Bài giảng Suy tim mạn góc nhìn từ ACC 2017 - PGS.TS Châu Ngọc Hoa

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Bài giảng với các nội dung: hai liệu pháp dược lý mới được FDA chấp thuận cho bệnh suy tim, dòng thời gian phê duyệt Ivabradine, thời gian chuẩn độ như được xác định trong các thử nghiệm mang tính bước ngoặt, lý do không đạt được liều đích, hiệu quả điều trị của Ivabradine theo huyết áp...

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Nội dung Text: Bài giảng Suy tim mạn góc nhìn từ ACC 2017 - PGS.TS Châu Ngọc Hoa

Suy tim mạn: GÓC NHÌN TỪ ACC 2017 PGS TS Châu Ngọc Hoa Bộ môn Nội ĐHYD Tp HCM
ACC Focused update on HF, 2017
Two New Pharmacological Therapies Approved by FDA for Heart Failure • Ivabradine (April 15, 2015) • Sacubitril/Valsartan (July 7, 2015)
WHO, WHEN AND WHY ADD ON IVABRADINE
Ivabradine approval timeline • 2005 approved in EU for angina • 2012 approved in EU for heart failure • 2015 approved in US for heart failure to reduce the risk for hospitalization for worsening heart failure in patients with stable, symptomatic chronic heart failure with LVEF ≤35%, who are in sinus rhythm with a resting heart rate of ≥70 beats per minute (bpm) and are taking maximally tolerated doses of beta-blockers or have a contraindication to beta-blockers.
Ivabradine Blocks If channel Slows heart rate Few if any other CV effects SHIFT Trial > 6500 HF patients (NYHA II-IV) LVEF < 35% Resting HR > 70 BPM Primary endpoint: composite of CV death/HF hospitalization On maximally tolerated beta-blocker
SHIFT: primary outcome CV death or hospitalization for HF (%) 40 HR= 0.82 p
SHIFT: HF hospitalization Hospitalization for HF (%) 30 Placebo HR= 0.74 20 10 Months 6 12 18 24 30 Swedberg K, et al. Lancet. 2010;376:875-885.
Ivabradine in HF Up-titrate beta blocker dose as much as possible Add on therapy to beta blocker; not replacement Does not lower blood pressure Contraindicated in atrial fibrillation Benefit greater in patients with higher baseline heart rate
Target doses as defined in the ESC guidelines Startingdose(mg) Targetdose(mg) ACEI Enalapril 2.5b.i.d 10-20b.i.d Lisinopril 2.5-5.0o.d 20-35o.d Ramipril 2.5o.d 5b.i.d Beta-blocker Bisoprolol 1.25o.d 10o.d Carvedilol 3.125b.i.d 25-50b.i.d Metoprololsuccinate 12.5/25o.d 200o.d MRA Eplerenone 25o.d 50o.d Spironolactone 25o.d 25-50o.d IfInhibitor Ivabradine 5b.i.d 7.5b.i.d
Can we reach and maintain „target” dose in „real-life” elderly HF patients with comorbidities ? CIBIS-ELD – 883 elderly HF patients; The primary endpoint: tolerability, defined as reaching and maintaining guideline- recommended target doses after 12 weeks treatment. Dungen HD, et al. Eur J Heart Fail. 2011:13:670–680.
Up-titration period as defined in the landmark trials Trials Targetdose (mg) Time to reach target/max tolerated dose ACEI Enalapril SOLVD 10b.i.d Notspecified Lisinopril ATLAS 35o.d 4weeks Beta-blocker Bisoprolol CIBISII 10o.d 11weeks Carvedilol COPERNICUS 25b.i.d 6weeks Metoprololsuccinate MERITHF 200o.d 6weeks Nebivolol SENIORS 10o.d 6weeks MRA Eplerenone EMPHASIS-HF 50o.d 4weeks IfInhibitor Ivabradine SHIFT 7.5b.i.d 2weeks 1- The SOLVD Investigators. N Engl J Med.1991;325:293-302. 2- Packer M, et al. Circulation. 1999;100:2312-2318. 3- CIBIS-II study group. Lancet.1999;353:9-13. 4- Packer M, et al. Circ. 2002;106:2194-2199. 5- Merit-HF study group. Lancet.1999;353:2001- 2007. 6- Zannad F, et al. N Engl J Med. 2011:364:11-21. 7- Swedberg K, et al. . Lancet 2010;376: 875-885.
Uptitration target in stable HF patients ACEIs Beta-blockers 4 weeks 6 weeks Dose MRAs Ivabradine 4 weeks 2 weeks .
Reasons for non-reaching target dose CIBIS-ELD: RCT aimed to reach guideline-recommended target doses 883 HF patients, NYHA II-IV, >65 y, no contraindication or intolerance to BB Dungen HD, et al. Eur J Heart Fail. 2011:13:670–680.
Yes but … My Patient … - is too old - has low blood pressure - has COPD - has renal impairment - is too sick
Treatment Effect of Ivabradine According to Blood Pressure Komajda M, et al. Eur Heart J. 2013;34 (Abst. Suppl), 610.
Effect of ivabradine on composite of Patients (%) CV death or HF hospitalization 50 45 40 COPD (placebo) 35 COPD (ivabradine) 30 Non-COPD (placebo) 25 Non-COPD (ivabradine) 20 15 10 5 0 6 12 18 24 N at risk 0 Time (months) COPD (pl) 372 298 250 209 110 COPD (iva) 358 312 266 216 124 NCOPD (pl) 2892 2570 2239 1852 979 NCOPD (iva) 2883 2616 2334 1957 1067 Tavazzi L, et al. Eur Heart J. 2013;34 (Abst. Suppl), 652.
Effect of ivabradine on composite of CV Patients (%) death or HF hospitalization 50 Placebo, renal dysfunction 40 Ivabradine,renal dysfunction Placebo, no renal dysfunction 30 Ivabradine, no renal dysfunction 20 10 0 6 12 18 24 30 0 N at risk Time (months) RD (pl) 799 706 612 488 261 95 RD (iva) 780 720 612 489 273 104 NRD (pl) 2293 2119 1847 1551 820 343 NRD (iva) 2288 2166 1963 1662 906 339 Voors A, et al. Eur Heart J. 2013;34 (Abst. Suppl).
Effect of early treatment of Ivabradine with BBs vs BB alone in patients hospitalized for WHF: randomized ETHIC study n=71 patients hospitalized for WHF Greater improvement in LVEF P=0.039 55. Ivabradine + BB BB alone 46. 44.8 38.1 P=0.039 LVEF, % 37. 32.9 31.9 29.8 29.9 28. 19. 10. Admission Dicharge 4 months FU Hidalgo FJ et al. Int J Cardiol. 2016;217:7-11