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1.
Circ J ; 86(8): 1245-1251, 2022 07 25.
Artículo en Inglés | MEDLINE | ID: mdl-35125371

RESUMEN

BACKGROUND: To determine the rate of undiagnosed atrial fibrillation (AF) we screened for AF using an oscillometric blood pressure (BP) monitor device followed by a single-lead handheld electrocardiogram (ECG), with confirmation by 12-lead ECG as the reference standard.Methods and Results: From October 2017 to August 2019, 1,148 patients were enrolled without known AF, who were aged ≥65 years with moderate-to-high stroke risk, at 71 centers in Japan. After exclusion of 7 patients with confirmed AF at the index visit, 1,141 patients were asked to use an oscillometric BP monitor twice daily for 2 weeks (max: 4 weeks) to detect an irregular pulse. The BP monitor detected an irregular pulse in 481 patients, of which 1 patient had confirmed AF. Thereafter, 480 patients were instructed to acquire ECGs twice daily for an additional 2 weeks (max: 4 weeks) using a single-lead handheld ECG device. The handheld ECG device detected irregular rhythm in 41 patients, of which 1 patient had confirmed AF. In total, undiagnosed AF was confirmed in 9 (0.8%) patients of the overall study cohort during the 24-week follow-up period. CONCLUSIONS: Sequential use of a BP monitor and handheld ECG for 4 weeks is a practical strategy for identifying undiagnosed AF in Japanese people at heightened risk of stroke.


Asunto(s)
Fibrilación Atrial , Accidente Cerebrovascular , Fibrilación Atrial/diagnóstico , Electrocardiografía/métodos , Humanos , Japón , Tamizaje Masivo/métodos , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control
2.
Heart Vessels ; 35(6): 743-749, 2020 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-31865431

RESUMEN

The correlation of fractional flow reserve, which is presently the gold standard for evaluating myocardial ischemia, with three-dimensional quantitative coronary analysis-based quantitative flow ratio (QFR) is well-known. This study aims to evaluate the relationship of QFR after second-generation drug-eluting stent (2nd gen-DES) implantation to clinical outcomes. A total of 61 consecutive lesions, on which 2nd gen-DES implantation was performed from October 2014 to December 2015, were analyzed. Contrast-flow QFR (c-QFR) was obtained using reliable software (QAngio XA 3D) by modeled hyperemic flow velocity derived from coronary angiography without pharmacologically induced hyperemia. Clinical and angiographic data at the follow-up (18-30 months) were obtained from all cases. c-QFR measurement was possible in 52 (85%) lesions. Of these, clinically-driven target vessel revascularization (TVR) was performed in 8 (15%) lesions. Vessel c-QFR was significantly lower in the TVR group (0.703 ± 0.163 vs. 0.883 ± 0.103, p = 0.016). In the results of the receiver operating characteristics analysis for TVR, area under the curve for vessel c-QFR was 0.857. The cutoff point for the prediction of TVR was defined as vessel c-QFR of ≤ 0.82, the sensitivity of 88%, and specificity of 80%. Conclusion: Vessel c-QFR can predict TVR after 2nd gen-DES implantation. Further investigation is warranted to evaluate whether c-QFR guided coronary intervention ameliorates TVR rate.


Asunto(s)
Angiografía Coronaria , Enfermedad de la Arteria Coronaria/terapia , Circulación Coronaria , Vasos Coronarios/diagnóstico por imagen , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea/instrumentación , Anciano , Anciano de 80 o más Años , Velocidad del Flujo Sanguíneo , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/fisiopatología , Vasos Coronarios/fisiopatología , Femenino , Reserva del Flujo Fraccional Miocárdico , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Valor Predictivo de las Pruebas , Diseño de Prótesis , Reproducibilidad de los Resultados , Estudios Retrospectivos , Resultado del Tratamiento
3.
Heart Vessels ; 35(8): 1125-1134, 2020 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-32253531

RESUMEN

This sub-analysis of the XAPASS, a prospective, single-arm, observational study, aimed to evaluate relationships between body mass index (BMI) and safety (major bleeding and all-cause mortality) and effectiveness [stroke/non-central nervous system (non-CNS) systemic embolism (SE)/myocardial infarction (MI)] outcomes in Japanese patients with non-valvular atrial fibrillation (NVAF) receiving rivaroxaban. Patients were categorized according to BMI (kg/m2) as underweight (< 18.5), normal weight (18.5 to < 25), overweight (25 to < 30), or obese (≥ 30). In total, 9578 patients with NVAF completed the 1-year follow-up and were evaluated; of these, 7618 patients had baseline BMI data. Overall, 542 (5.7%), 4410 (46.0%), 2167 (22.6%), and 499 (5.2%) patients were underweight, normal weight, overweight, and obese, respectively. Multivariable Cox regression analysis demonstrated that none of the BMI categories were independent predictors of major bleeding whereas being underweight was independently associated with increased all-cause mortality [hazard ratio (HR) 3.56, 95% confidence interval (CI) 2.40-5.26, p < 0.001]. The incidence of stroke/non-CNS SE/MI was higher in patients who were underweight than in those of normal weight (HR 2.11, 95% CI 1.20-3.70, p = 0.009). However, in multivariable analyses, being underweight was not identified as an independent predictor of stroke/non-CNS SE/MI (HR 1.64, 95% CI 0.90-2.99, p = 0.104). In conclusion, the high incidence of thromboembolic events and all-cause mortality in patients who were underweight highlights that thorough evaluation of disease status and comorbidities may be required in this population.


