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1.
J Res Adolesc ; 34(1): 159-172, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-38083990

RESUMEN

We examined cultural specificity in how adolescents' coping strategies in response to peer victimization are associated with adjustment with a sample of 7th-8th graders from the United States (n = 292, 60% female, Mage = 13.6, SD = 0.65) and South Korea (n = 462, 50.2% female, Mage = 13.7, SD = 0.58). Participants read scenarios describing victimization and rated the likelihood of utilizing different coping strategies. US adolescents rated conflict resolution, cognitive distancing, and revenge higher than Korean adolescents, while Korean adolescents endorsed social support seeking more than US adolescents. Social support seeking was positively associated with global self-worth in both countries; however, social support seeking was negatively related to depression and social anxiety only for Korean youth.


Asunto(s)
Habilidades de Afrontamiento , Víctimas de Crimen , Humanos , Adolescente , Femenino , Estados Unidos/epidemiología , Masculino , Grupo Paritario , Apoyo Social , República de Corea , Víctimas de Crimen/psicología
2.
J Youth Adolesc ; 51(10): 2018-2032, 2022 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-35523925

RESUMEN

Although there is cultural variability in how individuals make attributions for their own and others' behaviors, cultural variation in youth's attributions about peer victimization and their relation with internalizing problems has gone unexamined. To address this issue, adolescents from the U.S. (n = 292, 60% female, 79.5% White, Mage = 13.6, SD = 0.65) and Korea (n = 462, 50.2% female, Mage = 13.7, SD = 0.58) reported on their peer victimization, depressive symptoms, social anxiety, self-worth, and rated their attributions to vignettes about peer victimization. Multigroup confirmatory analyses found that Korean and American youth conceptualized characterological self-blame, behavioral self-blame, and externalization of blame similarly. However, Korean youth differentially endorsed each of the three types of attributions, while U.S. adolescents endorsed characterological self-blame and behavioral self-blame at similar levels. Attributions had unique relations with internalizing problems (depression, social anxiety, global self-worth) in each culture. In multigroup SEM analyses, characterological self-blame predicted all internalizing problems for U.S. adolescents, while behavioral self-blame was not uniquely related to internalizing problems. For Korean adolescents, behavioral self-blame significantly predicted all internalizing problems, whereas characterological self-blame predicted global self-worth only. The results suggest that attributions about victimization have different adjustment implications in Korea than in the U.S.


Asunto(s)
Acoso Escolar , Víctimas de Crimen , Adolescente , Femenino , Humanos , Masculino , Grupo Paritario , República de Corea , Percepción Social
3.
Coron Artery Dis ; 30(1): 59-66, 2019 01.
Artículo en Inglés | MEDLINE | ID: mdl-30507632

RESUMEN

BACKGROUND: Outcomes for stent-based coronary intervention of lesions with long diseased segments remain relatively unfavorable. This study sought to compare the efficacy of Resolute zotarolimus-eluting stents (R-ZES) and Xience everolimus-eluting stents (EES) for very long coronary lesions. METHODS AND RESULTS: This randomized, multicenter, prospective trial compared the use of R-ZES with EES for very long (≥50 mm) native coronary lesions. The primary end point was in-segment late luminal loss at 12-month angiographic follow-up. A total of 400 patients were needed to assess the primary end point. However, owing to very slow enrollment of patients, this trial was early terminated (302 patients were enrolled), and thus, this report provides descriptive information on primary and secondary end points. The R-ZES and EES groups had similar baseline characteristics. Lesion length was 49.6±10.2 and 50.6±13.3 mm in the R-ZES and EES groups, respectively (P=0.47). The number of stents used at the target lesion was 2.1±0.3 and 2.2±0.5, respectively. Twelve-month angiographic follow-up was performed in 50% of eligible patients. In-segment late luminal loss did not significantly differ between the R-ZES and EES groups (0.17±0.57 vs. 0.09±0.43 mm, P=0.32). In-segment binary restenosis rates were 8.1 and 5.3% in the R-ZES and EES groups, respectively (P=0.49). There were no significant between-group differences in the rate of adverse events (death, myocardial infarction, stent thrombosis, target lesion revascularization, and composite outcomes). CONCLUSION: For patients with very long native coronary artery disease, R-ZES and EES implantation showed comparable angiographic and clinical outcomes through 1 year of follow-up.


