Barriers in Access to Idarucizumab in Ischemic Stroke in a Middle-Income Country.

Background and Purpose: Current stroke guidelines contraindicate the use of thrombolytics if oral anticoagulants are taken within 48 hours of symptom onset. Idarucizumab is an alternative for patients on dabigatran who experience an acute stroke, so that alteplase may be used. However, this treatment may not be readily available in low/middle-income countries. Our objective is to describe barriers to access to the administration of idarucizumab. Methods: We applied a structured survey for health personnel, consulted databases of drug providers, and analyzed reports from the National Pharmacologic Surveillance Data to describe idarucizumab use and the related knowledge among prescribers and the drug distribution in health institutions in Colombia between January 2018 and January 2022. Results: In total, 23.6% of the 337 interviewed physicians' hospitals had access to idarucizumab, and 34.9% of the physicians were unaware of the use of this medication for ischemic stroke. Only 11 private institutions had access to this medication in Colombia. Four male patients with atrial fibrillation received thrombolytics for acute stroke, and two required subsequent mechanical thrombectomy. No fatal complications during hospitalization were observed. Complications included hematuria, hemorrhagic transformation and groin hematoma. None required transfusion or further intervention. All had favorable mRS scores at the 90-day follow-up. Conclusions: There are multiple barriers to access idarucizumab in Colombia. The main factors identified are the low medication availability in provincial hospitals and the low medical knowledge. However clinical results in this limited group are satisfactory. Stronger public policies are needed to guarantee optimal stroke treatment in patients on DOACs in Colombia.

Analyses of Mortality and Prevalence of Cerebrovascular Disease in Colombia, South America (2014-2016): A Cross-Sectional and Ecological Study.

BACKGROUND: Stroke is the second cause of death and the first cause of disability worldwide. However, although numerous reports regarding stroke epidemiology in Latin America have been published, they differ widely in terms of employed methods and end points. This is the first of a series of articles that describes the epidemiology of stroke and other cerebrovascular diseases (CVD) in the nation, as well as their correlation with recognized risk factors and social variables. METHODS: Descriptive analyses were performed using the Colombian vital registration system and social security information system as primary data sources. Rates and ratios were calculated, corrected for under-registration, and standardized. Secondary analyses were made using data from national surveys and government organizations on hypertension, diabetes mellitus, sedentarism, obesity, tobacco and alcohol consumption, and unsatisfied basic needs. Factorial multivariate multiple regression analyses were performed to evaluate correlations. Concentration curves and indices were calculated to evaluate for inequities in the distribution of events. RESULTS: Global CVD had a national mortality rate and a prevalence ratio of 28 and 142 per 100,000 persons, respectively. Nontraumatic intracranial hemorrhage had the highest mortality rate (ie, 15 per 100,000), while cerebral infarction and transitory cerebral ischemia had the highest prevalence ratios (ie, 28 and 29 per 100,000, respectively). Hypertension and tobacco use were the most relevant risk factors for most of the simple and multiple models, and cerebral amyloid angiopathy and nonpyogenous intracranial venous thrombosis were the disease categories with the most socially unequal distribution of deaths and cases (ie, concentration indices of .34 and .29, respectively). CONCLUSIONS: CVDs are a cause for concern in Colombia and a marker of healthcare inequality and social vulnerability. Nationwide control of risk factors such as hypertension and tobacco use, as well as the design and conduct of public policy focused on the vulnerable and medically underserved regions and on standardizing mandatory CVD registries might ease its burden.

Sex Differences Among Participants in the Latin American Stroke Registry.

Background Reports on sex differences in stroke outcome and risk factors are scarce in Latin America. Our objective was to analyze clinical and prognostic differences according to sex among participants in the LASE (Latin American Stroke Registry). Methods and Results Nineteen centers across Central and South America compiled data on demographics, vascular risk factors, clinical stroke description, ancillary tests, and functional outcomes at short-term follow-up of patients included from January 2012 to January 2017. For the present study, all these variables were analyzed according to sex at hospital discharge. We included 4788 patients with a median in-hospital stay of 8 days (interquartile range, 5-8); 2677 were male (median age, 66 years) and 2111 female (median age, 60 years). Ischemic stroke occurred in 4293: 3686 as cerebral infarction (77%) and 607 as transient ischemic attack cases (12.7%); 495 patients (10.3%) corresponded to intracerebral hemorrhage. Poor functional outcome (modified Rankin scale, 3-6) was present in 1662 (34.7%) patients and 38.2% of women (P<0.001). Mortality was present in 6.8% of the registry, with 7.8% in women compared with 6.0% in men (P=0.01). Death and poor functional outcome for all-type stroke showed a higher risk in female patients (hazard ratio, 1.3, P=0.03; and hazard ratio, 1.1, P=0.001, respectively). Conclusions A worse functional outcome and higher mortality rates occurred in women compared with men in the LASE, confirming sex differences issues at short-term follow-up.

