Efficacy and safety of dabrafenib-trametinib in the treatment of unresectable advanced/metastatic melanoma with BRAF-V600 mutation: A systematic review and network meta-analysis.

The current systematic review aimed to evaluate and compare the efficacy and safety of dabrafenib-trametinib with those of other therapeutic alternatives in the treatment of patients with unresectable advanced/metastatic melanoma with BRAF-V600 mutation. The search was carried out on four databases up to July 2018. Two separate network meta-analyses (NMA) were performed using the frequentist method (random effects): one with an exclusive population with BRAF-V600 mutation (NMA-pBRAFV600) and another with mixed population (with or without the mutation: NMA-pMixed). An evidence profile was included using the GRADE method for NMA. The validity of the final estimator in the NMA-pMixed was assessed via a sensitivity analysis. Nine clinical trials were included in the NMA-pBRAFV600. Dabrafenib-trametinib was found to have a favorable effect on overall survival (OS) and progression-free survival (PFS) compared with dabrafenib, vemurafenib, and dacarbazine and on partial response rate (PRR) and overall response rate compared with dacarbazine and vemurafenib. In the NMA-pMixed, dabrafenib-trametinib was found to have a positive effect on OS versus ipilimumab 3 mg/kg and on PFS and PRR versus ipilimumab, nivolumab, and pembrolizumab. However, dabrafenib-trametinib and vemurafenib-cobimetinib significantly differed in terms of efficacy. In addition, dabrafenib-trametinib has a favorable effect on Grades 3 and 4 adverse events.

Efficacy and safety of dabrafenib-trametinib in the treatment of unresectable or metastatic melanoma with BRAF V600 mutation: A systematic review and network meta-analysis.

The current systematic review aimed to evaluate the efficacy and safety of dabrafenib plus trametinib (dabrafenib-trametinib) with those of other therapeutic alternatives in the treatment of patients with BRAF V600 mutation unresectable or metastatic melanoma. The search was carried out on four databases up to July-2018. Two separate network meta-analyses (NMA) were performed using the frequentist method (random effects): one with an exclusive population with BRAF V600 mutation (NMA-pBRAFV600) and another with a mixed population (with or without the mutation: NMA-pMixed). An evidence profile was included using the GRADE method for NMA. The validity of the final estimator in the NMA-pMixed was assessed via sensitivity analysis. Five clinical trials were included in the NMA-pBRAFV600. In the NMA-pBRAFV600 population, dabrafenib-trametinib had a favorable effect on overall survival (OS) and progression-free survival (PFS) compared with dabrafenib, vemurafenib, and dacarbazine, and on partial response rate (PRR) and overall response rate (ORR) compared with dacarbazine and vemurafenib. In the NMA-pMixed population, dabrafenib-trametinib had a positive effect on OS vs ipilimumab 3 mg/kg and on PFS and PRR vs ipilimumab (3 and 10 mg/kg), nivolumab, and pembrolizumab. However, dabrafenib-trametinib, and vemurafenib-cobimetinib were comparable in terms of clinical efficacy. In addition, dabrafenib-trametinib was associated with less grades 3 and 4 adverse events.

Economic impact of dengue fever in Latin America and the Caribbean: a systematic review.

OBJECTIVES: To assess the economic impact of dengue in Latin America and the Caribbean using a systematic review that includes studies not previously considered by other reviews. METHODS: Cochrane methodology was used to conduct a systematic review of the cost of dengue in Latin America. PubMed Central, EMBASE, and the Biblioteca Virtual en Salud-which includes scientific, peer-reviewed journals not indexed by other databases-were searched from inception through August 2016. All articles that reported cost of illness data for countries in Latin America were included. Included studies underwent a methodological appraisal using a seven-question instrument designed for cost of illness studies. Extracted data were direct and indirect costs for outpatient and hospitalized cases and total cost of the disease. Values were adjusted to 2015 US dollars using the consumer price index. RESULTS: From a total of 848 initial references, 17 studies were included, mainly from Brazil, Colombia, Cuba, Mexico, and Puerto Rico; costs were available for 39 countries. The methodological appraisal showed that 70% of the studies met more than 70% of the evaluated items. The main economic impact of dengue was due to productivity costs. Average annual cost was more than US$ 3 billion. Direct costs represented over 70% of the total share for hospitalized cases. For outpatients, direct medical costs were low, but social costs were significant since indirect costs may account for up to 80% of the total cost. CONCLUSIONS: Dengue fever has a significant economic impact in Latin America. It is essential to develop new public health interventions, such as dengue vaccination, to decrease the propagation of the disease and its total cost.

