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 Trial Sponsor:
 Novartis
 Date Presented:
 08/29/2022
 Date Published:
 11/02/2022
 Date Updated:
 12/23/2022
 Original Posted Date:
 05/15/2021
MOVE TO Ethical clearance and Journal
appraisal
Hypothesis
Introduction
Objectives
Methodology
Statistical analysis
Result and discussion
Critical appraisal
Local applicability
•Outline
Hypothesis and Clinical question
Hypothesis
 Among patients with MI, complicated by reduced LVEF less
than 40%, pulmonary congestion or both…?
Clinical question
 Can sacubitril-valsartan compared to Ramipril reduce the
composite end point of death or first incident of heart failure.
MOA of RAAS system and ACEi/ARB
BACKGROUND
STUDY DESING
INCLUSION AND EXCLUSION CRITERIA
BASELINE CHARECTERISTICS
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
PRIMARY AND SECONDARY OUTCOME
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.
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
Weakness
• No Africa representation
• Less female participation
• Did not reached the primary outcome
Critical appraisal
Still im eding but see it dr nuredin

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PARADISE-MI.pptx2be.pptx

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  • 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 MOVE TO Ethical clearance and Journal appraisal
  • 4. Hypothesis Introduction Objectives Methodology Statistical analysis Result and discussion Critical appraisal Local applicability •Outline
  • 5. Hypothesis and Clinical question Hypothesis  Among patients with MI, complicated by reduced LVEF less than 40%, pulmonary congestion or both…? Clinical question  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
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  • 17. 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
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  • 23. 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.
  • 24. 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
  • 25. Weakness • No Africa representation • Less female participation • Did not reached the primary outcome Critical appraisal
  • 26. Still im eding but see it dr nuredin