Corticosteroids for the treatment of respiratory infection by Mycoplasma pneumoniae in children: A cost-utility analysis.

INTRODUCTION: Increasing evidence has demonstrated the effectiveness and safety of corticosteroids in community-acquired pneumonia in children. More economic evaluations incorporating the new evidence and in the pediatric population are needed to know the efficiency of this treatment. This study aimed to evaluate the cost utility of the use of corticosteroids as adjuvant treatment for children with Mycoplasma pneumonia. METHODS: A decision tree model was used to estimate the cost and quality adjusted life years (QALY) associated with cost-effectiveness as an adjunct treatment for children with Mycoplasma pneumonia with persistent signs after standard treatment with macrolide drugs for ≥1 week. Multiple sensitivity analyses were conducted. RESULTS: The QALYs per person estimated in the model for those treatments were 0.92 with corticosteroids plus antibiotics and 0.91 with antibiotics. The total costs per person were US$965 for corticosteroids plus antibiotics and US$1271 for antibiotics. This position of absolute dominance of corticosteroids plus antibiotics over antibiotics makes it unnecessary to estimate the incremental cost-effectiveness ratio. CONCLUSION: Corticosteroids are cost-effective as an adjunct treatment for children with Mycoplasma pneumoniae pneumonia with persistent signs after standard treatment with macrolide drugs for ≥1 week. Our evidence should motivate the evaluation of this treatment in other countries.

Ambrisentan for in pediatric pulmonary arterial hypertension: A cost-utility analysis.

INTRODUCTION: Despite the growing evidence of efficacy, little is known regarding the efficiency of ambrisentan to decrease cost and improve the functional classes of pediatric patients with pulmonary arterial hypertension. This study aims to determine the cost-utility of ambrisentan regarding sildenafil to treat pediatric patients with pulmonary arterial hypertension in Colombia. METHODS: A decision tree model was used to estimate the cost and quality-adjusted life-years (QALYs) of ambrisentan, or sildenafil in pediatric patients with pulmonary arterial hypertension. Multiple sensitivity analyses were conducted to evaluate the robustness of the model. Cost-effectiveness was evaluated at a willingness-to-pay (WTP) value of US$5180. RESULTS: The base-case analysis showed that compared with sildenafil, ambrisentan was associated with higher costs and higher QALYs. The expected annual cost per patient with ambrisentan was US$16,105 and with sildenafil was US$1431. The QALYs per person estimated with ambrisentan was 0.40 and for sildenafil was 0.39. The estimated improvement in quality of life and reduced costs results in an estimate of economic dominance for sildenafil over ambrisentan. CONCLUSION: Our economic evaluation shows that ambrisentan is not cost-effective regarding sildenafil to treat pediatric patients with pulmonary arterial hypertension in Colombia. Our study provides evidence that should be used by decision-makers to improve clinical practice guidelines.

Systematic review and cost-utility of high flow nasal cannula versus continuous positive airway pressure in children with acute severe or moderate bronchiolitis in Colombia.

BACKGROUND: Nasal Continuous Positive Airway Pressure (CPAP) and High-Flow Nasal Cannula (HFNC) have emerged as alternatives to orotracheal intubation and conventional invasive ventilation in patients with moderate to severe bronchiolitis. This study aims to evaluate the evidence and the cost-utility of HFNC compared to CPAP in infants with moderate-severe bronchiolitis in Colombia. METHODS: The search includes electronic databases such as Pubmed, ScienceDirect, and Embase. Through inclusion and exclusion criteria, screen randomized controlled trials. A decision tree model was used to estimate the cost-utility of CPAP compared with HFNC in infants with moderate-severe bronchiolitis. Sensitivity analysis of transition probabilities, utilities, and cost was carried out. RESULTS: Incorporate five studies that meet the criteria. The risk of intubation rate in the patients with CPAP is lower than HFNC (relative risk 0.62; 95% confidence interval 0.46-0.84; I2 = 0%) The base-case analysis showed that compared with HFNC, CPAP was associated with lower costs and higher quality-adjusted life years (QALYs). The expected annual cost per patient with CPAP was US$17,574 and with HFNC was US$29,421. The QALYs per person estimated with CPAP were 0.92 and with HFNC was 0.91. This position of absolute dominance of CPAP (CPAP has lower costs and higher QALYs than HFNI) makes it unnecessary to estimate the incremental cost-utility ratio. CONCLUSIONS: CPAP is cost-effective, over the HFNC, in infants with severe-moderate bronchiolitis in Colombia. Our study provides evidence that should be used by decision-makers to improve clinical practice guidelines and should be replicated to validate their results in other countries.