Asunto(s)
Enfermedad de la Arteria Coronaria/cirugía , Vasos Coronarios/diagnóstico por imagen , Stents Liberadores de Fármacos , Everolimus/farmacología , Intervención Coronaria Percutánea/métodos , Sirolimus/análogos & derivados , Anciano , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico , Vasos Coronarios/cirugía , Femenino , Estudios de Seguimiento , Humanos , Inmunosupresores/farmacología , Masculino , Estudios Prospectivos , Diseño de Prótesis , Factores de Riesgo , Método Simple Ciego , Sirolimus/farmacología , Resultado del Tratamiento
5.
JACC Cardiovasc Interv ; 8(4): 550-60, 2015 Apr 20.
Artículo en Inglés | MEDLINE | ID: mdl-25907082

RESUMEN

OBJECTIVES: This study sought to evaluate the optimal percutaneous coronary intervention techniques using drug-eluting stents for bifurcation coronary lesions. BACKGROUND: The optimal bifurcation stenting technique needs to be evaluated. METHODS: The trial included 2 randomization studies separated by the presence of side branch (SB) stenosis for patients having non-left main bifurcation lesions. For 306 patients without SB stenosis, the routine final kissing balloon or leave-alone approaches were compared. Another randomization study compared the crush or single-stent approaches for 419 patients with SB stenosis. RESULTS: Between the routine final kissing balloon and leave-alone groups for nondiseased SB lesions, angiographic restenosis occurred in 17.9% versus 9.3% (p=0.064), comprising 15.1% versus 3.7% for the main branch (p=0.004) and 2.8% versus 5.6% for the SB (p=0.50) from 214 patients (69.9%) receiving 8-month angiographic follow-up. Incidence of major adverse cardiac events including death, myocardial infarction, or target vessel revascularization over 1 year was 14.0% versus 11.6% between the routine final kissing balloon and leave-alone groups (p=0.57). In another randomization study for diseased SB lesions, 28.2% in the single-stent group received SB stents. From 300 patients (71.6%) receiving angiographic follow-up, between the crush and single-stent groups, angiographic restenosis rate was 8.4% versus 11.0% (p=0.44), comprising 5.2% versus 4.8% for the main branch (p=0.90) and 3.9% versus 8.3% for the SB (p=0.12). One-year major adverse cardiac events rate between the crush and single-stent groups was 17.9% versus 18.5% (p=0.84). CONCLUSIONS: Angiographic and clinical outcomes were excellent after percutaneous coronary intervention using drug-eluting stents with any stent technique for non-left main bifurcation lesions once the procedure was performed successfully.


Asunto(s)
Angioplastia Coronaria con Balón/métodos , Estenosis Coronaria/diagnóstico por imagen , Estenosis Coronaria/terapia , Vasos Coronarios/patología , Stents Liberadores de Fármacos , Adulto , Anciano , Angioplastia Coronaria con Balón/mortalidad , Causas de Muerte , Angiografía Coronaria/métodos , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/mortalidad , Estenosis Coronaria/mortalidad , Vasos Coronarios/diagnóstico por imagen , Femenino , Estudios de Seguimiento , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Falla de Prótesis , República de Corea , Medición de Riesgo , Stents , Análisis de Supervivencia , Factores de Tiempo , Resultado del Tratamiento
7.
Circ Cardiovasc Interv ; 7(3): 322-9, 2014 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-24823426

RESUMEN

BACKGROUND: Procedural and clinical outcomes still remain unfavorable for patients with long coronary lesions who undergo percutaneous coronary intervention. The current study, therefore, evaluated 2 innovative drug-eluting stents for the management of long-lesion coronary artery disease. METHODS AND RESULTS: This randomized, multicenter, prospective trial, called the Long Drug-Eluting Stent (LONG-DES) V trial, compared the biodegradable polymer-based biolimus A9-eluting stent (BES) and the durable polymer-based platinum chromium everolimus-eluting stent (PtCr-EES) in 500 patients with long (≥ 25 mm) coronary lesions. The primary end point of the trial was in-segment late luminal loss at the 9-month angiographic follow-up. The BES and PtCr-EES groups had similar baseline characteristics, with a slightly shorter lesion length in the BES group versus the PtCr-EES group (29.24 ± 12.17 versus 32.27 ± 13.84 mm; P = 0.016). In-segment late luminal loss was comparable between the 2 groups at the 9-month angiographic follow-up (BES, 0.14 ± 0.38 versus PtCr-EES, 0.11 ± 0.37 mm; difference, 0.031; 95% confidence interval, -0.053 to 0.091; P = 0.03 for a noninferiority margin of 0.11, P = 0.45 for superiority), as was in-stent late luminal loss (0.20 ± 0.41 versus 0.24 ± 0.38 mm; P = 0.29). The incidence of in-segment (6.1% versus 4.9%; P = 0.63) and in-stent (3.7% versus 4.9%; P = 0.59) binary restenosis was also similar between the groups. There was no significant between-group difference in the rate of composite outcome of death, myocardial infarction, and target vessel revascularization (41, 16.7% in BES versus 42, 16.5% in PtCr-EES; P=0.94). CONCLUSIONS: BES and PtCr-EES implantation showed analogous angiographic and clinical outcomes for patients with de novo long coronary lesions. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01186120.