Asunto(s)
Fibrilación Atrial/tratamiento farmacológico , Inhibidores del Factor Xa/uso terapéutico , Infarto del Miocardio/prevención & control , Obesidad/diagnóstico , Rivaroxabán/uso terapéutico , Accidente Cerebrovascular/prevención & control , Delgadez/diagnóstico , Tromboembolia/prevención & control , Anciano , Anciano de 80 o más Años , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/mortalidad , Índice de Masa Corporal , Comorbilidad , Inhibidores del Factor Xa/efectos adversos , Femenino , Factores de Riesgo de Enfermedad Cardiaca , Hemorragia/inducido químicamente , Humanos , Incidencia , Japón/epidemiología , Masculino , Persona de Mediana Edad , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/mortalidad , Obesidad/mortalidad , Vigilancia de Productos Comercializados , Estudios Prospectivos , Medición de Riesgo , Rivaroxabán/efectos adversos , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/mortalidad , Delgadez/mortalidad , Tromboembolia/diagnóstico , Tromboembolia/mortalidad , Factores de Tiempo , Resultado del Tratamiento
4.
Heart Vessels ; 35(3): 399-408, 2020 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-31492970

RESUMEN

Direct oral anticoagulants (DOACs), such as rivaroxaban, reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). However, it is still unclear whether the stroke reduction benefit outweighs the bleeding risk in elderly Japanese patients with NVAF. The Xarelto Post-Authorization Safety and Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS) was a real-world, prospective observational, post-marketing surveillance study on the safety and effectiveness of rivaroxaban in Japanese clinical practice. This sub-analysis evaluated the clinical outcomes of elderly patients aged ≥ 75 years. At the 1-year follow-up, there were 4,685 (48.91%) and 4,893 (51.09%) patients aged ≥ 75 and < 75 years, respectively. Safety and effectiveness outcomes were compared between patients aged ≥ 75 years and those aged < 75 years, and among 3 elderly sub-populations (age ranges: 75-79, 80-84, and ≥ 85 years). Patients aged ≥ 75 years had higher rates of major bleeding [2.22 vs. 1.35 events per 100 patient-years, hazard ratio (HR) 1.63, 95% confidence interval (CI) 1.17-2.28] and composite of stroke (ischemic or hemorrhagic)/non-central nervous system (non-CNS) systemic embolism (SE)/myocardial infarction (MI) (2.41 vs. 1.21 events per 100 patient-years, HR 1.97, 95% CI 1.40-2.77) compared to patients aged < 75 years. Intracranial hemorrhage rates were < 1 event per 100 patient-years in both groups (0.85 vs. 0.59 events per 100 patient-years, HR 1.43, 95% CI 0.85-2.40). Kaplan-Meier curves of major bleeding and stroke/non-CNS SE/MI showed that no significant differences of cumulative event rates were identified among the 3 elderly sub-populations. Stepwise Cox regression analyses revealed that creatinine clearance (CrCl) (<50 mL/min), hepatic impairment, and hypertension were specific predictors for major bleeding and no specific predictors were found for stroke/non-CNS SE/MI in patients aged ≥ 75 years. In conclusion, safety and effectiveness event rates were higher in patients aged ≥ 75 years compared with those aged < 75 years, yet, no distinct differences were observed among the 3 elderly sub-populations.


Asunto(s)
Fibrilación Atrial/tratamiento farmacológico , Embolia/prevención & control , Inhibidores del Factor Xa/administración & dosificación , Rivaroxabán/administración & dosificación , Accidente Cerebrovascular/prevención & control , Administración Oral , Factores de Edad , Anciano , Anciano de 80 o más Años , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/epidemiología , Embolia/diagnóstico , Embolia/epidemiología , Inhibidores del Factor Xa/efectos adversos , Femenino , Hemorragia/inducido químicamente , Humanos , Japón/epidemiología , Masculino , Persona de Mediana Edad , Vigilancia de Productos Comercializados , Estudios Prospectivos , Medición de Riesgo , Factores de Riesgo , Rivaroxabán/efectos adversos , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/epidemiología , Factores de Tiempo , Resultado del Tratamiento
5.
J Infect Chemother ; 26(7): 672-675, 2020 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-32131983