Vitamin A supplementation for the prevention of chronic lung disease in premature infants: A cost-utility analysis.

INTRODUCTION: Despite the growing evidence on efficacy, little is known regarding the efficiency of Vitamin A supplementation to decrease the probability of chronic lung disease (CLD) in preterm infants. This study aims to determine the cost-utility of Vitamin A to prevent CLD in preterm infants in Colombia. METHODS: A decision tree model was used to estimate the cost and quality-adjusted life-years (QALYs) of Vitamin A supplementation in preterm infants. Multiple sensitivity analyses were conducted to evaluate the robustness of the model. Cost-effectiveness was evaluated at a willingness-to-pay value of US$5180. RESULTS: Vitamin A was associated with lower costs and higher QALYs. The expected annual cost per patient with Vitamin A was US$1579 (95% CI US$1555-US$1585) and without Vitamin A was US$1913 (95% CI US$1891-US$1934). The QALYs per person estimated with Vitamin A was 0.66 (95% CI 0.66-0.67) and without Vitamin A was 0.61 (95% CI 0.60-0.61). This position of absolute dominance (Vitamin A has lower costs and higher QALYs than without Vitamin A) is unnecessary to estimate the incremental cost-effectiveness ratio. CONCLUSION: Our economic evaluation shows that Vitamin A is cost-effective to reduce the incidence rate of CLD in premature infants in Colombia. Our study provides evidence that should be used by decision-makers to improve clinical practice guidelines.

Dupilumab in children with moderate-to-severe asthma: A cost utility analysis.

INTRODUCTION: Dupilumab is an effective and safe medicine for the management of severe asthma. Due to its high cost, concerns are generated regarding its cost-effectiveness. This study aimed to estimate the cost-utility of dupilumab plus standard of care (SoC) versus SoC alone in children between 6 and 11 years old with severe asthma and eosinophilic phenotype. METHODS: A Markov-type model was developed to estimate costs and health outcomes of a simulated cohort of pediatric patients with persistent asthma treated over a 6-year period. To determine the robustness of the model deterministic and probabilistic sensitivity analyses were conducted. RESULTS: The quality-adjusted life-years (QALYs) per patient estimated were 0.85 with dupilumab and 0.84 with SoC. The total mean of discounted costs per patient per cycle were US$ 379 for dupilumab and US$ 19 for SoC. The incremental cost-effectiveness ratio estimated was $24 660 US$ per QALY CONCLUSION: Dupilumab is not cost-effective in Colombia in children between 6 and 11 years old with severe asthma and eosinophilic phenotype. Our evidence should motivate regulatory agencies to improve negotiations for new drugs with better information and evidence.

Bronchopulmonary dysplasia: Incidence and severity in premature infants born at high altitude.

