Healthcare resource use and costs associated with renal impairment in US patients with bone metastases from solid tumors.

Introduction During cancer progression, more than half of patients develop renal insufficiency, including chronic kidney disease. The primary and secondary objectives of this study were to estimate healthcare resource use and costs, respectively, associated with renal impairment in patients with bone metastases from solid tumors in the United States. Methods and materials This was a retrospective, observational cohort study conducted using administrative claims data for individuals with solid tumors and bone metastases. Control patients were matched to renal impairment patients using propensity scores (ratio up to 3:1) based on demographics, clinical characteristics, and baseline costs. Average per-patient per-year healthcare resource utilization and costs (total costs and cost components; 2013 dollars) were reported. Results In total, 2616 renal impairment patients were matched to 7211 control patients. Renal impairment patients had greater healthcare resource use compared with controls, including a greater mean number of hospital admissions (4.4 versus 2.1), longer average stay per hospital admission (7.4 versus 6.5 days), as well as greater mean number of physician office visits (22.9 versus 18.8), emergency department visits (3.1 versus 2.0), and hospital-based outpatient visits (18.8 versus 16.0) compared with control patients. Total costs were > $50,000 higher among renal impairment patients ($142,267 versus $88,839; P < 0.001), with hospital costs accounting for $72,557 for renal impairment patients, and $27,858 for control patients ( P < 0.001). Conclusion The healthcare resource use and costs associated with renal impairment in patients with bone metastases from solid tumors is high; efforts to reduce renal impairment in this population, including the potential avoidance of nephrotoxic agents, are warranted.

Sost deficiency led to a greater cortical bone formation response to mechanical loading and altered gene expression.

Bone adaptation optimizes mass and structure, but the mechano-response is already reduced at maturation. Downregulation of sclerostin was believed to be a mandatory step in mechano-adaptation, but in young mice it was shown that load-induced formation can occur independent of sclerostin, a product of the Sost gene. We hypothesized that the bone formation and resorption response to loading is not affected by Sost deficiency, but is age-specific. Our findings indicate that the anabolic response to in vivo tibial loading was reduced at maturation in Sost Knockout (KO) and littermate control (LC) mice. Age affected all anabolic and catabolic parameters and altered Sost and Wnt target gene expression. While load-induced cortical resorption was similar between genotypes, loading-induced gains in mineralizing surface was enhanced in Sost KO compared to LC mice. Loading led to a downregulation in expression of the Wnt inhibitor Dkk1. Expression of Dkk1 was greater in both control and loaded limbs of Sost KO compared to LC mice suggesting a compensatory role in the absence of Sost. These data suggest physical activity could enhance bone mass concurrently with sclerostin-neutralizing antibodies, but treatment strategies should consider the influence of age on ultimate load-induced bone mass gains.

Medication persistence and discontinuation of rivaroxaban and dabigatran etexilate among patients with non-valvular atrial fibrillation.

OBJECTIVE: To compare real-world persistence and discontinuation among non-valvular atrial fibrillation (NVAF) patients on rivaroxaban and dabigatran in the US. METHODS: A large nationally representative US claims database was used to conduct a retrospective cohort analysis of patients with NVAF on rivaroxaban or dabigatran between October 2010 and March 2013. The index date was the date of the first prescription of rivaroxaban or dabigatran. All patients had ≥6 months of data prior to the index date and were followed until the earliest of inpatient death, end of continuous enrollment, or end of the study period. Rivaroxaban patients were matched 1:1 with dabigatran patients using the propensity score matching technique. Cox proportional hazards models were employed to estimate the adjusted hazard ratios (aHRs) of non-persistence and discontinuation. Persistence was defined as absence of a refill gap of ≥60 days. Discontinuation was defined as no additional refill for at least 90 days and until the end of follow-up. RESULTS: A total of 30,337 NVAF patients on rivaroxaban or dabigatran met the study criteria. All 7259 rivaroxaban patients were matched 1:1 to dabigatran patients. Compared with dabigatran users, rivaroxaban patients were 11% less likely to become non-persistent with therapy (aHR: 0.89, 95% CI 0.84-0.95) and 29% less likely to discontinue therapy (aHR: 0.71, 95% CI 0.66-0.77). LIMITATIONS: Claims data are subject to miscoding and inaccuracies. Refill data may not fully reflect actual medication taken. Confounding may remain even after propensity score matching and additional adjustments in model. Longer follow-up may produce more precise estimates of persistence and discontinuation. CONCLUSIONS: This matched cohort analysis indicated that, compared to dabigatran, rivaroxaban was associated with better persistence and lower rates of discontinuation.