RESUMEN

AIM: Detection of coagulase-negative Staphylococcus in blood culture may be a result of either bacteremia or contamination. This often leads to diagnostic uncertainly. Our objective was to develop a method for differentiating whether a coagulase-negative Staphylococcus sp. positive blood culture represents bacteremia or contamination based on positive bottle detection pattern and time to positivity (TTP). METHODS: This study included 155 and 51 adults with positive blood cultures for Staphylococcus epidermidis and Staphylococcus hominis, respectively, over a three-year period from 2016 to 2018. Positive blood culture cases were categorized as either bacteremia or contamination based on the clinically available information, and the detection pattern and TTP in each category were investigated. RESULTS: A total of 57, 92, and 6 S. epidermidis positive blood cultures were categorized as bacteremia, contamination, and undetermined, respectively, whereas 15 and 36 S. hominis positive blood cultures were categorized as bacteremia and contamination, respectively. For positive blood cultures categorized as bacteremia, all four bottles in two sets of blood cultures were positive in 47/47 S. epidermidis and 14/14 S. hominis, respectively, whereas either one bottle in each of two sets or three bottles in two sets were positive in 10/19 S. epidermidis and 1/4 S. hominis, respectively; most of those TTPs were <48 h. Among them, the TTP in catheter-related blood stream infection was <24 h. CONCLUSION: Although clinical assessment is crucial to differentiate between bacteremia and contamination, a combination of positive bottle detection pattern and TTP is a valuable diagnostic auxiliary tool.


Asunto(s)
Bacteriemia/diagnóstico , Cultivo de Sangre/estadística & datos numéricos , Infecciones Relacionadas con Catéteres/diagnóstico , Infecciones Estafilocócicas/diagnóstico , Staphylococcus epidermidis/aislamiento & purificación , Staphylococcus hominis/aislamiento & purificación , Adulto , Bacteriemia/microbiología , Cultivo de Sangre/instrumentación , Cultivo de Sangre/normas , Infecciones Relacionadas con Catéteres/sangre , Contaminación de Equipos/prevención & control , Contaminación de Equipos/estadística & datos numéricos , Humanos , Valor Predictivo de las Pruebas , Estudios Retrospectivos , Manejo de Especímenes/instrumentación , Manejo de Especímenes/normas , Infecciones Estafilocócicas/sangre , Infecciones Estafilocócicas/microbiología
6.
J Stroke Cerebrovasc Dis ; 29(4): 104584, 2020 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-31983518

RESUMEN

BACKGROUND: It is important to understand the risk of thromboembolism and bleeding in patients with nonvalvular atrial fibrillation (NVAF) receiving direct oral anticoagulants; however, data on risk factors in Japanese patients are limited. METHODS: XAPASS (Xarelto Post-Authorization Safety and Effectiveness Study in Japanese Patients with Atrial Fibrillation) is a prospective observational study examining the safety and effectiveness of rivaroxaban in Japanese real-world clinical practice. We investigated risk factors for stroke/noncentral nervous system systemic embolism (non-CNS SE)/myocardial infarction (MI) and major bleeding using 1-year follow-up data. Associations between baseline characteristics and outcomes were examined by Cox regression analysis. RESULTS: During April 2012-June 2014, 11,308 patients newly started with rivaroxaban treatment were enrolled. Of 9578 patients with 1-year data fixed as of September 2017, 6220 patients who received appropriate dosages of rivaroxaban for their creatinine clearance were included in the present safety outcomes subanalysis, and 6198 were included in the effectiveness outcomes analysis. Stroke/non-CNS SE/MI was observed in 97 of 6198 patients (1.6%, 1.8 events/100 patient-years), and major bleeding occurred in 102 of 6220 patients (1.6%, 1.9 events/100 patient-years). Age greater than or equal to 75 years (hazard ratio [HR]: 2.27; [95% confidence interval (CI): 1.49, 3.47]), prior ischemic stroke/transient ischemic attack (2.08; [1.38, 3.13]), and antiplatelet use (3.23; [1.83, 5.70]) were associated with stroke/non-CNS SE/MI. Creatinine clearance less than 50 mL/min (HR: 1.86; [95% CI: 1.26, 2.75]), diabetes (1.55; [1.02, 2.35]), and antiplatelet use (3.04; [1.70, 5.45]) were associated with major bleeding. CONCLUSIONS: These results would help physicians to assess risks in Japanese patients with NVAF receiving rivaroxaban.