Asunto(s)
Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos , Intervención Coronaria Percutánea/métodos , Sirolimus/análogos & derivados , Anciano , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/mortalidad , Reestenosis Coronaria/epidemiología , Stents Liberadores de Fármacos/efectos adversos , Everolimus , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Infarto del Miocardio/epidemiología , Estudios Prospectivos , Método Simple Ciego , Sirolimus/efectos adversos , Tasa de Supervivencia , Trombosis/epidemiología , Resultado del Tratamiento
8.
Circulation ; 129(3): 304-12, 2014 Jan 21.
Artículo en Inglés | MEDLINE | ID: mdl-24097439

RESUMEN

BACKGROUND: The risks and benefits of long-term dual antiplatelet therapy remain unclear. METHODS AND RESULTS: This prospective, multicenter, open-label, randomized comparison trial was conducted in 24 clinical centers in Korea. In total, 5045 patients who received drug-eluting stents and were free of major adverse cardiovascular events and major bleeding for at least 12 months after stent placement were enrolled between July 2007 and July 2011. Patients were randomized to receive aspirin alone (n=2514) or clopidogrel plus aspirin (n=2531). The primary end point was a composite of death resulting from cardiac causes, myocardial infarction, or stroke 24 months after randomization. At 24 months, the primary end point occurred in 57 aspirin-alone group patients (2.4%) and 61 dual-therapy group patients (2.6%; hazard ratio, 0.94; 95% confidence interval, 0.66-1.35; P=0.75). The 2 groups did not differ significantly in terms of the individual risks of death resulting from any cause, myocardial infarction, stent thrombosis, or stroke. Major bleeding occurred in 24 (1.1%) and 34 (1.4%) of the aspirin-alone group and dual-therapy group patients, respectively (hazard ratio, 0.71; 95% confidence interval, 0.42-1.20; P=0.20). CONCLUSIONS: Among patients who were on 12-month dual antiplatelet therapy without complications, an additional 24 months of dual antiplatelet therapy versus aspirin alone did not reduce the risk of the composite end point of death from cardiac causes, myocardial infarction, or stroke. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT01186146.


Asunto(s)
Angioplastia Coronaria con Balón , Aspirina/administración & dosificación , Enfermedad de la Arteria Coronaria/tratamiento farmacológico , Stents Liberadores de Fármacos , Ticlopidina/análogos & derivados , Anciano , Aspirina/efectos adversos , Clopidogrel , Terapia Combinada , Enfermedad de la Arteria Coronaria/mortalidad , Quimioterapia Combinada , Femenino , Estudios de Seguimiento , Hemorragia/inducido químicamente , Hemorragia/mortalidad , Humanos , Masculino , Persona de Mediana Edad , Inhibidores de Agregación Plaquetaria/administración & dosificación , Inhibidores de Agregación Plaquetaria/efectos adversos , Estudios Prospectivos , Factores de Riesgo , Ticlopidina/administración & dosificación , Ticlopidina/efectos adversos , Resultado del Tratamiento
10.
Heart Asia ; 5(1): 228, 2013.
Artículo en Inglés | MEDLINE | ID: mdl-27326139
11.
Circ Cardiovasc Interv ; 5(5): 633-40, 2012 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-23048051

RESUMEN

BACKGROUND: Procedural and clinical outcomes still remain unfavorable for patients with long coronary lesions who undergo stent-based coronary interventions. Therefore, we compared the relative efficacy and safety of resolute zotarolimus-eluting stents (R-ZES) and sirolimus-eluting stents (SES) for patients with de novo long coronary lesions. METHODS AND RESULTS: This randomized, multicenter, prospective trial, called the Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-IV (LONG-DES IV) trial, compared long R-ZES and SES in 500 patients with long (≥25 mm) native coronary lesions. The primary end point of the trial was in-segment late luminal loss at 9-month angiographic follow-up. The baseline characteristics were not different between R-ZES and SES groups, including lesion lengths (32.4±13.5 mm versus 31.0±13.5 mm, P=0.27). At 9-month angiographic follow-up, the R-ZES was noninferior to the SES with respect to in-segment late luminal loss, the primary study end point (0.14±0.38 mm versus 0.12±0.43 mm, P for noninferiority=0.03, P for superiority=0.68). In addition, in-stent late luminal loss (0.26±0.36 mm versus 0.24±0.42 mm, P=0.78) and the rates of in-segment (5.2% versus 7.2%, P=0.44) and in-stent (4.0% versus 6.0%, P=0.41) binary restenosis were not significantly different between the 2 groups. There were no significant between-group differences in the rate of adverse clinical events (death, myocardial infarction, stent thrombosis, target-lesion revascularization, and composite outcomes). CONCLUSIONS: For patients with de novo long coronary artery disease, R-ZES implantation showed noninferior angiographic outcomes as compared with SES implantation. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01186094.


