Hospitalisation rates in patients switched from oral anti-psychotics to aripiprazole once-monthly for the management of schizophrenia

Abstract

Objective:

To report the design and preliminary results of a mirror-image study comparing total psychiatric hospitalisation rates pre- and post-switch to aripiprazole once-monthly, an extended release injectable solution.

Methods:

A multi-center, open-label mirror-image study of patients (18–65 years) with schizophrenia to compare total psychiatric hospitalisation rates between retrospective treatment with oral standard-of-care (SOC) anti-psychotics and prospective treatment with aripiprazole once-monthly in a naturalistic community setting in North America. Total psychiatric hospitalisation rates were assessed between retrospective (Months ?4 to ?1) and prospective treatment periods (Months 4–6) for patients who completed ≥3 months aripiprazole once-monthly.

Results:

One hundred and eighty-three patients entered the prospective phase. After switching to aripiprazole once-monthly, total psychiatric hospitalisation rates for the 3-month prospective period were significantly lower (p?<?0.0001, Exact McNemar’s test) compared with the retrospective 3-month period when the same patients received SOC anti-psychotics (6.6% [n?=?8/121] vs 28.1% [n?=?34/121], respectively; rate ratio?=?0.24). Similarly, total psychiatric hospitalisation rates for all patients who entered the prospective treatment phase were significantly lower (p?<?0.0001, Exact McNemar’s test) for the prospective 6 months following switch to aripiprazole once-monthly, compared with the retrospective 6-month SOC period (14.2% [n?=?26/183] vs 41.5% [n?=?76/183], respectively; rate ratio?=?0.34). Common treatment-emergent adverse events (occurring in ≥5% of patients) were psychotic disorder (7.7%), akathisia (7.2%), and insomnia (7.2%). Discontinuation (all causes) during the prospective phase was 44.8% (n?=?82/183).

Limitations:

Mirror-image studies do not include a parallel active control; as each patient serves as their own control, it cannot be determined whether other treatments may have similar effects. Treatment and trial effects may be difficult to separate. Independent factors such as admission patterns, insurance coverage, availability of hospital beds, and community support may influence rates of hospitalisation.

Conclusions:

Switching to aripiprazole once-monthly substantially reduced total psychiatric hospitalisation rates compared with retrospective rates in the same patients taking oral SOC.     

Respiratory-related medical expenditure and inpatient utilisation among COPD patients receiving long-acting bronchodilator therapy

Abstract

Objective:

To evaluate chronic obstructive pulmonary disease (COPD)-related expenditure and hospitalisation in COPD patients treated with tiotropium versus alternative long-acting bronchodilators (LABDs).

Methods:

Data were from the Thomson Reuters MarketScan Research Databases. COPD patients ≥35 years with at least one LABD claim between July 1, 2004 and June 30, 2006 were classified into five cohorts based on index LABD: monotherapy with tiotropium, salmeterol/fluticasone propionate, formoterol fumarate, or salmeterol or combination therapy. Demographic and clinical characteristics were evaluated for a 6-month pre-period and COPD-related utilisation and total costs were evaluated for a 12-month follow-up period. LABD relationship to COPD-related costs and hospitalisations were estimated by multivariate generalised linear modelling (GLM) and multivariate logistic regression, respectively.

Results:

Of 52,274 patients, 53% (n?=?27,457) were male, 71% (n?=?37,271) were ≥65?years, and three LABD cohorts accounted for over 90% of the sample [53% (n?=?27,654) salmeterol/fluticasone propionate, 23% (n?=?11,762) tiotropium, and 15% (n?=?7755) combination therapy]. Patients treated with salmeterol/fluticasone propionate (p?<?0.001), formoterol fumarate (p?=?0.032), salmeterol (p?=?0.004), or with combination therapy (p?<?0.001) had higher COPD-related costs and a greater risk of inpatient admission (p?<?0.01 for all) versus tiotropium.

