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This review provides an overview of the efficacy and safety of renal sympathetic denervation as a therapeutic approach for resistant hypertension. While the initial enthusiasm was sparked by the results of early clinical trials, it was dampened by the findings of the Symplicity HTN-3 study. However, recent advances in catheter technology and more refined patient selection criteria have yielded more promising results. Subsequent studies, such as SPYRAL HTN-OFF MED and RADIANCE II, demonstrated significant reductions in blood pressure, even in patients with mild to moderate hypertension. Despite the lack of robust data on major clinical outcomes, investigations into the time in therapeutic range for patients undergoing renal sympathetic denervation suggested potential cardiovascular benefits. Nevertheless, further research is needed to thoroughly understand the long-term impact, assess cost-effectiveness, and accurately identify which patient subgroups may derive the greatest benefits from this therapy.

Esta revisión brinda una síntesis de la eficacia y la seguridad de la denervación simpática renal como enfoque terapéutico para la hipertensión resistente. A pesar del entusiasmo inicial generado por los resultados de los primeros ensayos clínicos, la eficacia de esta terapia se vio comprometida por los hallazgos negativos del estudio Symplicity HTN-3. Sin embargo, recientes avances en la tecnología de catéteres y una refinada selección de los pacientes han proporcionado resultados más prometedores. Estudios posteriores, como SPYRAL HTN-OFF MED y RADIANCE II, demostraron reducciones significativas en la presión arterial, incluso en pacientes con hipertensión de leve a moderada. A pesar de la falta de datos sólidos sobre desenlaces clínicos importantes, las investigaciones sobre el tiempo en rango terapéutico de los pacientes sometidos a denervación simpática renal sugirieron posibles beneficios cardiovasculares. No obstante, se requiere una mayor investigación para comprender a fondo el impacto a largo plazo, evaluar la relación costo-efectividad y determinar con precisión qué subgrupos de pacientes podrían obtener los mayores beneficios de esta terapia.

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INTRODUCTION: Vitamin K antagonists (VKA) are a therapeutic alternative in patients with venous thromboembolic disease; however, numerous factors affect their pharmacology. OBJECTIVE: To evaluate the quality of VKA anticoagulation at three different time periods in Mexico. METHODS: Prospective study, nested in patient cohorts at three different clinical scenarios between 2013 and 2019. Outpatients with indication for treatment with VKAs for at least 12 months were included. Patients were managed according to the criteria of the treating physician. RESULTS: Patient general characteristics were similar between groups, except for the VKA indication. The results of 4,148 patients and 38,548 INR assessments were analyzed. The times in therapeutic range during the three phases of the study and pooled data were significantly higher for the anticoagulation clinic. Only the number of patient visits was significantly associated with the results, unlike age, gender, and type of VKA. CONCLUSIONS: VKAs are widely used, but it is difficult for therapeutic goals to be achieved, especially in non-specialized clinical services. Creation of anticoagulation clinics is an urgent need for the Mexican health system.

INTRODUCCIÓN: Los antagonista de la vitamina K (AVK) son una alternativa terapéutica en los pacientes con enfermedad tromboembólica venosa; sin embargo, numerosos factores afectan su farmacología. OBJETIVO: Evaluar la calidad de la anticoagulación AVK durante tres diferentes periodos en México. MÉTODOS: Estudio prospectivo, anidado en cohortes de pacientes en tres escenarios clínicos entre los años 2013-2019. Se incluyeron pacientes no hospitalizados con indicación para recibir AVK por al menos 12 meses, quienes fueron manejados de acuerdo con el criterio del médico tratante. RESULTADOS: Las características generales de los pacientes fueron similares entre los grupos, excepto por la indicación para usar los AVK. Se analizaron los resultados de 4148 pacientes y 38 548 evaluaciones de INR. Los tiempos en rango terapéutico durante las tres fases del estudio y los datos acumulados fueron significativamente mayores en la clínica de anticoagulación. Solo el número de visitas de control de los pacientes se asoció significativamente con los resultados, a diferencia de la edad, el sexo y el tipo de AVK. CONCLUSIONES: Los AVK se utilizan ampliamente, pero es difícil alcanzar la meta terapéutica, sobre todo en servicios clínicos no especializados. La creación de clínicas de anticoagulación es una necesidad urgente en el sistema mexicano de salud.

