | 18-months | |
| Hospitalized for anaphylaxis |
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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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| 36-months |
| Hospitalized for anaphylaxis | 54-months |
| Hospitalized for angioedema | 12-months |
| Hospitalized for angioedema | 18-months |
| Hospitalized for angioedema | 36-months |
| Hospitalized for angioedema | 54-months |
| Hospitalized for generalized urticaria | 12-months |
| Hospitalized for generalized urticaria | 18-months |
| Hospitalized for generalized urticaria | 36-months |
| Hospitalized for generalized urticaria | 54-months |
| Hospitalized for severe skin reactions | 12-months |
| Hospitalized for severe skin reactions | 18-months |
| Hospitalized for severe skin reactions | 36-months |
| Hospitalized for severe skin reactions | 54-months |
| Hospitalized for all endpoints | 12-months |
| Hospitalized for all endpoints | 18-months |
| Hospitalized for all endpoints | 36-months |
| Hospitalized for all endpoints | 54-months |
| Hospitalized/emergency room (ER) visits for hypersensitivity reactions | 12-months |
| Hospitalized/emergency room (ER) visits for hypersensitivity reactions | 18-months |
| Hospitalized/emergency room (ER) visits for hypersensitivity reactions | 36-months |
| Hospitalized/emergency room (ER) visits for hypersensitivity reactions | 54-months |
| Death from hypersensitivity reactions | 12-months |
| Death from hypersensitivity reactions | 18-months |
| Death from hypersensitivity reactions | 36-months |
| Death from hypersensitivity reactions | 54-months |
| Hospitalized for Stevens-Johnson syndrome (SJS) | 12-months |
| Hospitalized for Stevens-Johnson syndrome (SJS) | 18-months |
| Hospitalized for Stevens-Johnson syndrome (SJS) | 36-months |
| Hospitalized for Stevens-Johnson syndrome (SJS) | 54-months |
| Hospitalized for for toxic epidermal necrolysis (TEN) | 12-months |
| Hospitalized for for toxic epidermal necrolysis (TEN) | 18-months |
| Hospitalized for for toxic epidermal necrolysis (TEN) | 36-months |
| Hospitalized for for toxic epidermal necrolysis (TEN) | 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 |