Early initiation of long-acting injectable antipsychotic treatment is associated with lower hospitalization rates and healthcare costs in patients with schizophrenia: real-world evidence from US claims data

Objective: Early initiation of antipsychotic treatment in schizophrenia is associated with improved outcomes. This study aimed to determine if initiation of long-acting injectable (LAI) antipsychotic treatment early in a new schizophrenia episode is associated with lower hospitalization rates and healthcare costs in a real-world setting.

Methods: This retrospective (January 1, 2007–June 30, 2016) cohort analysis used claims from Truven Health Analytics MarketScan Commercial, Medicaid, and Medicare Supplemental databases. In adults ≥18?years with a new episode of schizophrenia, two mutually exclusive cohorts were identified based on time from first recorded schizophrenia diagnosis date to first date of LAI initiation (index date): ≤1?year (early initiators) and >1?year (late initiators). Logistic and general linear regression models were performed to estimate adjusted hospitalization rate and healthcare costs in a 1-year follow-up, controlling patient demographic and clinical characteristics, insurance type, baseline all-cause hospitalizations and ED visits, and baseline psychiatric medication use.

Results: Of the subjects, 32% (n?=?1388) initiated treatment early and 68% (n?=?2978) initiated treatment later. In risk-adjusted models, all-cause hospitalization rates were 22.2% (95% CI?=?19.9–24.6%) in early initiators and 26.9% (95% CI?=?25.2–28.7%) in late initiators (p?=?.002). Of early initiators, 14.1% (95% CI?=?12.3–16.1%) had a psychiatric hospitalization vs 19.2% (95% CI?=?17.7–20.8%) of late initiators (p?<?.001). Adjusted psychiatric healthcare costs were significantly lower in early initiators compared with late initiators [mean (95% CI)?=?$21,545 (20,355–22,734) vs $24,132 (23,330–24,933)] (p?<?.001).

Conclusions: LAI initiation within 1 year of a new schizophrenia episode led to lower hospitalization rates and healthcare costs compared with LAI initiation more than 1 year after a new episode.     

Efficacy and tolerability of switching therapy to vortioxetine versus other antidepressants in patients with major depressive disorder

Objectives:

To assess the relative efficacy and tolerability of vortioxetine against different antidepressant monotherapies in patients with major depressive disorder (MDD) with inadequate response to selective serotonin reuptake inhibitor (SSRI) or serotonin–norepinephrine reuptake inhibitor (SNRI) therapy.

Methods:

A systematic search was conducted for monotherapy studies in patients with MDD with inadequate response to first-line therapy. Treatments included SSRIs, SNRIs, and other antidepressants. Identified studies underwent a three-stage screening/data extraction process and critical appraisal. Adjusted indirect treatment comparisons (ITCs) on systematic literature review outputs were made using Bucher’s method, comparing remission rates and withdrawal rates due to adverse events (AEs).

Results:

Of 27 studies meeting the inclusion criteria, a few studies were of high quality according to the National Institute of Health and Care Excellence checklist. Three studies contributed to an evidence network for quantitative assessment comparing vortioxetine with agomelatine, sertraline, venlafaxine XR, and bupropion SR. Vortioxetine had a statistically significantly higher remission rate than agomelatine (risk difference [RD]: ?11.0% [95% CI: ?19.4; ?2.6]), and numerically higher remission rates than sertraline (RD: ?14.4% [95% CI: ?29.9; 1.1]), venlafaxine (RD: ?7.20% [95% CI: ?24.3; 9.9]), and bupropion (RD: ?10.70% [95% CI: ?27.8; 6.4]). Withdrawal rates due to AEs were statistically significantly lower for vortioxetine than sertraline (RD: 12.1% [95% CI: 3.1; 21.1]), venlafaxine XR (RD: 12.3% [95% CI: 0.8; 23.8]), and bupropion SR (RD: 18.3% [95% CI: 6.4; 30.1]).