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Resumen Introducción: Los antagonista de la vitamina K (AVK) son una alternativa terapéutica en los pacientes con enfermedad tromboembólica venosa; sin embargo, numerosos factores afectan su farmacología. Objetivo: Evaluar la calidad de la anticoagulación AVK durante tres diferentes periodos en México. Métodos: Estudio prospectivo, anidado en cohortes de pacientes en tres escenarios clínicos entre los años 2013-2019. Se incluyeron pacientes no hospitalizados con indicación para recibir AVK por al menos 12 meses, quienes fueron manejados de acuerdo con el criterio del médico tratante. Resultados: Las características generales de los pacientes fueron similares entre los grupos, excepto por la indicación para usar los AVK. Se analizaron los resultados de 4148 pacientes y 38 548 evaluaciones de INR. Los tiempos en rango terapéutico durante las tres fases del estudio y los datos acumulados fueron significativamente mayores en la clínica de anticoagulación. Solo el número de visitas de control de los pacientes se asoció significativamente con los resultados, a diferencia de la edad, el sexo y el tipo de AVK. Conclusiones: Los AVK se utilizan ampliamente, pero es difícil alcanzar la meta terapéutica, sobre todo en servicios clínicos no especializados. La creación de clínicas de anticoagulación es una necesidad urgente en el sistema mexicano de salud.

Abstract Introduction: Vitamin K antagonists (VKA) are a therapeutic alternative in patients with venous thromboembolic disease; however, numerous factors affect their pharmacology. Objective: To evaluate the quality of VKA anticoagulation at three different time periods in Mexico. Methods: Prospective study, nested in patient cohorts at three different clinical scenarios between 2013 and 2019. Outpatients with indication for treatment with VKAs for at least 12 months were included. Patients were managed according to the criteria of the treating physician. Results: Patient general characteristics were similar between groups, except for the VKA indication. The results of 4,148 patients and 38,548 INR assessments were analyzed. The times in therapeutic range during the three phases of the study and pooled data were significantly higher for the anticoagulation clinic. Only the number of patient visits was significantly associated with the results, unlike age, gender, and type of VKA. Conclusions: VKAs are widely used, but it is difficult for therapeutic goals to be achieved, especially in non-specialized clinical services. Creation of anticoagulation clinics is an urgent need for the Mexican health system.

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Poor adherence to warfarin treatment is a contributor to poor quality of treatment, which increases the risk of bleeding and thromboembolic events. This study aims to evaluate the impact of adherence to warfarin therapy on anticoagulation quality during 12 weeks of pharmaceutical care and after 1 year of follow-up for patients with atrial fibrillation and with poor TTR. The Arrhythmia Unit of tertiary hospital in Brazil. We included 262 patients with AF and poor quality of anticoagulation therapy with warfarin (TTR < 50%). Pharmacist-driven therapy management was performed for 12 weeks and patients were also evaluated 1 year after the end of the follow-up with a pharmacist. Adherence was classified into high adherence, medium adherence and low adherence. Impact of adherence to warfarin therapy after pharmaceutical care. Of the 262 patients, 160 were high adherence, 71 were medium adherence and 31 were low adherence. No statistically significant difference is found between adherence groups in demographic and clinical variables. The TTR basal means were not different among adherence groups (p = 0.386). However, the means of TTR 12 weeks and TTR 1 year after the end of protocol were statistically different among adherence groups (p < 0.001 and p = 0.002, respectively). When we compared TTR values at different times within the adherence group, we observed that there is a statistical difference between the three TTR means (basal versus 12 weeks versus 1 year after) within the adherence group (p < 0.001). Patients with poor anticoagulation control, who adhered to the treatment with warfarin during the pharmaceutical care had better anticoagulation quality compared to those who did not adhere to the therapy with warfarin.

