Randomized Trial for Evaluation in Secondary Prevention Efficacy of Combination Therapy-Statin and Eicosapentaenoic Acid (RESPECT-EPA)
Miyauchi K, Iwata H, Nishizaki Y, Inoue T, Hirayama A, Kimura K, Ozaki Y, Murohara T, Ueshima K, Kuwabara Y, Tanaka-Mizuno S, Yanagisawa N, Sato T, Daida H, RESPECT-EPA Investigators
Circulation · 73 citas
Etiquetas de revisión
Financiación no declaradaDatos neutrales que nuestra revisión registró sobre cómo se hizo este estudio. Describen el método, nunca si nos gusta el resultado.
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación no declarada
Publicación
- Publicado
- 2024-06-14 · Circulation · vol. 150 · número 6 · págs. 425–434
- Editorial
- Lippincott Williams & Wilkins
- Citado
- 90 citas · más que el 100% de estudios similares · 17.4× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 33 trabajos
- Acceso
- De pago
- Áreas de investigación
- Fatty Acid Research and Health · Lipoproteins and Cardiovascular Health · Eicosanoids and Hypertension Pharmacology
- Palabras clave
- Medicine, Eicosapentaenoic acid, Randomized controlled trial, Secondary prevention, Statin, Internal medicine, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Physical therapy, Oncology, Pharmacology, Fatty acid, Polyunsaturated fatty acid, Biochemistry
- MeSH
- humans, eicosapentaenoic acid, hydroxymethylglutaryl-coa reductase inhibitors, treatment outcome, drug therapy, combination, prospective studies, aged, middle aged, japan, female, male, coronary artery disease, secondary prevention
15 autores
- Katsumi Miyauchi🇯🇵Juntendo University
- Hiroshi Iwata🇯🇵Juntendo University
- Yuji Nishizaki🇯🇵Juntendo University
- Teruo Inoue🇯🇵🇬🇷Japanese Red Cross Society, Japan; Red Cross Hospital; Dokkyo Medical University
- Atsushi Hirayama🇯🇵Fukujuji Hospital
- KAZUO K. KIMURA🇯🇵Yokohama City University Medical Center; Yokohama City University
- Yukio Ozaki🇯🇵Fujita Health University
- Toyoaki Murohara🇯🇵Nagoya University
- Kenji Ueshima🇯🇵Uji Hospital; Takeda Hospital
- Yoshihiro Kuwabara🇯🇵Osaka International Cancer Institute
- Sachiko Tanaka‐Mizuno🇯🇵Kyoto University
- Naotake Yanagisawa🇯🇵Juntendo University
- Tosiya Shun Sato🇯🇵Kyoto University
- Hiroyuki Daida🇯🇵Juntendo University
- RESPECT-EPA Investigators
Resumen
El texto original del estudio, en el idioma en que se publicó.
Background
Low plasma levels of eicosapentaenoic acid (EPA) are associated with cardiovascular events. This trial aimed to assess the clinical benefits of icosapent ethyl in patients with coronary artery disease, a low EPA/arachidonic acid (AA) ratio, and statin treatment.
Methods
In this prospective, multicenter, randomized, open-label, blinded end-point study, patients with stable coronary artery disease and a low EPA/AA ratio (<0.4) were randomized to EPA (1800 of icosapent ethyl administered daily) or control group. The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, unstable angina pectoris, and coronary revascularization. The secondary composite end points of coronary events included sudden cardiac death, fatal and nonfatal myocardial infarction, unstable angina requiring emergency hospitalization and coronary revascularization, or coronary revascularization.
Results
Overall, 3884 patients were enrolled at 95 sites in Japan. Among them, 2506 patients had a low EPA/AA ratio, and 1249 and 1257 patients were randomized to the EPA and control group, respectively. The median EPA/AA ratio was 0.243 (interquartile range, 0.180-0.314) and 0.235 (interquartile range, 0.163-0.310) in the EPA and control group, respectively. Over a median period of 5 years, the primary end point occurred in 112 of 1225 patients (9.1%) and 155 of 1235 patients (12.6%) in the EPA and control group, respectively (hazard ratio, 0.79 [95% CI, 0.62-1.00]; P=0.055). Meanwhile, the secondary composite end point of coronary events in the EPA group was significantly lower (81/1225 [6.6%] versus 120/1235 [9.7%] patients; hazard ratio, 0.73 [95% CI, 0.55-0.97]). Adverse events did not differ between the groups, but the rate of new-onset atrial fibrillation was significantly higher in the EPA group (3.1% versus 1.6%; P=0.017).
Conclusions
Icosapent ethyl treatment resulted in a numerically lower risk of cardiovascular events that did not reach statistical significance in patients with chronic coronary artery disease, a low EPA/AA ratio, and statin treatment.
Registration
URL: https://www.umin.ac.jp/ctr/; Unique identifier: UMIN000012069.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial.
Confianza de la comunidad
Cargando…
¿Cuánto confías en los hallazgos de este estudio?
Comentarios
¿Algo está mal aquí?
Señala este estudio si su información, etiquetas o financiación parecen incorrectas. Un editor revisa cada señalamiento.
Información educativa sobre investigación publicada. No es consejo médico ni una recomendación para empezar o dejar nada.