Study of the Direct Costs of Asthma at a Healthcare Service Provider in Bogotá, Colombia.

OBJECTIVES: This study aimed to describe clinical characteristics and direct medical costs associated with disease treatment in Colombia patients with asthma from 1 healthcare provider. METHODS: This was a descriptive study with a retrospective data collection from a healthcare provider's electronic medical records in Colombia. A clinical, demographic, and healthcare resource utilization profile was developed over a 12-month observation period after the identification of eligible patients. To determine the mean cost per patient per year, the total frequencies of resource utilization were added, and the result was multiplied by the unit cost of each of them. RESULTS: A total of 7919 patients were included in the analysis. The mean ± SD cost per patient per year ranged from $189.5 ± $1.900.6 to $240.2 ± $1.903.6 depending on the price guidebook. The total cost had been driven by the medication use (79% of total cost) and by the outpatient visits (20% of total cost). CONCLUSIONS: In the population analyzed, the mean total direct cost per patient per year of asthma was $189.5 and $240.2, depending on the cost source. Direct medical costs were higher in cases classified as severe and in the adult and elderly population. When comparing the sources of resource utilization, it was found that the mean cost per patient obtained from real-life data is lower than the theoretical cost obtained from the bottom-up method with quantification of resources from experts. It is important to consider limitations related to study design and the evolving landscape of asthma treatments.

Cannabis and pain: a scoping review.

For centuries, cannabis has been used with many different purposes, including medicinal use, usually bypassing any formal approval process. However, during the last decade, interest in cannabis in medicine has been increasing, and several countries, including the United States and Canada, have produced their own legislation about marihuana and cannabis-based medicines. Because of this, interest in research has been increasing and evidence about its medical effects is becoming necessary. We conducted a review examining the evidence of cannabis in pain. Cannabis had been shown to be useful in acute and chronic pain, however recently, these results have been controverted. Within the different types of chronic pain, it has a weak evidence for neuropathic, rheumatic pain, and headache, modest evidence for multiple sclerosis related pain, and as adjuvant therapy in cancer pain. There is no strong evidence to recommend cannabis in order to decrease opioids in patients with chronic use. Even though cannabis-based medications appear to be mostly safe, mild adverse effects are common; somnolence, sedation, amnesia, euphoric mood, hyperhidrosis, paranoia, and confusion may limit the use of cannabis in clinical practice. Risks have not been systematically analyzed. Special concern arises on how adverse effect might affect vulnerable population such as elderly patients. More research is needed in order to evaluate benefits and risks, as well as the ideal administration route and dosages. As cannabis use increases in several countries, answers to these questions might be coming soon.

Cost-Effectiveness of the Dabrafenib Schedule in Combination With Trametinib Compared With Other Targeted Therapies, Immunotherapy, and Dacarbazine for the Treatment of Unresectable or Metastatic Melanoma With BRAFV600 Mutation in Colombia.