Asunto(s)
Angioplastia Coronaria con Balón/instrumentación , Fármacos Cardiovasculares/administración & dosificación , Enfermedad de la Arteria Coronaria/terapia , Stents Liberadores de Fármacos , Sirolimus/análogos & derivados , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/mortalidad , Distribución de Chi-Cuadrado , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Reestenosis Coronaria/etiología , Trombosis Coronaria/etiología , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Infarto del Miocardio/etiología , Estudios Prospectivos , Diseño de Prótesis , República de Corea , Factores de Riesgo , Sirolimus/administración & dosificación , Factores de Tiempo , Resultado del Tratamiento
12.
Circ Cardiovasc Interv ; 5(3): 365-71, 2012 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-22693347

RESUMEN

BACKGROUND: It remains unclear whether there are differences in the safety and efficacy outcomes between everolimus-eluting stents (EES) and sirolimus-eluting stents (SES) in contemporary practice. METHODS AND RESULTS: We prospectively enrolled 6166 consecutive patients who received EES (3081 patients) and SES (3085 patients) between April 2008 and June 2010, using data from the Interventional Cardiology Research In-Cooperation Society-Drug-Eluting Stents Registry. The primary end point was a composite of death, nonfatal myocardial infarction (MI), or target-vessel revascularization (TVR). At 2 years of follow-up, the 2 study groups did not differ significantly in crude risk of the primary end point (12.1% for EES versus 12.4% for SES; HR, 0.97; 95% CI, 0.84-1.12, P=0.66). After adjustment for differences in baseline risk factors, the adjusted risk for the primary end point remained similar for the 2 stent types (HR, 0.96; 95% CI, 0.82-1.12, P=0.60). There were also no differences between the stent groups in the adjusted risks of the individual component of death (HR, 0.93; 95% CI, 0.67-1.30, P=0.68), MI (HR, 0.97; 95% CI, 0.79-1.18, P=0.74), and TVR (HR, 1.10; 95% CI, 0.82-1.49, P=0.51). The adjusted risk of stent thrombosis also was similar (HR, 1.16; 95% CI, 0.47-2.84, P=0.75). CONCLUSIONS: In contemporary practice of percutaneous coronary intervention procedures, the unrestricted use of EES and SES showed similar rates of safety and efficacy outcomes with regard to death, MI, sent thrombosis, and TVR. Future longer-term follow-up is needed to better define the relative benefits of these drug-eluting stents. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01070420.


Asunto(s)
Angioplastia Coronaria con Balón/instrumentación , Fármacos Cardiovasculares/administración & dosificación , Stents Liberadores de Fármacos , Sirolimus/análogos & derivados , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Angioplastia Coronaria con Balón/mortalidad , Distribución de Chi-Cuadrado , Trombosis Coronaria/etiología , Everolimus , Femenino , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Infarto del Miocardio/etiología , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Diseño de Prótesis , Sistema de Registros , República de Corea , Medición de Riesgo , Factores de Riesgo , Sirolimus/administración & dosificación , Factores de Tiempo , Resultado del Tratamiento
13.
Am J Cardiovasc Drugs ; 12(3): 189-95, 2012 Jun 01.
Artículo en Inglés | MEDLINE | ID: mdl-22462558

RESUMEN

BACKGROUND: Fixed-dose combination drugs may enhance blood pressure (BP) goal attainment through complementary effects and reduced side effects, which leads to better compliance. OBJECTIVE: This study aimed to evaluate the efficacy and safety profiles of once-daily combination amlodipine/losartan versus losartan. METHODS: This was an 8-week, double-blind, multicenter, randomized phase III study conducted in outpatient hospital clinics. Korean patients with essential hypertension inadequately controlled on losartan 100 mg were administered amlodipine/losartan 5 mg/100 mg combination versus losartan 100 mg. The main outcome measures were changes in sitting diastolic blood pressure (DBP) and sitting systolic blood pressure (SBP) and BP response rate from baseline values, which were assessed after 4 and 8 weeks of treatment. Safety and tolerability were also assessed. RESULTS: At week 8, both groups achieved significant reductions from baseline in DBP (11.7 ± 7.0 and 3.2 ± 7.9 mmHg), which was significantly greater in the amlodipine/losartan 5 mg/100 mg combination (n = 70) group (p < 0.0001). Additionally, the amlodipine/losartan 5 mg/100 mg combination group achieved significantly greater reductions in SBP at week 8 and in SBP and DBP at week 4 compared with the losartan 100 mg (n = 72) group (all p < 0.0001). Response rates were significantly higher in the amlodipine/losartan 5 mg/100 mg group versus the losartan 100 mg group (81.4% vs 63.9% at week 4, p < 0.0192; 90.0% vs 66.7% at week 8, p < 0.001). Both treatments were generally well tolerated. CONCLUSION: Switching to a fixed-dose combination therapy of amlodipine/losartan 5 mg/100 mg was associated with significantly greater reductions in BP and superior achievement of BP goals compared with a maintenance dose of losartan 100 mg in Korean patients with essential hypertension inadequately controlled on losartan 100 mg. CLINICAL TRIAL REGISTRATION: Registered at Clinicaltrials.gov as NCT00940680.