Conclusions:

The current systematic literature review found a few high quality switch studies assessing monotherapies in patients with MDD with inadequate response to SSRI/SNRIs. ITCs indicated that switching to vortioxetine leads to numerically higher remission rates compared with other antidepressants. Vortioxetine is a well tolerated treatment, showing statistically lower withdrawal rates due to AEs compared with other antidepressants. Vortioxetine is a relevant therapeutic alternative in patients experiencing inadequate response to prior SSRI or SNRI therapy.     

Healthcare costs among adults with type 2 diabetes initiating saxagliptin or linagliptin: a US-based claims analysis

Objective: To compare healthcare costs of adults with type 2 diabetes (T2D) after initiation of saxagliptin or linagliptin, two antidiabetic medications in the dipeptidyl peptidase-4 inhibitor medication class.

Methods: Patients with T2D who were at least 18 years old and initiated saxagliptin or linagliptin (index date) between 1 June 2011 and 30 June 2014 were identified in the MarketScan Commercial and Medicare Supplemental Databases. All-cause healthcare costs and diabetes-related costs (T2D diagnosis on a medical claim and/or an antidiabetic medication claim) were measured in the 1 year follow-up period. Saxagliptin and linagliptin initiators were matched using propensity score methods. Cost ratios (CRs) and predicted costs were estimated from generalized linear models and recycled predictions.

Results: There were 34,560 saxagliptin initiators and 18,175 linagliptin initiators identified (mean ages 57 and 59; 55% and 56% male, respectively). Before matching, saxagliptin initiators had significantly lower all-cause total healthcare costs than linagliptin initiators (mean?=?$15,335 [SD $28,923] vs. mean =?$20,069 [SD $48,541], p?p?n?=?16,069 per cohort), saxagliptin initiators had lower all-cause follow-up costs than linagliptin initiators (CR?=?0.953, 95% CI?=?0.932–0.974, p?p?=?0.017; predicted costs?=?$3989 vs. $4159).

Conclusions: Adult patients with T2D initiating treatment with saxagliptin had lower total all-cause healthcare costs and diabetes-related medical costs over 1 year compared with patients initiating treatment with linagliptin.     

Healthcare resource utilization and costs among women diagnosed with uterine fibroids compared to women without uterine fibroids

Objective: To perform a retrospective, matched-cohort, longitudinal evaluation of annual pre- and post-diagnosis costs incurred among women with uterine fibroids (UF) (cases) compared to controls without UF.

Methods: Data were derived from the IBM Watson Health MarketScan Commercial Claims and Encounters and Medicaid Multi-State databases. Women aged 18–64?years with ≥1 inpatient or outpatient medical claim with an initial UF diagnosis (index date) from 1 January 2010 to 31 December 2014 were included. Healthcare resource utilization (HCRU) data including pharmacy, outpatient and inpatient hospital claims were collected for 1?year pre-index and ≤5?years post-index. All-cause costs (adjusted to 2017 $US) were compared between cases and controls using multivariable regression models.

Results: Analysis included 205,098 (Commercial) and 24,755 (Medicaid) case–control pairs. HCRU and total all-cause healthcare costs were higher for cases versus controls during the pre-index year and all years post-index. Total unadjusted mean all-cause costs were $1197 higher (p?<?.0001; Commercial) and $2813 higher (standardized difference 0.08; Medicaid) for cases during the pre-index year. Total adjusted mean all-cause costs in the first year post-index were $14,917 for cases versus $5717 for controls in the Commercial population, and $20,244 versus $10,544, respectively, in the Medicaid population. In Years 2–5 post-index, incremental mean adjusted total costs decreased, but remained significantly higher for cases versus controls at all time points in both populations (all p?<?.05).

Conclusions: Costs were higher for women with UF compared to women without UF during the pre-index year and over 5?years post-index; differences were greatest in the first year post-index.     

Adherence to iron chelation therapy in patients who switched from deferasirox dispersible tablets to deferasirox film-coated tablets

Objective: To compare real-world adherence to and persistence with deferasirox film-coated tablets (DFX-FCT) and deferasirox dispersible tablets (DFX-DT) among patients who switched from DFX-DT to DFX-FCT, overall and by disease type (sickle cell disease [SCD], thalassemia, and myelodysplastic syndrome [MDS]).