OBJECTIVES: Advanced melanoma accounts for 4% of malignant skin tumors, and approximately 80% of deaths are attributed to it. The most frequent mutation of the RAF gene is BRAFV600, which has been associated with a worse prognosis. The objective of the research was to evaluate the cost-effectiveness of the combined regimen of dabrafenib plus trametinib (D + T) compared with other targeted therapies, immunotherapy, and dacarbazine for the treatment of unresectable/metastatic melanoma with BRAFV600 mutation from the perspective of the Colombian health system. METHODS: A partitioned survival model with 3 states (progression-free survival, progression, and death) was used to evaluate the cost-effectiveness for a time horizon of 20 years. Owing to the perspective of the analysis, only direct medical costs were taken into account. The efficacy of the evaluated treatment and the comparators were measured in terms of overall survival and progression-free survival. All costs were expressed in Colombian pesos as of 2018, and outcomes and costs were discounted at 5% annually. Two analysis scenarios were considered, one in which only monitoring and follow-up costs were included in the progression phase and another in which costs of acquisition of possible treatment sequences were also included. RESULTS: In the first scenario (without postprogression medication costs), the combined D + T regimen was a dominant alternative to vemurafenib + cobimetinib but was not a cost-effective option compared with vemurafenib, nivolumab, ipilimumab, nivolumab + ipilimumab, pembrolizumab, and dacarbazine. In the second scenario (with drug costs in postprogression), D + T was dominant compared with vemurafenib + cobimetinib and cost-effective compared with nivolumab and pembrolizumab. Compared with other schemes, the incremental cost-effectiveness ratio was above the threshold of 3 gross domestic product per capita. Probabilistic sensitivity analyses showed that a willingness-to-pay threshold of Col$56 484 300 (US$19 108) per quality-adjusted life-year would not be reached at the current price of schema in Colombia. CONCLUSIONS: The combined scheme could be a cost-effective and even a cost-saving alternative to vemurafenib + cobimetinib, nivolumab, and pembrolizumab if the costs associated with the use of other medications are taken into account after progression to the first line of treatment. Compared with the other comparators, it produces a greater number of quality-adjusted life-years, but the incremental cost-effectiveness ratio is above that of the willingness to pay.

International Experience in Therapeutic Value and Value-Based Pricing: A Rapid Review of the Literature.

OBJECTIVES: To characterize at a global level the concept of therapeutic value (TV) and describe the experience of value-based pricing (VBP) policies in 6 reference countries. METHODS: We conducted a rapid review of the literature that addressed 2 exploratory research questions. A systematic and exhaustive search was carried out up to July 2018 in MEDLINE (Ovid), Embase, Scopus, and Web of Science. RESULTS: The concepts of TV and VBP are related; value frameworks for medicines should include social preferences, comparative effectiveness, safety, adoption viability, social impact, high quality of evidence, severity of illness, and innovation. The added therapeutic value (ATV) is the manner of measuring the therapeutic advantages of new medicines compared with existing ones in terms of comparative effectiveness and safety. There are variations in the mechanisms of reimbursement and drug pricing regulation between the countries of study. CONCLUSION: In a VBP system it is essential to establish the TV and ATV of a new medicine. Although there are no methodological guidelines for the implementation of VBP policies, the process implies from the beginning the definition of TV categories that will be included in the drug pricing and reimbursement systems. Agreements between the pharmaceutical industry and governments have become a useful tool as a negotiating mechanism in most countries.

Cost-Effectiveness of Natalizumab Compared With Fingolimod for Relapsing-Remitting Multiple Sclerosis Treatment in Colombia.

OBJECTIVES: Multiple sclerosis (MS) is a degenerative neurological disorder. Treatment aims to avoid relapses and disability progression. The purpose of this study was to evaluate the cost-effectiveness of natalizumab compared with fingolimod for treating highly active relapsing-remitting MS (RRMS) patients from the Colombian third-party payer perspective. METHODS: We used a Markov economic model from the perspective of the Colombian healthcare system to estimate the cost-effectiveness of natalizumab compared with fingolimod for RRMS with high disease activity or failure of interferons as first-line therapy. This model was centered on disability progression and relapses. We considered a 5-year time horizon with a 5% discount rate. We included only direct medical costs. Local experts were consulted to obtain resource utilization estimates, and local standardized costing methodologies and sources were used. Outcome was considered in terms of quality-adjusted life-years (QALYs). Utilities were extracted or calculated from the literature. Transition probabilities were calculated from available efficacy and safety information (1 USD = 3050.98 COP). RESULTS: Natalizumab showed lower total costs (USD 80 024 vs USD 98 137) and higher QALY yield (3.01 vs 2.94) than fingolimod, dominating it (incremental cost-effectiveness ratio = -$1861). Univariate sensitivity analysis showcased the relevance of the measures of effect on disability progression for natalizumab on model results. Probabilistic sensitivity analysis replicated base-case results in most simulations. CONCLUSIONS: This study showed that natalizumab dominated fingolimod with lower costs and higher QALYs in patients with high-activity RRMS. These results are consistent with previous published international literature.

Cost-Effectiveness of Bariatric Surgery Compared With Nonsurgical Treatment in People With Obesity and Comorbidity in Colombia.

