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Evidence Table 3Evidence profile of coronary heart disease/left ventricular dysfunction/heart failure

Quality AssessmentSummary of Findings
Results by StudySummary effect across studiesQuality of the evidence for each outcome (GRADE)
Study DesignRisk of biasInconsistencyIndirectnessImprecisionOther considerationsAbsolute effectRelative effect
LosartanCaptopril
Losartan compared with captopril
All-cause mortality
ELITEFair(−1)
Data inconsistent
(0)
Large study, likely generalizable to like populations
(0)
3 studies, although low event rates
(0)
Populations differ somewhat across studies
4.8%8.7%P=0.035Results inconsistent, effect of losartan unclear, in acute MI (OPTIMAAL) losartan not noninferior to captoprilModerate
ELITE IIFair15.9%17.7%P=0.16
OPTIMAALGood18%16%P=0.07; did not satisfy the non-inferiority criterion
Good: 1
Fair: 2
Limitations:(0)
Cardiovascular deaths
ELITEFair(−1) Data inconsistent(0)
Large study, likely generalizable to like populations
(0)
3 studies, although low event rates
(0)
Populations differ somewhat across studies
MI deaths: 1/352 (0.03%)MI deaths: 1.1%RR 0.76 (−0.83 to 0.97Lower rate with losartan in earlier (ELITE) trial, but higher rates in 2 subsequent studies in somewhat different populationsModerate
ELITE IIFairMI deaths: 2.0%MI deaths: 1.8%RR 1.11 (0.66 to 1.85)
OPTIMAALGoodCardiovascular deaths: 15.3%Cardiovascular deaths: 13.3%RR 1.17 (1.01 to 1.34), P=0.032
Good: 1
Fair: 2
Limitations: (0)
Sudden death or resuscitated arrest
ELITEFair(−1)
Data inconsistent
(0)
Large study, likely generalizable to like populations
(0)
3 studies, although low event rates
(0)
Populations differ somewhat across studies
1.4%3.8%RR 0.64 (0.03 to 0.86)Lower rate with losartan in earlier ELITE trial, but higher rates in 2 subsequent studies in somewhat different populationsModerate
ELITE IIFair9.0%7.3%P=0.08
OPTIMAALGood9.0%7.0%RR 1.19 (95% CI, 0.99 to 1.43), P=0.072
Good: 1
Fair: 2
Limitations:(0)
Cardiovascular events
ELITEFairNA, 1 study(0)
Large study, likely generalizable to like populations
(−1)
Large study, but low event rate
(0)
Populations differ somewhat across studies
NRNRNANSD Fatal or nonfatal reinfarction between groups in OPTIMAALModerate
ELITE IIFairNRNRNA
OPTIMAALGoodFatal or nonfatal reinfarction: 14%Fatal or nonfatal reinfarction: 14%RR 1.03 (95% CI, 0.89 to 1.18), P=0.72
Fair: 1
Limitations: (−1)
Hospital admissions
ELITEFair(−1)
Data inconsistent
(0)
Large studies likely generalizable
(0)
Large studies
(0)
Populations differ somewhat across studies
Total: 22.2%
HF: 5.7%
Total: 29.7%
HF: 5.7%
Total: L < C, P=0.014
HF: L=C, P=0.89
Results inconsistent; effect unclearModerate
ELITE IIFairTotal; 41.8%
HF: 17.1%
Total: 40.5%
HF: 18.6%
Total:P=0.45
HF: P=0.032
OPTIMAALGoodHF: 11.2%HF: 9.7%HF: RR 1.16(0.98 to 1..37), P=0.072
Good: 1
Fair: 2
Limitations: (0)
NYHA functional class
ELITEFair(0)
Between-group analyses consistent
(0)(0)
Large sample sizes
(0)
Note that OPTIMAAL population is acute MI with HF or decreased EF
Improved, P ≤ 0.001Improved, P ≤ 0.001NSD between groupsImproved in 2 HF studies; NSD between treatment groups in all 3 studiesHigh
ELITE IIFairImproved, P ≤ 0.01Improved, P ≤ 0.01NSD between groups
OPTIMAALGoodNSDNSDNSD between groups