Asunto(s)
Fibrilación Atrial/tratamiento farmacológico , Inhibidores del Factor Xa/efectos adversos , Hemorragia/inducido químicamente , Rivaroxabán/efectos adversos , Accidente Cerebrovascular/prevención & control , Tromboembolia/prevención & control , Administración Oral , Anciano , Anciano de 80 o más Años , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/epidemiología , Toma de Decisiones Clínicas , Inhibidores del Factor Xa/administración & dosificación , Femenino , Hemorragia/epidemiología , Humanos , Japón/epidemiología , Masculino , Persona de Mediana Edad , Selección de Paciente , Vigilancia de Productos Comercializados , Estudios Prospectivos , Medición de Riesgo , Factores de Riesgo , Rivaroxabán/administración & dosificación , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/epidemiología , Tromboembolia/diagnóstico , Tromboembolia/epidemiología , Factores de Tiempo , Resultado del Tratamiento
7.
Cerebrovasc Dis ; 48(1-2): 53-60, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31578012

RESUMEN

INTRODUCTION: Prior stroke is a risk factor for stroke and bleeding during anticoagulation in patients with atrial fibrillation (AF). Although rivaroxaban is widely prescribed to reduce their risk of stroke in patients with nonvalvular AF (NVAF), the real-world evidence on rivaroxaban treatment is limited. We aimed to examine the outcomes of rivaroxaban treatment in NVAF patients with prior ischemic stroke/transient ischemic attack (TIA) by using the data of the Xarelto Post-Authorization Safety and Effectiveness Study in Japanese -Patients with AF, a prospective, single-arm, observational study. METHODS: The clinical outcomes of 9,578 patients who completed the 1-year follow-up were evaluated. Safety and effectiveness outcomes were compared between patients with and without prior ischemic stroke/TIA. RESULTS: Among the patients, 2,153 (22.5%) had prior ischemic stroke/TIA. They were significantly older and had lower body weight, lower creatinine clearance, higher CHADS2, CHA2DS2-VASc, and modified HAS-BLED scores as compared to those without prior ischemic stroke/TIA. Any bleeding (9.1 vs. 7.2 events per 100 patient-years), major bleeding (2.3 vs. 1.6 events per 100 patient-years), and stroke/non-central nervous system systemic embolism/myocardial infarction (3.4 vs. 1.3 events per 100 patient-years) were more frequent in patients with prior ischemic stroke/TIA. Stepwise regression analysis suggested that body weight of ≤50 kg and diabetes mellitus were predictive of major bleeding in patients with prior ischemic stroke/TIA. CONCLUSIONS: Safety and effectiveness event rates were higher in patients with prior ischemic stroke/TIA than those without. This might be explained by differences in several risk profiles including age, body weight, renal function, and risk scores such as CHADS2 between the groups. Clinicaltrials.gov: NCT01582737.


Asunto(s)
Fibrilación Atrial/tratamiento farmacológico , Isquemia Encefálica/prevención & control , Inhibidores del Factor Xa/uso terapéutico , Ataque Isquémico Transitorio/prevención & control , Rivaroxabán/uso terapéutico , Accidente Cerebrovascular/prevención & control , Anciano , Anciano de 80 o más Años , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/epidemiología , Isquemia Encefálica/diagnóstico , Isquemia Encefálica/epidemiología , Inhibidores del Factor Xa/efectos adversos , Femenino , Hemorragia/inducido químicamente , Hemorragia/epidemiología , Humanos , Ataque Isquémico Transitorio/diagnóstico , Ataque Isquémico Transitorio/epidemiología , Japón/epidemiología , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Medición de Riesgo , Factores de Riesgo , Rivaroxabán/efectos adversos , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/epidemiología , Factores de Tiempo , Resultado del Tratamiento
8.
J Thromb Thrombolysis ; 48(4): 653-660, 2019 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-31432451

RESUMEN

The approved dose of oral anticoagulant rivaroxaban for patients with non-valvular atrial fibrillation (NVAF) in Japan is 15 mg once daily (od) in patients whose creatinine clearance is ≥ 50 mL/min, but recent real-world studies have demonstrated that these patients often received less than the recommended dose due to bleeding concerns. The effect of under-dosing on safety and effectiveness outcomes remains unclear. We used 1-year follow-up data from the XAPASS, a real-world Japanese prospective, single-arm, observational study. Of the 11,308 patients, 6521 patients who completed a 1-year follow-up and had a creatinine clearance ≥ 50 mL/min were included in this sub-analysis. Primary endpoints were any bleeding and a composite of stroke/non-central nervous system systemic embolism (non-CNS SE)/myocardial infarction (MI). Among the 6521 patients, 4185 (64.2%; mean CHADS2 score: 1.8) received the 15 mg od (recommended dose), whereas 2336 (35.8%; mean CHADS2 score: 2.3) received 10 mg od (under-dose). After adjusting for patient characteristics by propensity scoring and inverse probability of treatment weighting, incidence rates of major bleeding were comparable between under-dosed patients and patients who received the recommended dose (1.34 vs. 1.63 events/100 patient-years, p = 0.197), although the incidence rates of stroke/non-CNS SE/MI were higher in under-dosed patients than in those who received the recommended dose (2.15 vs. 1.48 events/100 patient-years, p = 0.009). In Japanese clinical practice, some NVAF patients receive rivaroxaban doses inconsistent with the recommendation. Considering the total clinical benefit, the recommended dose may be preferable in terms of balance of safety and effectiveness.Clinicaltrials.gov NCT01582737.


