Metabolic Outcomes in Patients Receiving Tyrosine Kinase Inhibitor (TKI) Therapy With Dasatinib or Nilotinib

Study Overview
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Brief Summary
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The purpose of this study was to determine how often and how likely patients are to develop Type 2 Diabetes or high cholesterol/lipids when receiving dasatinib or nilotinib as therapy for Chronic Myelogenous Leukemia (CML).

Official Title
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Assessment of Metabolic Outcomes Among Patients With Chronic Myelogenous Leukemia (CML) Initiating Therapy With a Tyrosine Kinase Inhibitor (TKI)

Conditions
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Chronic Myeloid Leukemia (CML)

Intervention / Treatment
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* Drug: dasatinib
* Drug: nilotinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older At least 1 prescription for nilotinib or dasatinib between 7/1/2006-12/31/2014 Continuously enrolled in the same health plan throughout the study period At least 2 diagnosis codes for CML at least 30 days apart as documented in medical insurance claims Exclusion Criteria: patients who had a documented diagnosis of diabetes in their medical claims or received a medication for diabetes before receiving dasatinib or nilotinib patients who had a documented diagnosis of high cholesterol/lipids in their medical claims or received a medication for high cholesterol/lipids before receiving dasatinib or nilotinib

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| dasatinib cohort<br>Patients with CML receiving dasatinib | Drug: dasatinib<br> <br> |
| nilotinib cohort<br>Patients with CML receiving nilotinib | Drug: nilotinib<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence rate of new-onset Type 2 Diabetes (T2DM) among patients with Chronic myelogenous leukemia (CML) receiving imatinib as first-line therapy in a commercially or Medicare insured population |  | approximately 101 months | 
| incidence rate of new-onset Type 2 Diabetes (T2DM) among patients with Chronic myelogenous leukemia (CML) receiving dasatinib as first-line therapy in a commercially or Medicare insured population |  | approximately 101 months | 
| incidence rate of new-onset Type 2 Diabetes (T2DM) among patients with Chronic myelogenous leukemia (CML) receiving nilotinib as first-line therapy in a commercially or Medicare insured population |  | approximately 101 months | 
| incidence rate of new-onset Hyperlipidemia (HLD) among patients with Chronic myelogenous leukemia (CML) receiving imatinib as first-line therapy in a commercially or Medicare insured population |  | approximately 101 months | 
| incidence rate of new-onset Hyperlipidemia (HLD) among patients with Chronic myelogenous leukemia (CML) receiving dasatinib as first-line therapy in a commercially or Medicare insured population |  | approximately 101 months | 
| incidence rate of new-onset Hyperlipidemia (HLD) among patients with Chronic myelogenous leukemia (CML) receiving nilotinib as first-line therapy in a commercially or Medicare insured population |  | approximately 101 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence rate of new-onset Type 2 Diabetes (T2DM) among patients with Chronic myelogenous leukemia (CML) receiving dasatinib as first- or second-line therapy in a commercially or Medicare insured population |  | approximately 101 months | 
| incidence rate of new-onset Type 2 Diabetes (T2DM) among patients with Chronic myelogenous leukemia (CML) receiving nilotinib as first- or second-line therapy in a commercially or Medicare insured population |  | approximately 101 months | 
| incidence rate of new-onset Hyperlipidemia (HLD) among patients with Chronic myelogenous leukemia (CML) receiving dasatinib as first- or second-line therapy in a commercially or Medicare insured population |  | approximately 101 months | 
| incidence rate of new-onset Hyperlipidemia (HLD) among patients with Chronic myelogenous leukemia (CML) receiving nilotinib as first- or second-line therapy in a commercially or Medicare insured population |  | approximately 101 months | 
| risk comparison of developing Type 2 Diabetes (T2DM) among patients treated with imatinib with respect to patients treated with dasatinib as first-line therapy and as first- or second-line therapy |  | approximately 101 months | 
| risk comparison of developing Type 2 Diabetes (T2DM) among patients treated with nilotinib with respect to patients treated with dasatinib as first-line therapy and as first- or second-line therapy |  | approximately 101 months | 
| risk comparison of developing Hyperlipidemia (HLD) among patients treated with imatinib with respect to patients treated with dasatinib as first-line therapy and as first- or second-line therapy |  | approximately 101 months | 
| risk comparison of developing Hyperlipidemia (HLD) among patients treated with nilotinib with respect to patients treated with dasatinib as first-line therapy and as first- or second-line therapy |  | approximately 101 months |