Rationale, design and methods of the CASHMERE study.
Carotid intima-media thickness (IMT) measurement is a noninvasive method used for quantification of early stage of atherosclerosis. Data suggest that the combination of statin and hormone replacement therapy (HRT) might be useful in reducing the early progression of atherosclerosis in postmenopausal women. The main aim of the study is to compare the effects of 12-month therapy with atorvastatin (80 mg/day), HRT (oral 17beta-estradiol 1 or 2 mg/day, plus cyclic dydrogesterone 10 mg) alone and their combination vs. placebo on the progression of carotid IMT by using a high-definition echotracking device. The secondary objectives are to assess the effects of the treatments vs. placebo on arterial stiffness, lipid profile and C-reactive protein. The CASHMERE trial is an European randomized study with a 2 x 2-factorial design, double blinded for atorvastatin and prospective randomized, open blinded endpoint evaluation (PROBE) method applied to HRT. The investigators can adjust the dose of estradiol at any time during follow-up if necessary. A total of 800 postmenopausal women with mild hypercholesterolemia and with no previous history of cardiovascular disease will be included and followed up by their physicians [general practitioners (GPs) or gynecologists] for 1 year. The CASHMERE trial is the first randomized clinical trial to examine the effects of a statin alone or combined with HRT on the structure and the function of carotid artery as early markers of atherosclerosis in postmenopausal women with mild hypercholesterolemia. The results are expected for 2007.
Simon
Tabassome
T
Department of Pharmacology, Paris VI University, Saint Antoine University Hospital AP-HP, Paris, France. tabassome.simon@chusa.jussieu.fr
Boutouyrie
Pierre
P
Gompel
Anne
A
Christin-Maitre
Sophie
S
Laurent
Stéphane
S
Thuillez
Christian
C
Zannad
Faiez
F
Bernaud
Corine
C
Jaillon
Patrice
P
D000368:Aged; D000069059:Atorvastatin; D001794:Blood Pressure / Q000187:drug effects / Q000502:physiology; D002318:Cardiovascular Diseases / Q000000981:diagnostic imaging / Q000453:epidemiology / Q000517:prevention & control*; D002339:Carotid Arteries / Q000000981:diagnostic imaging / Q000473:pathology; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004452:Echocardiography; D023381:Endpoint Determination; D015914:Estrogen Replacement Therapy; D005260:Female; D005263:Femoral Artery / Q000187:drug effects / Q000502:physiology; D006538:Heptanoic Acids / Q000627:therapeutic use; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000627:therapeutic use*; D006937:Hypercholesterolemia / Q000150:complications / Q000188:drug therapy; D008875:Middle Aged; D011446:Prospective Studies; D011758:Pyrroles / Q000627:therapeutic use; D012107:Research Design; D016896:Treatment Outcome
D006538:Heptanoic Acids; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011758:Pyrroles; D000069059:Atorvastatin