TỔNG QUAN VỀ TÍNH AN TOÀN VÀ TÍNH HIỆU QUẢ CỦA PRASUGREL TRÊN BỆNH NHÂN CÓ HỘI CHỨNG MẠCH VÀNH CẤP
Nội dung chính của bài viết
Tóm tắt
Đặt vấn đề: Trong điều trị Hội chứng mạch vành cấp (ACS), Prasugrel phối hợp với Aspirin được khuyến cáo ưu tiên cho bệnh nhân trưởng thành cần can thiệp mạch vành qua da để dự phòng biến cố huyết khối.
Mục tiêu: tổng quan hệ thống các bằng chứng về tính an toàn và hiệu quả của Prasugrel trên bệnh nhân ACS.
Phương pháp: tổng quan hệ thống được sử dụng để tìm kiếm các tài liệu đáp ứng tiêu chuẩn lựa chọn vào phân tích.
Kết quả: Tổng cộng 17 nghiên cứu về an toàn và 10 nghiên cứu về hiệu quả được đưa vào tổng quan hệ thống. Các kết quả cho thấy Prasugrel có tính an toàn hiệu quả tương đối tốt với thời gian theo dõi thường là trong vòng 12 tháng, ngắn nhất là 30 ngày và nhiều nhất là 10 năm. Prasugrel có độ an toàn tốt, với tỷ lệ biến chứng xuất huyết có đe dọa tính mạng dao động từ 0.1% đến 2,2% và xuất huyết não từ 0.16% đến 0,3% và không có sự khác biệt có ý nghĩa thống kê trong nghiên cứu so sánh với Ticagrelor. Về hiệu quả, thuốc giúp giảm biến cố tim mạch nghiêm trọng (MACE) từ 1% đến 11,1%, trong đó giảm tử vong do tim mạch từ 0.6% đến 3%.
Kết luận: Bằng chứng cho thấy Prasugrel có khả năng làm giảm các nguy cơ gặp biến cố tim mạch và có lợi ích về mặt lâm sàng khi so sánh với các thuốc khác trong nhóm thuốc ức chế thụ thể P2Y12.
Chi tiết bài viết
Từ khóa
Prasugrel, tính an toàn, tính hiệu quả, hội chứng vành cấp
Tài liệu tham khảo
1. WHO. Cardiovascular diseases (CVDs). Accessed June 13, 2024. https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds)
2. Steg PG, Goldberg RJ, Gore JM, et al. Baseline characteristics, management practices, and in-hospital outcomes of patients hospitalized with acute coronary syndromes in the Global Registry of Acute Coronary Events (GRACE)*. Am J Cardiol. 2002;90(4):358-363. doi:10.1016/S0002-9149(02)02489-X
3. Pinaire J, Azé J, Bringay S, Cayla G, Landais P. Hospital burden of coronary artery disease: Trends of myocardial infarction and/or percutaneous coronary interventions in France 2009–2014. PLOS ONE. 2019;14(5):e0215649. doi:10.1371/journal.pone.0215649
4. Clinical epidemiology, management and outcome of acute coronary syndromes in the Italian network on acute coronary syndromes (IN-ACS Outcome study): Acute Cardiac Care: Vol 14 , No 2 - Get Access. Accessed September 24, 2024. https://www.tandfonline.com/doi/full/10.3109/17482941.2012.655296
5. Segev A, Matetzky S, Danenberg H, et al. Contemporary use and outcome of percutaneous coronary interventions in patients with acute coronary syndromes: insights from the 2010 ACSIS and ACSIS-PCI surveys. doi:10.4244/EIJV8I4A73
6. Boer SPM de, Roos-Hesselink JW, Leeuwen MAH van, et al. Excess mortality in women compared to men after PCI in STEMI: An analysis of 11,931 patients during 2000–2009. Int J Cardiol. 2014;176(2):456-463. doi:10.1016/j.ijcard.2014.07.091
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9. Bộ Y tế. Quyết định 5332/QĐ-BYT 2020 tài liệu chuyên môn Thực hành chẩn đoán điều trị động mạch vành. THƯ VIỆN PHÁP LUẬT. February 19, 2024. Accessed March 11, 2024. https://thuvienphapluat.vn/van-ban/The-thao-Y-te/Quyet-dinh-5332-QD-BYT-2020-tai-lieu-chuyen-mon-Thuc-hanh-chan-doan-dieu-tri-dong-mach-vanh-460209.aspx
10. Roe MT, Goodman SG, Ohman EM, et al. Elderly patients with acute coronary syndromes managed without revascularization: insights into the safety of long-term dual antiplatelet therapy with reduced-dose prasugrel versus standard-dose clopidogrel. Circulation. 2013;128(8):823-833. doi:10.1161/CIRCULATIONAHA.113.002303