BACKGROUND: The increase in obesity prevalence and its relationship with multiple cardiovascular complications have raised the burden of obesity in the general population. Bariatric surgery has shown to be more effective in reducing weight than the traditional pharmacologic and nonpharmacologic treatments. OBJECTIVE: To evaluate the cost-effectiveness of this alternative compared with standard treatment in the Colombian context. METHODS: A Markov single cohort model was used to simulate the incremental cost per quality-adjusted life-year (QALY) gained every year over a base-case 5-year time horizon. The model considers 5 health states: comorbidity, remission, acute myocardial infarction, stroke, and death. Four comorbidity conditions were evaluated separately: diabetes, hypertension, dyslipidemia, and sleep apnea. The model was evaluated from a third-payer perspective. All costs were expressed in 2016 Colombian pesos ($1.00 = 3051 COP). A 5% annual discount rate was applied to both costs and outcomes. RESULTS: In baseline analysis, bariatric surgery was a cost-effective alternative compared with nonsurgical treatment in the diabetes and hypertension cohort with an incremental cost-effectiveness ratio of $6 194 899 and $43 689 527 per QALY gained, respectively. In the sleep apnea cohort, surgery has greater effectiveness and lower costs, which is why it is a dominant strategy. In the dyslipidemia cohort, bariatric surgery is dominated by the nonsurgical approach. CONCLUSION: The current study provides evidence that bariatric surgery is a cost-effective alternative among some cohorts in the Colombian setting. For obese patients with sleep apnea or diabetes, bariatric surgery is a recommendable alternative (dominant and cost-effective, respectively) for the Colombian healthcare system.

The Public Health Benefits and Economic Value of Routine Yellow Fever Vaccination in Colombia.

OBJECTIVES: To evaluate the public health benefits and economic value of live-attenuated yellow fever (YF) 17D vaccine in Colombia. METHODS: A decision tree model was used to assess the theoretical impact of routine YF vaccination of 1-year-olds (no "catch-up") during the interepidemic period from 1980 to 2002, avoiding capturing the impact of YF vaccine introduction in 2003. The vaccine was assumed to be 99% effective, to provide lifetime protection, and to cover 85% of the target population. Costs per disability-adjusted life-year (DALY) averted were computed from payer and societal perspectives. Univariate sensitivity analyses were performed. RESULTS: During the interepidemic period, routine YF vaccination would have averted 2223 nonfatal cases of YF and 65 deaths, leading to an overall reduction of 1365 DALYs. The net cost of this vaccination would have been $25 964 813 (payer's perspective) and $16 535 465 (societal perspective). Cost per DALY averted was $19 022 and $12 114 from payer and societal perspectives, respectively (all costs in 2015 US dollars). Vaccination was considered cost-effective from both perspectives (ie, between 1- and 3-fold the gross domestic product per capita, $7158) and remains so if price per dose was $2.75 or less and $4.66 from payer and societal perspectives, respectively. Underreporting had the largest impact on the results. CONCLUSIONS: Routine toddler YF vaccination in Colombia would have been considered cost-effective in the prevaccination era. This study provides insights on the value of vaccination in an upper middle-income country.

Quality of life in refractory generalized myasthenia gravis: A rapid review of the literature.

Generalized myasthenia gravis (GMG) is a neuromuscular transmission disorder that creates a fluctuating weakness of the voluntary muscles. This study is aimed at understanding the effect that refractory GMG has on the quality of life of patients who suffer from it, and the effect of eculizumab on it. A systematic literature search was conducted in MEDLINE (Ovid), EMBASE and the Cochrane Database of Systematic Reviews (Ovid). Eligibility criteria were verified via the title and summary and afterward through the full text. The risk of bias of the included randomized clinical trials was evaluated and the data were synthesized in a descriptive manner. Nine studies were identified that evaluated the quality of life of patients with GMG. Regarding the effect of eculizumab, two studies were identified. The quality of life in patients with GMG is lower compared to ocular myasthenia gravis (MG) and MG in remission, especially in the domains of physical function, physical role, bodily pain, vitality, and social function. Patients treated with eculizumab had a better perception of their quality of life compared to those who received placebo. GMG affects the quality of life more than other types of MG. This outcome is of great importance for the choice of therapeutic options in patients with refractory GMG. Eculizumab generates improvements in the perception of patients' quality of life compared to placebo, making it a relevant therapeutic option in the management of refractory GMG.