Methods: Patients were ≥2 years old and had ≥2 DFX-FCT claims over the study period and ≥2 DFX-DT claims before the index date (first DFX-FCT claim). The DFX-DT period was defined from the first DFX-DT claim to the index date; the DFX-FCT period was defined from the index date to the end of the study period. Adherence was measured as medication possession ratio (MPR) and proportion of days covered (PDC). Persistence was defined as continuous medication use without a gap ≥30 or 60 days between refills. Comparisons were conducted using paired-sample Wilcoxon sign-rank and McNemar’s tests.

Results: In total, 606 patients were selected (SCD: 348; thalassemia: 107; MDS: 106; other: 45). Adherence and persistence in the DFX-FCT vs DFX-DT period was significantly higher across all measures: mean MPR was 0.80 vs 0.76 (p?<?.001); 60.9% vs 54.3% of patients had MPR?≥?0.8 (p?=?.009); mean 3-month PDC was 0.83 vs 0.71 (p?<?.001); 64.2% vs 45.4% of patients had 3-month PDC?≥?0.8 (p?<?.001); 87.2% vs 63.4% of patients had 3-month persistence with no gap ≥30 days and 96.1% vs 79.9% with no gap ≥60 days (p?<?.001). Adherence and persistence improved after switching across all diseases, particularly MDS.

Conclusions: Adherence and persistence improved significantly after switching from DFX-DT to DFX-FCT for all diseases, but especially MDS.     

Increasing economic burden of tyrosine kinase inhibitor treatment failure by line of therapy in chronic myeloid leukemia

Objective:

To assess the economic burden of tyrosine kinase inhibitor (TKI) treatment failure in chronic myeloid leukemia (CML), by assessing all-cause health care resource use (HCRU) and costs in the year after treatment failure by line of therapy (LOT; 1L/2L/3L) using real-world data.

Methods:

Treatment episodes initiating a TKI of interest (index TKI) during June 2008–December 2011 were identified from the IMS PharMetrics Plus Health Plan Claims Database for adult patients with CML diagnosis (ICD-9-CM 205.1x), 120 days pre-index continuous enrollment (CE) and no clinical trial participation. Episodes experiencing treatment failure, defined as switch to a non-index TKI or discontinuation of index TKI (gap of?≥?60 days), and with 1 year CE post-failure, were analyzed. LOT was determined by number of unique TKIs used in the pre-index. All-cause HCRU and costs (2012 USD) in the 1 year post-failure were assessed by LOT, and the comparisons between 1L and 2L failures were also adjusted using multivariate generalized linear models (GLMs) to control for underlying differences.

Results:

A total of 706 episodes were identified (518 1L; 180 2L; 8 3L). Unadjusted HCRU over 1 year post-failure increased significantly. This was accompanied by a significant increase in unadjusted mean costs for 2L failures vs. 1L failures ($99,624 vs. $78,667, p?=?0.021, Δ$20,957). Following the adjustment using GLMs, adjusted mean costs were 38% higher (95% CI 1.14–1.68), driven primarily by use of medical services. In adjusted analyses, compared to 1L, 2L failures had: 45% more ambulatory visits (mean 31 vs. 21, 95% CI 1.26–1.66), 75% higher risk of hospitalization (33% vs. 23% hospitalized, 95% CI 1.16–2.64), and 73% higher medical costs (95% CI 1.31–2.29). Medical costs comprised a greater proportion of total costs in 2L vs. 1L (55% vs. 44%); pharmacy costs did not increase significantly.

Conclusions:

The economic burden over 1 year post TKI failure increased with each sequential line of TKI treatment failure.     

Comparing the economic burden of ischemic stroke patients with and without atrial fibrillation: a retrospective study in Beijing,China

Background: Little is known about the economic burden for ischemic stroke (IS) patients with atrial fibrillation (AF) in China.

Aim: We aimed to compare the economic burden of treatment-related costs in IS patients with AF vs. without AF in China.