Limitations:

These data are based on administrative claims and as such do not include clinical information or information on risk factors, like smoking status, that are relevant to this population.

Conclusions:

Patients treated with tiotropim had lower COPD-related expenditures and risk of hospitalisation than patients treated with other LABDs     

Comparison of second-generation antipsychotic treatment on psychiatric hospitalization in Medicaid beneficiaries with bipolar disorder

Abstract

Objective:

To compare second-generation antipsychotics on time to and cost of psychiatric hospitalization in Medicaid beneficiaries with bipolar disorder.

Methods:

Retrospective study using healthcare claims from 10 US state Medicaid programs. Included beneficiaries were aged 18–64, initiated a single second-generation antipsychotic (aripiprazole, olanzapine, quetiapine, risperidone, or ziprasidone) between 1/1/2003–6/30/2008 (initiation date?=?index), and had a medical claim with an ICD-9-CM diagnosis code for bipolar disorder. A 360-day post-index period was used to measure time to and costs of psychiatric hospitalization (inpatient claims with a diagnosis code for a mental disorder [ICD-9-CM 290.xx–319.xx] in any position). Cox proportional hazards models and Generalized Linear Models compared time to and costs of psychiatric hospitalization, respectively, in beneficiaries initiating aripiprazole vs each other second-generation antipsychotic, adjusting for beneficiaries’ baseline characteristics.

Results:

Included beneficiary characteristics: mean age 36 years, 77% female, 80% Caucasian, aripiprazole (n?=?2553), mean time to psychiatric hospitalization or censoring?=?85 days; olanzapine (n?=?4702), 81 days; quetiapine (n?=?9327), 97 days; risperidone (n?=?4377), 85 days; ziprasidone (n?=?1520), 82 days. After adjusting for baseline characteristics, time to psychiatric hospitalization in beneficiaries initiating aripiprazole was longer compared to olanzapine (hazard ratio [HR]?=?1.52, p?<?0.001), quetiapine (HR?=?1.40, p?<?0.001), ziprasidone (HR?=?1.33, p?=?0.032), and risperidone, although the latter difference did not reach significance (HR?=?1.18, p?=?0.13). The adjusted costs of psychiatric hospitalization in beneficiaries initiating aripiprazole were significantly lower compared to those initiating quetiapine (incremental per-patient per-month difference?=?$42, 95% CI?=?$16–66, p?<?0.05), but not significantly lower for the other comparisons.

Limitations:

This study was based on a non-probability convenience sample of the Medicaid population. Analyses of administrative claims data are subject to coding and classification error.

Conclusions:

Medicaid beneficiaries with bipolar disorder initiating aripiprazole had significantly longer time to psychiatric hospitalization than those initiating olanzapine, quetiapine, or ziprasidone, and significantly lower adjusted costs for psychiatric hospitalization than those initiating quetiapine.     

Risk of all-cause hospitalization in COPD patients initiating long-acting or short-acting beta agonist therapy

Abstract

Objective:

This retrospective claims study investigated the rates of all-cause hospitalization among chronic obstructive pulmonary disease (COPD) patients initiating treatment with short-acting beta agonists (SABA) or long-acting beta agonists (LABA).

Methods:

Data from the 5% national sample of Medicare enrollees for 2006–2008 were used. Patients initiating COPD therapy were identified as those with no COPD therapy for ≥ 6-months prior to initiating SABA or LABA (administered via dry-powder inhalers, metered-dose inhalers, or nebulizer) treatment. All patients were continuously eligible for Medicare Parts A, B, and D for 18 months. Those enrolled in Medicare Advantage, who had asthma, or were < 65 years old were excluded. Differences in the rates of all-cause hospitalizations and time to all-cause hospitalization during the 6-month follow-up period were examined, while adjusting for demographics, clinical indicators, and health service use.