Burden of Disease Attributable to Obesity and Overweight in Colombia.

OBJECTIVES: To estimate the burden of disease attributable to obesity and overweight conditions using disability-adjusted life-years (DALYs) in Colombia. METHODS: The burden of disease was estimated following an adapted methodology published by the World Health Organization. A selection of diseases was performed in which overweight and obesity are risk factors. DALYs were calculated by obtaining the proportion of cases and deaths of every disease that can be attributable to obesity and overweight conditions. The economic impact of obesity was calculated by multiplying the cost of care per patient for each comorbidity by the number of cases attributable exclusively to obesity. RESULTS: A total of 997 371 DALYs were estimated, 45% of which corresponded to men; 81% of DALYs corresponded to years lived with disability. Conditions with greater attributable DALYs are, in order, hypertension (31.6% of the total DALYs), type 2 diabetes mellitus (28.0%), cardiac ischemic disease (14.6%), and lower back pain (11.2%). An estimation of 20.5 DALYs per 1000 inhabitants was made. The economic impact of care for comorbidities associated with obesity could amount to $2158 million. CONCLUSIONS: Obesity and overweight conditions are related to higher mortality and disability than previously estimated; effective interventions aimed at prevention and treatment will have a high impact on quality of life.

Cost-effectiveness of Carbetocin versus Oxytocin for Prevention of Postpartum Hemorrhage Resulting from Uterine Atony in Women at high-risk for bleeding in Colombia.

OBJECTIVE: To assess the cost-effectiveness of carbetocin versus oxytocin for prevention of postpartum hemorrhage (PPH) due to uterine atony after vaginal delivery/cesarean section in women with risk factors for bleeding. METHODS: A decision tree was developed for vaginal delivery and another one for cesarean, in which a sequential analysis of the results was obtained with the use of carbetocin and oxytocin for prevention of PPH and related consequences. A third-party payer perspective was used; only direct medical costs were considered. Incremental costs and effectiveness in terms of quality-adjusted life years (QALYs) were evaluated for a one-year time horizon. The costs were expressed in 2016 Colombian pesos (1 USD = 3,051 Col$). RESULTS: In the vaginal delivery model, the average cost of care for a patient receiving prophylaxis with uterotonic agents was Col$ 347,750 with carbetocin and Col$ 262,491 with oxytocin, while the QALYs were 0.9980 and 0.9979, respectively. The incremental cost-effectiveness ratio is above the cost-effectiveness threshold adopted by Colombia. In the model developed for cesarean section, the average cost of a patient receiving prophylaxis with uterotonics was Col$ 461,750 with carbetocin, and Col$ 481,866 with oxytocin, and the QALYs were 0.9959 and 0.9926, respectively. Carbetocin has lower cost and is more effective, with a saving of Col$ 94,887 per avoided hemorrhagic event. CONCLUSION: In case of elective cesarean delivery, carbetocin is a dominant alternative in the prevention of PPH compared with oxytocin; however, it presents higher costs than oxytocin, with similar effectiveness, in cases of vaginal delivery.