Methods: This retrospective analysis used economic burden data from the Beijing urban health insurance database. Using a random sampling method, 10% of the patients diagnosed with IS from 1 January through 31 December 2012 were enrolled. First hospitalization was considered as the index event and hospital utilization after the index event was followed up until September 2013. Overall healthcare cost during the study period was analyzed.

Results: In 4061 patients with IS (mean?±?SD age, 68.45?±?13.95 years; AF: 992; without AF: 3069), the AF group had a higher percentage of patients with co-morbidities at baseline. Compared with the non-AF group, the AF group had significantly greater hospitalization at the index event (p?p?Conclusions: AF increased the use of healthcare resources, treatment cost, and economic burden in patients with IS. Therefore, prevention of cardio-embolic events in patients with AF by anticoagulants may decrease the economic burden in patients with IS.     

Increased healthcare resource utilization in higher disease activity levels in initiators of TNF inhibitors among US rheumatoid arthritis patients

Objective: Determine healthcare resource utilization (HCRU) in biologic-naïve initiators of TNF inhibitors (TNFis) associated with their disease activity from a national cohort of rheumatoid arthritis (RA) patients.

Methods: RA patients were identified at their first TNFi initiation (index date) in the Corrona registry. Patients with age of RA onset <18, comorbid psoriasis/psoriatic arthritis, fibromyalgia, or osteoarthritis were excluded. Patients were categorized into disease activity (DA) strata by the lowest level of DA (and sustaining low levels for at least two visits) using the Clinical Disease Activity Index (CDAI) across all visits in Corrona while on a TNFi during 1 year after initiation. Rates of all-cause and RA-related hospitalizations, rheumatologist visits, and joint surgeries while on TNFi therapy were reported and compared across DA levels along with the incidence rate ratio (IRR) adjusted for age, gender, and RA duration using Poisson mixed models.

Results: Of 1931 RA patients: 15% achieved sustained remission, 22% remission, 14% sustained low DA, 23% low DA and 27% moderate/high DA (M/HDA). Those in M/HDA had statistically higher rates of hospitalizations (37.3 per 100 patient years (py), 95% CI: 31.6–43.7 and joint surgeries (20.8 per 100 py, 95% CI: 16.6–25.8) compared to the sustained remission cohort, resulting in respective IRRs of 2.3 (p?<?0.001) and 1.7 (p?=?0.046).

Conclusion: Many biologic naïve RA patients initiating TNFi failed to achieve sustained remission during a 1 year period while remaining on TNFi therapy. Patients in higher DA levels had higher HCRU rates vs. patients in sustained remission, suggesting that achieving treat-to-target goals would reduce health care expenses.     

Treatment patterns and Medicaid spending in comorbid schizophrenia populations: once-monthly paliperidone palmitate versus oral atypical antipsychotics

Objective: To compare treatment patterns and Medicaid spending between schizophrenia patients initiating once-monthly paliperidone palmitate (PP1M) and oral atypical antipsychotics (OAAs) within four comorbid populations: cardiovascular disease (CVD), diabetes, hypertension and obesity.

Methods: Five-state Medicaid data identified comorbid adults with schizophrenia initiating PP1M or OAAs (index) from September 2009 balanced with inverse probability of treatment weighting. Chi-squared and t-tests compared index antipsychotic (AP) exposure (no gap >90 days) duration, AP polypharmacy, and index AP adherence (proportion of days covered ≥80%) and persistence (no gap ≥60 days) at 12 months post-index. Linear models with a non-parametric bootstrap procedure compared costs.

Results: PP1M patients consistently had longer index AP exposure (e.g. CVD: 244 vs. 189 days; p?p?p?p?=?.031). Persistence was consistently more likely for PP1M versus OAA patients (e.g. CVD: 49.9% vs. 27.4%; p?p?Conclusions: Treatment with PP1M versus OAAs may reduce AP polypharmacy and increase AP persistence in comorbid patients with schizophrenia, without increasing total healthcare costs. Comorbidities are a highly prevalent driver of excess mortality in this vulnerable population; thus, future studies should specifically address the real-world effectiveness of therapies, including long acting injectable therapies (LAIs), for these patients.     