Asunto(s)
Amlodipino/uso terapéutico , Antihipertensivos/uso terapéutico , Hipertensión/tratamiento farmacológico , Losartán/uso terapéutico , Adulto , Amlodipino/administración & dosificación , Amlodipino/efectos adversos , Bloqueadores del Receptor Tipo 1 de Angiotensina II/administración & dosificación , Bloqueadores del Receptor Tipo 1 de Angiotensina II/efectos adversos , Bloqueadores del Receptor Tipo 1 de Angiotensina II/uso terapéutico , Antihipertensivos/administración & dosificación , Antihipertensivos/efectos adversos , Presión Sanguínea/efectos de los fármacos , Bloqueadores de los Canales de Calcio/administración & dosificación , Bloqueadores de los Canales de Calcio/efectos adversos , Bloqueadores de los Canales de Calcio/uso terapéutico , Método Doble Ciego , Combinación de Medicamentos , Femenino , Humanos , Hipertensión/fisiopatología , Losartán/administración & dosificación , Losartán/efectos adversos , Masculino , Persona de Mediana Edad , República de Corea , Factores de Tiempo , Resultado del Tratamiento
14.
Circ J ; 76(5): 1102-8, 2012.
Artículo en Inglés | MEDLINE | ID: mdl-22382382

RESUMEN

BACKGROUND: Positive peri-stent vascular remodeling (PPVR) after drug-eluting stent (DES) implantation is an important mechanism of late-acquired stent malapposition (LASM). METHODS AND RESULTS: A total of 226 patients (sirolimus-eluting stent [SES], n=105; paclitaxel-eluting stent [PES], n=121) from the Poststent Optimal Stent Expansion Trial who underwent a post-intervention and 9-month follow-up intravascular ultrasound were followed clinically for 5 years. PPVR was arbitrarily defined as a >10% increase in the external elastic membrane volume index at follow-up. PPVR and LASM occurred more frequently with SESs than with PESs. The 5-year rate of major adverse cardiac events was lower with SES than with PES (10.7% vs. 23.2%, P=0.002). The late and very late stent thrombosis (ST) rate was similar between the 2 DES types, but it was higher in patients with PPVR than in those without PPVR (8.8% vs. 1.3%, P=0.009) regardless of the DES type. Early discontinuation (<1 year) of dual antiplatelet therapy (DAPT; hazard ratio [HR], 24.14; 95% confidence interval [CI]: 4.90-118.87; P<0.001), PPVR (HR, 14.94; 95%CI: 1.85-120.46; P=0.011), LASM (HR, 8.01; 95%CI: 1.93-33.16; P=0.004), and stent length (HR, 1.14; 95%CI: 0.98-1.32 per mm; P=0.078) were associated with increased risk of late and very late ST. CONCLUSIONS: PPVR and LASM development after DES implantation, along with early discontinuation of DAPT and longer stent length, are important risk factors of late and very late ST.


Asunto(s)
Enfermedad Coronaria/terapia , Stents Liberadores de Fármacos/efectos adversos , Inmunosupresores/efectos adversos , Sirolimus/efectos adversos , Trombosis/diagnóstico por imagen , Anciano , Elasticidad , Femenino , Estudios de Seguimiento , Humanos , Inmunosupresores/farmacología , Masculino , Persona de Mediana Edad , Inhibidores de Agregación Plaquetaria/administración & dosificación , Estudios Prospectivos , Sirolimus/farmacología , Trombosis/tratamiento farmacológico , Trombosis/etiología , Ultrasonografía
15.
Am J Cardiovasc Drugs ; 12(1): 35-47, 2012 Feb 01.
Artículo en Inglés | MEDLINE | ID: mdl-22217192

