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RU2012101275A - Композиции и способы понижения уровня триглицеридов без повышения уровня хс-лпнп у субъекта, получающего сопутствующую терапию - Google Patents

Композиции и способы понижения уровня триглицеридов без повышения уровня хс-лпнп у субъекта, получающего сопутствующую терапию Download PDF

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RU2012101275A
RU2012101275A RU2012101275/15A RU2012101275A RU2012101275A RU 2012101275 A RU2012101275 A RU 2012101275A RU 2012101275/15 A RU2012101275/15 A RU 2012101275/15A RU 2012101275 A RU2012101275 A RU 2012101275A RU 2012101275 A RU2012101275 A RU 2012101275A
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Ян ОСТЕРЛОХ
Пьер УИКЕР
Рене БРАКМАН
Пареш СОНИ
Мехар МАНКУ
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Амарин Фарма, Инк.
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Abstract

1. Способ уменьшения уровня триглицеридов у субъекта, получающего постоянную статиновую терапию с исходным уровнем триглицеридов натощак, составляющим от приблизительно 200 мг/дл до приблизительно 500 мг/дл, причем способ включает в себя введение субъекту фармацевтической композиции, содержащей от приблизительно 1 г до приблизительно 4 г сверхчистой EPA в день, причем (1) при введении композиции субъекту ежедневно в течение периода, составляющего 12 недель, субъект демонстрирует по меньшей мере на 5% меньший уровень триглицеридов натощак, чем плацебо-контрольный субъект, получающий постоянную статиновую терапию без сопутствующей сверхчистой EPA в течение периода, составляющего 12 недель, (2) субъект, по существу, не демонстрирует увеличение ХС-ЛПНП в сыворотке, и (3) плацебо-контрольный субъект также имеет исходный уровень триглицеридов натощак, равный приблизительно от 200 мг/дл до приблизительно 500 мг/дл.2. Способ по п.1, в котором субъект и плацебо-контрольный субъект имеют исходный уровень ХС-ЛПНП в сыворотке, составляющий от приблизительно 40 мг/дл до приблизительно 115 мг/дл.3. Способ по п.2, в котором при введении композиции субъекту ежедневно в течение периода, составляющего 12 недель, и получения плацебо-контрольным субъектом постоянной статиновой терапии без сопутствующей терапии сверхчистой EPA в течение периода, составляющего 12 недель, субъект демонстрирует более низкий уровень ХС-ЛПНП в сыворотке, чем плацебо-контрольный субъект.4. Способ по п.3, в котором при введении композиции субъекту ежедневно в течение периода, составляющего 12 недель, и получения плацебо-контрольным субъектом постоянной статиновой терапии без

Claims (19)