A risk scoring system to predict coronary stent thrombosis

Objective: Stent thrombosis (ST) is a potentially life-threatening complication of percutaneous coronary intervention (PCI). We aimed to develop a scoring system to predict the risk of ST following PCI.

Research design and methods: Odds ratios (ORs) for risk factors associated with ST were identified from a meta-analysis based on a systematic literature review, and through consensus expert opinion (Delphi–RAND method). The combined ORs were used to calculate risk scores for acute (within 24?hours), early (within 30 days) and late (31 days to 1 year) ST. Risk scores were validated against patient-level data from the TRITON-TIMI 38 study. Twenty risk factors were identified.

Results: The most highly predictive factor for early and late ST was “incomplete duration of dual antiplatelet therapy”. Derived total risk scores ranged from 0 to 22 for acute and early ST, and from 0 to 20 for late ST. Increasing scores were associated with an increasing risk of ST when applied to trial data. Model discrimination was 0.60 (p?=?.0028), 0.67 (p?p?Conclusion: Our weighted scoring system may help to stratify ST risk and individualize antiplatelet therapy in patients undergoing PCI.     

Escitalopram in the treatment of major depressive disorder: A meta-analysis

ABSTRACT

Objective: To assess the relative antidepressant efficacy of escitalopram and comparator antidepressants.

Research design and methods: A meta-analysis was performed using studies in major depressive disorder (MDD) comparing escitalopram with active controls, including selective serotonin reuptake inhibitors [SSRIs] (citalopram, fluoxetine, paroxetine, sertraline) and serotonin/noradrenaline reuptake inhibitors [SNRIs] (venlafaxine, duloxetine). Adult patients had to meet DSM-IV criteria for MDD.

Main outcome measures: The primary outcome measure was the treatment difference in Montgomery–Åsberg Depression Rating Scale (MADRS) total score at week?8. Secondary outcome measures were response and remission (MADRS total score ≤?12) rates.

Results: Individual patient data (N?=?4549) from 16 randomized controlled trials were included in the analyses (escitalopram n?=?2272, SSRIs n?=?1750, SNRIs n?=?527). Escitalopram was significantly more effective than comparators in overall treatment effect, with an estimated mean treatment difference of 1.1?points on the MADRS (p?<?0.0001), and in responder (63.7?vs. 58.3%, p?<?0.0001) and remitter (53.1?vs. 49.4%, p?<?0.0059) analyses. Escitalopram was significantly superior to SSRIs, with an estimated difference in response of 62.1?vs. 58.4% and remission of 51.6?vs. 49.0%. In comparison to SNRIs, the estimated difference in response was 68.3?vs. 59.0% (p?=?0.0007) and for remission the difference was 57.8?vs. 50.5% (p?=?0.0088). These results were similar for severely depressed patients (baseline MADRS ≥?30). Sensitivity analyses were performed with data from articles reporting Hamilton Rating Scale for Depression (HAMD) scores. The 8-week withdrawal rate due to adverse events was 5.4% for escitalopram and 7.9% for the comparators (p?<?0.01). This difference was accounted for by statistically significant higher attrition rates in the SNRI comparisons. This work may be limited by the clinical methodology underlying meta-analytic studies, in particular, the exclusion of trials that fail to meet predetermined criteria for inclusion.

Conclusions: In this meta-analysis, superior efficacy of escitalopram compared to SSRIs and SNRIs was confirmed, although the superiority over SSRIs was largely explained by differences between escitalopram and citalopram.     

