Management of relapsing–remitting multiple sclerosis in Latin America: Practical recommendations for treatment optimization

Correale, Jorge; Abad, Patricio; Alvarenga, Regina; Alves-Leon, Soniza Vieira; Armas, Elizabeth; Barahona, Jorge; Buzó, Ricardo; Corona, Teresa; Cristiano, Edgardo; Gracia, Fernando; Bonitto, Juan García; Macias, Miguel; Soto, Alonso; Vizcarra, Darwin; Freedman, Mark S.

doi:10.1016/j.jns.2014.02.017

Cited by 26 publications

(26 citation statements)

References 140 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Multiple sclerosis (MS) is one of the most common, autoimmune, inflammatory, demyelinating diseases of the central nervous system in young adults, affecting approximately 2.3 million people worldwide [ 1 , 2 ]. Differences in the risk of MS and the disease course have been reported earlier in the Latin American population as compared to the well-studied Caucasian population [ 3 – 8 ]. For example, the Latin American MS population has higher age at disease onset and slower rate of progression of disability over time [ 4 ].…”

Section: Introductionmentioning

confidence: 97%

Safety and Tolerability of Fingolimod in Latin American Patients with Relapsing-Remitting Multiple Sclerosis: The Open-Label FIRST LATAM Study

Ordoñez-Boschetti¹,

Rey

Cruz³

et al. 2015

Adv Ther

Self Cite

View full text Add to dashboard Cite

IntroductionFingolimod 0.5 mg is an orally active sphingosine 1-phosphate receptor modulator approved for use in adults with relapsing multiple sclerosis (MS). The efficacy and safety profile of fingolimod has been well characterized in a large clinical development program. Here, we report the safety and tolerability of fingolimod in relapsing-remitting MS (RRMS) patients from Latin America.MethodsA total of 162 patients with RRMS, predominantly from Latin American countries (138/162), were enrolled in this 16-week, single treatment arm, open-label, multi-center study. Unlike the phase III pivotal studies, this study permitted enrollment of patients with controlled diabetes, certain cardiac and pulmonary conditions, older age, and higher baseline Expanded Disability Status Scale. All patients were monitored clinically for a minimum of 6 hours after the first dose. Safety and tolerability assessments were based on adverse events, clinically notable laboratory abnormalities, vital signs, ophthalmic examinations, and electrocardiograms.ResultsOverall, the safety and tolerability profile was consistent with that reported previously in phase 3 studies and the FIRST study. Adverse events (AEs) were predominantly mild (n = 49, 35.5%) or moderate (n = 27, 19.6%). Three patients (2.2%) discontinued fingolimod due to AEs. Infections were reported in 33 patients (23.9%) and were predominantly mild in nature (n = 28, 20.3%). Increases in alanine aminotransferase enzymes of ≥3, ≥5 and ≥10 upper limit of normal were reported in five (3.7%), three (2.2%) and one (0.7%) patients, respectively. Hypertension cases (n = 3; 2.2%) did not result in treatment discontinuation and were controlled with antihypertensive therapy. Following first-dose administration, the majority of patients (90.6%) were discharged at 6 h. During the first-dose monitoring, 5 cases of bradycardia were reported; none required extended monitoring or treatment for symptomatic bradycardia.ConclusionThe first dose of fingolimod 0.5 mg was well tolerated in RRMS patients from Latin America. The overall safety profile was clinically manageable and consistent with previous fingolimod studies.FundingNovartis.Trial registration: ClinicalTrials.gov #NCT01497262.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-015-0224-2) contains supplementary material, which is available to authorized users.

show abstract

Section: Introductionmentioning

confidence: 97%

Safety and Tolerability of Fingolimod in Latin American Patients with Relapsing-Remitting Multiple Sclerosis: The Open-Label FIRST LATAM Study

Ordoñez-Boschetti¹,

Rey

Cruz³

et al. 2015

Adv Ther

Self Cite

View full text Add to dashboard Cite

show abstract

“…Se identificó al interferón beta-1A como el fármaco más recobrado dentro del grupo evaluado, dado que es un medicamento de primera línea sugerido por guías de práctica clínica latinoamericanas por reducir significativamente la mortalidad (7,14,18,19). Cabe aclarar que estas estimaciones de costos corresponden únicamente a los fármacos, y no incluyen otros costos directos de la enfermedad como rehabilitación, hospitalización por recaídas, gastos por parte del paciente y su familia, o costos indirectos como productividad perdida del paciente y su cuidador.…”

Section: Discussionunclassified

Estado actual de la esclerosis múltiple en Colombia

Jiménez

2023

Acta Neurol Colomb

View full text Add to dashboard Cite

Introducción: Dos estudios epidemiológicos de esclerosis múltiple (EM) la describen como de bajo riesgo en Colombia. Hay, sin embargo, nuevos sistemas de información que permiten una aproximación más precisa. Objetivo:Estimar la prevalencia nacional de EM, así como por regiones del país, y analizar los costos de los fármacos usados en Colombia. Materiales y métodos: Se obtuvieron datos del Registro Individual de Prestación de Servicios de Salud (RIPS), con el código diagnóstico G35X para esclerosis múltiple, tomando los diagnósticos confirmados nuevos y repetidos entre 2009 y 2013, por sexo, grupo etario y departamento. Para el análisis de medicamentos se usó la base de datos Sismed del 2014, incluyendo los fármacos disponibles en Colombia: interferón beta-1A, interferón beta-1B, acetato de glatiramer, natalizumab, fingolimod y mitoxantrona. Resultados:Según los RIPS, en Colombia se atendieron, en el período 2009-2013, un total de 3.462 personas con diagnóstico de esclerosis múltiple. La prevalencia nacional para el período fue de 7,52/100.000, con las cifras más altas en Bogotá (16,25), donde se atendieron 1.213 pacientes, seguido de los departamentos del Quindío (13,03) y Risaralda (11,18). La mayor proporción de pacientes se encuentra entre los 50 y 54 años de edad, y las mujeres representan más del 70%. Adicionalmente, en 2014 se invirtieron 86.000 millones de pesos (43 millones de dólares) en medicamentos para esclerosis múltiple, lo que equivale a cerca de 25 millones por paciente.

show abstract

“…LA KOL report a fair amount of time during their patients' DMD initiation visit, which could be a good indicator of important therapy aspects being discussed with the patient and their families. KOL were adherent to LA guidelines about the scheduled frequency of patient's visits per year to the outpatient clinic [4]. On the other hand, most neurologists relied on self-report when evaluating adherence.…”

Section: Tablementioning

confidence: 99%