OBJETIVO: Avaliar a relação custo-eficácia da carbetocina versus oxitocina para prevenção de hemorragia pós-parto (HPP) vaginal e cesariana devido à atonia uterina em mulheres com fatores de risco para desenvolver sangramento. MéTODOS: Foram desenvolvidos protocolos de manejo para parto vaginal e outra para parto por cesárea e analisados resultados obtidos com carbetocina e oxitocina na prevenção de HPP, assim como, consequências relacionadas à ocorrência do evento hemorrágico. A perspectiva utilizada foi a do terceiro pagador, portanto, apenas os custos médicos diretos foram levados em consideração. Os custos incrementais e a eficácia em termos de anos de vida ajustados pela qualidade (QALY) foram avaliados para um horizonte de tempo de um ano. Os custos foram expressos em pesos colombianos de 2016 (1 USD = 3.051 Col$). RESULTADOS: No modelo de parto vaginal, o custo médio de cuidados para um paciente que recebeu profilaxia com agentes uterotônicos foi de Col$ 347.750 com carbetocina e Col$ 262.491 com oxitocina, enquanto os QALYs foram 0,9980 e 0,9979, respectivamente. O índice incremental de custo-efetividade está acima do limite de custo-efetividade adotado pela Colômbia. No modelo desenvolvido para parto por cesárea, o custo médio do paciente que recebeu profilaxia com terapia uterotônica foi de Col$ 461.750 com carbetocina e Col$ 481.866 com oxitocina e os QALYs foram 0,9959 e 0,9926, respectivamente. A carbetocina foi a alternativa com menor custo e maior efetividade com uma economia de $94.887 por evento hemorrágico evitado. CONCLUSãO: A carbetocina no parto eletivo por cesárea é uma alternativa dominante na prevenção da PPH em relação à oxitocina; porém representa custos mais altos com uma eficácia similar à da oxitocina no caso de parto vaginal.

Costo-efectividad de dos esquemas de prevención de la infección por citomegalovirus en pacientes con trasplante renal y riesgo intermedio en Colombia.

Introducción. El citomegalovirus es la causa más frecuente de infección en pacientes con trasplante renal. Existen dos estrategias de similar efectividad para prevenirlo: la profilaxis universal con valganciclovir durante 90 días o el tratamiento anticipado verificando la carga viral semanal y aplicándolo solo si esta es positiva.Objetivo. Determinar cuál de estas dos estrategias sería más costo-efectiva en pacientes de riesgo intermedio en Colombia.Materiales y métodos. Se diseñó un árbol de decisiones bajo la perspectiva del tercer pagador considerando únicamente los costos médicos directos en pesos colombianos (COP) del 2014 durante un periodo de un año en una población de pacientes con riesgo intermedio para citomegalovirus (donante positivo y receptor positivo, o donante negativo y receptor positivo). Las probabilidades de transición se extrajeron de los estudios clínicos y se validaron con expertos mediante el método Delphi.Los costos de los procedimientos se basaron en el manual tarifario ISS 2001, con un incremento del 33 % a partir del índice de precios al consumidor (IPC) en salud de 2014, en tanto que los de los medicamentos se extrajeron de las circulares del Ministerio de Salud y del Sistema de Información de Medicamentos (Sismed).Resultados. La profilaxis universal con valganciclovir resultó ser menos costosa y se asoció con una menor probabilidad de infección. El costo promedio del primer año de tratamiento anticipado sería de COP$ 30'961.290, mientras que el universal sería de COP$ 29'967.834, es decir, un costo 'incremental' de COP$ 993.456.Conclusiones. Para los pacientes de riesgo intermedio con trasplante renal en Colombia, la profilaxis universal es la mejor estrategia por ser menos costosa y reducir el riesgo de infección.

Cost Effectiveness of Dulaglutide Compared with Liraglutide and Glargine in Type 2 Diabetes Mellitus Patients in Colombia.

BACKGROUND: Diabetes treatment includes very diverse drugs. It is essential to identify which drugs offer the best value for their costs. OBJECTIVES: To estimate comparative cost effectiveness for treating diabetes mellitus with dulaglutide, liraglutide, or glargine in Colombia. METHODS: A Markov model including diabetic microvascular and macrovascular complications was used to estimate cost-effectiveness. We used annual cycles, a 5-year time horizon, 5% discount rate, and third-party payer's perspective. Main outcomes were quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs). Transition probabilities were obtained from primary studies and costs from local databases and studies. We used a threshold of 3 times the Colombian per capita gross domestic product (US $17,270 for 2015; US $1 = 2,743 Columbian pesos) to assess cost effectiveness. RESULTS: Total costs related to dulaglutide, liraglutide, and glargine were US $8,633, US $10,756, and US $5,783, yielding 3.311 QALYs, 3.229 QALYs, and 3.156 QALYs, respectively. Dulaglutide dominated liraglutide given lower total costs and higher QALYs. The estimated ICER for dulaglutide compared with glargine was US $18,385, greater than the accepted threshold. Sensibility analysis shows that decreased dulaglutide cost, increased consumption of glargine, nondaily injection, and number and cost of glucometry could result in ICERs lower than the threshold. Probabilistic sensitivity analysis showed consistent results. CONCLUSIONS: This estimation indicates that dulaglutide dominates liraglutide. Its ICER is, however, greater than the accepted threshold for Colombia in base case compared with glargine. By increasing population weight or glargine consumption, dulaglutide becomes cost effective compared with glargine, which could identify a niche where dulaglutide is the best option.