换用文拉法辛或度洛西汀对抑郁症残留症状的疗效观察

目的 探索文拉法辛或度洛西汀对选择性五羟色胺再摄取抑制剂（selective serotonin reuptake inhibitor,SSRI）类药物抗抑郁疗效不佳抑郁症患者的疗效及安全性。方法 对2015年11月-2016年10月间就诊且SSRI类抗抑郁药疗效不佳或有残余症状的96例首发抑郁症患者,以单纯随机的方式分为2组,经洗脱期后,分别给予可变剂量的文拉法辛或度洛西汀治疗,进行为期12周的前瞻性研究,在基线及第2,4,6,8,12周末评定汉密尔顿抑郁量表（Hamilton Depression Scale,HAMD-17）、汉密尔顿焦虑量表（Hamilton Anxiety Scale,HAMA）、治疗出现的不良反应量表（Treatment Emergent Symptom Scale,TESS）;同时由患者自评快感缺失量表（Snaith-Hamilton Pleasure Scale,SHAPS）、愉快情绪体验量表（Temporal Experience Pleasure Scale,TEPS）,分析和评价2组的疗效及安全性。结果 12周末,换用去甲肾上腺素和五羟色胺再摄取抑制剂（serotonin and norepinephrine reuptake inhibitor,SNRI）类药物后,患者总体有效率和治愈率分别为73.96%和39.58%,同治疗前相比,HAMD-17、HAMA、SHAPS、TEPS分值均有较大改善（P<0.05或P<0.01）,但文拉法辛组及度洛西汀组间的疗效无统计学差异（P>0.05）。2组的不良反应相似,主要为口干、便秘、乏力、性功能障碍等,但文拉法辛组的血压增高现象略多（P<0.05）。结论 SSRI类药物抗抑郁疗效不佳者,换用SNRI类药物后能有效改善包括快感缺失在内的抑郁症状。文拉法辛和度洛西汀疗效相近,安全性均较好,其中文拉法辛对血压影响较度洛西汀明显,应慎用于高血压患者。     

Transitioning from oral risperidone or paliperidone to once-monthly paliperidone palmitate: a real-world analysis among Veterans Health Administration patients with schizophrenia who have had at least one prior hospitalization

Abstract

Objective: To address gaps in the literature on healthcare resource utilization (HRU) and costs among patients with schizophrenia and prior hospitalization who transition from oral risperidone or paliperidone (oral ris/pali) to once-monthly paliperidone palmitate (PP1M) in a real-world setting by comparing treatment patterns, HRU, and costs 12-months pre- and post-transition to PP1M among Veterans Health Administration (VHA) patients affected by schizophrenia who have had ≥1 hospitalization.

Methods: VHA patients with schizophrenia (aged ≥18?years) who initiated oral ris/pali, had ≥1 all-cause inpatient stay, and transitioned to PP1M from January 2015–March 2017 were included from the VHA database. The first transition date to PP1M was identified as the index date. Patients were required to have continuous health plan eligibility for 12?months pre- and post-PP1M. Outcomes were compared using the Wilcoxon signed-rank and McNemar’s test, as appropriate.

Results: The study included 319 patients (mean [SD] age?=?51.6 [4.2] years) during 12 months of baseline and follow-up. During pre-PP1M transition, 7.2% of the patients were adherent (proportion of days covered [PDC]?≥?80%) to oral ris/pali. Post-PP1M transition, 27.6% of the patients were adherent to PP1M. Comparison of HRU outcomes from the pre- to post-PP1M transition revealed significantly lower all-cause inpatient stays (3.5 vs 1.4, p?<?.0001) and shorter inpatient length of stay (43.4 vs 18.3?days, p?<?.0001). Similar trends were seen for mental health and schizophrenia-related HRU. Cost outcome comparison indicated significantly lower all-cause inpatient costs ($64,702 vs $24,147, p?<?.0001), total medical costs ($87,917 vs $56,947, p?<?.0001), and total costs ($91,181 vs $69,106, p?<?.0001). A similar trend was observed for mental health and schizophrenia-related costs.

Conclusions: Transitioning from oral ris/pali to PP1M may significantly improve HRU and provide potential cost savings in VHA patients with schizophrenia and ≥1 prior hospitalization.     

Comparison of effectiveness and safety of treatment with apixaban vs. other oral anticoagulants among elderly nonvalvular atrial fibrillation patients

Objective: To compare the risk of stroke/systemic embolism (S/SE) and major bleeding (MB) of elderly (≥65 years of age) nonvalvular atrial fibrillation (NVAF) patients initiating apixaban vs. rivaroxaban, dabigatran, or warfarin.