RESUMEN

BACKGROUND: Despite recommendations for more intensive treatment and the availability of several effective treatments, hypertension remains uncontrolled in many patients. OBJECTIVE: The aim of this study was to determine the dose-response relationship and assess the efficacy and safety of amlodipine or losartan monotherapy and amlodipine camsylate/losartan combination therapy in patients with essential hypertension. METHODS: This was an 8-week, randomized, double-blind, factorial design, phase II, multicenter study conducted in outpatient hospital clinics among adult patients aged 18-75 years with essential hypertension. At screening, patients received placebo for 2-4 weeks. Eligible patients (n=320) were randomized to one of eight treatment groups: amlodipine 5 mg or 10 mg, losartan 50 mg or 100 mg, amlodipine camsylate/losartan 5 mg/50 mg, 5 mg/100 mg, 10 mg/50 mg, or 10 mg/100 mg. MAIN OUTCOME MEASURES: The assumption of strict superiority was estimated using the mean change in sitting diastolic blood pressure (DBP) at 8 weeks. Safety was monitored through physical examinations, vital signs, laboratory test results, ECG, and adverse events. RESULTS: The reduction in DBP at 8 weeks was significantly greater in patients treated with the combination therapies compared with the respective monotherapies for all specified comparisons except amlodipine camsylate/losartan 10 mg/100 mg versus amlodipine 10 mg. The incidence of adverse events in the group of patients treated with the amlodipine camsylate/losartan 10 mg/50 mg combination tended to be higher than for any other group (27.9%, 12/43); however, the effect was not statistically significant. CONCLUSION: Combination amlodipine camsylate/losartan (5 mg/50 mg, 5 mg/100 mg and 10 mg/50 mg) resulted in significantly greater BP lowering compared with amlodipine or losartan monotherapy, and was determined to be generally safe and tolerable in patients with essential hypertension. CLINICAL TRIAL REGISTRATION: Registered at clinicaltrials.gov: NCT00942344.


Asunto(s)
Amlodipino/administración & dosificación , Antihipertensivos/administración & dosificación , Hipertensión/tratamiento farmacológico , Losartán/administración & dosificación , Adulto , Anciano , Presión Sanguínea/efectos de los fármacos , Presión Sanguínea/fisiología , Método Doble Ciego , Combinación de Medicamentos , Quimioterapia Combinada , Femenino , Humanos , Hipertensión/fisiopatología , Masculino , Persona de Mediana Edad
16.
Am J Cardiol ; 109(5): 607-13, 2012 Mar 01.
Artículo en Inglés | MEDLINE | ID: mdl-22172241

RESUMEN

There is currently no established standard treatment for in-stent restenosis (ISR) after the implantation of a drug-eluting stent (DES). The aim of this study was to investigate the efficacy of DES versus balloon angioplasty (BA) for the treatment of DES ISR in a multicenter registry cohort. After matching propensity scores of 805 patients with DES ISR treated with either DES (n = 422) or BA (n = 383), 268 matched pairs were selected and analyzed for major adverse cardiac events, a composite of death, myocardial infarction, and target-vessel revascularization, as the primary end point. Baseline clinical and lesion characteristics of the matched pairs were similar. Survival free of major adverse cardiac events at 2 years was higher with DES compared to BA (88.9% vs 78.7%, p <0.001), mainly because of higher TVR-free survival (92.4% vs 81.0%, p <0.001). Among various baseline variables, BA (hazard ratio 2.546, 95% confidence interval 1.412 to 4.593, p = 0.002) was the most important independent risk factor for recurrent target vessel revascularization, followed by acute coronary syndromes as the clinical presentation of DES ISR, and previous implantation of a sirolimus-eluting stent. Survival free of death, myocardial infarction, or stent thrombosis did not differ between the 2 groups. Whereas there was no significant difference in survival free of target vessel revascularization between DES and BA for focal ISR lesions, DES was superior to BA in diffuse ISR lesions (94.3% vs 75.2% at 2 years, p <0.001). In conclusion, compared to BA, the implantation of DES was safe and more effective in the treatment of DES ISR.


Asunto(s)
Angioplastia Coronaria con Balón/métodos , Reestenosis Coronaria/cirugía , Stents Liberadores de Fármacos , Electrocardiografía , Infarto del Miocardio/epidemiología , Sistema de Registros , Causas de Muerte/tendencias , Angiografía Coronaria , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/epidemiología , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Infarto del Miocardio/diagnóstico , Infarto del Miocardio/etiología , Pronóstico , Puntaje de Propensión , Modelos de Riesgos Proporcionales , República de Corea/epidemiología , Estudios Retrospectivos , Factores de Riesgo , Tasa de Supervivencia/tendencias , Insuficiencia del Tratamiento , Resultado del Tratamiento
17.
Clin Ther ; 33(12): 1953-63, 2011 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-22136978