Asunto(s)
Fibrilación Atrial/tratamiento farmacológico , Rivaroxabán/administración & dosificación , Anciano , Fibrilación Atrial/complicaciones , Manejo de la Enfermedad , Inhibidores del Factor Xa/administración & dosificación , Inhibidores del Factor Xa/uso terapéutico , Femenino , Adhesión a Directriz , Hemorragia/inducido químicamente , Humanos , Masculino , Persona de Mediana Edad , Pautas de la Práctica en Medicina , Rivaroxabán/uso terapéutico , Accidente Cerebrovascular/etiología , Resultado del Tratamiento
12.
Int Heart J ; 57(3): 336-40, 2016 May 25.
Artículo en Inglés | MEDLINE | ID: mdl-27149999

RESUMEN

Chronic inflammation is known to occur in diabetes mellitus (DM) and contributes to atrial fibrosis, possible substrates for atrial fibrillation. We tested the hypothesis that dipeptidyl peptidase (DPP)-4 inhibitors prevent the formation of atrial fibrosis through their anti-inflammatory activity, beyond the effects of controlling blood glucose.DM models obtained by administration of streptozotocin (STZ) were divided into 3 groups: with PKF275-055, a DPP-4 inhibitor in group D, glibenclamide in group SU, and no additional drug in group P. At 8 weeks after STZ administration, the heart was subjected to Masson trichrome staining and immunohistochemistry with anti-ED2, ED3, and smooth muscle actin antibody.The % area of fibrosis in atria of group P accounted for 14.7% ± 4.1%, showing a significant increase in fibrosis when compared with the control group. In group SU, the % area accounted for 7.9% ± 2.9%, indicating significant deceased fibrosis by sulfonylurea. Meanwhile, we could not find significant differences in group D when compared to group P or group SU. While ED3-positive cells increased in group P (1.12% ± 0.24%), they were significantly decreased in groups D and SU (0.41% ± 0.22% and 0.55% ± 0.29%, respectively). Between group D and SU, however, there were no significant differences in the amount of cells positive to ED2, ED3, and smooth muscle actin antibodies.In STZ-induced DM rats, administration of sulfonylurea and DPP-4 inhibitors inhibited inflammation and fibrosis of the atria. However, no significant differences were observed between the 2 antidiabetic drugs.


Asunto(s)
Adamantano/análogos & derivados , Fibrilación Atrial , Diabetes Mellitus Experimental , Inhibidores de la Dipeptidil-Peptidasa IV/farmacología , Fibrosis Endomiocárdica , Gliburida/farmacología , Atrios Cardíacos , Nitrilos/farmacología , Pirrolidinas/farmacología , Adamantano/farmacología , Animales , Antiinflamatorios/farmacología , Fibrilación Atrial/fisiopatología , Fibrilación Atrial/prevención & control , Diabetes Mellitus Experimental/sangre , Diabetes Mellitus Experimental/complicaciones , Diabetes Mellitus Experimental/tratamiento farmacológico , Diabetes Mellitus Experimental/fisiopatología , Fibrosis Endomiocárdica/etiología , Fibrosis Endomiocárdica/metabolismo , Fibrosis Endomiocárdica/prevención & control , Femenino , Atrios Cardíacos/efectos de los fármacos , Atrios Cardíacos/patología , Atrios Cardíacos/fisiopatología , Hipoglucemiantes/farmacología , Inmunohistoquímica , Inflamación/metabolismo , Inflamación/prevención & control , Ratas , Ratas Wistar , Estadística como Asunto
13.
Int J Clin Pharmacol Ther ; 53(10): 866-74, 2015 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-26308176

