The results after 12 months in this RCT which was blinded only for radiologists who made the plaque evaluation are rather disappointing or at best mitigated.
Comparatively to the standard regime the intensive statin therapy showed:
-no depletion in the fatty content of the plaque, indeed the two regimes led to an increase in the total plaque volume.
-an increase of the calcium content of the plaque in the intensive group
-no decrease in the MACE
-a decrease the "vulnerability" of the predetermined vulnerable plaques as assessed by total volumes but only for the patients treated with an intensive regime. The vulnerable patients were 18/96/140 and 18 plaques , 8 in the conventional regime and 10 in the intensive one.
Table 1
Size of the cohort 140 patients recruted 96 evaluable patients
Treatment Rosu +/- Ezetimibe Standard dose
LDL-C < 1.8 mmol 40 mg Simvastatin
Duration of treatment (m) 12 12
Table 2
Treatment regime Intensive Conventional
Number of patients 48 48
MACE
AMI 2 1
Unstable Angina 6 8
Vulnerable plaques 10 8
http://ac.els-cdn.com/S0021915015013593/1-s2.0-S0021915015013593-main.pdf
And another disappointing result with different parameters:
http://eurheartj.oxfordjournals.org/content/early/2014/08/28/eurheartj.ehu373.full
Table 1
Size of the cohort 140 patients recruted 96 evaluable patients
Treatment Rosu +/- Ezetimibe Standard dose
LDL-C < 1.8 mmol 40 mg Simvastatin
Duration of treatment (m) 12 12
Table 2
Treatment regime Intensive Conventional
Number of patients 48 48
MACE
AMI 2 1
Unstable Angina 6 8
Vulnerable plaques 10 8
http://ac.els-cdn.com/S0021915015013593/1-s2.0-S0021915015013593-main.pdf
And another disappointing result with different parameters:
http://eurheartj.oxfordjournals.org/content/early/2014/08/28/eurheartj.ehu373.full
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