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Effect of rosuvastatin on progression of carotid intima media thickness in low risk individuals: Results of the METEOR trial Dr Serge Kownator Cardiologue.

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Présentation au sujet: "Effect of rosuvastatin on progression of carotid intima media thickness in low risk individuals: Results of the METEOR trial Dr Serge Kownator Cardiologue."— Transcription de la présentation:

1 Effect of rosuvastatin on progression of carotid intima media thickness in low risk individuals: Results of the METEOR trial Dr Serge Kownator Cardiologue Thionville, France Investigateur français de létude METEOR Diapositives extraites de la présentation de JR CRUISE - ACC 2007.

2 Rationale Carotid intima media thickness (CIMT) is a reliable marker of atherosclerotic burden, relates to cardiovascular risk factors, and predicts future cardiovascular events Greater LDL-C reductions with more intensive statin therapy may result in greater effects on atherosclerosis Further studies are needed to confirm the effects of efficacious statins in low risk individuals with subclinical disease

3 Primary objective – to assess whether rosuvastatin therapy over two years could slow progression of CIMT compared to placebo and/or induce regression of CIMT, in all sites of the carotid artery in subjects with a low risk of CHD (Framingham Risk Score < 10%) and evidence of subclinical atherosclerosis Secondary objectives – to assess whether rosuvastatin therapy could slow progression of CIMT compared to placebo and/or induce regression of CIMT, in the common carotid artery, in the carotid bulb, and in the internal carotid artery Crouse JR III, et al. JAMA (12): METEOR - objectives

4 Sites de mesure METEOR

5 Rosuvastatin 40 mg Placebo METEOR – study design Double blind, placebo controlled, multicenter trial Randomization Months CIMT Lipids 6-week run-in/ eligibility

6 Study population Major inclusion criteria Men aged years; women aged years LDL-C 120 to < 190 mg/dL (3.1 to < 4.9 mmol/L) with no coronary heart disease (CHD) risk factor other than age LDL-C 120 to 1 risk factor and a 10-year CHD risk of < 10% Triglycerides < 500 mg/dL (< 5.7 mmol/L) Maximum CIMT of at least 1.2 mm at any site and less than 3.5 mm in all sites

7 Study population Major exclusion criteria High risk patients –Clinical evidence of atherosclerosis –Diabetes mellitus 10 year Framingham risk of CHD > 10% Lipid lowering therapy in the previous 12 months Active liver disease or hepatic dysfunction Creatine kinase > 3 x ULN at baseline

8 METEOR - patient flow 5751 subjects screened for lipids, CV risk and CIMT; 984 randomized Rosuvastatin 40 mg n = 702 Placebo n = 282 ITT n = 624 Completed two year follow-up n = 530 ITT n = 252 Completed two year follow up n = 208 No follow up CIMT Discontinued later N = 78N = 30 N = 94 N = 44 Crouse JR III, et al. JAMA (12):

9 METEOR – baseline characteristics Rosuvastatin (n = 702) Placebo (n = 282) Male gender, n (%)421 (60)167 (59) Mean age (SD), years57 (6.2)57 (6.0) Mean BMI (SD), kg/m (4.0)27.5 (4.0) 2+ CHD risk factors, n (%)223 (32)111 (39) Smokers, n (%)22 (3)16 (6) Hypertension, n (%)138 (20)58 (21) HDL-C < 40 mg/dL, n (%)64 (9)36 (13) MeanMax CIMT all 12 sites (SD), mm 1.15 (0.19)1.17 (0.20) LDL-C mg/dL, mean (SD)155 (24.1)154 (24.2) SD = standard deviation; BMI = body mass index; CHD = coronary heart disease; MeanMax = mean of the maximum; CIMT = carotid intima-media thickness; LDL-C = low-density lipoprotein cholesterol.

10 METEOR - percentage change in LDL-C, HDL-C, TG, TC and non-HDL-C *P < vs placebo. Time-weighted least squares mean change. Rosuvastatin 40 mg n = 624 Placebo n = LDL-CHDL-CTGTCNon-HDL-C Mean change from baseline (%) * * * * * Crouse JR III, et al. JAMA (12):

11 METEOR primary end point: Time (years) Change in IMT of 12 carotid sites (mm) Progression Regression P = NS (rosuvastatin vs zero slope) Placebo mm/yr (n = 252) Rosuvastatin 40 mg mm/yr (n = 624) P < (rosuvastatin vs placebo) Placebo; Change in CIMT (95% CI) Rosuvastatin 40 mg; Change in CIMT (95% CI) Rate of change of maximum IMT at 12 carotid sites Rosuvastatin vs placebo Crouse JR III, et al. JAMA (12):

12 Rosuvastatin 40mg n = 624Placebo n = 252 Primary Max CIMT (for all 12 sites) Secondary; Max CIMT for: CCA sites Carotid bulb sites ICA sites Mean common carotid Change in CIMT, mm/y (95% CI) * ( to ) ( to ) * ( to ) ( to ) * ( to ) End point ( to ) ** ( to ) ( to ) * ( to ) ( to ) Effect of rosuvastatin on carotid IMT CIMT = carotid intima media thickness; CCA = common carotid artery; ICA = internal carotid artery. *P < RSV vs placebo; **P = 0.02 RSV vs placebo. Crouse JR III, et al. JAMA (12):

13 METEOR – safety % subjects with adverse events Rosuvastatin (n = 700) Placebo (n = 281) Myalgia CK > 10 X ULN Rhabdomyolysis00 ALT > 3 X ULN Hepatitis00 Proteinuria shift * Renal failure00 Cardiac SAEs0.90 Neoplasms Deaths1/7020/282 *Shift in dipstick urine protein from none/trace at baseline to 2+ post baseline. Creutzfeldt-Jakob disease, not related to study treatment. Exercise-associated.

14 Conclusion Dans une population à bas risque mais ayant des lésions artérielles infra-cliniques on observe une stabilisation de la maladie artérielle sous rosuvastatine par rapport au placebo

15 Remarques 1.METEOR nest pas une étude orientée vers la pratique, elle teste un concept –Il ny a pas dindication à lheure actuelle a un traitement par Rosuvastatine 40 mg chez ce type de patient –On ne peut pas monitorer en pratique leffet du traitement sur la paroi artérielle 2.Certaines études ont montré une régression des lésions infracliniques au niveau carotidien –Le niveau de risque des patients et la méthodologie de lexamen nétaient pas comparables

16 Sites de mesure ARBITER ASAP LIPID CAIUS KAPS REGRESS PLAC II ACAPS MARS PLAC II KAPS METEOR

17 Remarques 3.Des études orientées cette fois vers les évènements cliniques sont nécessaires pour confirmer les résultats observés


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