Mardekian, Jack

BackgroundSystemic therapy (ST) can be deferred in patients who have metastatic renal cell carcinoma (mRCC) and slow‐growing metastases. Currently, this subset of patients managed with active surveillance (AS) is not well described in the literature.MethodsThis was a prospective observational study of patients with mRCC across 46 US community and academic centers. The objective was to describe baseline characteristics and demographics of patients with mRCC initially managed by AS, reasons for AS, and patient outcomes. Descriptive statistics were used to characterize demographics, baseline characteristics, and patient‐related outcomes. Wilcoxon 2‐sample rank‐sum tests and χ2 tests were used to assess differences between ST and AS cohorts in continuous and categorical variables, respectively. Kaplan‐Meier survival curves were used to assess survival.ResultsOf 504 patients, mRCC was initially managed by AS (n = 143) or ST (n = 305); 56 patients were excluded from the analysis. Disease was present in 69% of patients who received AS, whereas the remaining 31% had no evidence of disease. At data cutoff, 72 of 143 patients (50%) in the AS cohort had not received ST. The median overall survival was not reached (95% CI, 122 months to not estimable) in patients who received AS versus 30 months (95% CI, 25‐44 months) in those who received ST. Quality of life at baseline was significantly better in patients who were managed with AS versus ST.ConclusionsAS occurs frequently (32%) in real‐world clinical practice and appears to be a safe and appropriate alternative to immediate ST in selected patients.

Background: The AMPLIFY randomized clinical trial showed that apixaban was associated with significantly lower major bleeding (MB) compared to warfarin for patients with venous thromboembolism (VTE). The main objective of this study was to compare the risk of major bleeding (MB), clinically relevant non-major bleeding (CRNM), and recurrent VTE among VTE patients treated with apixaban vs warfarin in the US Medicare population. Methods: Patients (aged ≥65 years) prescribed apixaban or warfarin within 30 days following a VTE event diagnosed in hospital or ambulatory setting were identified from 01SEPT2014-31DEC2016 using 100% CMS Medicare data. The first apixaban or warfarin prescription claim outside of the hospital was defined as the index date. Patients were required to have had continuous health plan enrollment for 6 months and no parenteral or oral anticoagulant use before the index VTE event. Outcomes were assessed from index date to the earliest of discontinuation, switch, health plan disenrollment, death, 6 months post-index date, or 31DEC2016. One-to-one propensity score matching (PSM) was used to balance patient characteristics. Cox proportional hazard models were used to estimate the risk of MB, CRNM bleeding, and recurrent VTE. Results: Among 37,799 patients meeting inclusion criteria, 25,284 patients initiated warfarin (66.9%) and 12,515 patients initiated apixaban (33.1%). Post-PSM, 11,363 matched pairs of apixaban-warfarin patients were identified, with a mean follow-up period of 4.0 and 4.4 months. Mean age was 78 years; nearly 37% of patients were male with a mean Charlson Comorbidity Index score of 2.9 in both groups. Apixaban was associated with a lower risk of MB (HR: 0.76; 95% CI: 0.64-0.91) and CRNM bleeding (HR: 0.77; 95% CI: 0.70-0.84) compared to warfarin. The risk of recurrent VTE was similar among apixaban and warfarin patients (HR: 1.04; 95% CI: 0.75-1.43; Figure). Conclusions: Among US Medicare patients with VTE, apixaban was associated with a lower risk of MB and CRNM bleeding and similar risk of recurrent VTE compared to warfarin. These results may be supportive in evaluating the risk-benefit ratio of apixaban for treatment of elderly VTE patients.

AbstractObjectivesCompare healthcare resource utilization (HCRU) and costs between patients prescribed opioids (RxOP) and those who were not (NoRxOP) during an emergency department (ED) or inpatient visit.MethodsRetrospective cohort analysis was performed (January 2006 to September 2010). Continuously eligible RxOP patients in ED/inpatient settings (January 2007 to September 2009) were included if age was ≥ 12 years by initial prescription date (or random date between first ED/inpatient admission and September 30, 2009 [NoRxOP patients]).Healthcare resource utilization and costs for 12 months after initial prescription were compared. Univariate descriptive analyses were performed for baseline and outcome variables and compared using appropriate tests. Risk adjustment compared HCRU between RxOP and NoRxOP cohorts for the postindex period.ResultsOf 27,599 eligible patients, RxOP patients (n = 18,819) were younger, less likely to be male, more likely to reside in southern United States and to have Preferred Provider Organization health plans, and had lower comorbidity index scores, compared with NoRxOP patients (n = 8,780). RxOP patients were less likely to have nonpain‐related comorbidities and more frequently diagnosed with pain‐related comorbidities.Unmatched and propensity‐matched RxOP patients experienced higher HCRU and costs in all subcategories (total, inpatient, outpatient ED, physician, pharmacy, other outpatient settings). Opioid abuse frequency was low in patients with common diagnoses/procedures within 3 months before initial prescription (0.48%). Average time to abuse was < 1 year (201 days).ConclusionMost patients were prescribed opioids initially during ED/inpatient visits and incurred higher HCRU than those not prescribed opioids. Among those with diagnosed opioid abuse after initiating opioids, time to diagnosis was rapid (range: 14 to 260 days) for patients with common diseases and procedures.