Trials Flashcards
1
Q
CONSENSUS
A
NEJM 1987
RCT, enalapril (vs placebo) improved survival
-in >250 pts w/ NYHA IV HFrEF 6mo and 12 mo
2
Q
SOLVD
A
NEJM 1992
- RCT, enalapril (vs placebo) reduced HF hospitalizations, HF incidence and mortality
- in > 4200 asymptomatic HF patient w/ EF < 35% taking diuretics/digoxin after 4 years
3
Q
CHARM-added
A
Lancet 2003
-Addition of candesartan (vs placebo) to ACEi in HFrEF, EF < 40%, reduced CV mortality and HF hospitalization
4
Q
CHARM-alternative
A
Lancet 2003
- Candesartan (vs placebo) reduced CV mortality (by 20%) and HF hospitalizations (by 40%)
- in >2000 pts with HFrEF, who were intolerant to ACEi
5
Q
I-PRESERVE
A
NEJM 2008
-irbesartan did NOT reduced death or hospitalization, in pts w/ HFrEF, EF<45%
6
Q
PARADIGM-HF
A
NEJM 2014
- ARNI (vs enalapril 10 mg BID) reduced CV mortality, all-cause mortality, and HF hospitalization
- in > 8000 chronic HFrEF pts, EF < 40% and < 35%, NYHA II-IV.
- ARNI was well tolerated except for hypotension.
7
Q
PIONEER-HF
A
NEJM 2019
- ARNI (vs enalapril 10 mg BID) reduced NT-proBNP concentration
- in > 800 pts w/ acute decompensated HF, at 4 and 8 weeks.
8
Q
EVALUATE-HF
A
JAMA 2019
- ARNI at target dose 97/103 mg BID (vs enalapril 10 mg QD) did not show differences in change of aortic stiffness (measured with characteristic impedance via echo)
- neither of them lowered aortic stiffness
- in HFrEF < 40%, after 12 weeks
9
Q
PARAGON-HF
A
NEJM 2019
- ARNI 97/103 mg BID (vs valsartan 160 mg BID) did NOT reduce HF hospitalizations/CVD death (rate ratio 0.87, 95%CI 0.75-1.01)
- in > 4800 pts w HFpEF > 45%, NYHA II,III,IV, structural heart disease
- However, ARNI was a/w less renal dysfunction (1.4% vs 2.7%, HR 0.5)
- PARAGON was performed given positive results of PARAMOUNT (phase 2 trial in HFpEF).
- FDA approved ARNI in HFpEF in Dec 2020 after analyzing PARAGON-HF
10
Q
OVERTURE
A
- omapatrilat (a previous neprilysin inhibitor) is a/w higher freq of angioedema (OVERTURE trial).
- Omapatrilat was a/w lower mortality and hospitalization as compared to enalapril, but produced too much angioedema!
11
Q
MERIT-HF
A
Lancet 1999
- metoprolol succinate 12.5-25 mg daily (vs placebo) reduced all-cause mortality (by 34%), all-cause hospitalizations, and CV events
- in ~4000 pts w/HFrEF <40%, NYHA II-III
12
Q
CIBIS-II
A
Lancet 1999
- bisoprolol (start dose 1.2510 mg daily (vs placebo) reduced all-cause mortality
- in HFrEF < 35%, NYHA III-IV
13
Q
COPERNICUS
A
Circulation 2002
- carvedilol (3.125 – 25 mg BID, uptitrated q2w) vs placebo reduced risk of death and HF hospitalizations (by 31%)
- in > 2000 euvolemic pts w/HFrEF < 25%, NYHA III-IV
14
Q
COMET
A
Lancet 2003
- carvedilol 3.125-25 mg BID (vs metoprolol tartrate 5-50 mg BID) reduced all-cause mortality
- in >3000 pts w/ HFrEF < 35%, NYHA II-IV
- after 4.8 years
- Largest and most well-known head-to-head trial of Beta blockers
- Criticism: it used metoprolol Tartrate (instead of succinate).
15
Q
RALES
A
NEJM 1999
- spironolactone 25-50 mg daily (vs placebo) reduced all-cause mortality (by 30%), SCD, and HF hospitalization
- > 1600 in pts w/ HFrEF < 35%, NYHA III-IV
- Aldactone a/w gynecomastia/mastalgia (10% vs 1%).
- Only 10% of pts were on beta blockers