Metabolic Outcomes in Patients Receiving Tyrosine Kinase Inhibitor (TKI) Therapy With Dasatinib or Nilotinib
- Registration Number
- NCT02733445
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2650
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description dasatinib cohort dasatinib Patients with CML receiving dasatinib nilotinib cohort nilotinib Patients with CML receiving nilotinib
- Primary Outcome Measures
Name Time Method 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 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
- Secondary Outcome Measures
Name Time Method 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 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 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 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 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