Suicide in the Indigenous Population of Latin America: A Systematic Review.

OBJECTIVE: Due to the high rates of suicide reported among many ethnic minorities, a systematic review is presented on suicide in indigenous populations of Latin America. METHODS: Systematic review in PubMed, Scopus, PsycNET, Scielo and Scholar Google. RESULTS: From an initial total of 1862 articles, 41 were included for data extraction. They include 21 from Brazil, 13 from Colombia, 2 from Chile, 1 from Peru, and 4 articles grouped from different countries. Suicide is a public health issue in many communities. Lifestyle changes, industrialisation, environmental degradation, and alcohol have led the indigenous population experiencing what has been described as "cultural death."

Urinothorax: Case report and systematic review of the literature.

Urinothorax, the presence of urine in the pleural space, is a rare cause of pleural effusion, usually associated with obstructive uropathy, or urinary trauma. We present the case of a 3 year-old boy and a systematic review of the literature of the 44 cases encountered. After resection of a Wilm's tumour in the right kidney our patient presented acute respiratory distress associated with radiographically confirmed pleural effusion. With the initial diagnosis of pneumonia or malignant pleural effusion, a closed thoracotomy was performed. The liquid obtained suggested urine, which was confirmed by the laboratory. Cystoscopy with retrograde pyelography detected a fistula on the posterior wall of the right kidney. The report of cases worldwide is low, probably due to its low incidence but also to underdiagnosis. Respiratory symptoms are not always present and urological symptoms usually predominate. Diagnosis requires a high degree of clinical suspicion and is confirmed by the main biochemical marker: The ratio >1.0 pleural fluid creatinine and creatinine serum.

Costoefectividad del régimen combinado de mirabegron/solifenacina en el tratamiento del síndrome de vejiga hiperactiva en Colombia / Cost-effectiveness of the Combined Regimen of Mirabegron/Solifenacin in the Treatment of Overactive Bladder Syndrome in Colombia

Objetivo Evaluar la costoefectividad incremental del régimen combinado de mirabegron/solifenacina en comparación con el uso temprano de toxina botulínica, desde la perspectiva del sistema de salud colombiano, para el tratamiento de adultos con vejiga hiperactiva. Métodos Se empleó un modelo de Markov en que se comparan dos secuencias de tratamiento, una con y otra sin mirabegron/solifenacina, para evaluar la costoefectividad en un horizonte temporal de cinco años. Debido a la perspectiva de análisis, sólo se tuvieron en cuenta los costos médicos directos. La eficacia del tratamiento evaluado y su comparador fue medida en términos de la reducción de episodios diarios de incontinencia y de la frecuencia de micciones. Los costos fueron expresados en pesos colombianos de 2019, y se aplicó una tasa de descuento de 5% tanto para desenlaces como para costos. Resultados Para el caso base, el costo del tratamiento en la secuencia que incluye mirabegron/solifenacina fue mayor, pero generó un mayor número de años de vida ajustados por calidad, y así e obtuvo una razón de costoefectividad incremental de $13.637,184 si se considera el desenlace de reducción de episodios diarios de incontinencia de 50%, y de $29.313,848 si se considera el del 100%. Conclusiones De acuerdo con los resultados de esta evaluación, para un horizonte de análisis de cinco años, la secuencia de tratamiento con mirabegron/solifenacina es una alternativa costoefectiva, si se considera un umbral de disposición a pagar de tres veces el producto interno bruto (PIB) per cápita.

