Treatment patterns and use of healthcare resources of patients with atherosclerotic cardiovascular disease and hypercholesterolemia and patients with familial hypercholesterolemia in Spain: Protocol of the Reality study.

Background: Atherosclerotic cardiovascular diseases (ASCVD) and dyslipidemia are associated to a higher risk of cardiovascular events, mortality, use of healthcare resources and costs. In Spain, the evidence about the administration of lipid-lowering treatments in clinical practice, and their clinical effectiveness in patients with ASCVD and hypercholesterolemia and patients with FH is scarce. Therefore, a multidisciplinary working group of cardiologists, family physicians, internal medicine specialists and neurologists was gathered for the Reality study. The aim of this study is to describe the demographic and clinical characteristics, comorbidities, and concomitant medication of patients with ASCVD and hypercholesterolemia and of patients with familial hypercholesterolemia (FH). The use of healthcare resources and costs associated to the management of these diseases after their diagnosis were also considered. Methods: This is an observational and retrospective study, based on the BIG-PAC® database, which includes the electronic medical registries (EMRs) of 1.8 million people from 7 Autonomous Communities in Spain (including public primary care centers and hospitals). The study includes patients who had a new or recurrent episode of ASCVD during the recruitment period (from 01/01/2017 to 31/12/2018). The index date will be defined as the date of the ASCVD event, and the follow-up period will be 24 months. According to their first diagnosis in the database, patients will be classified as ASCVD (5 groups: stable/unstable angina, acute myocardial infarction, ischemic stroke, transient ischemic attack, and peripheral arterial disease) or FH. Discussion: This study aims to analyze the treatment patterns and use of healthcare resources of ASCVD and FH in Spain. The prevalence of these disorders will also be estimated. Due to the high morbidity and mortality associated with these diseases, it is expected that our study will provide useful information for healthcare systems and decision makers to improve the management of these disabling diseases.

Clinical and economic consequences of ozenoxacin vs. other topical antibiotics for the treatment of impetigo: a real-life study in Spain.

Background: Impetigo is a common dermatological paediatric infection that can be treated with topical antibiotics: the common are mupirocin (MUP), fusidic acid (FA) and, most recently, ozenoxacin (OZ). Aim: This study assesses the clinical and economic consequences of the use of OZ vs. MUP and vs. FA for the treatment of impetigo in routine clinical practice in Spain. Methods: This is a retrospective observational study using real-life data from electronic medical records of patients with impetigo who started treatment with OZ, MUP or FA (maximum follow-up: 3 months; n = 10,974). We compared treatment duration, comorbidities, use of systemic medication, complications, utilization of resources and associated costs across treatments (p<0.05). Cost-effectiveness of OZ was assessed from a social perspective. Complication rates and treatment duration were the effectiveness measures. Results: Mean age was 12.6 (standard deviation [SD]: 16.6) years; 48.6% were male; treatment: 9.3% (OZ), 56.4% (MUP), 34.5% (FA). The percentage of patients ending treatment after 2 weeks was 87.6% (OZ) vs. 83.2% (MUP) vs. 82.4% (FA); p<0.001; complication rates were 1.8% (OZ), 3.3% (MUP) and 3.2% (FA), p<0.001; mean costs were €158 (OZ), €265 (MUP) and €287 (FA), p<0.001. Conclusions: OZ is a cost-effective and dominant alternative for the treatment of impetigo.

Impact of Remdesivir on the Treatment of COVID-19 During the First Wave in Spain.

INTRODUCTION: Spain was one of the most affected countries during the first wave of COVID-19, having the highest mortality rate in Europe. The aim of this retrospective study is to estimate the impact that remdesivir-the first drug for COVID-19 approved in the EU-would have had in the first wave. METHODS: This study simulated the impact that remdesivir could have had on the Spanish National Health System (SNHS) capacity (bed occupancy) and the number of deaths that could have been prevented, based on two scenarios: a real-life scenario (without remdesivir) and an alternative scenario (with remdesivir). It considered the clinical results of the ACTT-1 trial in hospitalized patients with COVID-19 and pneumonia who required supplemental oxygen. The occupancy rates in general wards and ICUs were estimated in both scenarios. RESULTS: Remdesivir use could have prevented the admission of 2587 patients (43.75%) in the ICUs. It could have also increased the SNHS capacity in 5656 general wards beds and 1700 ICU beds, showing an increase in the number of beds available of 17.53% (95% CI 3.98%-24.42%) and 23.98% (95% CI 21.33%-28.22%), respectively, at the peak of the occupancy rates. Furthermore, remdesivir use could have prevented 7639 deaths due to COVID-19, which implies a 27.51% reduction (95% CI 14.25%-34.07%). CONCLUSIONS: Remdesivir could have relieved the pressure on the SNHS and could have reduced the death toll, providing a better strategy for the management of COVID-19 during the first wave.