BACKGROUND: Bronchopulmonary dysplasia (BPD) is the most common cause of chronic lung disease in children born prematurely. There is little information about the epidemiology and severity of BPD places with high altitude. This study aimed to evaluate the frequency of BPD severity levels and the associated risk factors with severity in a cohort of preterm newborns ≤36weeks of gestational age born in Rionegro, Colombia MATERIALS AND METHODS: We carried out a retrospective analytical cohort of preterm newborns without major malformations from Rionegro, Colombia between 2011 and 2018 admitted to neonatal intensive unit at high altitude (2200 m above sea level). The main outcomes were the incidence and severity of BPD. RESULTS: The BPD incidence was 23.5% 95% (confidence interval [CI], 19.6-27.7). BPD was grade 1 in 69.9%, grade 2 in 15.5% and grade 3 in 14.5% of patients. After modeling regression analysis, the final variables associated with BPD severity levels were: sepsis (odds ratio [OR], 4.15; 95% CI, 1.33-12.96) and pulmonary hypertension (OR: 3.86; 95% CI, 1.30-11.4). CONCLUSION: The incidence of BPD was higher and similar to cities with higher altitudes. In our population, the variables associated with BPD severity levels were: sepsis and pulmonary hypertension. It is necessary to increase the awareness of risk factors, the effect of clinical practices, and early recognition of BPD to reduce morbidity in patients with this pathology.

Cost-effectiveness analysis of phenotypic-guided versus guidelines-guided bronchodilator therapy in viral bronchiolitis.

OBJECTIVES: Although recent evidence suggests that management of viral bronchiolitis requires something other than guidelines-guided therapy, there is a lack of evidence supporting the economic benefits of phenotypic-guided bronchodilator therapy for treating this disease. The aim of the present study was to compare the cost-effectiveness of phenotypic-guided versus guidelines-guided bronchodilator therapy in infants with viral bronchiolitis. METHODS: A decision analysis model was developed to compare the cost-effectiveness of phenotypic-guided versus guidelines-guided bronchodilator therapy in infants with viral bronchiolitis. Phenotypic-guided bronchodilator therapy was defined as the administration of albuterol in infants exhibiting a profile of increased likelihood of response to bronchodilators. The effectiveness parameters and costs of the model were obtained from systematic reviews of the literature with meta-analyses and electronic medical records. The main outcome was the avoidance of hospital admission after initial care in the emergency department. RESULTS: Compared to guidelines-guided strategy, treating patients with viral bronchiolitis with the phenotypic-guided bronchodilator therapy strategy was associated with lower total costs (US$250.99; 95% uncertainty interval [UI]: US$184.37 to $336.51 vs. US$263.46; 95% UI: US$189.81 to $349.19 average cost per patient) and a higher probability of avoidance of hospital admission (0.7902; 95% UI: 0.7315-0.8356 vs. 0.7638; 95% UI: 0.7062-0.8201), thus leading to dominance. Results were robust to deterministic and probabilistic sensitivity analyses. CONCLUSIONS: Compared to guidelines-guided strategy, treating infants with viral bronchiolitis using the phenotypic-guided bronchodilator therapy strategy is a more cost-effective strategy, because it involves a lower probability of hospital admission at lower total treatment costs.

The cost-utility of intravenous magnesium sulfate for treating asthma exacerbations in children.

INTRODUCTION: Although evidence supports the use of intravenous magnesium sulfate (MS) in asthma exacerbations, MS continues to be considered a second-line drug for managing pediatric asthma exacerbations. This study aimed to evaluate the cost-utility of MS in asthma exacerbations. METHODS: We used a decision tree model to estimate the cost-utility of MS compared to treatment without MS (control group) in children with asthma exacerbations. Cost data were obtained from a retrospective study from tertiary centers in Rionegro, Colombia, while utilities were collected from the literature. Probabilistic sensitivity analysis was carried out using the Monte Carlo technique with a simulation of a hypothetical cohort of 10 000 patients to generate expected cost utilities with 95% confidence intervals. We used a cost-effectiveness acceptability curve to evaluate the uncertainty surrounding the cost-utility of MS. RESULTS: The model showed that MS had a lower total cost than the control group (US $1149 vs US $1598 average cost per patient) and higher quality-adjusted life years (0.60 vs 0.52 average per patient), showing dominance. The probability that MS provides a more cost-effective use of resources compared with standard therapy exceeds 99% for all willingness-to-pay thresholds. CONCLUSION: Intravenous MS was less expensive and more effective than treatment without intravenous MS in children with asthma exacerbations. Our study provides evidence that should be used by decision-makers to improve clinical practice guidelines and should be replicated to validate its results in other middle-income countries.

