Cor Vasa 2005, 46(7-8):269-275

Modulating progression of advanced atherosclerosis in the carotid bifurcation and the risk of vascular events by fluvastatin and fenofibrate-Results of the Neurological Ultrasound Study (NUS

David Školoudík^1,*, Michal Bar¹, Daniel Václavík², Ondřej Škoda³, Jaroslav Korsa⁴, Pavel Hradílek¹, Karla Šimíčková¹, Vladimír Kosek⁵, Věra Ploticová⁶, Kateřina Urbancová⁷

¹ Neurologická klinika, Fakultní nemocnice s poliklinikou, Ostrava-Poruba

² Neurologické oddělení, Vítkovická nemocnice blahoslavené Marie Antoníny, Ostrava

³ Neurologické oddělení, Nemocnice Pelhřimov, Pelhřimov

⁴ Neurologická klinika, Fakultní nemocnice Královské Vinohrady, Praha

⁵ Oddělení statistických analýz

⁶ Lipologická ambulance, Fakultní nemocnice s poliklinikou, Ostrava-Poruba

⁷ Lipologická ambulance, Vítkovická nemocnice blahoslavené Marie Antoníny, Ostrava, Česká republika

Multicentric studies have demonstrated statins and fibrates reduce the risk for cardiovascular events, with statins additionally slowing down progression of intima-media thickness (IMT) in the carotid arteries. However, statins and fibrates have not been shown to have an effect on atherosclerotic plaques bigger than 1.5 mm in carotids. The Neurological Ultrasound Study (NUS) is an open-label randomized, multicenteric study currently in progress in four centers of neurosonography in the Czech Republic.


Aim of study:
The study was designed to determine whether or not there is a difference in the rate of progression of advanced atherosclerosis in the carotid bifurcation during therapy with fluvastatin or fenofibrate. A total of 376 patients with neurological symptoms, an atherosclerotic plaque (IMTmax.) in the carotid bifurcation over 2.0 mm (mean, 3.05 mm) and total cholesterol levels over 5.0 mmol/L (mean, 6.54 mmol/L) were randomized into two study arms (fluvastatin 40 mg and fenofibrate 200 mg). Patients were on ultrasound and clinical follow-up every three months for a period of two years.

Results:
IMTmax. progression in the carotid bifurcation was significantly lower in the fluvastatin group already at 15 months of therapy. Other independent risk factors for IMTmax. progression included older age and greater baseline IMTmax.. The number of cardiovascular events was non-significantly lower in the fenofibrate group, with 29 events in 24 patients in the fenofibrate group vs. 36 events in 31 patients in the fluvastatin group. The risk of a cardiovascular event was higher in patients after a transient ischemic attack or stroke and in those with higher baseline IMTmax..

Conclusion:
Fluvastatin is superior to fenofibrate in reducing progression of advanced atherosclerosis in the carotid bifurcation. With optimal treatment of hypertension, diabetes and other associated conditions, atherosclerosis plaque progression is primarily dependent on age and baseline IMTmax.

Keywords: Fluvastatin; Fenofibrate; Atherosclerosis; Carotid bifurcation

Published: July 1, 2005  Show citation