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 PDFInfo
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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.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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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 |
Publications (2)
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RU2012101275A true RU2012101275A (ru) | 2013-07-27 |
RU2519043C2 RU2519043C2 (ru) | 2014-06-10 |
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RU2012101275/15A RU2519043C2 (ru) | 2009-06-15 | 2010-06-15 | Композиции и способы понижения уровня триглицеридов без повышения уровня хс-лпнп у субъекта, получающего сопутствующую терапию |
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US (17) | US8455472B2 (ru) |
EP (3) | EP3318255B1 (ru) |
KR (5) | KR101958515B1 (ru) |
CN (6) | CN108096209A (ru) |
AU (8) | AU2010260129B2 (ru) |
BR (1) | BRPI1011883A2 (ru) |
CA (3) | CA3129996A1 (ru) |
CO (1) | CO6491035A2 (ru) |
CY (3) | CY1120102T1 (ru) |
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