Costs of the management of hemophilia A with inhibitors in Spain.

Introduction: Emicizumab is a first-in-class monoclonal antibody, recently authorized for the treatment of hemophilia A with inhibitors. This study aims to estimate the direct and indirect costs of the management of hemophilia A with inhibitors, in adult and pediatric patients, including the prophylaxis with emicizumab. Methods: We calculated the costs of the on-demand and prophylactic treatments with bypassing agents (activated prothrombin complex concentrate and recombinant activated factor VII) and the emicizumab prophylaxis, from the societal perspective, over 1 year. The study considered direct healthcare costs (drugs, visits, tests, and hospitalizations), direct non-healthcare costs (informal caregivers), and indirect costs (productivity loss). Data were obtained from a literature review and were validated by an expert group. Costs were expressed in 2019 euros. Results: Our results showed that the annual costs of the prophylactic treatment per patient varied between €543,062.99 and €821,415.77 for adults, and €182,764.43 and €319,826.59 for children, while on-demand treatment was €532,706.84 and €789,341.91 in adults, and €167,523.05 and €238,304.71 in pediatric patients. In relation to other prophylactic therapies, emicizumab showed the lowest costs, with up to a 34% and 43% reduction in the management cost of adult and pediatric patients, respectively. It reduced the bleeding events and administration costs, as this drug is less frequently administered by subcutaneous route. Emicizumab prophylaxis also decreased the cost of other healthcare resources such as visits, tests, and hospitalizations, as well as indirect costs. Conclusion: In comparison to prophylaxis with bypassing agents, emicizumab reduced direct and indirect costs, resulting in cost savings for the National Health System and society.

Development of a Solid Formulation Containing a Microemulsion of a Novel Artemisia Extract with Nematocidal Activity for Oral Administration.

BACKGROUND: Intestinal nematode infections are usually treated with benzimidazole drugs, but the emergence of resistance to these drugs has led to an increasing demand of new anthelmintic strategies. A new microemulsion formulation (ME) consisting of an Artemisia absinthium extract with proven nematocidal efficacy was previously developed. The aim of our study is to implement a D-optimal mixture design methodology to increase the amount of a silica material (loaded with this ME) in a tablet formulation, considering its tensile strength and disintegration time. METHODS: 16 experiments or combinations of the 6 tablet components (loaded silica, microcrystalline cellulose, polyvinylpyrrolidone, croscarmellose, Syloid® 244 FP and magnesium stearate) were assessed. Tensile strength and disintegration time models were developed, and an optimization process was carried out. RESULTS: Tensile strength was improved by increasing the polyvinylpyrrolidone content, while croscarmellose decreased the disintegration time. The optimized powder mixture contains 49.7% w/w of the loaded silica material. A compression force of 12 kN was applied to the powder mixture to form tablets with a tensile strength of 2.0 MPa and a disintegration time of 3.8 min. CONCLUSIONS: Our results show that D-optimal mixture designs provide a promising approach to formulate liquid-loaded silica materials.

Cost-utility analysis of germline BRCA1/2 testing in women with high-grade epithelial ovarian cancer in Spain.

PURPOSE: Germline mutations in BRCA1 and/or BRCA2 genes (gBRCA1/2m) are associated with an increased risk of breast cancer (BC) and ovarian cancer (OC). The aim of this study was to estimate the efficiency of providing germline BRCA1/2 testing to high-grade epithelial ovarian cancer (HGEOC) patients without family history of OC or BC and the subsequent testing and management of their relatives with gBRCA1/2m in Spain. METHODS/PATIENTS: Incident HGEOC patients without family history of OC or BC who were gBRCA1/2m carriers and their relatives were simulated in a 50-year time horizon. The study compared two scenarios: BRCA1/2 testing vs no testing, using the perspective of the Spanish National Health Service. Cancer risk among gBRCA1/2m carriers was estimated based on their age and whether they had undergone risk-reducing surgeries. Direct healthcare costs and utilities of patients who developed EOC and BC were also included. A probabilistic sensitivity analysis (PSA) with 5 thousand simulations was developed considering ± 25% of the base-case value. RESULTS: The BRCA1/2-testing scenario amounted to €13,437,897.43 while the no-testing scenario amounted to €12,053,291.17. It was estimated that the screening test improved the quality of life among the patients' relatives by 43.8 quality-adjusted life years (QALYs). The incremental cost-utility ratio (ICUR) was €31,621.33/QALY in the base case. The PSA showed that 89.12% of the simulations were below the €50,000/QALY threshold. CONCLUSION: Providing this screening test to HGEOC patients and their relatives is cost-effective and it allows one to identify a target population with high risk of cancer to provide effective prevention strategies.