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BACKGROUND: Warfarin is the most common oral anticoagulant drug, especially in low-income and emerging countries, because of the high cost of direct oral anticoagulant (DOACs), or when warfarin is the only proven therapy (mechanical prosthetic valve and kidney dysfunction). The quality of warfarin therapy is directly associated with dose management. Evidence shows that pharmaceutical care achieves a better quality of therapy with warfarin. However, there are no studies showing this intervention in a specific patient group with poor quality of anticoagulation in a long period after the end of the follow-up by a pharmacist. Thus, the aim of this study was to evaluate whether the quality of warfarin therapy driven by a pharmacist remains stable in the long term after the end of follow up with a pharmacist, in AF patients with poor quality of anticoagulation. METHODS: This is a prospective study, which evaluated about 2,620 patients and selected 262 patients with AF and poor quality of anticoagulation therapy with warfarin (TTR<50% - based on the last three values of international normalized ratio). Pharmacist-driven therapy management was performed up to 12 weeks. Data from patients were evaluated 1 year after the end of the follow-up with pharmacist. RESULTS: Comparison between mean TTR after 12 weeks of pharmaceutical care (54.1%) and mean TTR one year after the end of the pharmaceutical care (56.5%; p=0.081) did not achieve statistical difference, demonstrating that the increment of quality due to intervention of 12 weeks was maintained for 1 year after intervention. CONCLUSION: The long-term impact of pharmaceutical care was beneficial for patients with AF and poor quality of warfarin anticoagulation. This design might be an important strategy to treat a subgroup of patients without proven effectiveness of warfarin.

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INTRODUCTION: Warfarin continues to be the most widely used anticoagulant in clinical practice around the world for the prevention of thromboembolic events in patients with atrial fibrillation (AF). The evaluation of the quality of anticoagulation control, estimated by time in therapeutic range (TTR), is accepted as a good method to evaluate the quality of anticoagulation. The variability of TTR can be explained by the presence of variants of the CYP2C9 and VKORC1 genes. METHODS: This study examined the association between polymorphisms of the CYP2C9 and VKORC1 genes and control of oral anticoagulation, through TTR, in patients with AF. A cross-sectional study was conducted within a cohort follow-up. The study comprised of 317 patients with AF, using warfarin, who were followed up for one year. The genotyping of genes CYP2C9 (rs1057910), (rs1799853) and VKORC1 (rs923231) was performed by PCR in real time, using TaqMan probes. RESULTS: Patients who had variant genotypes for the CYP2C9*3 gene (rs1057910) presented higher TTR (TTR 81-100%) when compared to when compared to the <45% and 46-60% TTR groups (p=0.005 and p=0.002, respectively). Regarding VKORC1 (rs923231), patients who had the variant genotype for the VKORC1 (rs923231) gene also presented a higher TTR (TTR 81-100%), when when compared to the <45% and 46-60% TTR groups (p=0.005 and p=0.004, respectively). In a multivariate model, VKORC1 (rs923231) remained associated for comparisons with the TTR groups (<45% vs 81-100% groups, p=0.01; and 46-60% vs 81-100% groups, p=0.01). CONCLUSION: The genotypes of the CYP2C9*3 (AA) and VKORC1 -1639 (GG) genes were associated with the worst quality of anticoagulation control (TTR) in patients with AF using warfarin in the northeast of Brazil.