1. Способ уменьшения уровня триглицеридов у субъекта, получающего постоянную статиновую терапию с исходным уровнем триглицеридов натощак, составляющим от приблизительно 200 мг/дл до приблизительно 500 мг/дл, причем способ включает в себя введение субъекту фармацевтической композиции, содержащей от приблизительно 1 г до приблизительно 4 г сверхчистой EPA в день, причем (1) при введении композиции субъекту ежедневно в течение периода, составляющего 12 недель, субъект демонстрирует по меньшей мере на 5% меньший уровень триглицеридов натощак, чем плацебо-контрольный субъект, получающий постоянную статиновую терапию без сопутствующей сверхчистой EPA в течение периода, составляющего 12 недель, (2) субъект, по существу, не демонстрирует увеличение ХС-ЛПНП в сыворотке, и (3) плацебо-контрольный субъект также имеет исходный уровень триглицеридов натощак, равный приблизительно от 200 мг/дл до приблизительно 500 мг/дл.
2. Способ по п.1, в котором субъект и плацебо-контрольный субъект имеют исходный уровень ХС-ЛПНП в сыворотке, составляющий от приблизительно 40 мг/дл до приблизительно 115 мг/дл.
3. Способ по п.2, в котором при введении композиции субъекту ежедневно в течение периода, составляющего 12 недель, и получения плацебо-контрольным субъектом постоянной статиновой терапии без сопутствующей терапии сверхчистой EPA в течение периода, составляющего 12 недель, субъект демонстрирует более низкий уровень ХС-ЛПНП в сыворотке, чем плацебо-контрольный субъект.
4. Способ по п.3, в котором при введении композиции субъекту ежедневно в течение периода, составляющего 12 недель, и получения плацебо-контрольным субъектом постоянной статиновой терапии без сопутствующей терапии сверхчистой EPA в течение периода, составляющего 12 недель, субъект демонстрирует по меньшей мере на 5% более низкий уровень ХС-ЛПНП в сыворотке, чем плацебо-контрольный субъект.
5. Способ по п.3, в котором при введении композиции субъекту ежедневно в течение периода, составляющего 12 недель, и получения плацебо-контрольным субъектом постоянной статиновой терапии без сопутствующей терапии сверхчистой EPA в течение периода, составляющего 12 недель, субъект демонстрирует по меньшей мере на 10% более низкий уровень ХС-ЛПНП в сыворотке, чем плацебо-контрольный субъект.
6. Способ по п.3, в котором при введении композиции субъекту ежедневно в течение периода, составляющего 12 недель, и получения плацебо-контрольным субъектом постоянной статиновой терапии без сопутствующей терапии сверхчистой EPA в течение периода, составляющего 12 недель, субъект демонстрирует по меньшей мере на 10% более низкий уровень триглицеридов натощак, чем плацебо-контрольный субъект.
7. Способ по п.3, в котором при введении композиции субъекту ежедневно в течение периода, составляющего 12 недель, и получения плацебо-контрольным субъектом постоянной статиновой терапии без сопутствующей терапии сверхчистой EPA в течение периода, составляющего 12 недель, субъект демонстрирует по меньшей мере на 15% более низкий уровень триглицеридов натощак, чем плацебо-контрольный субъект.
8. Способ по п.3, в котором при введении композиции субъекту ежедневно в течение периода, составляющего 12 недель, и получения плацебо-контрольным субъектом постоянной статиновой терапии без сопутствующей терапии сверхчистой EPA в течение периода, составляющего 12 недель, субъект демонстрирует по меньшей мере на 25% более низкий уровень триглицеридов натощак, чем плацебо-контрольный субъект.
9. Способ по п.1, в котором сверхчистая EPA содержит по меньшей мере 95% по весу этилэйкозапентаеноата, от приблизительно 0,2% до приблизительно 0,3% по весу этилоктадекатетраеноата, от приблизительно 0,05% до приблизительно 0,20% по весу этилнонаэкапентаеноата, от приблизительно 0,2% до приблизительно 0,4% по весу этиларахидоната, от приблизительно 0,3% до приблизительно 0,5% по весу этилэйкозатетраеноата и от приблизительно 0,05% до приблизительно 0,15% этилгенэйкозапентаеноата.
10. Способ по п.9, в котором сверхчистая EPA содержит по меньшей мере 95% по весу этилэйкозапентаеноата, от приблизительно 0,22% до приблизительно 0,28% по весу этилоктадекатетраеноата, от приблизительно 0,075% до приблизительно 0,15% по весу этилнонаэкапентаеноата, от приблизительно 0,25% до приблизительно 0,35% по весу этиларахидоната, от приблизительно 0,3% до приблизительно 0,4% по весу этилэйкозатетраеноата и от приблизительно 0,075% до приблизительно 0,15% этилгенэйкозапентаеноата.
11. Способ по п.1, в котором сверхчистая EPA заключена в капсулу.
12. Способ по п.11, в котором капсула содержит желатин.
13. Способ по п.12, в котором от 1 до 4 упомянутых капсул вводят субъекту каждый день.
14. Способ по п.1, в котором статин выбирают из группы, состоящей из аторвастатина, розувастатина и симвастатина.
15. Способ по п.14, в котором субъект и плацебо-контролируемый субъект имеют исходный уровень индекса массы тела не выше чем 45 кг/м2.
16. Способ по п.15, в котором субъект не получает сопутствующей ниациновой или фибратной терапии.
17. Способ по п.1, в котором субъект и плацебо-контрольный субъект имеют исходный уровень систолического давления крови в положении сидя менее чем или равный приблизительно 160 мм рт. ст. и исходный уровень диастолического давления крови в положении сидя менее чем приблизительно 100 мм рт. ст.
18. Способ по п.1, в котором сверхчистая EPA не содержит DHA или ее производного.
19. Способ понижения уровня триглицеридов у субъекта, имеющего 10-летний риск коронарной болезни сердца на основании анализа риска ATP III, равный по меньшей мере 20%, причем способ включает в себя определение субъекта, имеющего 10-летний риск коронарной болезни сердца на основании анализа риска ATP III, равный по меньшей мере 20%, и введение субъекту понижающее триглицериды эффективное количество сверхчистого E-EPA.
RU2012101275/15A 2009-06-15 2010-06-15 Композиции и способы понижения уровня триглицеридов без повышения уровня хс-лпнп у субъекта, получающего сопутствующую терапию RU2519043C2 (ru)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US18713209P 2009-06-15 2009-06-15
US61/187,132 2009-06-15
PCT/US2010/038683 WO2010147994A1 (en) 2009-06-15 2010-06-15 Compositions and methods for lowering triglycerides without raising ldl-c levels in a subject on concomitant statin therapy

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