Adverse events and intravenous versus oral bisphosphonate use in patients with osteoporosis and cancer in the U.S.

This observational study utilized a patient-level database of more than 55 million patients and 70 U.S.-based health plans compiled from 2000-2006. Patients diagnosed with osteoporosis or various cancers were categorized according to bisphosphonate use (via IV, oral, or none). Continuous enrollment for at least six months pre- and post-index diagnosis was required. Outcomes of adverse events were defined as inflammatory conditions of the jaw, including osteonecrosis; major jaw surgery for necrotic or inflammatory conditions; or jaw surgeries for malignancies. Propensity scores and multivariate regression analyses were used to determine adjusted odds ratios for adverse events based on IV or oral bisphosphonate use relative to no bisphosphonate use, controlling for patient demographics, co-morbidities, prior dental or oral surgery, physician likelihood of prescribing oral versus IV bisphosphonates, and antibiotic, hormonal treatment, or thalidomide use. Subgroup analyses-excluding patients using oral corticosteroids-were conducted. After controlling for numerous demographic, clinical, and instrumental variables, this study found significant relationships between IV bisphosphonate use and both inflammatory conditions of the jaw and major jaw surgery for necrotic or inflammatory conditions in patients with osteoporosis or various cancers. While no significant relationship was observed for oral bisphosphonates, continued research is warranted to assess the long-term use of the medications and adverse events in patients with osteoporosis.

Cost and resource utilization comparisons of second-generation antihistamines vs. montelukast for allergic rhinitis treatment.

This study evaluates the costs and utilization burden associated with oral, branded second-generation antihistamines (BSGAs) compared with montelukast (MTLK) as first-choice treatment in newly diagnosed allergic rhinitis (AR) patients without asthma. We compared annual medical costs of illness and utilization changes from 1 year before index AR diagnosis to 1 year after for continuously enrolled AR patients initiating therapy with BSGA or MTLK. Multivariate regressions for each outcome variable adjusted for confounders including age, sex, geographic region, Charlson Comorbidity Index, RxRisk Score, 18 comorbidity groups, and payer type. Treatment selection bias was evaluated by propensity score with all covariates plus instrumental variables including physician type and likelihood of prescribing MTLK versus BSGA. Insurance claims data for the years 2003-2007 included AR patients in all regions of the United States. The final sample included 13,703 AR patients taking BSGAs (84%) or MTLK (16%). After confounder adjustment, MTLK patients experienced higher total medical costs ($1,542 versus $989), drug costs ($714 versus $477), AR drug costs ($474 versus $298), and outpatient visit costs ($480 versus $277) than BSGA patients (all values of p < 0.025). MTLK patients experienced higher total visits (0.96), AR outpatient visits (0.71), and comorbidity visits (0.12) than BSGA patients (all values of p < 0.01). MTLK patients were more likely to add additional AR therapy medications (MTLK, 43.2%; BSGA, 31.6%; p < 0.01). New AR patients prescribed MTLK as first-line medication therapy have higher medical costs and resource utilization than those prescribed first-line oral BSGAs. These differences persisted after adjustment for patient fixed effects, available confounders, and treatment propensity scores.

Treatment Persistence and Discontinuation with Rivaroxaban, Dabigatran, and Warfarin for Stroke Prevention in Patients with Non-Valvular Atrial Fibrillation in the United States.

A retrospective cohort analysis of the US MarketScan claims databases was performed to compare persistence and discontinuation rates between the vitamin K antagonist warfarin and the non-vitamin K antagonist oral anticoagulants rivaroxaban and dabigatran in patients with non-valvular atrial fibrillation. The analysis included adult patients with non-valvular atrial fibrillation newly initiated on rivaroxaban, dabigatran, or warfarin between November 1, 2011 and December 31, 2013, with a baseline CHA2DS2-VASc score ≥2, two or more non-valvular atrial fibrillation diagnosis codes (427.31), and ≥6 months' continuous medical and pharmacy benefit enrollment before oral anticoagulant initiation. Propensity score matching was performed to match patients receiving rivaroxaban with those receiving dabigatran (1:1) and warfarin (1:1). Patients were followed until the first event of inpatient death, end of continuous enrollment, or end of study period. Medication persistence was defined as absence of a refill gap of >60 days. Discontinuation was defined as no additional refill for >90 days and through to end of follow-up. Hazard ratios (HRs) of oral anticoagulant persistence and discontinuation were estimated using Cox proportional hazard models. In total, 3,2634 patients were included (n = 10878/oral anticoagulant group). Rivaroxaban was associated with better persistence than both dabigatran (HR 0.64, 95% confidence interval [CI] 0.62-0.67) and warfarin (HR 0.62, 95% CI 0.59-0.64) and lower discontinuation than dabigatran (HR 0.61, 95% CI 0.58-0.64) and warfarin (HR 0.65, 95% CI 0.62-0.68). Real-world analysis of oral anticoagulant use may reveal whether the relatively high persistence/low discontinuation demonstrated for rivaroxaban translates into lower rates of stroke.