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OBJECTIVES: To investigate the significance of "subtherapeutic" vs "therapeutic" antiepileptic drug (AED) plasma levels with respect to treatment adherence. MATERIAL AND METHODS: One hundred and seventy patients with refractory temporal lobe epilepsy who underwent video-EEG monitoring in view of a surgical indication had their AEDs (carbamazepine, phenobarbital, phenytoin, and valproate) rapidly withdrawn following a standardized schedule. Plasma levels were measured at admission, and during the 2 days of drug withdrawal. Adherence and nonadherence were identified by the development of plasma levels from day 1 through day 3. Frequencies of an initial level below the reference range in both groups were compared. RESULTS: Adherence was found in 73.2% of cases, and nonadherence in 26.8%. Low levels were seen equally often (about 1/4 of cases) in adherent and nonadherent cases. The vast majority (73.7%) of low levels had another explanation than nonadherence (eg low-dose treatment or enzyme induction). Of 42 nonadherent cases, the vast majority of 76.2% had unsuspicious plasma levels at admission. CONCLUSIONS: "Subtherapeutic" AED plasma levels only rarely are caused by nonadherence whereas levels in the "therapeutic range" by no means prove that the patient is adherent to treatment. For meaningful interpretation, any level needs to be compared with other levels of the same patient. Our findings strongly emphasize the principle of individualized therapeutic AED monitoring as promoted by the Therapeutic Strategies Commission of the ILAE.

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Thromboembolic events are associated with high mortality and morbidity indexes. In this context, warfarin is the most widely prescribed oral anticoagulant agent for preventing and treating these events. This medication has a narrow therapeutic range and, consequently, patients usually have difficulty in achieving and maintaining stable target therapeutics. Some studies on the literature about oral anticoagulant management showed that pharmacists could improve the efficiency of anticoagulant therapy. However, the majority of these studies included general patients retrospectively. The aim of this study was to prospectively evaluate a pharmacist's warfarin management in patients with poor quality of anticoagulation therapy (Time in the Therapeutic Range- TTR < 50%). We included 268 patients with atrial fibrillation (AF) and without stable dose of warfarin (TTR < 50%, based on the last three values of International Normalized Ratio-INR). We followed them up for 12 weeks, INR values were evaluated and, when necessary, the dose adjustments were performed. During the first four visits, patient's INR was measured every 7 days. Then, if INR was within the target therapeutic range (INR: 2-3), the patient was asked to return in 30 days. However, if INR was out the therapeutic target, the patient was asked to return in 7 days. Adherence evaluation was measured through questionnaires and by counting the pills taken. Comparison between basal TTR (which was calculated based on the three last INR values before prospective phase) and TTR of 4 weeks (calculated by considering the INR tests from visits 0 to 4, in the prospective phase of the study) and basal TTR and TTR of 12 weeks (calculated based on the INR tests from visits 0 to 12, in the prospective phase of the study) revealed significant statistical differences (0.144 ± 0.010 vs. 0.382 ± 0.016; and 0.144 ± 0.010 vs. 0.543 ± 0.014, p < 0.001, respectively). We also observed that the mean TTR of 1 year before (retrospective phase) was lower than TTR value after 12 weeks of pharmacist-driven treatment (prospective phase) (0.320 ± 0.015; 0.540 ± 0.015, p < 0.001). In conclusion, pharmaceutical care was able to improve TTR values in patients with AF and poor quality of anticoagulation with warfarin.

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BACKGROUND: Oral anticoagulation therapy with vitamin K antagonists (VKA) such as warfarin and acenocoumarol is recommended in patients with atrial fibrillation (AF) and risk factors for embolism. The quality of anticoagulation control with VKA may be assessed by the time in therapeutic range (TTR). In our country, there are no data available about the quality of anticoagulation in patients with AF. The primary goal of our study was to assess the level of effective anticoagulation in a multicenter network of anticoagulation clinics in Argentina, which included patients with nonvalvular AF (NVAF) treated with VKA oral anticoagulants. METHODS: The TERRA trial is a multicenter, cross-sectional study involving 14 anticoagulation clinics that were invited to participate and recruit 100 consecutive patients with NVAF treated with VKA for more than 1 year. The international normalized ratio (INR) values were retrospectively obtained from patient charts, and TTR was calculated using the Rosendaal method. RESULTS: A total of 1190 patients were included in the analysis. Mean age was 74.9 ± 9.9 years, and 52.5% of the patients were male. Median TTR was 67.5% (interquartile interval 54-80). During 55% of the TTR, INR was >3. Interinstitution variability was substantial, with a range of 57.7% ± 17% to 87.7% ± 17%, P < .001. The 10th percentile of TTR was 41%, the 20th percentile was 50%, the 30th was 58%, and the 35th percentile was 60%. In 40% of patients, TTR was <70%. CONCLUSION: In this multicenter study, mean TTR values in patients with AF under VKA were similar to those in international therapeutic clinical trials (55%-65%). Marked variations among institutions were observed and, although average results obtained were high, one third of the patients exhibited a TTR below 60%. This cutoff value is conservative according to current recommendations, and guidelines suggest that when management with VKA cannot be improved, patients should be switched to direct oral anticoagulants. The addition of TTR calculation to clinical practice may help improve the quality of oral anticoagulation in patients with AF, thus improving anticoagulation outcomes.