Good: 1
Fair: 2
Limitations: (0)
Quality of life
ELITEFair(0)
Consistent results in 2 studies
(0)
Data likely generalizable to similar populations
(0)
Large sample sizes
Populations differ somewhat across studies↑ QoL↑ QoLNSD between groupsQoL improved with NSD between groupsHigh
ELITE IIFair↑ QoL↑ QoLNSD between groups
OPTIMAALGoodNRNRNA
Good: 1
Fair: 2
Limitations: (0)
Quality AssessmentSummary of Findings
Study DesignStudy qualityInconsistencyIndirectnessImprecisionOther considerationsResults by StudySummary effect across studiesQuality of the evidence for each outcome (GRADE)
Absolute effectRelative effect
LosartanCaptopril
Enalapril compared with losartan
All-cause mortality
Dickstein 1995FairNRNRNANA
Guazzi 1997PoorNRNRNA
Guazzi 1999FairNRNRNA
Lang 1997Fair-poorNRNRNA
Vescovo 1998PoorNRNRNA
Good: 0
Fair: 2
Fair-poor: 1
Poor: 2
Cardiovascular deaths
Dickstein 1995FairNRNRNANA
Guazzi 1997PoorNRNRNA
Guazzi 1999FairNRNRNA
Lang 1997Fair-poorNRNRNA
sVescovo 1998PoorNRNRNA
Good: 0
Fair: 2
Fair-poor: 1
Poor: 2
Sudden death or resuscitated arrest
Dickstein 1995FairNRNRNANA
Guazzi 1997PoorNRNRNA
Guazzi 1999FairNRNRNA
Lang 1997Fair-poorNRNRNA
Vescovo 1998PoorNRNRNA
Good: 0
Fair: 2
Fair-poor: 1
Poor: 2
Cardiovascular events
Dickstein 1995FairNRNRNANA
Guazzi 1997PoorNRNRNA
Guazzi 1999FairNRNRNA
Lang 1997Fair-poorNRNRNA
Vescovo 1998PoorNRNRNA
Good: 0
Fair: 2
Fair-poor: 1
Poor: 2
Hospital admissions
Dickstein 1995FairNRNRNANA
Guazzi 1997PoorNRNRNA
Guazzi 1999FairNRNRNA
Lang 1997Fair-poorNRNRNA
Vescovo 1998PoorNRNRNA
Good: 0
Fair: 2
Fair-poor: 1
Poor: 2
NYHA functional class, symptoms, exercise capacity
Dickstein 1995Fair(0)
Data are consistent
(−1)
Is outcome of interest Studies are small and potentially selected groups with limited generalizability
(−1)
3 studies with small sample sizes
(0)NSD exercise capacity; symptoms and NYHA class improvedNSD exercise capacity; symptoms and NYHA class improvedNSD between groupsExercise capacity and symptoms improved within both treatment groups; NSD between groupsLow
Guazzi 1997PoorNRNRNSD exercise tolerance between groups
Guazzi 1999FairNRNRNA
Lang 1997Fair-poor↑exercise tolerance 50mg group (P=0.06); ↑ walk test (P-value NR)↑exercise tolerance(P=0.03); ↑ walk test (P-value NR)NSD between groups in exercise tolerance, signs and symptoms of HF
Vescovo 1998Poor↑exercise tolerance, P=0.03↑exercise tolerance, P=0.03NR
Good: 0
Fair: 2
Fair-poor: 1
Poor: 2
Quality of life
Dickstein 1995FairNA(−1)
Is outcome of interest Study is very small and potentially selected population
(−1)
Study is small (n=20)
(0)NRNRNANSD between groupsLow
Guazzi 1997PoorNRNRNA
Guazzi 1999FairNSDNSDNSD between groups
Lang 1997Fair-poorNRNRNA
Vescovo 1998PoorNRNRNA
Fair: 1
Limitations: (−1)

From: Evidence Tables

Cover of Drug Class Review: Direct Renin Inhibitors, Angiotensin Converting Enzyme Inhibitors, and Angiotensin II Receptor Blockers
Drug Class Review: Direct Renin Inhibitors, Angiotensin Converting Enzyme Inhibitors, and Angiotensin II Receptor Blockers: Final Report [Internet].
Norris S, Weinstein J, Peterson K, et al.
Portland (OR): Oregon Health & Science University; 2010 Jan.
Copyright © 2009, Oregon Health & Science University, Portland, Oregon.

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