RESUMEN

OBJECTIVE: A thorough QT study of favipiravir, a novel antiviral agent, was conducted using a randomized, doubleblind, 4-group, 4-period crossover, placebo-and positive-controlled (open-label moxifloxacin) design. MATERIALS AND METHODS: 56 healthy Japanese adults of both sexes received single oral doses of favipiravir 1,200 and 2,400 mg (Avigan® Tablets, Toyama Chemical Co., Ltd.), moxifloxacin 400 mg, and a placebo. QT intervals after these treatments were measured under blinded conditions. The primary endpoint was the time-matched, placebo-adjusted change in corrected QT intervals using the Fridericia method (QTcF) from predose for favipiravir or moxifloxacin (ΔΔQTcF). RESULTS: Lower bounds of the two-sided 90% confidence interval of ΔΔQTcF values for moxifloxacin exceeded 3 msec at all time points, and the maximum value was 14.0 (11.8-16.1, 90% confidence interval) msec at 3 hours after administration. Similarly, maximum ΔΔQTcF values for favipiravir were 0.833 (-1.33-3.00) msec at 3 hours after administration of 1,200 mg, and 0.500 (-1.88-2.88) msec at 6 hours after administration of 2,400 mg. Calculation of the sample size using the ΔΔQTcF value of moxifloxacin indicated that 25 subjects would be sufficient for detection at a power of 90% or higher, which meets the criteria for assuring assay sensitivity. CONCLUSIONS: It is possible to use a smaller number of subjects in thorough QT studies in Japan than in Europe and the US utilizing moxifloxacin as a positive control. There were no detectable effects of favipiravir on the QT/QTc interval.


Asunto(s)
Amidas/farmacología , Antivirales/farmacología , Electrocardiografía/efectos de los fármacos , Pirazinas/farmacología , Adulto , Amidas/efectos adversos , Amidas/sangre , Antivirales/efectos adversos , Antivirales/sangre , Estudios Cruzados , Método Doble Ciego , Femenino , Humanos , Masculino , Pirazinas/efectos adversos , Pirazinas/sangre , Adulto Joven
14.
Int Heart J ; 56(5): 555-7, 2015.
Artículo en Inglés | MEDLINE | ID: mdl-26346519

RESUMEN

Electrical storm (ES) was observed in an 82-year-old man with recent myocardial infarction. Conventional therapy, including amiodarone, could not suppress the ES. After more than 100 electrical defibrillations, we were finally able to control the ES with the administration of landiolol. It is known that landiolol can inhibit ES. However, we hesitate to use landiolol in patients with low cardiac output. We would like to emphasize that careful use of landiolol should be considered in patients with refractory ES after myocardial infarction, although cardiac output is severely reduced.


Asunto(s)
Cardioversión Eléctrica/métodos , Morfolinas/administración & dosificación , Infarto del Miocardio , Urea/análogos & derivados , Antagonistas Adrenérgicos beta/administración & dosificación , Anciano de 80 o más Años , Angiografía Coronaria/métodos , Electrocardiografía , Humanos , Masculino , Infarto del Miocardio/complicaciones , Infarto del Miocardio/fisiopatología , Taquicardia Ventricular/etiología , Taquicardia Ventricular/fisiopatología , Resultado del Tratamiento , Urea/administración & dosificación
15.
Circ J ; 78(5): 1091-6, 2014.
Artículo en Inglés | MEDLINE | ID: mdl-24662400

RESUMEN

BACKGROUND: A nationwide survey of catheter ablation for atrial fibrillation (AF) was conducted in Japan to determine the mid-term performance of the therapy from analysis of the 1-year outcome of registered patients. METHODS AND RESULTS: A total of 2,137 patients who underwent AF ablation in September 2011 and March 2012 were initially registered. In 2013, the 1-year follow-up data of 1,208 patients (56.5% of 2,137) from 119 centers were collected. Average age was 61.9±10.7 years. Patients with paroxysmal AF (PAF) constituted 64.3%. Persistent AF (pAF) and long-standing pAF (LS-pAF) were 20.4% and 15.3%, respectively. For all patients, 76.7% underwent their first AF ablation. At 1 year after AF ablation, 70.9%, 61.4%, and 56.2% of PAF, pAF, and LS-pAF patients, respectively, were free from AF or clinical/partial success (PAF vs. pAF or LS-pAF: P<0.01). Re-ablation was performed in 11.3%, 16.3%, and 17.3%, respectively. Multivariate logistic regression analysis revealed that procedure time (odds ratio [OR] 0.82, P=0.000), and results of AF induction test (OR 1.36, P<0.02) were significantly related to successful outcome. CONCLUSIONS: Approximately 70% of PAF and 60% of nonPAF patients were free from AF recurrence or had clinical/partial success status. Shorter procedure time and elimination of AF inducibility were independent predictors of mid-term success of AF ablation.