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The home prothrombin time/international normalized ratio (PT/INR) self-management could be convenient for patients, enhancing treatment compliance and improving the quality of the oral anticoagulation. However, patient self-management (PSM) of oral anticoagulation may not be feasible for up to half of the patients due to cognitive or educational issues. In the present study, we aimed to evaluate the feasibility of a PSM program in a public health medical center that provides care for low-income patients. We also aimed to determine the accuracy of individual point-of-care devices (CoaguChek XS(®)) during long-term of home manipulation. Patients' time-in-therapeutic range (TTR) and perception of quality of life, were evaluated at scheduled study-visits to the center. Additionally, the accuracy of individual CoaguChek XS(®) was evaluated in comparison to the standard automated coagulometer at scheduled study-visits to the center. Twenty-five patients were included in the PSM program. The median TTR of patients was 75 % before inclusion, 72 % at 3 months, 75 % at 6 months and 100 % at 12 months after the beginning of self-management (P = 0.14).The median DASS scores were 64, 63, 61.5 and 71.5 before inclusion and at 3, 6 and 12 months, respectively (P = 0.09). One hundred paired INR values were obtained. Correlation between INR values delivered by individual CoaguChek XS(®) and the automated coagulometer was 94 % and the mean result bias was 0.07 INR units. The coefficient of correlation and the mean bias between methods was stable during 24 months of follow-up. The present study suggests that PSM is feasible for patients treated in the public health system and that the results delivered by CoaguChek XS(®) have long-term reliability.

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En el tratamiento de anticoagulación con warfarina, la reducción de eventos tromboembólicos debe ser valorada con el riesgo de sangrado. El tiempo de rango terapéutico (TRT) por el método de Rosenda al es una herramienta que valora la calidad en la monitorización de la terapia anticoagulante y se correlaciona con presencia de eventos tromboembólicos o sangrados. En este estudio se describe el tiempo de rango terapéutico (TRT R), los factores relacionados con menor (TRT R) y los efectos adversos presentados en la clínica de anticoagulación. Métodos y resultados: Estudio descriptivo de corte transversal entre el 1º de enero de 2011 y el 29 de febrero de 2012. Fueron evaluados 2232 resultados de INR de 319 pacientes. 98.550 días de seguimiento. 44% (108) hombres, 66% (211) mujeres, la edad promedio 60.3 años, siete visitas promedio/año, dosis semanal de warfarina 29.8 mg. La dosis semanal presenta una relación inversa con la edad, en menores de 45 años 37.9 mg y en mayores de 75 años 22.1 mg. El TRT R incrementó de 48-54%, respectivamente. Las indicaciones para anticoagulación: fibrilación auricular (FA) 38% (121), enfermedad tromboembólica venosa (ETEV) 35% (112), prótesis valvulares (PV) 17.5%(56) y embolia o trombosis arterial (EA) 9.5%(30). 228 pacientes (71%) presentaron un TRT R promedio del 64%. (40-100) INR mayor de 5 en 2.24% e INR menor de 1.5 en 10.9%. Sangrados menores: 16 pacientes (5%), sangrado mayor se presentó en dos pacientes (0.65%) y un evento adverso por embolia (0.32%). Los factores asociados a un TRT R bajo fueron: sexo masculino, enfermedad tromboembólica venosa, uso de warfarina genérica, edad menor de 55 años, tiempo menor de un año y menos de cinco visitas. Conclusiones: El tiempo de rango terapéutico TRT es una medición útil para establecer la eficacia de la terapia anticoagulante con warfarina. La meta de 60% en tiempo de rango terapéutico garantiza menos efectos adversos por sangrado o trombosis. Un número bajo de visitas y anticoagulación menor de un año están asociados a bajo TRT. (Acta Med Colomb 2016; 41: 42-48).

