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See also:
All cardiovascular prevention clinical trials
All heart failure clinical trials
All clinical trials of cholesterol lowering intervention
All clinical trials of rosuvastatin
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Treatments
Studied treatment |
rosuvastatin 10mg/d
|
Control treatment |
placebo
|
Patients
Patients |
patients at least 60 years of age with NYHA class II, III, or IV ischemic, systolic heart failure |
Method and design
Randomized effectives |
2514 / 2497 (studied vs. control) |
Design |
Parallel groups |
Blinding |
double blind |
Follow-up duration |
32.9 months median |
Primary endpoint |
cardiovascular death, MI, stroke |
Results
Endpoint
Studied treat. n/N
Control treat. n/N
Graph
RR [95% CI]
new-onset diabetes
100 / 1771
88 / 1763
1,13 [0,86;1,49]
Non fatal MI
115 / 2514
141 / 2497
0,81 [0,64;1,03]
Fatal stroke
35 / 2514
32 / 2497
1,09 [0,67;1,75]
Cardiovascular death
488 / 2514
487 / 2497
1,00 [0,89;1,11]
Coronary event
554 / 2514
588 / 2497
0,94 [0,85;1,04]
Non vascular death
138 / 2514
159 / 2497
0,86 [0,69;1,08]
cardiovascular events
692 / 2514
732 / 2497
0,94 [0,86;1,03]
All cause death
728 / 2514
759 / 2497
0,95 [0,87;1,04]
Fatal MI
15 / 2514
9 / 2497
classic
1,66 [0,73;3,78]
Non fatal stroke
89 / 2514
104 / 2497
0,85 [0,64;1,12]
0
2
1.0
Relative risks
|
Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
Studied treat. |
Control treat. |
new-onset diabetes
|
100 / 1771 (5,6%) |
88 / 1763 (5,0%) |
1,13 |
[0,86;1,49] |
sub group |
|
Non fatal MI
|
115 / 2514 (4,6%) |
141 / 2497 (5,6%) |
0,81 |
[0,64;1,03] |
|
|
Fatal stroke
|
35 / 2514 (1,4%) |
32 / 2497 (1,3%) |
1,09 |
[0,67;1,75] |
|
|
Cardiovascular death
|
488 / 2514 (19,4%) |
487 / 2497 (19,5%) |
1,00 |
[0,89;1,11] |
|
|
Coronary event
|
554 / 2514 (22,0%) |
588 / 2497 (23,5%) |
0,94 |
[0,85;1,04] |
|
|
Non vascular death
|
138 / 2514 (5,5%) |
159 / 2497 (6,4%) |
0,86 |
[0,69;1,08] |
|
|
cardiovascular events
|
692 / 2514 (27,5%) |
732 / 2497 (29,3%) |
0,94 |
[0,86;1,03] |
|
|
All cause death
|
728 / 2514 (29,0%) |
759 / 2497 (30,4%) |
0,95 |
[0,87;1,04] |
|
|
Fatal MI
|
15 / 2514 (0,6%) |
9 / 2497 (0,4%) |
1,66 |
[0,73;3,78] |
|
|
Non fatal stroke
|
89 / 2514 (3,5%) |
104 / 2497 (4,2%) |
0,85 |
[0,64;1,12] |
|
|
The primary endpoint (if exists) appears in blod characters
|
Reference(s) used for data extraction:
0:
11590: Lipinski MJ, Cauthen CA, Biondi-Zoccai GG, Abbate A, Vrtovec B, Khan BV, Vetrovec GWMeta-analysis of randomized controlled trials of statins versus placebo in patients with heart failure.Am J Cardiol 2009;104:1708-16
|
Endpoint |
studied treat. |
control treat. |
mean diff |
Absolute risk reduction (for a follow-up of 32.9 months median)
|
Endpoint |
Events rate |
Absolute risk reduction (ARR) |
Studied treat. |
Control treat. |
new-onset diabetes |
5,65% |
4,99% |
0,66%
|
Non fatal MI |
4,57% |
5,65% |
-1,07%
|
Fatal stroke |
1,39% |
1,28% |
0,11%
|
Cardiovascular death |
19,41% |
19,50% |
-0,09%
|
Coronary event |
22,04% |
23,55% |
-1,51%
|
Non vascular death |
5,49% |
6,37% |
-0,88%
|
cardiovascular events |
27,53% |
29,32% |
-1,79%
|
All cause death |
28,96% |
30,40% |
-1,44%
|
Fatal MI |
5,97‰ |
3,60‰ |
0,24%
|
Non fatal stroke |
3,54% |
4,16% |
-0,62%
|
Meta-analysis of all similar trials:
cholesterol lowering intervention in cardiovascular prevention for all chronical situations
cholesterol lowering intervention in heart failure for all type of patients
cholesterol lowering intervention in heart failure for elderly
Reference(s)
TrialResults-center ID |
TRC6786
|
Trials register # |
NCT00206310
|
Study web site link |
, |
-
Kjekshus J, Apetrei E, Barrios V, B�hm M, Cleland JG, Cornel JH, Dunselman P, Fonseca C, Goudev A, Grande P, Gullestad L, Hjalmarson A, Hradec J, J�nosi A, Kamensk� G, Komajda M, Korewicki J, Kuusi T, Mach F, Mareev V, McMurray JJ, Ranjith N, Schaufelberg.
Rosuvastatin in older patients with systolic heart failure..
N Engl J Med 2007;357:2248-61
Pubmed
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Hubmed
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