11. Baker WL, White CM. Role of prasugrel, a novel P2Y (12) receptor antagonist, in the management of acute coronary syndromes. Am J Cardiovasc Drugs. 2009;9(4):213-229. doi:10.2165/1131209-000000000-00000
12. European Public Assessment Report for Efient. European Medicines Agency website. Accessed June 13, 2024. https://www.ema.europa.eu/en/documents/overview/efient-epar-summary-public_en.pdf
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14. Higgins J, Thomas J. Cochrane Handbook for Systematic Reviews of Interventions.; 2021. https://training.cochrane.org/handbook/current/chapter-i
15. Wiviott SD, Braunwald E, McCabe CH, et al. Prasugrel versus Clopidogrel in Patients with Acute Coronary Syndromes. N Engl J Med. 2007;357(20):2001-2015. doi:10.1056/NEJMoa0706482
16. Viikilä J, Nieminen T, Tierala I, Laine M. Safety of the primary percutaneous coronary intervention strategy combining pre-hospital prasugrel, enoxaparin and in-hospital bivalirudin in acute ST-segment elevation myocardial infarction. BMC Cardiovasc Disord. 2016;16(1):154. doi:10.1186/s12872-016-0333-0
17. Räber L, Klingenberg R, Heg D, et al. Safety of Prasugrel Loading Doses in Patients Pre-Loaded With Clopidogrel in the Setting of Primary Percutaneous Coronary Intervention: Results of a Nonrandomized Observational Study. JACC Cardiovasc Interv. 2015;8(8):1064-1074. doi:10.1016/j.jcin.2015.03.023
18. Bacquelin R, Oger E, Filippi E, et al. Safety of prasugrel in real-world patients with ST-segment elevation myocardial infarction: 1-year results from a prospective observational study (Bleeding and Myocardial Infarction Study). Arch Cardiovasc Dis. 2016;109(1):31-38. doi:10.1016/j.acvd.2015.08.005
19. Kaul U, Sethi A, Arambam P, et al. Safety of Prasugrel in Indian patients - multicentric registry of 1000 cases. Indian Heart J. 2014;66(6):598-601. doi:10.1016/j.ihj.2014.11.001
20. Gill K, Servati N, Flahive J, Fraielli K. Safety and Efficacy of Triple Therapy With Ticagrelor or Prasugrel Versus Clopidogrel After Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction. J Cardiovasc Pharmacol Ther. 2021;26(6):625-629. doi:10.1177/10742484211031436
21. Yetgin T, Boersma E, Smits PC, et al. One-year efficacy and safety of routine prasugrel in patients with acute coronary syndromes treated with percutaneous coronary intervention: results of the prospective rijnmond collective cardiology research study. Neth Heart J Mon J Neth Soc Cardiol Neth Heart Found. 2018;26(7-8):393-400. doi:10.1007/s12471-018-1126-0
22. Ruiz-Nodar JM, Esteve-Pastor MA, Rivera-Caravaca JM, et al. One-year efficacy and safety of prasugrel and ticagrelor in patients with acute coronary syndromes: Results from a prospective and multicentre ACHILLES registry. Br J Clin Pharmacol. 2020;86(6):1052-1061. doi:10.1111/bcp.14213
23. Chon MK, Jung SM, Lee SY, et al. Incidence of Cardiovascular Events and Safety Profile of Prasugrel in Korean Patients With Acute Coronary Syndrome. Circ J Off J Jpn Circ Soc. 2020;84(9):1582-1586. doi:10.1253/circj.CJ-20-0125
24. Jackson LR 2nd, Peterson ED, McCoy LA, et al. Impact of Proton Pump Inhibitor Use on the Comparative Effectiveness and Safety of Prasugrel Versus Clopidogrel: Insights From the Treatment With Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome (TRANSLATE-ACS) Study. J Am Heart Assoc. 2016;5(10). doi:10.1161/JAHA.116.003824