Effects of combinational CYP3A5 6986A>G polymorphism in graft liver and native intestine on the pharmacokinetics of tacrolimus in liver transplant patients: a meta-analysis.

BACKGROUND: Many studies have reported reduced tacrolimus dose-adjusted exposure in individuals expressing the CYP3A5*1 allele. A meta-analyses of the current data may help characterize the extent of impact this polymorphism has on tacrolimus pharmacokinetics in adult liver transplant recipients and whether donor or recipient genotype is the most influential factor. METHODS: Structured searches, of studies that evaluated the association between CYP3A5*1 allele and tacrolimus pharmacokinetics in adult liver transplant recipients, were conducted using Embase and Medline. A meta-analysis comparing tacrolimus daily dose, trough concentrations (C0), and dose-adjusted trough concentrations (C0/dose) across the donor and recipient genotype pairs was conducted using a random effects model. RESULTS: Eight studies, involving a total of 694 adult liver transplant recipients, were included. Dose-adjusted tacrolimus trough concentrations were significantly lower in those in whom the donor or recipient expressed a *1 allele compared with those in whom neither the donor nor recipient expressed this allele at 7 days and 2, 3, 6, and 12 months after transplant [standardized mean differences between expressers and nonexpressers of -1.98, -2.12, -2.39, -3.68, and -3.26 (ng/mL)/(mg·kg·d), respectively]. CONCLUSIONS: Results of the meta-analysis demonstrated that, in adult liver transplant patients, CYP3A5 expression in either the donor or recipient resulted in a need for a higher mean tacrolimus daily dose to achieve the target drug exposure. In the immediate posttransplant period, recipient expression of a CYP3A5*1 allele seemed to have the greatest influence on tacrolimus pharmacokinetics with donor expression of a CYP3A5*1 allelle possibly becoming more important with increasing time after transplant.

Chemoprophylaxis in contacts of patients with leprosy: systematic review and meta-analysis / Quimioprofilaxis en contactos de pacientes con lepra: revisión sistemática y metanálisis

OBJECTIVE: To identify and summarize randomized clinical trials (RCTs) that assessed the effectiveness of chemoprophylaxis to prevent leprosy in contacts of patients newly diagnosed with the disease. METHODS: All studies were extracted from Medline (PubMed 1966 to November 2008), the Cochrane Controlled Trials Register (number 3 2008), LILACS (1982 to November 2008), and Scirus (November 2008). Manual searches and searches of crossed references of assessed articles were also done. RCTs' risk of bias was assessed according to the methodology proposed by the Cochrane Collaboration. The main outcome measure was diagnosis of leprosy (secondary cases) in contacts of patients with the disease (primary cases). RESULTS: The search identified 320 references, from which 7 RCTs with a total of 66 311 participants were included and evaluated. The combined results from the RCTs favored chemoprophylaxis to placebo with 2-4 years of follow-up (6 RCTs, 66 107 participants, relative risk (RR) 0.59, 95 percent confidence interval (CI) 0.50-0.70, I² = 0 (I² describes percent total variation across studies caused by heterogeneity)). Single-dose rifampicin (21 711 participants, RR 0.43, 95 percent CI 0.28-0.67, number needed to treat 285), dapsone once or twice weekly for at least 2 years (3 RCTs, 43 137 participants, RR 0.60, 95 percent CI 0.48-0.76, I² = 0), and acedapsone every 10 weeks for 7 months (2 RCTs, 1 259 participants, RR 0.49, 95 percent CI 0.33-0.72, I² = 0) were significantly superior to placebo in preventing secondary cases of leprosy. CONCLUSION: Chemoprophylaxis is effective in lowering the incidence of leprosy in contacts of patients diagnosed with the disease.