Results:

Among 3017 COPD patients who met the inclusion criteria, 883 (30%) were LABA users and 2134 (70%) were SABA users. Overall, 21% of patients (16% [144/883] of LABA and 23% [492/2134] of SABA) had a hospitalization during the follow-up period. Mean time to hospitalization was 86 days for LABA vs 64 days for SABA patients (p?<?0.05). The adjusted hazard ratio for hospitalization in a Cox proportional hazards model was 0.74 (95% CI?=?0.62–0.90) for patients treated with LABA vs. SABA.

Limitations:

The analysis was adjusted for multiple background characteristics, but important measures of severity in COPD, such as measures of lung functioning, were not available and may have differed between patients treated with LABA or SABA.

Conclusions:

The results of this analysis indicate COPD patients initiating LABA treatment had a longer time to all-cause hospitalization and a 26% lower risk of hospitalization during the 6-months follow-up period compared to those initiating SABA therapy.     

Impact of completing chronic hepatitis C (CHC) treatment on post-therapy healthcare cost

Background:

Chronic hepatitis C (CHC) is associated with significant economic burden. This study evaluated the healthcare cost alleviation associated with treatment of CHC.

Methods:

Health insurance claims from 60 self-insured US companies were analyzed (01/2001–03/2012). Adult patients with ≥1 CHC diagnosis (ICD-9-CM: 070.44, 070.54), initiating interferon, and with ≥2 dispensings and with ≥48 weeks of follow-up were selected. Patients diagnosed with HIV or who completed only 24 weeks of interferon therapy (a surrogate for CHC genotypes 2 and 3) were excluded from the study. Interferon users were categorized into complete and discontinued therapy cohorts. During the post–48-week treatment period, cohorts were compared for healthcare resource utilization using rate ratios (RRs), as well as healthcare costs using per-patient per-year (PPPY) cost differences.

Results:

A total of 1017 patients who completed and 953 patients who discontinued interferon therapy were identified. Relative to the discontinued therapy cohort, the completed therapy cohort had significantly fewer hospitalizations (RR [95% CI]?=?0.74 [0.68, 0.81], p?p?p?=?0.039), which translated into significantly lower total healthcare costs PPPY (cost difference [95% CI]?=?$4540 [1570, 7680], p?=?0.004) and hospitalization costs (cost difference [95% CI]?=?$3039 [1140, 5248], p?=?0.002). Non–CHC-related costs accounted for 55% and CHC-related costs for 45% of the all-cause cost difference between cohorts.

Limitations:

Claims data may have contained inaccuracies, and genotypes of patients with CHC could not be confirmed. The study consisted of privately insured individuals and may not be generalizable to the entire CHC population.

Conclusion:

Compared to discontinued therapy patients, CHC patients who completed interferon therapy and presumably had a higher rate of achieving SVR were found to have lower levels of healthcare resource utilization and costs post-therapy. The reduction was primarily in costs associated with non–HCV-related comorbidities.     

Pharmacological control of secondary hyperparathyroidism in hemodialysis subjects: a cost consequences analysis of data from the FARO study

Abstract

Background and objectives:

Secondary hyperparathyroidism (SHPT) is a frequent complication of CKD with incidence, prevalence, and costs increasing worldwide. The objective of this analysis was to estimate therapy cost of SHPT in a sub-population of the FARO study.

Materials and Methods:

In the FARO study, an observational survey aimed to evaluate patterns of treatment in patients with SHPT who had undergone hemodialysis, pharmacological treatments and biochemical parameters evolution data were collected in four surveys. Patients maintaining the same treatment in all sessions were grouped by type of treatment and evaluated for costs from the Italian National Health Service perspective.