Asunto(s)
Fibrilación Atrial/terapia , Ablación por Catéter/métodos , Sistema de Registros , Anciano , Pueblo Asiatico , Fibrilación Atrial/epidemiología , Fibrilación Atrial/fisiopatología , Ablación por Catéter/efectos adversos , Femenino , Estudios de Seguimiento , Humanos , Japón , Masculino , Persona de Mediana Edad
16.
Circ J ; 78(5): 1112-20, 2014.
Artículo en Inglés | MEDLINE | ID: mdl-24632790

RESUMEN

BACKGROUND: The purpose of this study was to provide precise data on the current status of catheter ablation for atrial fibrillation (AF) in Japan. METHODS AND RESULTS: The Japanese Heart Rhythm Society requested that members retrospectively register data for AF ablation performed in September 2011, March 2012, and September 2012. A total of 165 centers submitted data for 3,373 patients (age, 62±11 years; male, 76.1%; paroxysmal AF, 64.4%). Pulmonary vein isolation (PVI) and additional ablation were performed in 97.5% and 77.4% of patients, respectively. 3-D mapping systems and irrigated-tip catheters were used in 94.8% and 87.7% of the patients, respectively. Although the mean CHADS2 score was 1.0±1.0, the majority received oral anticoagulant (OAC) during and following the procedure (69.8% and 97%, respectively). Vitamin K antagonist (VKA) prescription, however, decreased (1st vs. 3rd survey, during and following the procedure, 59.3% vs. 47.8% and 81.7% vs. 55.2%, respectively, P<0.0001, both) and that of new OAC (NOAC) increased drastically (9.6% vs. 24.2% and 15.8% vs. 42.1%, respectively, P<0.0001). Early complications were reported in 4.5% of the patients, but no instance of early death was reported. CONCLUSIONS: In addition to PVI, additional ablation procedures are also performed very frequently. Although the mean CHADS2 score was low, peri-procedural OAC therapy was commonly performed, and NOAC drastically superseded VKA.


Asunto(s)
Anticoagulantes/administración & dosificación , Fibrilación Atrial/terapia , Ablación por Catéter , Sistema de Registros , Vitamina K/antagonistas & inhibidores , Pueblo Asiatico , Fibrilación Atrial/mortalidad , Femenino , Humanos , Japón , Masculino , Persona de Mediana Edad
17.
J Stroke Cerebrovasc Dis ; 23(10): 2520-2526, 2014.
Artículo en Inglés | MEDLINE | ID: mdl-25245483

RESUMEN

BACKGROUND: The postmarketing surveillance registry evaluated the safety and efficacy of rivaroxaban in Japanese patients with atrial fibrillation (AF) treated with rivaroxaban. METHODS: A total of 10,038 patients with AF were enrolled between April 18, 2012 and December 16, 2013. Overall, 48.9% of the patients were of 75 years or older. The median CHADS2 score was 2 (interquartile range, 1-3). A total of 54.7% of patients had switched from an anticoagulant/antiplatelet drug, whereas 45.3% were treatment naive. Initial analysis was conducted for the 1039 patients who had completed the 6-month follow-up examinations by the end of June 2013. The low dose (10 mg/d) of rivaroxaban had been selected for approximately one quarter of the patients because of bleeding risks and advanced age in addition to renal impairment, although the high dose (15 mg/d) should have been selected. RESULTS: Major and nonmajor clinically relevant bleeding events were observed in 36 of 1035 patients. Five of 16 patients who concomitantly used 2 or more antiplatelet agents developed a bleeding event. Bleeding events were observed in 8 of 158 patients who were of 75 years or older and weighed 50 kg or less. The composite end point event of stroke, systemic embolism, or myocardial infarction was observed in 6 of 1034 patients. CONCLUSIONS: This registry will continue to provide insights into the safety and efficacy of rivaroxaban in real-world practice.


Asunto(s)
Anticoagulantes/efectos adversos , Fibrilación Atrial/complicaciones , Morfolinas/efectos adversos , Inhibidores de Agregación Plaquetaria/efectos adversos , Vigilancia de Productos Comercializados , Tiofenos/efectos adversos , Administración Oral , Factores de Edad , Anciano , Anciano de 80 o más Años , Pueblo Asiatico , Embolia/etiología , Embolia/prevención & control , Femenino , Estudios de Seguimiento , Hemorragia/inducido químicamente , Hemorragia/epidemiología , Humanos , Riñón/efectos de los fármacos , Masculino , Persona de Mediana Edad , Morfolinas/administración & dosificación , Morfolinas/uso terapéutico , Inhibidores de Agregación Plaquetaria/administración & dosificación , Sistema de Registros , Factores de Riesgo , Rivaroxabán , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/prevención & control , Tiofenos/administración & dosificación , Tiofenos/uso terapéutico , Resultado del Tratamiento
18.
Nihon Rinsho ; 71(1): 43-8, 2013 Jan.
Artículo en Japonés | MEDLINE | ID: mdl-23631170

RESUMEN

ECG, 24-h ambulatory ECG, and related tests have been used to clarify the pathophysiological features of atrial fibrillation as well as to detect the relationship between symptoms and episodes of tachyarrhythmia. These testes are also potent to estimate the efficacy of pharmacological and nonpharmacological treatments. Proarrhythmic events during the treatment with antiarrhythmic agents may be avoided by careful follow-up using ECG. Recently, an implantable loop recorder electrocardiogram is available to identify the culprit episode of syncope. Atrial fibrillation is a cause of syncope in only a small proportion of patients.


