HOPE renal insufficiency subgroup Trial

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Systematic review and meta-analysis

This trial is included in the following systematic reviews and meta-analyses:

cardiovascular prevention - antioxydants - patients with renal disease

cardiovascular prevention - antioxydants - secondary prevention

WACS beta-caroten, 2007 - beta carotene vs placebo

WACS vitamin E, 2007 - vitamin E vs placebo

HOPE renal insufficiency subgroup, 2004 - vitamin E vs placebo

Tepel, 2003 - acetylcysteine vs placebo

WAVE (Waters), 2002 - combination vs placebo

HPS antioxidant, 2002 - combination vs placebo

HATS, 2001 - combination vs placebo

SPACE, 2000 - vitamin E vs placebo

HOPE, 2000 - vitamin E vs placebo

GISSI, 1999 - vitamin E vs control

ATBC 2nd prev subgroup (vitamin E), 1998 - vitamin E vs placebo

ATBC 2nd prev subgroup (b carotene), 1998 - beta carotene vs placebo

MVP, 1997 - combination vs placebo

CHAOS, 1996 - vitamin E vs placebo

Treatments

Studied treatment	vitamin E 400 IU/day, natural
Control treatment	placebo

Patients

patients with either known cardiovascular disease or diabetes and at least one additional coronary risk factor and renal insufficiency (sub group)

Inclusion criteria

55 years or older, had a history of cardiovascular disease (coronary artery disease, stroke, or peripheral arterial disease), or diabetes in the presence of at least one additional cardiovascular risk factor [total cholesterol >5.2 mmol/L, HDL cholesterol��0.9 mmol/L, hypertension (defined as use of medication(s) to treat high blood pressure or blood pressure at the time of recruitment >160 mm Hg systolic or >90 mm Hg diastolic), known microalbuminuria, or current smoking]

Exclusion criteria

dipstickpositive proteinuria at baseline, serum creatinine >200 lmol/L (2.3 mg/dL), history of congestive heart failure, or known low left ventricular ejection fraction (<40%), hyperkalemia, uncontrolled hypertension, myocardial infarction, unstable angina, or stroke within one month prior to study enrollment; use of or intolerance to vitamin E or ACE inhibitors

Baseline characteristics

Women (%)	12.7%
age (yr)	68.45y
Body mass index	27.6

Method and design

Randomized effectives	499 / 494 (studied vs. control)
Design	Factorial plan
Blinding	double-blind
Follow-up duration	4.5y
Number of centre	multicentre
Geographic area	North and South America, Europe
Hypothesis	Superiority
Primary endpoint	not defined
Remarks	subgroup analysis

Remarks / Comments

Post-hoc analysis

Results

Endpoints and data reported in the trial's publication(s)

Endpoint	Events (%)		Relative Risk	95% CI
Endpoint	Studied treat.	Control treat.	Relative Risk	95% CI
Composite of myocardial infarction, stroke, or death from CV causes	115 / 499 (23,0%)	109 / 494 (22,1%)	1,04	[0,83;1,32]
Myocardial infarction	81 / 499 (16,2%)	83 / 494 (16,8%)	0,97	[0,73;1,28]
Stroke	26 / 499 (5,2%)	25 / 494 (5,1%)	1,03	[0,60;1,76]
Death from CV causes	57 / 499 (11,4%)	57 / 494 (11,5%)	0,99	[0,70;1,40]
Total mortality	85 / 499 (17,0%)	93 / 494 (18,8%)	0,90	[0,69;1,18]
Unstable angina	76 / 499 (15,2%)	77 / 494 (15,6%)	0,98	[0,73;1,31]
Heart failure hospitalizations	31 / 499 (6,2%)	28 / 494 (5,7%)	1,10	[0,67;1,80]
Revascularization procedures	107 / 499 (21,4%)	88 / 494 (17,8%)	1,20	[0,93;1,55]
Any heart failure	83 / 499 (16,6%)	63 / 494 (12,8%)	1,30	[0,96;1,77]
Transient ischemic attacks	33 / 499 (6,6%)	34 / 494 (6,9%)	0,96	[0,61;1,53]
Unstable angina with ECG changes	27 / 499 (5,4%)	32 / 494 (6,5%)	0,84	[0,51;1,37]

Endpoints used by the meta-analysis and data retained for this trial

Endpoint Studied treat.
n/N Control treat.
n/N Graph RR [95% CI]

Coronary event

81 / 499
83 / 494
0,97 [0,73;1,28]

Cardiovascular death

57 / 499
57 / 494
0,99 [0,70;1,40]

cardiovascular events

115 / 499
109 / 494
1,04 [0,83;1,32]

All cause death

85 / 499
93 / 494
0,90 [0,69;1,18]

stroke (fatal and non fatal)

26 / 499
25 / 494
1,03 [0,60;1,76] 0 2 1.0

Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
Relative risks
Endpoint	Studied treat.	Control treat.	Relative Risk	95% CI	Endpoint definition in the trial	Ref
Coronary event	81 / 499 (16,2%)	83 / 494 (16,8%)	0,97	[0,73;1,28]	Myocardial infarction
Cardiovascular death	57 / 499 (11,4%)	57 / 494 (11,5%)	0,99	[0,70;1,40]	Death from CV causes
cardiovascular events	115 / 499 (23,0%)	109 / 494 (22,1%)	1,04	[0,83;1,32]	Composite of myocardial infarction, stroke, or death from CV causes
All cause death	85 / 499 (17,0%)	93 / 494 (18,8%)	0,90	[0,69;1,18]	Total mortality
stroke (fatal and non fatal)	26 / 499 (5,2%)	25 / 494 (5,1%)	1,03	[0,60;1,76]	Stroke	0
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction: 0:

Endpoint	Events rate		Absolute risk reduction (ARR)
Absolute risk reduction
Endpoint	Studied treat.	Control treat.	Absolute risk reduction (ARR)
Coronary event	16,23%	16,80%	-5,7‰
Cardiovascular death	11,42%	11,54%	-1,2‰
cardiovascular events	23,05%	22,06%	9,8‰
All cause death	17,03%	18,83%	-17,9‰
stroke (fatal and non fatal)	5,21%	5,06%	1,5‰

Meta-analysis of all similar trials:

antioxydants in cardiovascular prevention for patients with renal disease

antioxydants in cardiovascular prevention for secondary prevention

Reference(s)

Trials register #

Mann JF, Lonn EM, Yi Q, Gerstein HC, Hoogwerf BJ, Pogue J, Bosch J, Dagenais GR, Yusuf S. Effects of vitamin E on cardiovascular outcomes in people with mild-to-moderate renal insufficiency: results of the HOPE study.. Kidney Int 2004;65:1375-80 - 10.1111/j.1523-1755.2004.00513.x
Pubmed | Hubmed | Fulltext

HOPE renal insufficiency subgroup study, 2004