Results:

Four cohorts were identified: patients treated with oral (PO) calcitriol (n?=?182), intravenous (IV) calcitriol (n?=?34), IV paricalcitol (n?=?62), and IV paricalcitol?+?cinacalcet therapy (n?=?20); the cinacalcet monotherapy group was not analysed due to low number of patients (n?=?9). Parathyroid hormone (PTH) level at baseline and effectiveness of treatments in suppressing PTH level were assessed to test comparability among cohorts: calcitriol PO patients were significantly less severe than others (PTH level at baseline lower than 300?pg/ml; p?<?0.0001); calcitriol IV patients did not reach significant reduction in PTH level. Paricalcitol and paricalcitol?+?cinacalcet treatment groups results were comparable, while only the IV paricalcitol cohort’s PTH level, weekly dosage, and cost decreased significantly from the first to the fourth survey (p?=?0.020, p?=?0.012, and p?=?0.0124, respectively). Total costs per week of treatment (including calcium-based phosphate binder and sevelamer) were significantly lower in the paricalcitol vs paricalcitol?+?cinacalcet cohort (p?<?0.001). Major limitations of this study are related to the survey design: not controlled and lack of comparability between cohorts; however, reflective of true practice patterns.

Conclusions:

The IV Paricalcitol cohort had significantly lower treatment costs compared with patients treated with paricalcitol?+?calcimemtics (p?<?0.001), without a significant difference in terms of baseline severity and PTH control.     

Adherence,persistence, healthcare utilization,and cost benefits of guideline-recommended hepatitis B pharmacotherapy

Abstract

Objective:

To compare pharmacotherapy adherence, persistence, and healthcare utilization/costs among US patients with chronic hepatitis B (CHB) initiated on an oral antiviral monotherapy recommended as first-line treatment by current national (US) guidelines vs an oral antiviral not recommended as first-line monotherapy.

Research design and methods:

In this retrospective cohort study, patients aged 18–64 with medical claims for CHB who initiated an oral antiviral monotherapy for CHB between 07/01/05 and 01/31/10 were identified from a large US commercial health insurance claims database. Patients were continuously enrolled for a 6-month baseline period and ≥ 90 days follow-up. They were assigned to ‘currently recommended first-line therapy’ (RT: entecavir or tenofovir) or ‘not currently recommended first-line therapy’ (NRT: lamivudine, telbivudine, or adefovir) cohorts.

Main outcome measures:

Multivariate analyses were conducted to compare treatment adherence, persistence, healthcare utilization, and costs for RT vs NRT cohorts.

Results:

Baseline characteristics were similar between RT (n?=?825) and NRT (n?=?916) cohorts. In multivariate analyses, RT patients were twice as likely as NRT patients to be adherent (OR?=?2.09; p?<?0.01) and persistent (mean: RT?=?361 days, NRT?=?298 days; p?<?0.01) and half as likely to have an inpatient stay (OR?=?0.527; p?<?0.01). Between the two oral antivirals recommended as first-line treatment, even though pharmacy cost was higher for entecavir, mean total healthcare costs for entecavir and tenofovir were similar ($1214 and $1332 per patient per month, respectively). Similar results were also observed with regard to adherence, persistence, and healthcare use for entecavir and tenofovir.

Conclusions:

A limitation associated with analysis of administrative claims data is that coding errors can be mitigated but are typically not fully eradicated by careful study design. Nevertheless, the current findings clearly indicate the benefits of initiating CHB treatment with an oral antiviral monotherapy recommended as first-line treatment by current guidelines.     

Real-world utilization of molecular diagnostic testing and matched drug therapies in the treatment of metastatic cancers

Aims: To assess the frequency of biopsies and molecular diagnostic testing (human DNA/RNA analysis), anti-cancer drug use (genomically-matched targeted therapy [GMTT], unmatched targeted therapy [UTT], endocrine therapy [ET], and chemotherapy [CT]), and medical service costs among adults with metastatic cancer.

Methods: Adults diagnosed with metastatic breast, non-small cell lung (NSCLC), colorectal, head and neck, ovarian, and uterine cancer (2010Q1–2015Q1) were identified in the OptumHealth Care Solutions claims database and followed from first metastatic diagnosis for ≥1 month and until the end of data availability. Utilization was assessed for each cancer cohort (all and patients aged ≥65 years); per-patient-per-month (PPPM) medical service costs were assessed for all patients. Testing frequency estimates were applied to Surveillance, Epidemiology, and End Results Program data to estimate the number of untested patients (2010–2014).