In the treatment of warfarin anticoagulation, reduction of thromboembolic events must be evaluated with the risk of bleeding. Time in therapeutic range (TTR) by the method of Rosendaal is a tool that values quality monitoring anticoagulant therapy and correlates with the presence of thromboembolic events or bleeding. In this study time therapeutic range (TTR), factors associated with lower (TTR) and adverse effects presented in the anticoagulation clinic are presented. Methods and Results: A descriptive cross-sectional study from 1° January 2011 and 29th February 2012. 2232 results of INR of 319 patients were assessed. 98550 days follow up. 44% (108) were men, 66% (211) women, average age 60.3 years, seven average visits/year, warfarin weekly dose of 29.8mg. The weekly dose has an inverse relationship with age; in patients under 45 years 37.9 mg., and in patients over 75 years, 22.1 mg. The TTR increased from 48 to 54%, respectively. Indications for anticoagulation: atrial fibrillation (AF) 38% (121), venous thromboembolic disease (VTE) 35% (112), prosthetic valves (PV) 17.5% (56) and emboli or arterial thrombosis (EA) 9.5% (30). 228 patients (71%) had a TTR average of 64%. (40-100), INR greater than 5 in 2.24% and INR less than 1.5 in 10.9%. Minor bleeding: 16 patients (5%), major bleeding occurred in two patients (0.65%) and oneadverse event of embolism (0.32%). The factors associated with low TTR were male gender, venous thromboembolic disease, use of generic warfarin, age less than 55 years, time shorter than one year and less than five visits. Conclusions: TTR is a useful measurement to establish the efficacy of anticoagulant therapy with warfarin. The goal of a 60% TTR ensures fewer adverse effects from bleeding or thrombosis. A low number of visits and anticoagulation less than a year are associated with low TTR. (ActaMed Colomb 2016; 41: 42-48).

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Determinar teóricamente el margen terapéutico y experimentalmente, los parámetros de la equivalencia biofarmacéutica de dos lotes de tabletas de multifuentes de digoxina de 0,25 mg. Material y Métodos: Se estudiaron dos lotes, cada una de 200 tabletas de multifuentes de digoxina de 0,25 mg, asignándoles el código de multifuente TDH025lote 105031 y TDF025 lote 10940431. El margen terapéutico teórico se determinó mediante la fórmula farmacocinética VT = Fracción α/ Fracción α predicha x concentración usual; luego, por diferencia de la CmE y CME se obtuvo el margen terapéutico. El Método analítico utilizado para la cuantificación del principio activo, fue el descrito en la Farmacopea Internacional de la Organización Mundial de la Salud (OMS); la prueba de desgaste por rozamiento y el grado de dureza, se determinó de acuerdo a la USP. Resultados: el margen terapéutico fue 1,2 ng/ml; los parámetros de la equivalencia biofarmacéutica: porcentajes de principio activo de los dos lotes de medicamentos multifuentes se encontraron dentro del rango de aceptación (90-110%) propuestos por la USP y la OMS: El desgaste por rozamiento del TDH025 presentó un 0,55% y el TDF025 tuvo un 0,56%, ambos valores estuvieron por debajo del 1% (valor aceptable) y la dureza indicó un soporte de choque mecánico aceptable. Las 06 tabletas se desintegraron completamente, al pasar por un tamiz Nº 10 (1700 μM), en un medio de disolución simulado de pH gástrico e intestinal en un tiempo menor de 5 minutos. Conclusión: Se demostró la equivalencia biofarmacéutica de los medicamentos multifuentes de digoxina de 0,25 mg TDH025 lote 105031 y del TDF025 lote 10940431, de acuerdo al criterio de aceptación de la USP y OMS, el principio activo (digoxina) cuantificado en cada lote estuvo dentro del rango de 90-110%; los parámetros de desgaste por rozamiento y la dureza, indicaron una adecuada estabilidad en su tiempo de vida útil...