RESUMEN

BACKGROUND: The number of hypertensive patients achieving treatment targets is not ideal with therapies that engage a single mechanism of action, and combination therapies using different mechanisms of action can increase drug efficacy in a synergistic way. OBJECTIVE: This noninferiority study compared the clinical efficacy and safety profile of fixed-dose combination of amlodipine/losartan 5/50 mg and amlodipine 10 mg monotherapy in essential hypertensive patients who respond poorly to amlodipine 5 mg monotherapy. METHODS: This was a double-blind, multicenter, randomized trial of hypertensive patients (N = 185) aged ≥18 years taking amlodipine 5 mg during the run-in treatment period but failed to achieve sitting diastolic blood pressure (DBP) <90 mm Hg. After randomization into the amlodipine/losartan 5/50 mg fixed-dose combination group (n = 92) and the amlodipine 10 mg monotherapy group (n = 93), treatment was maintained without dose escalation for 8 weeks. The noninferiority margin was prespecified as 4 mm Hg after 8 weeks of treatment for the difference of the average change in DBP between treatments. The primary efficacy evaluation of noninferiority was tested using a confidence interval approach with a 97.5% 1-sided lower confidence limit using the average difference in DBP measured at baseline and 8 weeks. RESULTS: After 8 weeks, the DBP of both groups decreased from baseline by 8.9 (6.1) and 9.4 (7.5) mm Hg, respectively (difference = -0.5 [6.9] mm Hg, 95% CI: -2.5 to 1.5). Secondary end points of reductions in DBP after 4 weeks (-8.1 [6.7] vs -9.9 [7.3] mm Hg, difference = -1.8 mm Hg, 95% CI: -3.9 to 0.2) and sitting systolic blood pressure after 4 (-10.2 [11.8] vs -12.8 [10.2] mm Hg, difference = -2.6 mm Hg, 95% CI: -5.9 to 0.6) and 8 weeks (-12.2 [11.0] vs -13.4 [11.3] mm Hg, difference = -1.2 mmHg, 95% CI: -4.4 to 2.1) were comparable between the 2 treatment groups. There were 38 adverse events in 20 patients (21.7%) in the amlodipine/losartan 5/50 mg fixed-dose combination group and 31 in 24 patients (26.1%) in the amlodipine 10 mg monotherapy group; most were mild. There were 7 adverse events in 6 patients (6.5%) related to treatment in the fixed-dose combination group and 13 in 10 patients (10.9%) in the monotherapy group (P = 0.30). CONCLUSIONS: Fixed-dose combination amlodipine/losartan 5/50 mg was not inferior in terms of reductions in DBP after 8 weeks of treatment and had comparable safety profile to amlodipine 10 mg in patients who did not respond to amlodipine 5 mg monotherapy. ClinicalTrials.gov identifier: NCT00940667.


Asunto(s)
Amlodipino/administración & dosificación , Bloqueadores del Receptor Tipo 1 de Angiotensina II/administración & dosificación , Antihipertensivos/administración & dosificación , Presión Sanguínea/efectos de los fármacos , Bloqueadores de los Canales de Calcio/administración & dosificación , Hipertensión/tratamiento farmacológico , Losartán/administración & dosificación , Adulto , Amlodipino/efectos adversos , Análisis de Varianza , Bloqueadores del Receptor Tipo 1 de Angiotensina II/efectos adversos , Antihipertensivos/efectos adversos , Bloqueadores de los Canales de Calcio/efectos adversos , Distribución de Chi-Cuadrado , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Combinación de Medicamentos , Femenino , Humanos , Hipertensión/diagnóstico , Hipertensión/fisiopatología , Losartán/efectos adversos , Masculino , Persona de Mediana Edad , República de Corea , Factores de Tiempo , Resultado del Tratamiento
18.
Echocardiography ; 28(10): 1119-24, 2011 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-21854441

RESUMEN

BACKGROUNDS: Recent studies have shown that thermal therapy by means of warm waterbaths and sauna has beneficial effects in chronic heart failure. However, a comprehensive investigation of the hemodynamic effects of thermal vasodilation on coronary arteries has not been previously undertaken. In this study, we studied the effect of a warm footbath (WFB) on coronary arteries in patients with coronary artery disease (CAD), as well as any adverse effect. METHODS: We studied 21 patients (33.3% men, mean age 60.8 ± 13.5 years) with CAD. Coronary flow Doppler examination of the left anterior descending coronary artery and coronary flow reserve (CFR) were performed and measured using adenosine before and after a WFB. RESULTS: Systolic and diastolic blood pressure and heart rate did not change with the WFB. Mean velocity of diastolic coronary flow significantly increased (diastolic mean flow velocity: 18.3 ± 7.1 cm/sec initial, 21.5 ± 8.0 cm/sec follow-up, P = 0.002) and CFR significantly improved (1.6 ± 0.4 vs. 2.2 ± 0.5, P < 0.001) after WFB. The WFB was well accepted and no relevant adverse effects were observed. The change of CFR after WFB correlated well with diastolic function (E', r = 0.51, P = 0.031; E/E', r =-0.675, P = 0.002). CONCLUSIONS: A WFB significantly improved CFR without any adverse effects in patients with mild-to-moderate CAD and can be applied with little risk of a coronary artery event if appropriately performed.