Asunto(s)
Electrocardiografía , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/fisiopatología , Fibrilación Atrial/terapia , Diagnóstico por Computador , Electrocardiografía/métodos , Electrodos Implantados , Humanos , Evaluación de Resultado en la Atención de Salud , Síncope/etiología , Síncope/fisiopatología
19.
Circ J ; 76(10): 2343-7, 2012.
Artículo en Inglés | MEDLINE | ID: mdl-22786471

RESUMEN

BACKGROUND: Agents with α-2 adrenoreceptor (AR) agonistic action have reportedly suppressed tachyarrhythmias. METHODS AND RESULTS: We hypothesized that α-2 AR agonists would have an inhibitory effect on abnormal repolarization-related ventricular tachyarrhythmias (VTs). To test this hypothesis, the effects of 2 clinically available α-2 AR agonists (dexmedetomidine and clonidine) on the occurrence of VTs were assessed in a methoxamine-sensitized rabbit model of acquired long QT syndrome (Study 1: n=45). In control rabbits, administration of methoxamine and nifekalant almost invariably caused VTs (14/15). In contrast, incidence of VT significantly decreased during the treatment with dexmedetomidine (1µg·kg(-1)·min(-1): 5/12 [P<0.01 vs. control]) or with clonidine (33.3µg·kg(-1)·min(-1): 10/18 [P<0.01]). To verify that VTs in this animal model are triggered by early afterdepolarization (EAD), the monophasic action potential on the left ventricular surface was recorded in 28 open-chest rabbits (Study 2). EAD-like hump was less frequently detected during treatment with clonidine or dexmedetomidine (2/14) than in saline-treated rabbits (9/10, P<0.005). Presence of a hump was significantly related to the advent of VTs (P<0.05). CONCLUSIONS: Agents with α-2 AR agonistic action have an inhibitory effect on VTs in a rabbit model of long QT syndrome. Alpha-2 AR agonists, especially dexmedetomidine, may be a therapeutic choice for abnormal repolarization-related VTs that are resistant to conventional treatment.


Asunto(s)
Agonistas de Receptores Adrenérgicos alfa 2/farmacología , Clonidina/farmacología , Dexmedetomidina/farmacología , Síndrome de QT Prolongado/tratamiento farmacológico , Taquicardia/tratamiento farmacológico , Agonistas de Receptores Adrenérgicos alfa 1/efectos adversos , Agonistas de Receptores Adrenérgicos alfa 1/farmacología , Animales , Antiarrítmicos/efectos adversos , Antiarrítmicos/farmacología , Modelos Animales de Enfermedad , Sistema de Conducción Cardíaco/fisiopatología , Humanos , Síndrome de QT Prolongado/inducido químicamente , Síndrome de QT Prolongado/fisiopatología , Metoxamina/efectos adversos , Metoxamina/farmacología , Pirimidinonas/efectos adversos , Pirimidinonas/farmacología , Conejos , Taquicardia/inducido químicamente , Taquicardia/fisiopatología
20.
J Arrhythm ; 38(3): 369-379, 2022 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-35785372

RESUMEN

Background: To evaluate the impact of three risk factors (age [≥75 years], renal impairment [creatinine clearance <50 ml/min], and low body weight [≤50 kg]) on the risk of any bleeding events, all-cause mortality, and stroke, non-central nervous system (non-CNS) systemic embolism (SE), and myocardial infarction (MI) in patients with nonvalvular atrial fibrillation (NVAF) treated with rivaroxaban in a real-world clinical setting. Methods: The Xarelto Post-Authorization Safety and Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS) is a prospective, single-arm, observational study. Enrolled patients were divided into four subgroups by the number of risk factors. Results: Overall, 9823 patients were included: 4299 with low risk, 2816 with moderate risk, 1574 with high risk, and 1134 with very high risk. The hazard ratios (95% confidence interval) (reference: low risk) for the moderate-, high-, and very-high-risk groups were 1.62 (1.19, 2.21) (p = 0.002), 2.15 (1.47, 3.15) (p < 0.001), and 2.49 (1.60, 3.87) (p <0.001) for major bleeding, and 1.98 (1.47, 2.66), 2.29 (1.59, 3.29), and 2.74 (1.81, 4.16) (p <0.001 for all) for stroke/non-CNS SE/MI, respectively. Conclusions: Age ≥75 years and renal impairment, but not low body weight, were determinants for major bleeding. The accrual of three risk factors was associated with increased risk for major bleeding and stroke/non-CNS SE/MI in patients with NVAF receiving rivaroxaban; there was no increase in the cumulative risk for these with an increasing number of risk factors.

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