Results: Patients with metastatic cancer (n?=?8,193; breast [n?=?3,414], NSCLC [n?=?2,231], colorectal [n?=?1,611], head and neck [n?=?511], ovarian [n?=?275], and uterine [n?=?151]) were 63 years old (mean), with 11.1–22.2 months of observation. Biopsy and molecular diagnostic testing frequencies ranged from 7% (uterine) to 73% (ovarian), and from 34% (head and neck) to 52% (breast), respectively. Few were treated with GMTT (breast, 11%; NSCLC, 9%; colorectal, 6%). Treatment with UTT ranged from 0.7% (uterine) to 21% (colorectal). Biopsy, diagnostic testing, and anti-cancer drug therapy were less frequent for those ≥65 years. Medical service costs (PPPM, mean) ranged from $6,618 (head and neck) to $9,940 (ovarian). The estimated number of untested new patients with metastatic cancer was 636,369 (all) and 341,397 (≥65).

Limitations: In addition to the limitations of claims analyses, diagnostic testing frequency may be under-estimated if patients underwent testing prior to study inclusion.

Conclusions: The low frequency of molecular diagnostic testing suggests there are opportunities to better inform management of patients with advanced cancer, particularly decisions to treat with GMTT.     

Perioperative outcomes and hospital costs associated with flowable gelatin hemostatic matrix for lumbar surgeries in real world hospital setting

Abstract

Background: Efficient hemostasis during lumbar surgery (LS) is associated with better perioperative outcomes. Flowable gelatin hemostatic matrix (FGHM) is a new type of absorbable hemostatic agent, which is effective to control bleeding during spinal surgery. This study aimed to assess the impact of FGHM on perioperative outcomes and hospital costs associated with LS.

Methods: This study retrospectively analyzed medical and billing records of patients who underwent LS for spinal degenerative disease in a Chinese tertiary care hospital from 2014 to 2016. The identified patients were further stratified into a FGHM group (n?=?108) (using the combination of FGHM and gelatin sponge) and a historical control group (using oxidized cellulose and/or collagen, n?=?82) for the adjusted comparisons of the perioperative outcomes using a propensity score matching method. Multiple generalized linear regression was conducted to assess the impact of using FGHM on total hospitalization costs.

Results: Comparisons of 64 propensity score matched pairs showed a significantly lower blood transfusion rate (34.4% vs 64.1%, p?=?0.005), lower blood transfusion volume (182.7?±?312.4 vs 301.3?±?281.0?mL, p?=?0.045), reduced post-surgery drainage tube placement rate (82.8% vs 93.8%, p?=?0.046), and shorter post-operative days on antibiotics (6.0?±?2.6 vs 7.1?±?2.4 days, p?=?0.010) in the FGHM group. Although with a relatively high acquisition price, the use of FGHM for hemostasis in LS did not increase the total hospitalization costs (coefficient = ?0.001, p?=?0.972).

Conclusions: The use of FGHM in LS improved perioperative outcomes related to hemostatic effects without increasing overall hospital costs in a real-world hospital setting.     

Treatment patterns and resource utilization and costs among patients with pulmonary arterial hypertension in the United States

Abstract

Objective:

To explore treatment patterns and resource utilization and cost for subjects with pulmonary arterial hypertension (PAH).

Research design:

Retrospective claims database analysis of 706 patients with PAH enrolled in a large, geographically diverse US managed-care organization.