Asunto(s)
Baños , Enfermedad de la Arteria Coronaria/fisiopatología , Enfermedad de la Arteria Coronaria/rehabilitación , Pie/fisiopatología , Reserva del Flujo Fraccional Miocárdico , Hipertermia Inducida/métodos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Femenino , Humanos , Masculino , Persona de Mediana Edad , Resultado del Tratamiento , Ultrasonografía
19.
Yonsei Med J ; 52(5): 717-26, 2011 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-21786434

RESUMEN

PURPOSE: It is unknown whether cilostazol pretreatment reduces postprocedural myonecrosis (PPMN). Cilostazol pretreatment reduces PPMN after percutaneous coronary intervention (PCI). MATERIALS AND METHODS: A total of 120 patients with stable angina scheduled for elective PCI were randomly assigned to a 7-day pretreatment with Cilostazol (200 mg/day) or to a control group. Creatine kinase-MB (CK-MB) and cardiac troponin I (cTnI) levels were measured at baseline and at 6 and 24 hours after PCI. The primary end-point was the occurrence of PPMN, defined as any CK-MB elevation above the upper normal limit (UNL). Aspirin and clopidogrel were co-administered for 7 days before PCI, and resistance to these agents was then assayed using the VerifyNow System. RESULTS: There was no difference in baseline characteristics between the final analyzable cilostazol (n=54) and the control group (n=56). Despite a significantly greater % inhibition of clopidogrel in the cilostazol group (39±23% versus 25±22%, p=0.003), the incidence of PPMN was similar between the cilostazol group (24%) and the control group (25%, p=1.000). The rate of CK-MB elevation at ≥3 times UNL was also similar between the two groups (6% versus 5%, p=0.583). The incidence of cTnI increase over the UNL or to 3 times the UNL was not different between the two groups. There was no significant difference in terms of the rate of adverse events during follow- up, although the cilostazol group showed a tendency to have a slightly higher incidence of entry site hematoma. CONCLUSION: This trial demonstrated that adjunctive cilostazol pretreatment might not significantly reduce PPMN after elective PCI in patients with stable angina.


Asunto(s)
Angioplastia Coronaria con Balón/efectos adversos , Inhibidores de Fosfodiesterasa 3/administración & dosificación , Tetrazoles/administración & dosificación , Anciano , Angina Estable/tratamiento farmacológico , Angina Estable/enzimología , Angina Estable/terapia , Cilostazol , Forma MB de la Creatina-Quinasa/sangre , Femenino , Lesiones Cardíacas/etiología , Lesiones Cardíacas/prevención & control , Humanos , Masculino , Persona de Mediana Edad , Miocardio/patología , Necrosis , Estudios Prospectivos
20.
Catheter Cardiovasc Interv ; 77(1): 15-21, 2011 Jan 01.
Artículo en Inglés | MEDLINE | ID: mdl-20928842

RESUMEN

OBJECTIVES: The aims of this study were to identify the efficacy of optimal stent expansion (OSE) according to the Multicenter Ultrasound Stenting in Coronaries Study (MUSIC Study) criteria in drug-eluting stent (DES) and compare paclitaxel-eluting stent (PES) to sirolimus-eluting stent (SES). BACKGROUND: Although poststent high-pressure balloon dilatation is proposed after bare metal stent implantation according to OSE, defined by the criteria of the MUSIC Study, very little data are available in DES. METHODS: Two hundred fifty patients (M:F = 149:101; age, 61.5 ± 9.2 years) who underwent 9-month follow-up angiography in the Poststent Optimal Stent Expansion Trial (POET) were included in this study. We assessed angiographic in-stent restenosis (ISR) and neointima volume (NV) using IVUS at 9 months. RESULTS: At 9-month follow up, there were no significant differences in ISR and NV index (NV/stent length, mm(2) ) between patients with and without OSE. However, the rate of ISR and NV index were higher in PES [ISR: 18 (13.7%) and 4 (3.4%), P = 0.004; NV index: 1.02 ± 0.99 mm(2) and 0.21 ± 0.37, P < 0.001 in PES and SES]. CONCLUSIONS: OSE according to the MUSIC Study criteria was not related to ISR and NV in the DES era but PES had a significantly higher ISR rate and NV than SES after poststent high-pressure balloon dilatation.


Asunto(s)
Angioplastia Coronaria con Balón/instrumentación , Fármacos Cardiovasculares/administración & dosificación , Angiografía Coronaria , Enfermedad de la Arteria Coronaria/terapia , Reestenosis Coronaria/diagnóstico por imagen , Stents Liberadores de Fármacos , Paclitaxel/administración & dosificación , Sirolimus/administración & dosificación , Ultrasonografía Intervencional , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Reestenosis Coronaria/etiología , Reestenosis Coronaria/prevención & control , Femenino , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Oportunidad Relativa , Valor Predictivo de las Pruebas , Estudios Prospectivos , Diseño de Prótesis , República de Corea , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
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