SKE

3.  Trial Sponsor:
 Novartis
 Date Presented:
 08/29/2022
 Date Published:
 11/02/2022
 Date Updated:
 12/23/2022
 Original Posted Date:
 05/15/2021

4. Hypothesis
Introduction
Objectives
Methodology
Statistical analysis
Result and discussion
Critical appraisal
Local applicability
•Outline

5. Hypothesis
 Clinical question
 Among patients with MI, complicated by reduced LVEF less
than 40%, pulmonary congestion or both
 Can sacubitril-valsartan compared to Ramipril reduce the
composite end point of death or first incident of heart failure.

6. MOA of RAAS system and ACEi/ARB

8. BACKGROUND

11. STUDY DESING

12. INCLUSION AND EXCLUSION CRITERIA

15. BASELINE CHARECTERISTICS

18. During trial visit
 Patients Were Evaluated Periodically At Trial Visits For and hospital
stay
 Weight change
 Health Status
 Adverse Events.
 MACE
 Vital Signs,
 Glycated Hemoglobin Level,
 eGFR,
 Quality of life

19. PRIMARY AND SECONDARY OUTCOME

24. summary
 In a vigorously managed enhanced risk AMI population
compared to active therapy with ramipril:

• Sacubitril/valsartan did not result in a significantly lower
rate of CV death, heart failure hospitalization or outpatient
heart failure requiring treatment.

• Pre-specified observations of reductions in both the
investigator reports of the primary composite as well as in
the total (recurrent) adjudicated events support incremental
clinical benefits of sacubitril/valsartan.

• The safety and tolerability of sacubitril/valsartan in this AMI
population was comparable to that of the ACEi.

25. Critical appraisal
⚫Strengths
 Study design was CRT
 Sample size
 Appropriate statistical analysis
 Baseline characteristics are similar among all patients. with OGDMT
 Similar use of medications to manage other health conditions

26. Weakness
• No Africa representation
• Less female participation
• Did not reached the primary outcome
Critical appraisal

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