Methods: NVAF patients with Medicare Advantage coverage in the US initiating oral anticoagulants (OACs, index event) were identified from the Humana database (1 January 2013–30 September 2015) and grouped into cohorts depending on OAC initiated. Propensity score matching (PSM), 1:1, was conducted among patients treated with apixaban vs. each other OAC, separately. Rates of S/SE and MB were evaluated in the follow-up. Cox regressions were used to compare the risk of S/SE and MB between apixaban and each of the other OACs during the follow-up.

Results: The matched pairs of apixaban vs. rivaroxaban (n?=?13,620), apixaban vs. dabigatran (n?=?4654), and apixaban vs. warfarin (n?=?14,214) were well balanced for key patient characteristics. Adjusted risks for S/SE (hazard ratio [HR] vs. rivaroxaban: 0.72, p?=?.003; vs. warfarin: 0.65, p?p?p?p?=?.27) and MB (HR: 0.82, p?=?.23) of NVAF patients treated with apixaban vs. dabigatran trended to be lower, but did not reach statistical significance.

Conclusions: In the real-world setting after controlling for differences in patient characteristics, apixaban is associated with significantly lower risk of S/SE and MB than rivaroxaban and warfarin, and a trend towards better outcomes vs. dabigatran among elderly NVAF patients in the US.     

The clinical and economic burden of cytomegalovirus management post allogeneic hematopoietic stem cell transplantation in Japan – a retrospective database study

Abstract

Introduction: Reactivation of cytomegalovirus (CMV) infection is a major threat and it causes significant morbidity and mortality after allogeneic hematopoietic stem cell transplantation (allo-HSCT). There remains, however, a paucity of evidence regarding the economic burden of current CMV management in Japan. The aim of this study is to characterize the healthcare resource utilization (HCRU) and cost incurred for CMV management post allo-HSCT, using a Japanese hospital claims database.

Methods: Patients who underwent allo-HSCT between April 2010 and March 2018 were identified and followed up for 180?days.

Results: In total, 916 patients were included for analysis and categorized into CMV (?) group and CMV (+) group based on the presence of a CMV episode within 100?days post allo-HSCT. A CMV episode was defined as evidence of receiving at least one dose of the following anti-CMV drugs, ganciclovir, foscarnet, or valganciclovir. The mean (± standard deviation [SD]) total length of stay was 93.6 (± 43.7) days in the CMV (+) group, which was significantly longer than 55.9 (±40.6) days in the CMV (?) group, and this trend was more pronounced in patients with multiple CMV episodes. The mean (±SD) total medical cost within 180?days post allo-HSCT was US$122,328 (±56,977) in the CMV (+) group, while the mean total medical cost was US$75,344 (±43,821) in the CMV (?) group. Moreover, transfusion and antimicrobial use was observed as the major medication cost component, which is suggestive of the indirect effect of CMV episodes.

Conclusion: This study demonstrated that CMV episodes post allo-HSCT were associated with increased HCRU and cost.     

Educational lectures enhance knowledge about the human immunodeficiency virus (HIV) and reduce risky behavior and fear among methadone maintenance treatment patients

Abstract

Background: The aim of this study was to characterize human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS)-related knowledge and stigma among methadone maintenance treatment (MMT) patients and evaluate the contribution of an educational lecture in reducing risky behavior and unjustified overprotective behavior due to fear and stigma among MMT patients. Methods: Patients from an MMT clinic within a tertiary medical center were invited to an educational lecture on HIV/AIDS. Seventy participants (of current 330) were chosen by a random sample (December 2015), plus at-risk patients and HIV patients. Attendee compliance and change in scores of questionnaires on knowledge (modified HIV-K-Q-22) and on sexual and injection behaviors were studied. Results: Forty-six patients (65.7% compliance) attended the lecture, and their knowledge and behavior scores improved 2?weeks post-lecture (knowledge: from 14.2?±?3 to 19.0?±?2.2 [P?<?.0005], sexual behavior: from 12.1?±?2.9 to 8.8?±?3.0 [P?<?.0005], and injection behavior: from 7.3?±?6.2 to 0.2?±?1.3 [P?<?.0005]). The unjustified fear of proximity to HIV carriers reported by 50% attendees fell to 35% post-lecture. Eight months post-lecture, the scores on knowledge and risky behavior of 21 randomly chosen attendees were still better than pre-lecture scores (knowledge: 15.4?±?2.3 vs. 17.2?±?1.8 [paired t test, P?=?.001], sexual behavior: 13.2?±?2.3 vs. 9.7?±?2.9 [P?<?.0005], and injection behavior: 9.3?±?5.6 vs. 2.8?±?3.1 [P?<?.0005]). Drug abuse and treatment adherence were not related to intervention and to risky behavior. Conclusions: More knowledge, less fear, and less risky behavior immediately and at 8?months post-lecture reflect the success and importance of the educational intervention. Future efforts are needed in order to reduce ignorance and fear associated with HIV/AIDS.     

