Maturitas 41 (2002) 51–60 Effect of postmenopausal hormone replacement on atherosclerosis in femoral arteries Peter Angerer *, Stefan Sto ¨ rk, Wolfgang Kothny, Clemens von Schacky Klinikum der Uniersita ¨t Mu ¨nchen, Institut und Poliklinik fu ¨r Arbeits - und Umweltmedizin, Medizinische Klinik -Innenstadt, Ziemssenstraße 1, 80336 Mu ¨nchen, Germany Received 26 January 2001; received in revised form 9 July 2001; accepted 16 July 2001 Abstract Objecties: On the basis of epidemiological and experimental data, it has been supposed that hormone replacement therapy (HRT) inhibits atherosclerosis in postmenopausal women. This randomized controlled trial examined whether 1 mg 17-estradiol daily, combined cyclically with 0.025 mg gestodene in every month (HRT 1), or in every third month (HRT 2) slows the increase of intima-media thickness in femoral arteries compared with no HRT. Methods: Healthy postmenopausal women (n =321) with an increased risk for future vascular disease as indicated by 1 mm of intima-media thickness in the carotid arteries were equally randomized to one of the three groups for 48 weeks. Ultrasound scans of femoral arteries were recorded at study start and study end, together with a thorough clinical examination and laboratory work-up. Results: Complete scans were obtained in 260 of the 264 subjects who participated until study end. Mean maximum intima-media thickness of four femoral artery segments (common and superficial, both sides) was 0.93 0.37 mm (mean S.D.) at study start. It increased by 0.02 0.05, 0.02 0.05, and 0.03 0.05 mm in the HRT 1, HRT 2 and no HRT groups, respectively (HRT 1 versus no HRT, HRT 2 versus no HRT; both P 0.2). Compared with no HRT, HRT significantly lowered follicle stimulating hormone, low-density lipoprotein cholesterol, and fibrinogen. Conclusions: In this 1-year trial, irrespective of the progestogen dose used, HRT with 1 mg 17-estradiol did not inhibit progression of femoral artery atheroslerosis in postmenopausal women with subclinical vascular disease. © 2002 Elsevier Science Ireland Ltd. All rights reserved. Keywords: 17-Estradiol; Hormone replacement therapy; Atherosclerosis; Femoral arteries; Intima-media thickness; Randomized controlled trial www.elsevier.com/locate/maturitas Abbreiations: ABI, ankle/brachial (systolic blood pressure) index; CAD, coronary artery disease; FSH, follicle stimulating hormone; HDL, high-density lipoprotein cholesterol; HRT, hormone replacement therapy; IMT, intima-media thickness; LDL, low-density lipoprotein cholesterol; PAD, peripheral arterial disease. * Corresponding author. Tel.: +49-89-5160-2440; Fax: +49-89-5160-4444. E-mail address: peter.angerer@arbeits.med.uni-muenchen.de (P. Angerer). 0378-5122/02/$ - see front matter © 2002 Elsevier Science Ireland Ltd. All rights reserved. PII:S0378-5122(01)00255-9