OBJETIVO: Identificar y hacer un compendio de los ensayos clínicos aleatorizados (ECA) que evaluaron la eficacia de la quimioprofilaxis para prevenir la lepra en los contactos de pacientes con diagnóstico reciente de esa enfermedad. MÉTODOS: Se extrajeron todos los estudios de Medline (PubMed, de 1966 a noviembre de 2008), el Registro de Ensayos Controlados de Cochrane (No. 3 de 2008), LILACS (de 1982 a noviembre de 2008) y Scirus (noviembre de 2008). Se hicieron búsquedas manuales y se localizaron referencias cruzadas de los artículos analizados. Se evaluó el riesgo de sesgo de los ECA de acuerdo con la metodología propuesta por la Colaboración Cochrane. El principal criterio de valoración fue el diagnóstico positivo de lepra (casos secundarios) en los contactos de pacientes con esa enfermedad (casos primarios). RESULTADOS: Se identificaron 320 referencias, de las cuales se evaluaron 7 ECA con un total de 66 311 participantes. Los resultados combinados de los ECA favorecieron la quimioprofilaxis frente al placebo con 2-4 años de seguimiento (6 ECA, 66 107 participantes; riesgo relativo [RR] = 0,59; intervalo de confianza de 95 por ciento [IC95 por ciento]: 0,50 a 0,70; I²= 0 [I² describe la variación porcentual total en los estudios debida a la heterogeneidad]). Una dosis única de rifampicina (21 711 participantes; RR = 0,43; IC95 por ciento: 0,28 a 0,67; número necesario a tratar: 285), dapsona una o dos veces por semana durante al menos 2 años (3 ECA, 43 137 participantes; RR = 0,60; IC95 por ciento: 0,48 a 0,76, I² = 0) y acedapsona cada 10 semanas durante 7 meses (2 ECA, 1 259 participantes; RR = 0,49; IC95 por ciento: 0,33 a 0,72; I² = 0) fueron significativamente superiores que el placebo en la prevención de casos secundarios de lepra. CONCLUSIONES: La quimioprofilaxis es eficaz para reducir la incidencia de lepra en los contactos de pacientes diagnosticados con esta enfermedad.

Chemoprophylaxis in contacts of patients with leprosy: systematic review and meta-analysis.

OBJECTIVE: To identify and summarize randomized clinical trials (RCTs) that assessed the effectiveness of chemoprophylaxis to prevent leprosy in contacts of patients newly diagnosed with the disease. METHODS: All studies were extracted from Medline (PubMed 1966 to November 2008), the Cochrane Controlled Trials Register (number 3 2008), LILACS (1982 to November 2008), and Scirus (November 2008). Manual searches and searches of crossed references of assessed articles were also done. RCTs' risk of bias was assessed according to the methodology proposed by the Cochrane Collaboration. The main outcome measure was diagnosis of leprosy (secondary cases) in contacts of patients with the disease (primary cases). RESULTS: The search identified 320 references, from which 7 RCTs with a total of 66 311 participants were included and evaluated. The combined results from the RCTs favored chemoprophylaxis to placebo with 2-4 years of follow-up (6 RCTs, 66 107 participants, relative risk (RR) 0.59, 95% confidence interval (CI) 0.50-0.70, I(2) = 0 (I(2) describes percent total variation across studies caused by heterogeneity)). Single-dose rifampicin (21 711 participants, RR 0.43, 95% CI 0.28-0.67, number needed to treat 285), dapsone once or twice weekly for at least 2 years (3 RCTs, 43 137 participants, RR 0.60, 95% CI 0.48-0.76, I(2) = 0), and acedapsone every 10 weeks for 7 months (2 RCTs, 1 259 participants, RR 0.49, 95% CI 0.33-0.72, I(2) = 0) were significantly superior to placebo in preventing secondary cases of leprosy. CONCLUSION: Chemoprophylaxis is effective in lowering the incidence of leprosy in contacts of patients diagnosed with the disease.