Aim To evaluate the incremental cost-effectiveness of the combined regimen of mirabegron/solifenacin compared with the early use of botulinum toxin, from the perspective of the Colombian health system, for the treatment of adults with overactive bladder. Methods A Markov model comparing two treatment sequences, one with and one without mirabegron/solifenacin, was used to assess cost-effectiveness over a five-year period. Due to the perspective of the analysis, only direct medical costs were considered. The efficacy of the evaluated treatment and its comparator was measured in terms of the reduction in the daily incontinence episodes and the frequency of micturition. The costs were expressed in Colombian pesos of 2019, and a discount rate of 5% was applied for both outcomes and costs. Results For the base case, the cost of the treatment in the sequence that includes mirabegron/solifenacin was higher, but it generated a greater number of quality-adjusted years of life, thus obtaining an incremental cost-effectiveness ratio of $13,637,184 when considering the outcome of 50% of reduction in the daily incontinence episodes, and $29,313,848 when considering 100%. Conclusions According to the results of the present assessment, for a five-year period of analysi, the mirabegron/solifenacin treatment sequence is a cost-effective alternative when considering a threshold of willingness to pay three times the per capita gross domestic product (GDP).

Economic Analysis of Deep Brain Stimulation in Parkinson Disease: Systematic Review of the Literature.

BACKGROUND: Parkinson disease (PD) is a chronic multifaceted neurodegenerative disorder of adult onset that affects quality of life and places a burden on patients, caregivers, and society. In early disease, dopaminergic therapy improves motor symptoms, but as the disease progresses, symptoms tend to increase in frequency and severity, even with best medical treatment (BMT). Deep brain stimulation (DBS) becomes an option for certain patients, but cost becomes an important issue. OBJECTIVE: We performed a systematic review of the literature of economic studies of the use of DBS in patients with PD, including costs studies or economic evaluations expressed as cost per improvement in quality life, decrease in dose of pharmacological treatments, and the decrease of caregiver burden. METHODS: We reviewed the following databases: Medline/PubMed, Embase, Cochrane Database of Systematic Reviews, LILACS, Cochrane Central Register of Controlled Trials, WHO International Clinical Trials Registry Platform ICTRP portal and ClinicalTrials.gov from 1980 to 2015. Costs have been converted or adjusted to 2016 US dollars (US$). RESULTS: Nine studies were identified. The average cost of DBS for a patient with PD in 5 years is US$186,244. The quality-adjusted life year was higher in DBS compared with BMT after at least 2 years of treatment, with an average incremental cost utility ratio of US$41,932 per additional quality-adjusted life year gained. Costs in the first year are higher with DBS because of direct costs related to the surgical procedure, the device, and the more frequent controls. Studies show better results with a longer time horizon (up to 5 years). CONCLUSION: DBS is a cost-effective intervention for patients with advanced PD, but it has a high initial cost compared with BMT. However, DBS reduces pharmacologic treatment costs and should also reduce direct, indirect, and social costs of PD on the long term.

Pen Devices for Insulin Self-Administration Compared With Needle and Vial: Systematic Review of the Literature and Meta-Analysis.

OBJECTIVES: Pen devices offer advantages compared with vial and syringe (VaS). The purpose of this article was to evaluate efficacy of pen devices compared to VaS. METHODS: A systematic review of literature was performed in 8 different databases. References were independently screened and selected. Primary observational or experimental studies comparing pen devices with VaS for insulin administrations were included. Studies on specific populations were excluded. Risk of bias was evaluated using appropriate tools. Data on glycosylated hemoglobin (HbA1c), hypoglycemia, adherence, persistence, patient preference, and quality of life (QOL) were collected. Meta-analysis was performed when appropriate. Heterogeneity and risk of publication bias were evaluated. Otherwise, descriptive analyses of the available data was done. RESULTS: In all, 10 348 articles were screened. A total of 17 studies were finally selected: 7 experimental and 10 analytical. The populations of the included articles were mainly composed of adults with type 2 diabetes mellitus. Important risk of bias was found in all of the articles, particularly experimental studies. Meta-analyses were performed for HbA1c, hypoglycemia, adherence and persistence. Pen device showed better results in mean HbA1c change, patients with hypoglycemia, adherence and persistence compared to VaS. No difference was observed in number of patients achieving <7% HbA1c. Preference studies showed a tendency favoring pen devices, however nonvalidated tools were used. One QoL study showed improvements in some subscales of SF-36. CONCLUSIONS: There is evidence that pen devices offer benefits in clinical and, less clearly, patient-reported outcomes compared to VaS for insulin administration. However, these results should be taken with caution.