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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
| Fulltext
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