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RU2017121277A - Фармацевтические композиции, содержащие epa и сердечно-сосудистое средство, и способы их применения - Google Patents

Фармацевтические композиции, содержащие epa и сердечно-сосудистое средство, и способы их применения Download PDF

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RU2017121277A
RU2017121277A RU2017121277A RU2017121277A RU2017121277A RU 2017121277 A RU2017121277 A RU 2017121277A RU 2017121277 A RU2017121277 A RU 2017121277A RU 2017121277 A RU2017121277 A RU 2017121277A RU 2017121277 A RU2017121277 A RU 2017121277A
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RU2746945C2 (ru
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Мехар МАНКУ
Джонатан РОУ
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АМАРИН КОРПОРЕЙШН ПиЭлСи
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Claims (20)

1. Применение этилового эфира эйкозапентаеновой кислоты при получении фармацевтической композиции для снижения риска инфаркта миокарда и/или инсульта у субъекта, получающего лечение статинами, где субъект имеет исходный уровень триглицеридов натощак от приблизительно 135 до приблизительно 500 мг/дл и, где 4 г этилового эфира эйкозапентаеновой кислоты вводят субъекту в день в течение периода, по меньшей мере, приблизительно 4 месяцев.
2. Применение по п.1, где композицию вводят субъекту в от 1 до 4 единиц дозирования в день.
3. Применение по п.1, где этиловый эфир эйкозапентаеновой кислоты составляет по меньшей мере приблизительно 96 мас.% всех омега-3 жирных кислот в фармацевтической композиции.
4. Применение по п.1, дополнительно включающее стадию измерения исходного липидного профиля субъекта до введения фармацевтической композиции субъекту.
5. Применение по п.1, где субъект имеет одно или более из следующего: исходный уровень не HDL холестерина от 200 до приблизительно 300 мг/дл; исходный уровень общего холестерина от приблизительно 250 до приблизительно 300 мг/дл; исходный уровень VLDL холестерина от приблизительно 140 до приблизительно 200 мг/дл; исходный уровень HDL холестерина от приблизительно 10 до приблизительно 30 мг/дл и/или исходный уровень LDL холестерина от приблизительно 40 до приблизительно 100 мг/дл.
6. Применение по п.1, где у субъекта имеется: исходный уровень не HDL холестерина от приблизительно 200 до приблизительно 300 мг/дл; исходный уровень общего холестерина от приблизительно 250 до приблизительно 300 мг/дл; исходный уровень VLDL холестерина от приблизительно 140 до приблизительно 200 мг/дл; исходный уровень HDL холестерина от приблизительно 10 до приблизительно 30 мг/дл и/или исходный уровень LDL холестерина от приблизительно 40 до приблизительно 100 мг/дл.
7. Применение по п.1, где лечение статинами включает введение субъекту статина и, необязательно, эзетимиба.
8. Применение по п.1, где субъекту:
не вводили 200 мг или более в день ниацина и/или фибратов в течение по меньшей мере 28 дней до введения фармацевтической композиции; (b) не вводили омега-3 жирные кислоты в течение периода времени, начинающегося за 28 дней до введения фармацевтической композиции; или (c) субъект не принимал пищевые добавки, содержащие омега-3 жирные кислоты в течение периода времени, начинающегося за 28 дней до введения фармацевтической композиции.
9. Применение по п.8, где период времени заканчивается не ранее чем через 6 месяцев после первого введения фармацевтической композиции.
10. Применение по п.8, где период времени заканчивается после приблизительно 6 месяцев, приблизительно 1 года, приблизительно 2 лет, приблизительно 3 лет, приблизительно 4 лет, приблизительно 5 лет или более чем приблизительно 5 лет первого введения Фармацевтической композиции.
11. Применение по п.1, где субъекту вводят приблизительно 4 г фармацевтической композиции в день в течение по меньшей мере приблизительно 2 лет.
12. Применение по п.1, где субъекту вводят приблизительно 4 г фармацевтической композиции в день в течение по меньшей мере приблизительно 3 лет.
13. Применение по п.1, где субъекту вводят приблизительно 4 г фармацевтической композиции в день в течение по меньшей мере приблизительно 4 лет.
14. Применение этилового эфира эйкозапентаеновой кислоты при получении фармацевтической композиции для снижения риска инфаркта миокарда и/или инсульта у субъекта получающего лечение статинами с установленным сердечно-сосудистым заболеванием, причем 4 г фармацевтической композиции вводят субъекту в день в течение периода по меньшей мере, приблизительно 4 месяцев, и субъект имеет исходный уровень триглицеридов натощак от приблизительно 135 до приблизительно 500 мг/дл.
15. Применение по п.14, где установленное сердечно-сосудистое заболевание определяется наличием любого из: окументированного заболевания коронарной артерии, документированного цереброваскулярного заболевания, документированной каротидного заболевания, документированного заболевания периферических артерий или их комбинаций.
16. Применение по п.14, где композицию вводят субъекту в от 1 до 4 единиц дозирования в день.
17. Применение по п.14, где этиловый эфир эйкозапентаеновой кислоты составляет по меньшей мере приблизительно 96 мас.% всех омега-3 жирных кислот в фармацевтической композиции.
18. Применение по п.14, где субъект имеет одно или несколько из следующего: исходный уровень не HDL холестерина от приблизительно 200 до приблизительно 300 мг/дл; исходный уровень общего холестерина от приблизительно 250 до приблизительно 300 мг/дл; исходный уровень VLDL холестерина от приблизительно 140 до приблизительно 200 мг/дл; исходный уровень HDL холестерина от приблизительно 10 до приблизительно 30 мг/дл и/или исходный уровень LDL холестерина от приблизительно 40 до приблизительно 100 мг/дл.
19. Применение по п.14, где субъект имеет: исходный уровень не HDL холестерина от приблизительно 200 до приблизительно 300 мг/дл; исходный уровень общего холестерина от приблизительно 250 до приблизительно 300 мг/дл; исходный уровень VLDL холестерина от приблизительно 140 до приблизительно 200 мг/дл; исходный уровень HDL холестерина от приблизительно 10 до приблизительно 30 мг/дл и/или исходный уровень LDL холестерина от приблизительно 40 до приблизительно 100 мг/дл.
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