Rate of hypoglycemia in patients with type 2 diabetes receiving metformin plus saxagliptin versus metformin plus sulfonylurea: a retrospective observational cohort study using administrative claims data.

OBJECTIVES: Hypoglycemia is a limiting factor in the management of diabetes. Studies comparing oral antidiabetic medications are needed to identify treatment options that can help clinicians and patients minimize their associated hypoglycemia risk. The purpose of this study was to compare hypoglycemia rates in patients with type 2 diabetes on metformin who initiated treatment with saxagliptin versus sulfonylurea (SU). METHODS: This retrospective analysis utilized US healthcare claims data from the Truven Health MarketScan Research Databases. Data were from adults on metformin monotherapy who added saxagliptin or SU between 1 August 2009 and 31 December 2010. Hypoglycemia event rates were compared during the 4 months after initiation of saxagliptin or SU. A hypoglycemia event was defined as a diagnosis of hypoglycemia on an outpatient or emergency room claim, a principal diagnosis on a hospital claim, or a glucagon injection in an outpatient setting. Patients taking SU were matched to patients taking saxagliptin (5 to 1) using propensity scores, and the rate ratio was further adjusted using multivariate regression. A total of 22,592 patients (1567 taking saxagliptin; 21,025 taking SU) qualified. RESULTS: During 120 days of follow-up, there were 396 hypoglycemia events. Most of the hypoglycemia events (91.9%) occurred in the outpatient setting. There were no inpatient or emergency room hypoglycemia events in the saxagliptin cohort. The overall unadjusted rate of hypoglycemia was significantly lower in the saxagliptin cohort than in the SU cohort (1.74 vs 5.58 per 100 person-years; p < 0.001). The rate of hypoglycemia also was significantly lower in the saxagliptin cohort versus the propensity-matched SU cohort (1.74 vs 4.45 per 100 person-years; p = 0.005). Matching reduced the treatment effect by approximately 20%. The rate ratio comparing saxagliptin with the unmatched and propensity-matched SU cohorts was 0.31 (95% CI: 0.14-0.6) and 0.39 (95% CI: 0.17-0.77), respectively. The multivariate adjustment decreased the hypoglycemia rate ratio 0.37 (95% CI: 0.19-0.74). CONCLUSION: In a database reflective of real-world clinical practice, saxagliptin had a lower risk of hypoglycemia than SU in patients with type 2 diabetes receiving metformin. These results add confidence to similar findings from clinical trials.

Medication persistence and discontinuation of rivaroxaban versus warfarin among patients with non-valvular atrial fibrillation.

OBJECTIVES: To compare real-world persistence and discontinuation among non-valvular atrial fibrillation (NVAF) patients on rivaroxaban and warfarin in the US. RESEARCH DESIGN AND METHODS: A large nationally representative US claims database was used to conduct a retrospective cohort analysis of patients with NVAF treated with rivaroxaban or warfarin from 1 July 2010 through 31 March 2013. Index date was the date of the first prescription of rivaroxaban or warfarin. All patients were followed until the earliest of inpatient death, end of continuous enrollment, or end of study period. Rivaroxaban patients were matched 1:1 by propensity scores. Medication persistence was defined as absence of refill gap of ≥ 60 days. Discontinuation was defined as no additional refill for at least 90 days and until the end of follow-up. Cox proportional hazards models were estimated to examine the adjusted hazard ratios (aHRs) of rivaroxaban vs. warfarin on non-persistence and discontinuation. RESULTS: A total of 32,886 NVAF patients on rivaroxaban or warfarin met the study inclusion criteria. Each of the 7259 rivaroxaban patients identified were matched 1:1 to warfarin patients. Patients on rivaroxaban had a significantly better rate of persistence (aHR: 0.63, 95% CI 0.59-0.68) and lower rate of discontinuation (aHR: 0.54, 95% CI 0.49-0.58) compared to warfarin recipients. LIMITATIONS: Claims data may have contained inaccuracies and miscoding. Confounding may remain even after propensity score matching and additional adjustments in model. Refill data may not fully reflect actual medication use. Longer follow-up may produce more precise estimates of persistence and discontinuation. CONCLUSION: This matched cohort analysis indicated that rivaroxaban was associated with significantly higher medication persistence and lower discontinuation rates compared to warfarin.