25. Schüpke S, Neumann FJ, Menichelli M, et al. Ticagrelor or Prasugrel in Patients with Acute Coronary Syndromes. N Engl J Med. 2019;381(16):1524-1534. doi:10.1056/NEJMoa1908973
26. Lam ASM, Yan BPY, Lee VWY. Efficacy and safety comparing prasugrel/ticagrelor and clopidogrel in Hong Kong post-acute coronary syndrome patients-A 10-year cohort study. Clin Cardiol. 2021;44(8):1072-1079. doi:10.1002/clc.23653
27. Koyabu Y, Abe S, Sakuma M, et al. Short-term Safety and Mid-term Efficacy of Prasugrel Versus Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention. Intern Med Tokyo Jpn. 2019;58(16):2315-2322. doi:10.2169/internalmedicine.2262-18
28. Liu PY, Su CH, Kuo FY, et al. Prasugrel switching from clopidogrel after percutaneous coronary intervention for acute coronary syndrome in Taiwanese patients: an analysis of safety and efficacy. Cardiovasc Interv Ther. 2022;37(2):269-278. doi:10.1007/s12928-021-00771-w
29. Saito S, Isshiki T, Kimura T, et al. Efficacy and safety of adjusted-dose prasugrel compared with clopidogrel in Japanese patients with acute coronary syndrome: the PRASFIT-ACS study. Circ J Off J Jpn Circ Soc. 2014;78(7):1684-1692. doi:10.1253/circj.cj-13-1482
30. Hagiwara H, Fukuta H, Hashimoto H, et al. A comparison of the safety and effectiveness of prasugrel and clopidogrel in younger population undergoing percutaneous coronary intervention: A retrospective study using a Japanese claims database. J Cardiol. 2021;77(3):285-291. doi:10.1016/j.jjcc.2020.10.001
31. Almendro-Delia M, García-Alcántara Á, de la Torre-Prados MV, et al. Safety and Efficacy of Prasugrel and Ticagrelor in Acute Coronary Syndrome. Results of a “Real World” Multicenter Registry. Rev Espanola Cardiol Engl Ed. 2017;70(11):952-959. doi:10.1016/j.rec.2017.05.003
32. Shahzeb, Ali N, Hadi A, et al. Elective percutaneous coronary interventions-A comparision of efficacy of Clopidogrel and Prasugrel. J Ayub Med Coll Abbottabad JAMC. 2015;27(1):174-177. doi:PMID:%2026182769
33. Daiichi Sankyo. Jasugrel (prasugrel) [package insert]. Drug Administration Vietnam. 2024. Accessed March 1, 2024. https://dichvucong.dav.gov.vn/congbothuoc/index
34. 2023 ESC Guidelines for the management of acute coronary syndromes. Accessed March 26, 2024. https://www.escardio.org/Guidelines/Clinical-Practice-Guidelines/Acute-Coronary-Syndromes-ACS-Guidelines
2. Steg PG, Goldberg RJ, Gore JM, et al. Baseline characteristics, management practices, and in-hospital outcomes of patients hospitalized with acute coronary syndromes in the Global Registry of Acute Coronary Events (GRACE)*. Am J Cardiol. 2002;90(4):358-363. doi:10.1016/S0002-9149(02)02489-X
3. Pinaire J, Azé J, Bringay S, Cayla G, Landais P. Hospital burden of coronary artery disease: Trends of myocardial infarction and/or percutaneous coronary interventions in France 2009–2014. PLOS ONE. 2019;14(5):e0215649. doi:10.1371/journal.pone.0215649
4. Clinical epidemiology, management and outcome of acute coronary syndromes in the Italian network on acute coronary syndromes (IN-ACS Outcome study): Acute Cardiac Care: Vol 14 , No 2 - Get Access. Accessed September 24, 2024. https://www.tandfonline.com/doi/full/10.3109/17482941.2012.655296
5. Segev A, Matetzky S, Danenberg H, et al. Contemporary use and outcome of percutaneous coronary interventions in patients with acute coronary syndromes: insights from the 2010 ACSIS and ACSIS-PCI surveys. doi:10.4244/EIJV8I4A73
6. Boer SPM de, Roos-Hesselink JW, Leeuwen MAH van, et al. Excess mortality in women compared to men after PCI in STEMI: An analysis of 11,931 patients during 2000–2009. Int J Cardiol. 2014;176(2):456-463. doi:10.1016/j.ijcard.2014.07.091
