We identified one randomized controlled trial that evaluated rapid COJEC versus standard induction therapy in patients with high-risk neuroblastoma. No clear evidence of a difference in complete response, treatment-related mortality, overall survival, and event-free survival between the treatment alternatives was found. This could be the result of low power or too short a follow-up period. Results of both early and late toxicities were ambiguous. Information on progression-free survival and health-related quality of life were not available. This trial was performed in the 1990s. Since then, many changes in, for example, treatment and risk classification have occurred. Therefore, based on the currently available evidence, we are uncertain about the effects of rapid COJEC and standard induction therapy in patients with high-risk neuroblastoma. More research is needed for a definitive conclusion.
Introduction
Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of mortality in Italy, accounting for 22% of total deaths. Lowering low-density lipoprotein cholesterol (LDL-C) levels reduces the risk of cardiovascular (CV) events; thus, lipid-lowering therapy (LLT) is the first-line treatment for patients with ASCVD and hypercholesterolaemia. However, many patients with ASCVD fail to reach LDL-C treatment thresholds, leaving them at greater risk of CV events. Inpatient care accounts for 51% of total expenditure on cardiovascular disease in the European Union, but healthcare resource utilization (HCRU) data for ASCVD in Italy is limited.
Methods
The study analysed healthcare claims data for 17,881 patients with acute coronary syndrome, ischemic stroke or peripheral artery disease from the Umbria 2 and Marche regions of Italy. LLT treatment patterns and CV event rates were collected and HCRU estimated in the year before and after the index event.
Results
High-intensity LLTs were prescribed to 44.3% of patients and 49.6% received moderate-/low-intensity LLTs during the 6 months after the index event. The first year CV event rate was 18.0/100 patient-years for patients receiving high-intensity LLTs and 17.2/100 patient-years for those on moderate-/low-intensity LLTs. Higher costs were associated with patients untreated with LLT 6 months post-index event (€8323) than patients prescribed high-intensity (€6278) or moderate-/low-intensity LLTs (€6270). Hospitalization accounted for most of the total costs.
Conclusions
This study found that CV events in secondary prevention Italian patients are associated with substantial HCRU and costs. More intensive LDL-C lowering can prevent CV events, easing the financial burden on the healthcare system.
Supplementary Information
The online version contains supplementary material available at 10.1007/s12325-021-01960-y.
Objectives: To evaluate the occurrence of acute readmissions of patients in secondary prevention for Atherosclerotic Cardiovascular Disease (ASCVD) using Health Information Systems (HIS) in Italy. Methods: Retrospective observational study on claims database from Marche and Umbria regions (1.8 million of inhabitants), including patients aged 18-80 years with one or more hospitalizations for Acute Coronary Syndrome (ACS), Ischemic Stroke and Transient Ischemic Attack (IS), and Peripheral Artery Disease (PAD). Patients were discharged between 2009 and 2012 for Marche and between 2011 and 2014 for Umbria, and should have had at least 2 prescriptions of lipid lowering therapies (statins and/or ezetimibe) in the 365 days prior to and/or in the 180 days following the first cardiovascular (CV) hospitalization (index-event). Patients were followed up for 2 to 5 years to verify the occurrence of hospitalizations for subsequent CV events (ACS, IS and PAD). Results were stratified by type of index condition (ACS, IS and PAD). CV hospitalization event rates (HER) were calculated for the year following the event, and cumulative incidence of rehospitalization was calculated for patients with 5 years follow-up. Results: 17,881 patients were included; 56.3% with history of ACS, 22.7% of IS and 21% of PAD. First year HER was estimated at 17.6 per 100 patients-year (15.4 for ACS, 13.9 for IS and 28.4 for the PAD cohorts). Additionally, among the 4,690 patients with follow-up information up to 5 years (26.2% of total sample size), 30.3% were hospitalized due to CV events in this period: ACS (27.5%), IS (26.6%) and PAD (42.5%). Conclusions: The recurrent CV HER in this study provides real-world estimates of CV disease burden in secondary prevention patients in Italy. The high proportion of rehospitalizations in these patients, despite being treated with LLT, highlights the need to improve patient management in a population with a substantial unmet need.
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