Real-world comparative outcomes of US type 2 diabetes patients initiating analog basal insulin therapy.

OBJECTIVE: To evaluate outcomes in insulin-naive patients with type 2 diabetes mellitus (T2DM) who initiated insulin glargine or insulin detemir. METHODS: Retrospective data were analyzed from the US General Electric Centricity electronic medical records (EMR) database from patients (≥18 years old) with T2DM initiating insulin glargine or detemir between January 1, 2006, and December 31, 2010. Included patients had EMR data for ≥6 months prior to (baseline) and ≥12 months after (follow-up) the index date (date of first insulin prescription), and at least one OAD and/or GLP-1 receptor agonist prescription order during baseline, but no previous insulin prescription. Patients were matched on baseline characteristics 5:1, insulin glargine to detemir, to ameliorate selection bias. Outcomes assessed were persistence with insulin therapy, glycemic control, hypoglycemia, body weight, and body mass index over follow-up. RESULTS: Insulin glargine and detemir groups were similar in terms of gender (51.0% and 51.5% female, P = 0.7356), age (57.8 and 57.4 years, P = 0.3368), A1C (9.4% and 9.4%, P = 0.6642), and body weight (101.9 kg and 102.4 kg, P = 0.4920) at baseline. During follow-up, patients initiating insulin glargine were more persistent (80.1% vs 67.8%, P < 0.0001) and had a greater change in A1C (-1.11% vs -0.96%, P = 0.0479). Percentage change in weight (0.91% and 0.65%, P = 0.2734) and hypoglycemia prevalence (3.6% vs 4.1%, P = 0.4338) were similar between groups. CONCLUSIONS: Results from this real-world EMR analysis suggest that among T2DM patients, initiating insulin treatment with insulin glargine may be associated with better treatment persistence and glycemic control, with similar prevalence of hypoglycemia and weight change, compared with initiating with insulin detemir. This study is limited by the retrospective nature of the data collection using EMRs and inability to confirm accuracy and completeness of data by secondary chart review.

Economic comparison of rasburicase and allopurinol for treatment of tumor lysis syndrome in pediatric patients.

PURPOSE: Economic outcomes of rasburicase and allopurinol for treatment of tumor lysis syndrome (TLS) in pediatric patients were compared. METHODS: Claims data from a large hospital database were used to conduct the analysis. Pediatric patients diagnosed with TLS and administered rasburicase or allopurinol within two days of hospital admission were eligible for inclusion. Patients were excluded if they were age ≥18 years or received hemodialysis on admission. Patients receiving rasburicase were propensity score matched to allopurinol-treated patients based on sex, race, hospital type, provider type, payer type, admission source, use of electrolyte modification therapy, and comorbid diagnoses. Differences in health care costs, length of stay (LOS), and duration of subsequent critical care were assessed using γ-distributed generalized linear models with a log-link function. Results A total of 63 allopurinol-treated and 63 rasburicase-treated patients were matched in the analysis. The mean age of patients was 7.4 years, and girls comprised 27% of the sample. Rasburicase-treated patients incurred a mean cost of $30,470 per hospitalization, compared with $35,165 for allopurinol-treated patients (p = 0.427). Duration of critical care was significantly shorter for rasburicase-treated patients (1.4 days versus 2.5 days for allopurinol-treated patients, p = 0.0001); however, mean LOS did not statistically differ between groups, averaging 13.8 days for patients treated with rasburicase and 14.9 days for the allopurinol-treated group. CONCLUSION: Examination of claims from a large hospital database showed that treatment with rasburicase, compared with allopurinol, was associated with a significant reduction in critical care days but not with a significant difference in mean LOS or total cost.