Relationship between potential opioid-related adverse effects and hospital length of stay in patients receiving opioids after orthopedic surgery.

STUDY OBJECTIVE: To determine whether there is an association between opioid-related adverse effects and postoperative hospital length of stay (p-LOS). DESIGN: Retrospective medical record review. SETTING: Large academic medical center. PATIENTS: Random sample of 402 patients (mean age 60.2 yrs, 50.3% female) who underwent orthopedic spine, hip, knee, or shoulder surgery during 2007 and received opioids during or after the procedure. MEASUREMENTS AND MAIN RESULTS: Potential opioid-related adverse effects were identified by using established criteria. Bivariate and multivariate analyses (generalized linear regression model, log transformed) were used to identify predictors of p-LOS. The model also estimated the effect of specific types of adverse effects and adverse-effect combinations on p-LOS. Mean ± SD p-LOS was 3.0 ± 2.1 days; median oral morphine equivalent postoperative dose was 60 mg/day. More than half of the patients (54.2%) experienced one or more adverse effects, 25.6% experienced two or more adverse effects, and 7.2% experienced three or more adverse effects. The composite of nausea and vomiting was experienced by 36.1% of study patients, and 12.6% had at least one emesis episode. Constipation and confusion were documented in 6.5% and 3.7% of patients, respectively. Constipation (p<0.0001), emesis (p<0.001), and confusion (p<0.01) were associated with increased p-LOS after adjusting for other significant variables. Patients with constipation had an adjusted 49% (95% confidence interval [CI] 25-77%) longer p-LOS (additional 1.4 days) compared with patients without constipation. Emesis and confusion significantly increased p-LOS by 25% (95% CI 10-42%) and 38% (95% CI 11-72%), respectively. Incremental increases in p-LOS for patients with two adverse effects (p=0.02), three adverse effects (p<0.001), and four adverse effects (p<0.001) versus patients with no adverse effects were 15%, 40%, and 82%, respectively. CONCLUSION: Constipation, emesis, and confusion were associated with increased p-LOS in patients receiving opioids after orthopedic surgery. In addition, there was a significant linear relationship between the number of adverse effects/patient and increased p-LOS, and the strength of the association increased as the number of adverse effects increased. Although the opioid dosages and adverse-effect rates were typical, these findings reinforce the need to balance pain management with risk of events.

Population-based worksite obesity management interventions: a qualitative case study.

Due to the increased prevalence of obesity and associated direct and indirect costs to employers, weight management programs have become an integral component of employer and insurer benefits plans. The programs vary in foci, scope, breadth, and implementation. The aim of this study was to explore promising employer-sponsored population-based obesity management programs. A case study that utilized a telephonic semi-structured questionnaire was conducted with small and large organizations located in different regions of the United States that had been recruited to participate. Eight employers and 1 health care advocacy coalition who met the inclusion criteria were interviewed about features of their weight management programs. The case study revealed a number of themes consistent with reports in the literature and reflecting cited best practices. Key findings include confirmation that weight management is a significant component of the wellness strategy in all participating organizations because employers are invested in population health programs and cost savings. Based upon their experience and knowledge, occupational health specialists are responsible for designing, implementing, managing, and evaluating employee health programs. Almost all employers utilize electronic media as a prominent component of wellness and disease management initiatives. Experience has shown that incentives-both financial and nonmonetary-are effective motivators for employee engagement and outcomes. However, while employers report success, favorable outcomes have been difficult to quantify.