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Kidney Cancer Journal 45 and sunitinib. A comparator group allowed for descriptive evaluation of three other drugs in the anti-VEGF class in order to place the pazopanib-specific results in context. Patients and Methods A descriptive, retrospective cohort study was conducted using two de-identified data sources: a US healthcare claims database, the Clinformatics™ DataMart Multiplan (IMPACT), a product of OptumInsight Life Sciences Inc., and the PHARMO Database Network in The Netherlands. The IMPACT system is a comprehensive, de-identified inpatient and outpatient health insurance claims database with more than 107 million non-elderly, insurance-carrying patients participating in 46 different healthcare plans, serving members across nine census regions in the US. The PHARMO Database Network is a populationbased medical record tracking system covering 65 municipal areas with 3.2 million community-dwelling inhabitants of the Netherlands. The two specific PHARMO databases linked for this study were the Dutch National Medical Register that reflects all hospital admissions, and the outpatient pharmacy database containing drug dispensing information from community pharmacies. Inclusion criteria for the anti-VEGF cohorts were tailored to each data source due to differences in database structure. For IMPACT, RCC patients were included if prescribed or administered pazopanib or one of the other specified anti-VEGF agents on or after October 1, 2009, the FDA approval date for pazopanib in the US Drugs were identified by text string and/or National Drug Codes. A one year screening window from October 1, 2008 until September 30, 2009 was used to identify any anti-VEGF drugs used prior to the study start date. The study index date was the first administration or prescription for the only or first anti-VEGF agent after October 1, 2009. Identified using an ICD-9 diagnostic code (189.0), the RCC diagnosis had to occur October 1, 2008 or later and must have occurred no later than 30 days after the anti-VEGF index date. Patients using only one anti-VEGF drug during the study period were examined separately from those with more than one drug, as were patients using an anti-VEGF drug in a first-line (1L) setting versus a subsequent line of treatment. A first-line therapy was defined as drug treatment received before another anti-VEGF drug. Secondline or higher therapies are those received following another anti-VEGF drug. For patients with multiple anti- VEGF use, outcomes are listed by the therapy that was taken closest prior to or at the time of the cardiovascular event. Patients were followed from the index date to the earliest event for each cardiovascular outcome, death, or until the end of study follow-up, September 30, 2012, whichever was reached first. Patients with another primary cancer diagnosis in the five years prior to the index date were excluded and continuous IMPACT enrolment with pharmacy benefits since October 1, 2009 was required for study inclusion. Patients with a history of cardiovascular events prior to the index date were not omitted. For the PHARMO Database Network, RCC patients were included if an anti-VEGF had been dispensed or administered on or after February 1, 2011 (date of first pazopanib prescription in The Netherlands). The first dispensing or administration within this period was defined as the index date; drugs were identified by ATC codes (pazopanib, L01XE11; sorafenib, L01XE05; sunitinib, L01XE04). Hospitalization for RCC was used as a proxy for RCC diagnosis, based on primary or secondary hospital discharge diagnoses codes occurring at any time before or after the index date. Patients were excluded if diagnosed with a secondary cancer between the RCC hospitalization and the index date or if less than one year of medical history data prior to the index date was available. RCC was not an approved indication for bevacizumab in the Netherlands at the time of pazopanib approval, and hence was not assessed with the PHARMO data. Primary hospitalization codes were used to capture the cardiovascular outcomes; secondary codes were not included as they may relate to prevalent disease. Patients were followed until the date of cardiovascular event, death, end of the study period (December 31, 2012), or end of follow up in the database (either by moving outside the PHARMO catchment area or end of data collection in the pharmacy), whichever occurred first. The following cardiovascular outcomes were captured via ICD-9 diagnostic codes, as follows: myocardial infarction (MI), 410.9; unstable angina (UA), 411.1; Torsades de Pointes (TP), 426.82; cerebrovascular accident (CVA), 434.91; and transient ischemic attack (TIA), 435.9. Separate incidence proportions (cumulative incidence) and corresponding 95% confidence intervals (CI) were calculated for each type of cardiovascular event in the pazopanib and comparator groups. Each CI was calculated using the exact binomial method. When multiple events for a patient occurred for the same cardiovascular outcome, only the first event was used for the incidence analyses. Results The study population was 71% male and the median age was 61 years. Among pazopanib users, 40% (4/10) of patients who experienced an outcome during the study period had a history of cardiovascular events in the year prior to index date (Table 1). No bevacizumab-only patient with cardiovascular events occurring during the study period experienced cardiovascular events in the prior year. However, 38% (5/13) of sorafenib-only and 14% (4/29) of sunitinib-only patients with cardiovascular events during the study period also had a cardiovascular event in the year prior to the index date. In IMPACT, a total of 226 pazopanib users and 610 patients treated with the other anti-VEGF agents met the eligibility criteria. The mean and median follow-up time was 413 and 347 days, respectively, for pazopanib pa


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