Results:

In the final sample of PAH patients treated with bosentan (n?=?251) or sildenafil (n?=?455), average age was 57 years, 86% of patients were commercially insured, and 52% of patients were male. Gender distribution varied significantly across subgroups, with a lower proportion of males in the bosentan (30%) subgroup compared with the sildenafil group (64%) (p?<?0.001). Average baseline Charlson comorbidity score was 2.4. Average numbers of fills per month were 0.8 and 0.4 for bosentan and sildenafil patients, respectively (p?<?0.001). Over 80% of patients received only one PAH treatment in the first 90 days following the index date, with 28% of bosentan and 13% of sildenafil patients receiving combination therapy (p?<?0.001). Over one-third of bosentan patients and one-quarter of sildenafil patients experienced a dose increase in the follow-up period (p?=?0.009). Sixteen percent of sildenafil patients experienced a dose decrease in the follow-up period, while a smaller proportion of patients receiving bosentan (4%) experienced a dose decrease (p?<?0.001). On average, number of PAH-related per subject per month (PSPM) inpatient stays and emergency department visits and PSPM length of inpatient stays were statistically similar between the subgroups. PAH-related PSPM healthcare costs were high for both subgroups, with average monthly costs of $5,332 and $3,632 among bosentan and sildenafil patients, respectively (p?=?0.003). Differences in total costs were driven mainly by differences in pharmacy expenditures.

Conclusions:

Of the oral agents approved for treating PAH at the time of this study, sildenafil was most commonly prescribed as index therapy and was also associated with the lowest costs, largely due to significantly lower pharmacy costs. This study is characterized by limitations inherent to claims database analyses, such as the potential for coding errors and lack of information on whether a drug was taken as prescribed. Furthermore, PAH severity (WHO functional class) was not assessed.     

Guidelines-based treatment associated with improved economic outcomes in nontuberculous mycobacterial lung disease

Abstract

Background: The prevalence of nontuberculous mycobacterial lung disease (NTMLD) in the US has increased; however, data characterizing the associated healthcare utilization and expenditure at the national level are limited.

Objective: To examine associations between economic outcomes and the use of anti-Mycobacterium avium complex (MAC) guidelines-based treatment (GBT) for newly-diagnosed NTMLD in a US national managed care claims database (Optum^® Clinformatics^® Data Mart).

Methods: NTMLD was defined as having ≥2 claims for NTMLD (ICD-9 031.0; ICD-10 A31.0) on separate occasions ≥30?days apart (between 2007 and 2016). The cohort included patients insured continuously over a period of at least 36?months (12?months before initial NTMLD diagnostic claim and for the subsequent 24?months). Treatment was classified as GBT (consistent with American Thoracic Society/Infectious Diseases Society of America guidelines), non-GBT, or untreated. All-cause hospitalization rates and total healthcare expenditures at Year 2 were assessed as outcomes of the treatment prescribed in Year 1 after NTMLD diagnosis.

Results: A total of 1,039 patients met study criteria for NTMLD (GBT, n?=?294; non-GBT, n?=?298; untreated, n?=?447). After adjustment for baseline characteristics, GBT was associated with a significantly lower all-cause hospitalization risk vs non-GBT (odds ratio [OR]?=?0.53; 95% CI = 0.33–0.85, p?=?0.008), and vs being untreated (OR = 0.57; 95% CI = 0.35–0.91, p?=?0.020). Adjusted total healthcare expenditure in Year 2 with GBT ($69,691) was lower than that with non-GBT ($77,624) with a difference of ?$7,933 (95% CI = ?$14,968 to ?$899; p?=?0.03).

Conclusions: Patients with NTMLD in a US managed care claims database who were prescribed GBT had lower hospitalization risk than those who were prescribed non-GBT or were untreated. GBT was associated with lower total healthcare expenditure compared with non-GBT.     

Healthcare resource utilization with ixazomib or placebo plus lenalidomide-dexamethasone in the randomized,double-blind,phase 3 TOURMALINE-MM1 study in relapsed/refractory multiple myeloma

Aims: The aim of this analysis was to assess healthcare resource utilization in the pivotal phase 3 TOURMALINE-MM1 study of the oral proteasome inhibitor ixazomib or placebo plus lenalidomide and dexamethasone (Rd) in relapsed and/or refractory multiple myeloma (RRMM).