To determine the therapeutic safety theoretically and experimentally, the biopharmaceutical equivalence parameters of two batches of multisource Digoxin tablets of 0.25mg. Material and Methods: Two batches, each of 200 tablets multisource digoxin 0.25 mg were studied, assigning code multisource TDH025 Lot 105031 and TDF025 Lot 10940431. The therapeutic range was determined by theoretical formula VT = αFraction pharmacokinetics / αpredicted fraction by usual concentration x, then by the difference CmE and CME, the therapeutic range was obtained. The analytical method used for quantification of the active ingredient, was described in The International Pharmacopoeia of the World Health Organization (WHO); while the fretting test and the hardness was determined according to the USP. Results: The therapeutic index is 1.2 ng/ml; and evaluation of the parameters of the biopharmaceutical equivalence percentages of active ingredient of the two lots of multisource drugs are within the acceptance range (90-110%) given in the USP and WHO. The fretting of TDH025 fretting batch 105031 was 0.55% and TDF025 was 0.56%, both values are below 1% which is acceptable value; and hardness indicates an acceptable mechanical shock endurance. The 06 tablets were completely disintegrated, passing through a No. 10 (1700 uM) sieve, in a dissolution medium simulating gastric and intestinal pH in less than 5 min. Conclusion: Biopharmaceutical equivalence of multisource drugs digoxin 0.25 mg TDH025 TDF025 batch batch 105031 and 10940431 was demonstrated according to the acceptance criteria of the WHO and USP, the active ingredient (digoxin) quantified in each batch were within the range of 90-110%; attrition and hardness parameters indicate adequate stability in their lifetime...

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Introducción: La terapia anticoagulante oral es una herramienta esencial para prevenir eventos tromboembólicos. Los fármacos más utilizados para este propósito son los antagonistas de vitamina K, cuyo efecto se monitoriza con el International Normalized Ratio (INR). Existen varios factores que afectan el nivel de anticoagulación. Objetivo: Identificar los factores asociados a un INR fuera de rango terapéutico. Metodología: Estudio observacional de corte transversal que analizó los datos de pacientes en TACO, controlados en un policlínico especializado del Hospital Naval Almirante Nef. Resultados: Se analizaron los datos de 374 pacientes, correspondiendo 196 a hombres (52,4 por ciento). La edad promedio fue de 74 +/- 12 años. Un total de 272 pacientes presentaron un INR en rango terapéutico (72,7 por ciento), 102 usuarios tenían un INR no adecuado para su patología (27.3 por ciento). Los principales motivos asociados a un INR fuera de rango fueron: Olvido en la toma de medicamentos (35,3 por ciento), alteraciones dietarias (16,7 por ciento) e interacciones farmacológicas (14,7 por ciento). Se encontró asociación estadísticamente significativa con una edad > 80 años y un INR fuera de rango terapéutico (p=0,03). Discusión: Los pacientes en TACO controlados en el policlínico especializado del Hospital Naval Almirante Nef, presentan una frecuencia mayor de INR dentro de rango terapéutico que lo reportado por la literatura. Los factores reportados como probables causas de presentar un nivel de anticoagulación fuera de rango terapéutico coinciden con los descritos en diversos estudios. Finalmente, queda de manifiesto la importancia del cuidado de los adultos mayores, dado que son los más susceptibles de presentar un control inadecuado, particularmente aquellos que tienen 80 o más años.

