Rationale, design and methods of the CASHMERE study

Area of Science:

• Cardiovascular Medicine
• Endocrinology
• Pharmacology

Background:

• Carotid intima-media thickness (IMT) quantifies early atherosclerosis.
• Postmenopausal women are at increased risk for cardiovascular disease.
• Statin and hormone replacement therapy (HRT) may impact atherosclerosis progression.

Purpose of the Study:

• To compare the effects of atorvastatin, HRT, and their combination versus placebo on carotid IMT progression over 12 months.
• To assess secondary outcomes including arterial stiffness, lipid profile, and C-reactive protein.
• To evaluate early markers of atherosclerosis in postmenopausal women with mild hypercholesterolemia.

Main Methods:

• The CASHMERE trial is a European randomized study with a 2x2 factorial design.
• 800 postmenopausal women with mild hypercholesterolemia were included.
• High-definition echotracking assessed carotid IMT; PROBE method for HRT.

Main Results:

• Results are expected for 2007.
• The study compared atorvastatin (80 mg/day) and HRT (estradiol/dydrogesterone) alone and in combination against placebo.
• Secondary objectives included assessing arterial stiffness, lipid profile, and C-reactive protein.

Conclusions:

• The CASHMERE trial is the first randomized clinical trial to examine statin and HRT effects on carotid artery structure and function.
• This research focuses on early atherosclerosis markers in postmenopausal women.
• Findings will elucidate the role of combination therapy in managing cardiovascular risk.