Gaps in Guidelines for the Management of Diabetes in Low- and Middle-Income Versus High-Income Countries-A Systematic Review.

OBJECTIVE: The extent to which diabetes (DM) practice guidelines, often based on evidence from high-income countries (HIC), can be implemented to improve outcomes in low- and middle-income countries (LMIC) is a critical challenge. We carried out a systematic review to compare type 2 DM guidelines in individual LMIC versus HIC over the past decade to identify aspects that could be improved to facilitate implementation. RESEARCH DESIGN AND METHODS: Eligible guidelines were sought from online databases and websites of diabetes associations and ministries of health. Type 2 DM guidelines published between 2006 and 2016 with accessible full publications were included. Each of the 54 eligible guidelines was assessed for compliance with the Institute of Medicine (IOM) standards, coverage of the cardiovascular quadrangle (epidemiologic surveillance, prevention, acute care, and rehabilitation), translatability, and its target audiences. RESULTS: Most LMIC guidelines were inadequate in terms of applicability, clarity, and dissemination plan as well as socioeconomic and ethical-legal contextualization. LMIC guidelines targeted mainly health care providers, with only a few including patients (7%), payers (11%), and policy makers (18%) as their target audiences. Compared with HIC guidelines, the spectrum of DM clinical care addressed by LMIC guidelines was narrow. Most guidelines from the LMIC complied with less than half of the IOM standards, with 12% of the LMIC guidelines satisfying at least four IOM criteria as opposed to 60% of the HIC guidelines (P < 0.001). CONCLUSIONS: A new approach to the contextualization, content development, and delivery of LMIC guidelines is needed to improve outcomes.

Uso del activador de plasminógeno tisular recombinante (rt-PA) en el ataque cerebrovascular isquémico (ACVi) en Colombia: un estudio de costo-efectividad / Tissue plasminogen activador (rt-PA) for acute ischemic stroke in Colombia: a cost-effectiveness study

INTRODUCIÓN: en Colombia el ataque cerebrovascular (ACV) es un enorme problema de salud pública, es la tercera causa de muerte y la segunda de años de vida potenciales perdidos (AVPP). El rt-PA ha demostrado su costo-efectividad en el tratamiento del ACV. MATERIAL Y MÉTODOS: para estimar el costo-efectividad de la terapia trmbolítica se comparo la terpia usual contra la aplicación de terapia usual mas rt-PA, se calculo el costo del tratamiento y se calcularon los costo tanto de la complicación hemorrágica como de la discapacidad aguda y crónica en pesos colombianos con base en un tarifario de uso corriente en el sistema de salud nacional y se calculo la expectativa d evid apara un paciente típico de ACV. Dado que en Colombia no hay estudios de trombólisis se extrajeron los datos de ensayos con rt-PA, controlados con placebo; también se analizaron los meta-análisis sobre este tema. RESULTADOS: aunque el costo de la terapia usual es menor que el de la terpia combinada con rt-PA ésta es más efectiva y brinda una mejor costo efectivida (diferencia de 1,07 años de vida ajustados por QALYS), es decir que por cada año asi ajustado se deben invertir $1.138.373 pesos, como se demostró en el análisis de sensibilidad realizado para estos hallazgos. CONCLUSIÓN: la trombólisis con rt-PA es costo-efectiva en Colombia con las tarifas actuales del sistema y en los diversos escenarios contemplados en el análisis de sensibildad.

INTRODUCTION: stroke is a major public health problem in Colombia, is the third leading cause of death and second of potential life years lost. rt-PA has proven its cost-effectiveness in the treatment of ischaemic stroke. PATIENTS AND METHODS: to estimate the cost-effectiveness of thrombolytic therapy, usual therapy was compared against the application of usual therapy and rt-PA, cost treatments was calculate. The cost of both: hemorrhagic complications, acute and chronic disability was done in Colombian pesos based on a current price in national health system, life expectancy was calculated too for a typical stroke patient. Given that in Colombia there are no studies of thrombolytic theraphy we extracted data from trials with rt-PA and placebo-controlled, and also analyzed some meta-analysis on this subject. RESULTS: although the cost of usual therapy is less than the combined therapy, this one is more effective and it provides a better cost-efectiveness (difference of 1.07 years of life QALYS adjusted), meaning that for each year of life, the national healt system must invest $ 1,138,373 pesos, as demonstrated in the sensitivity analysis performed for these findings. CONCLUSION: thrombolysis with rt-PA is cost-effective in Colombia, with current prices of health system in differents sensitivity analysis.