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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Chronic Myeloid Leukemia (CML)

Treatments: Drug: nilotinib; Drug: dasatinib

Study type: Observational

Funder types: Industry

Identifiers

NCT02733445

CA180-633

Details and patient eligibility

About

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).

Enrollment: 2,650 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2,650 participants in 2 patient groups

dasatinib cohort

Description:

Patients with CML receiving dasatinib

Treatment:

Drug: dasatinib

nilotinib cohort

Description:

Patients with CML receiving nilotinib

Treatment:

Drug: nilotinib