7. WHO. Cardiovascular diseases (CVD) in Viet Nam. Accessed March 26, 2024. https://www.who.int/vietnam/health-topics/cardiovascular-diseases
8. Nguyen TV, Bui KX, Tran KD, Le D, Nguyen TN. Non-ST elevation acute coronary syndrome in patients aged 80 years or older in Vietnam: An observational study. PLOS ONE. 2020;15(6):e0233272. doi:10.1371/journal.pone.0233272
9. Bộ Y tế. Quyết định 5332/QĐ-BYT 2020 tài liệu chuyên môn Thực hành chẩn đoán điều trị động mạch vành. THƯ VIỆN PHÁP LUẬT. February 19, 2024. Accessed March 11, 2024. https://thuvienphapluat.vn/van-ban/The-thao-Y-te/Quyet-dinh-5332-QD-BYT-2020-tai-lieu-chuyen-mon-Thuc-hanh-chan-doan-dieu-tri-dong-mach-vanh-460209.aspx
10. Roe MT, Goodman SG, Ohman EM, et al. Elderly patients with acute coronary syndromes managed without revascularization: insights into the safety of long-term dual antiplatelet therapy with reduced-dose prasugrel versus standard-dose clopidogrel. Circulation. 2013;128(8):823-833. doi:10.1161/CIRCULATIONAHA.113.002303
11. Baker WL, White CM. Role of prasugrel, a novel P2Y (12) receptor antagonist, in the management of acute coronary syndromes. Am J Cardiovasc Drugs. 2009;9(4):213-229. doi:10.2165/1131209-000000000-00000
12. European Public Assessment Report for Efient. European Medicines Agency website. Accessed June 13, 2024. https://www.ema.europa.eu/en/documents/overview/efient-epar-summary-public_en.pdf
13. Bộ Y tế. Thông tư 20/2022/TT-BYT danh mục thanh toán thuốc hóa dược được hưởng bảo hiểm y tế mới nhất. THƯ VIỆN PHÁP LUẬT. January 27, 2024. Accessed March 11, 2024. https://thuvienphapluat.vn/van-ban/The-thao-Y-te/Thong-tu-20-2022-TT-BYT-danh-muc-thanh-toan-thuoc-hoa-duoc-duoc-huong-bao-hiem-y-te-548898.aspx
14. Higgins J, Thomas J. Cochrane Handbook for Systematic Reviews of Interventions.; 2021. https://training.cochrane.org/handbook/current/chapter-i
15. Wiviott SD, Braunwald E, McCabe CH, et al. Prasugrel versus Clopidogrel in Patients with Acute Coronary Syndromes. N Engl J Med. 2007;357(20):2001-2015. doi:10.1056/NEJMoa0706482
16. Viikilä J, Nieminen T, Tierala I, Laine M. Safety of the primary percutaneous coronary intervention strategy combining pre-hospital prasugrel, enoxaparin and in-hospital bivalirudin in acute ST-segment elevation myocardial infarction. BMC Cardiovasc Disord. 2016;16(1):154. doi:10.1186/s12872-016-0333-0
17. Räber L, Klingenberg R, Heg D, et al. Safety of Prasugrel Loading Doses in Patients Pre-Loaded With Clopidogrel in the Setting of Primary Percutaneous Coronary Intervention: Results of a Nonrandomized Observational Study. JACC Cardiovasc Interv. 2015;8(8):1064-1074. doi:10.1016/j.jcin.2015.03.023
18. Bacquelin R, Oger E, Filippi E, et al. Safety of prasugrel in real-world patients with ST-segment elevation myocardial infarction: 1-year results from a prospective observational study (Bleeding and Myocardial Infarction Study). Arch Cardiovasc Dis. 2016;109(1):31-38. doi:10.1016/j.acvd.2015.08.005
19. Kaul U, Sethi A, Arambam P, et al. Safety of Prasugrel in Indian patients - multicentric registry of 1000 cases. Indian Heart J. 2014;66(6):598-601. doi:10.1016/j.ihj.2014.11.001
20. Gill K, Servati N, Flahive J, Fraielli K. Safety and Efficacy of Triple Therapy With Ticagrelor or Prasugrel Versus Clopidogrel After Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction. J Cardiovasc Pharmacol Ther. 2021;26(6):625-629. doi:10.1177/10742484211031436