Introduction: Oral anticoagulant therapy is an essential tool for prevention of thromboembolic events. The drugs most commonly used for this purpose are the vitamin K antagonists, which are monitored through the International Normalized Ratio (INR). Several factors affect the level of anticoagulation. Aim: To identify factors associated with an INR outside the therapeutic range. Methods: Cross-sectional observational study that analyzed data from patients in oral anticoagulant therapy, controlled at the anticoagulant clinic of the Almirante Nef Naval Hospital. Results: We analyzed data from 374 patients, 196 of them men (52.4 percent). Mean age was 74 +/- 12 years. 272 patients (72.7 percent) had an INR within the therapeutic range; 102 (27.3 percent) had an inadequate INR. Major factors associated with an INR out of range were: forgetting to take the medication (35.3 percent), alterations in diet (16.7 percent) and drug interactions (14.7 percent). A statistically significant association was found between age over 80 years and an INR outside the therapeutic range (p = 0,03). Conclusions: Patients followed for oral anticoagulant therapy at a specialized clinic have an INR within therapeutic range most of the time. Factors reported as probable causes of inadequate INR were consistent with those described in several studies. Special attention should be paid to elderly patients, as they are the most susceptible to inadequate control.

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Introducción: La anticoagulación constituye una terapia farmacológica habitual en la práctica clínica diaria. En Chile, los ACO disponibles y utilizados son warfarina y acenocumarol, no existiendo mayores experiencias nacionales documentadas sobre el mayor beneficio de un fármaco en particular. Objetivo: Analizar y comparar la eficacia terapéutica de warfarina y acenocumarol en una población ambulatoria. Metodología: Estudio retrospectivo, longitudinal. Se analizó 188 pacientes que estuvieron en tratamiento con acenocumarol durante más de un año, y que luego fueron cambiados a warfarina. Se registró: sexo, edad, efectos adversos, diagnóstico y justificación de inicio de ACO. Se obtuvo el promedio del International Normalizad Ratio (INR) de los últimos 3 meses de tratamiento con acenocumarol. Luego, se sustituyó por warfarina, obteniendo luego de un año de tratamiento, el INR promedio de los últimos 3 meses. Los pacientes se agruparon en tres grupos: Bajo rango terapéutico (INR<2.0), en rango terapéutico (INR=2.0-3.0), sobre rango terapéutico (INR>3.0). Resultados: En los pacientes con acenocumarol, se observó 67 (35,64 por ciento) bajo rango terapéutico; 91 (48,4 por ciento) en rango terapéutico; y 30 (15,96 por ciento) sobre rango terapéutico. Luego del cambio a warfarina, 76 (40,43 por ciento) bajo rango terapéutico; 95 (50,53 por ciento) en rango terapéutico; y 17 (9,04 por ciento) sobre rango terapéutico, diferencias no significativas. Bajo el efecto de ambos fármacos no se registraron hemorragias mayores y no hubo diferencia significativa en hemorragias menores. Discusión: La eficacia terapéutica fue similar con ambos fármacos. A pesar de que con acenocumarol se obtuvo mayor porcentaje de pacientes sobre rango terapéutico, no se observaron complicaciones mayores en el periodo de seguimiento.

Background: oral anticoagulation is frequently needed in clinical practice. Warfarin and acenocumarol are available in Chile for this purpose. Locally there is no evidence favoring one over the other Aim: To compare the efficacy of warfarin and acenocumarol in an ambulatory population. Method: A retrospective study compared data on 188 patients with over 1 year of treatment with acenocumarol, before and after being switched over to treatment with warfarin. Demographic data, adverse effects, diagnosis and indication for oral anticoagulation were record. INRs obtained in the last 3 months of treatment with each agent were compared. Patients were classified in 3 groups: insufficient level (INR < 2.0), adequate level (INR 2.0- 3.0) and high level (INR > 3.0) of anticoagulation. Results: With acenocumarol, low level INR was present in 35.6 percent>, adequate INR in 48.4 percent> and high INR in 15.9 percent> of subjects. After switching to warfarin, corresponding levels in each group were 40.4 percent>, 50.3 percent> and 9 percent> (NS). There were no serious bleeding episodes in either group; minor hemorrhages occurred with similar frequency in both groups. Conclusion: There was similar clinical efficacy of oral anticoagulation with acenocumarol compared to warfarin. The slightly higher percentage of acenocumarol treated patients exhibiting a high IRN level did not result in increased risk of hemorrhage.

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