Novel therapy for heart failure
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give some information about ARNI and levosimendan
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Novel therapy for heart failure
- 1. By Waseem Omar A. Lecturer of cardiology
- 7. PARADIGM-HF trial Prospective Comparison of ARNI with ACE-I to Determine Impact on Global Mortality and Morbidity in Heart Failure
- 8. the largest clinical trial ever conducted in heart failure (8442 patients over 47 countries). Stopped early due to compelling efficacy: risk of CV death was significantly reduced.
- 9. 2 weeks 1-2 weeks 2-4 weeks Single-blind run-in period Double-blind period (1:1 randomization) Enalapril 10 mg BID 100 mg BID 200 mg BID Enalapril 10 mg BID LCZ696 200 mg BID PARADIGM-HF: Study Design Randomization LCZ696
- 10. Primary end point: Cardiovascular death or heart failure hospitalization Secondary end point: all cause mortality.
- 11. In heart failure with reduced ejection fraction, when compared with recommended doses of enalapril: LCZ696 was more effective than enalapril in . . . •Reducing the risk of CV death and HF hospitalization •Reducing the risk of CV death by incremental 20% •Reducing the risk of HF hospitalization by incremental 21% •Reducing all-cause mortality by incremental 16% •Incrementally improving symptoms and physical limitations PARADIGM-HF: Summary of Findings
- 12. LCZ696 was better tolerated than enalapril . . . • Less likely to cause cough, hyperkalemia or renal impairment • Less likely to be discontinued due to an adverse event • More hypotension, but no increase in discontinuations • Not more likely to cause serious angioedema
- 13. 10% Angiotensin Neprilysin Inhibition With LCZ696 Doubles Effect on Cardiovascular Death of Current Inhibitors of the Renin-Angiotensin System 20% 30% 40% ACE inhibitor Angiotensin receptor blocker 0% %DecreaseinMortality 18% 20% Effect of ARB vs placebo derived from CHARM-Alternative trial Effect of ACE inhibitor vs placebo derived from SOLVD-Treatment trial Effect of LCZ696 vs ACE inhibitor derived from PARADIGM-HF trial Angiotensin neprilysin inhibition 15%
- 16. What should I know about ARNI????
- 17. Trade name:
- 18. Dosing & Uses Recommended starting dose: 49 mg/51 mg PO BID Target maintenance dose: After 2-4 weeks, double the dose to the target maintenance dose of 97 mg/103 mg PO BID as tolerated. Patients not taking an ACE inhibitor or other ARB: Reduce starting dose to 24 mg/26 mg BID.
- 19. Renal impairment Mild-to-moderate (eGFR ≥30 mL/min/1.73 m²): No starting dose adjustment required Severe (eGFR <30 mL/min/1.73 m²): Reduce starting dose to 24 mg/26 mg BID; double the dose every 2-4 weeks to target maintenance dose of 97 mg/103 mg BID as tolerated
- 20. Hepatic impairment Mild (Child-Pugh A): No starting dose adjustment required Moderate (Child-Pugh B): Reduce starting dose to 24 mg/26 mg BID; double the dose every 2-4 weeks to target maintenance dose of 97 mg/103 mg BID as tolerated Severe (Child-Pugh C): Not recommended
- 21. Adverse Effects >10%: Hypotension (18%), Hyperkalemia (12%) 1-10%: Cough (9%), Dizziness (6%), Orthostasis (2.1%) <1%: Angioedema,
- 22. Black Box Warnings Discontinue as soon as possible when pregnancy is detected Drug affects renin-angiotensin system, causing oligohydramnios, which may result in fetal injury or death
- 23. Contraindications Hypersensitivity to any component History of angioedema related to previous ACE inhibitor or ARB therapy Should not be administered concomitantly with ACE inhibitors or within 36 hours of the last dose of ACE inhibitor Concomitant use with aliskiren in patients with diabetes
- 24. Cautions Observe for signs and symptoms of angioedema Sacubitril/valsartan lowers blood pressure and may cause symptomatic hypotension especially in patients who are volume-depleted or salt-depleted. Monitor renal function and potassium levels.
- 30. We need a new drug!!!!! Levosimendan
- 37. NO dose adjustment in mild and moderate hepatic and renal impairment contraindicated in severe renal and hepatic Impairment
- 39. Thanks