21. Yetgin T, Boersma E, Smits PC, et al. One-year efficacy and safety of routine prasugrel in patients with acute coronary syndromes treated with percutaneous coronary intervention: results of the prospective rijnmond collective cardiology research study. Neth Heart J Mon J Neth Soc Cardiol Neth Heart Found. 2018;26(7-8):393-400. doi:10.1007/s12471-018-1126-0
22. Ruiz-Nodar JM, Esteve-Pastor MA, Rivera-Caravaca JM, et al. One-year efficacy and safety of prasugrel and ticagrelor in patients with acute coronary syndromes: Results from a prospective and multicentre ACHILLES registry. Br J Clin Pharmacol. 2020;86(6):1052-1061. doi:10.1111/bcp.14213
23. Chon MK, Jung SM, Lee SY, et al. Incidence of Cardiovascular Events and Safety Profile of Prasugrel in Korean Patients With Acute Coronary Syndrome. Circ J Off J Jpn Circ Soc. 2020;84(9):1582-1586. doi:10.1253/circj.CJ-20-0125
24. Jackson LR 2nd, Peterson ED, McCoy LA, et al. Impact of Proton Pump Inhibitor Use on the Comparative Effectiveness and Safety of Prasugrel Versus Clopidogrel: Insights From the Treatment With Adenosine Diphosphate Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome (TRANSLATE-ACS) Study. J Am Heart Assoc. 2016;5(10). doi:10.1161/JAHA.116.003824
25. Schüpke S, Neumann FJ, Menichelli M, et al. Ticagrelor or Prasugrel in Patients with Acute Coronary Syndromes. N Engl J Med. 2019;381(16):1524-1534. doi:10.1056/NEJMoa1908973
26. Lam ASM, Yan BPY, Lee VWY. Efficacy and safety comparing prasugrel/ticagrelor and clopidogrel in Hong Kong post-acute coronary syndrome patients-A 10-year cohort study. Clin Cardiol. 2021;44(8):1072-1079. doi:10.1002/clc.23653
27. Koyabu Y, Abe S, Sakuma M, et al. Short-term Safety and Mid-term Efficacy of Prasugrel Versus Clopidogrel in Patients Undergoing Percutaneous Coronary Intervention. Intern Med Tokyo Jpn. 2019;58(16):2315-2322. doi:10.2169/internalmedicine.2262-18
28. Liu PY, Su CH, Kuo FY, et al. Prasugrel switching from clopidogrel after percutaneous coronary intervention for acute coronary syndrome in Taiwanese patients: an analysis of safety and efficacy. Cardiovasc Interv Ther. 2022;37(2):269-278. doi:10.1007/s12928-021-00771-w
29. Saito S, Isshiki T, Kimura T, et al. Efficacy and safety of adjusted-dose prasugrel compared with clopidogrel in Japanese patients with acute coronary syndrome: the PRASFIT-ACS study. Circ J Off J Jpn Circ Soc. 2014;78(7):1684-1692. doi:10.1253/circj.cj-13-1482
30. Hagiwara H, Fukuta H, Hashimoto H, et al. A comparison of the safety and effectiveness of prasugrel and clopidogrel in younger population undergoing percutaneous coronary intervention: A retrospective study using a Japanese claims database. J Cardiol. 2021;77(3):285-291. doi:10.1016/j.jjcc.2020.10.001
31. Almendro-Delia M, García-Alcántara Á, de la Torre-Prados MV, et al. Safety and Efficacy of Prasugrel and Ticagrelor in Acute Coronary Syndrome. Results of a “Real World” Multicenter Registry. Rev Espanola Cardiol Engl Ed. 2017;70(11):952-959. doi:10.1016/j.rec.2017.05.003
32. Shahzeb, Ali N, Hadi A, et al. Elective percutaneous coronary interventions-A comparision of efficacy of Clopidogrel and Prasugrel. J Ayub Med Coll Abbottabad JAMC. 2015;27(1):174-177. doi:PMID:%2026182769
33. Daiichi Sankyo. Jasugrel (prasugrel) [package insert]. Drug Administration Vietnam. 2024. Accessed March 1, 2024. https://dichvucong.dav.gov.vn/congbothuoc/index
34. 2023 ESC Guidelines for the management of acute coronary syndromes. Accessed March 26, 2024. https://www.escardio.org/Guidelines/Clinical-Practice-Guidelines/Acute-Coronary-Syndromes-ACS-Guidelines