Enteric-coated budesonide for the induction and maintenance of remission of Crohn’s disease in children

Objective: These studies evaluated the safety and efficacy of enteric-coated budesonide for the induction and maintenance of remission of mild-to-moderate Crohn’s disease (CD) in children.

Methods: The consecutive, multicenter, open-label, non-comparative studies enrolled patients aged 6–17 years. In the induction study, patients with active CD of the ileum and/or ascending colon received budesonide 9?mg or 6?mg once daily for 8 weeks; in the maintenance study, patients in remission received budesonide 6?mg once daily for 12 weeks. The primary objective was assessment of safety, including glucocorticosteroid-related side effects and serum cortisol levels. Efficacy was assessed using the Pediatric Crohn’s Disease Activity Index (PCDAI), and health-related quality of life (HRQoL) using the IMPACT-III questionnaire.

Results: In the induction study (n?=?108), most adverse events were related to CD, commonly abdominal pain; possible glucocorticosteroid-related effects included acne and increased appetite but without significant weight gain. Subnormal morning cortisol levels were observed in 32 of 103 patients after 8 weeks. Budesonide reduced disease activity from baseline (mean?±?standard deviation, 9.1?±?8.5 vs. 19.1?±?10.1, p?p?n?=?50), mean disease activity worsened (p?=?.047) with HRQoL unchanged (p?=?.33).

Conclusions: Budesonide treatment was generally well tolerated, although the potential for adrenal suppression was noted. Budesonide was effective for induction of remission in children with mild-to-moderate CD but not for maintaining remission (ClinicalTrials.gov identifiers: NCT01444092, NCT01453946).     

Channelling of SSRIs and SNRIs use in the Tayside population, Scotland

PURPOSE: To compare the user profiles of the two classes of drug, using the Tayside Medicines Monitoring Unit (MEMO) record-linkage database. METHODS: A cohort study was carried out in the population of Tayside in Scotland. A total of 13 901 selective serotonin re-uptake inhibitor (SSRI) users and 1417 selective norepinephrine re-uptake inhibitor (SNRI) users were identified during the period of December 2000 to November 2001. A logistic regression model was used to assess the association between drug use and patients profiles and a Cox regression model was employed to examine the effect of drug use and mortality outcome. RESULTS: Compared to SNRI patients, SSRI patients were significantly older (28.8% >/= 60 year vs. 26.2%), more likely to be female (70.9% vs. 67.8%), had more cardiovascular disease history (10.1% vs. 8.5%), but were less deprived (9.7% in the highest deprivation category vs. 12.4%), had less digestive disease (27.9% vs. 31.0%) and less history of drug overdose hospitalisation (7.2% vs. 11.9%). SNRI patients had more drug switching than SSRI patients (62.0% for recent users, 33.2% for prevalent users vs. 39.1%, 26.1%, respectively). The age-standardised mortality rates during the follow-up period until December 2003 were 5.3% for SSRI and 5.9% for SNRI users. CONCLUSION: There was clear evidence that SSRI and SNRI were used in patient groups with different characteristics. This channelling sometimes favoured an improved mortality outcome and sometimes favoured a worse outcome. Overall there was no mortality difference between the two classes of drugs.