Methods: In this double-blind, placebo-controlled, randomized study (NCT01564537), 722 patients with RRMM following 1–3 prior lines of therapy received Rd plus ixazomib (ixazomib-Rd; n?=?360) or matching placebo (placebo-Rd; n?=?362) until disease progression or unacceptable toxicity. Healthcare resource utilization data were captured on Day 1 of each 28-day cycle, every 4 weeks during follow-up for progression-free survival, and every 12 weeks during subsequent follow-up, and included medical encounters (length of stay, inpatient, outpatient, and reason) and number of missing days from work or other activities for patients and caregivers.

Results: Exposure-adjusted rates of hospitalization were similar between the ixazomib-Rd and placebo-Rd arms, at 0.530 and 0.564 per patient year (ppy), respectively, as were outpatient visit rates (3.305 and 3.355 ppy). Mean length of hospitalization per patient was 10.0 and 10.8 days, respectively. In both arms, hospitalization and outpatient visit rates were higher in patients with two or three prior lines of treatment (ixazomib-Rd: 0.632 and 3.909 ppy; placebo-Rd: 0.774 and 3.539 ppy) compared with patients with one prior line (ixazomib-Rd: 0.460 and 2.888 ppy; placebo-Rd: 0.436 and 3.243 ppy). Patients and their caregivers who missed any work or other activity missed a median of 7 and 5 days in the ixazomib-Rd arm, respectively, vs 8 and 4 days with placebo-Rd.

Limitations: The study was not powered for a statistical comparison of healthcare resource utilization between treatment arms, nor did it capture costs associated with utilization of the identified healthcare resources.

Conclusions: This pre-specified analysis demonstrated that the all-oral triplet regimen of ixazomib added to Rd did not increase healthcare resource utilization compared with placebo-Rd.     

Length of stay and economic consequences with rivaroxaban vs enoxaparin/vitamin K antagonist in patients with DVT and PE: findings from the North American EINSTEIN clinical trial program

Objective:

Venous thromboembolism (VTE) (deep vein thrombosis [DVT] and pulmonary embolism [(PE]) represents a substantial economic burden to the healthcare system. Using data from the randomized EINSTEIN DVT and PE trials, this North American sub-group analysis investigated the potential of rivaroxaban to reduce the length of initial hospitalization in patients with acute symptomatic DVT or PE.

Methods:

A post-hoc analysis of hospitalization and length-of-stay (LOS) data was conducted in the North American sub-set of patients from the randomized, open-label EINSTEIN trial program. Patients received either rivaroxaban (15?mg twice daily for 3 weeks followed by 20?mg once daily; n?=?405) or dose-adjusted subcutaneous enoxaparin overlapping with (guideline-recommended ‘bridging’ therapy) and followed by a vitamin K antagonist (VKA) (international normalized ratio?=?2.0–3.0; n?=?401). The open-label study design allowed for the comparison of LOS between treatment arms under conditions reflecting normal clinical practice. LOS was evaluated using investigator records of dates of admission and discharge. Analyses were carried out in the intention-to-treat population using parametric tests. Costs were applied to the LOS based on weighted mean cost per day for DVT and PE diagnoses obtained from the Healthcare Cost and Utilization Project dataset.

Results:

Of 382 patients hospitalized, 321 (84%), had acute symptomatic PE; few DVT patients required hospitalization. Similar rates of VTE patients were hospitalized in the rivaroxaban and enoxaparin/VKA treatment groups, 189/405 (47%) and 193/401 (48%), respectively. In hospitalized VTE patients, rivaroxaban treatment produced a 1.6-day mean reduction in LOS (median?=?1 day) compared with enoxaparin/VKA (mean?=?4.5 vs 6.1; median?=?3 vs 4), translating to total costs that were $3419 lower in rivaroxaban-treated patients.

Conclusion:

In hospitalized North American patients with VTE, treatment with rivaroxaban produced a statistically significant reduction in LOS. When treating DVT and PE patients, clinicians should consider newer anti-coagulants with less complex treatment regimens.