AstraZeneca reports landmark statin results

AstraZeneca's Crestor (rosuvastatin) has reportedly reversed plaque build-up in the arteries of patients with evidence of coronary artery disease (CAD), marking the first time a statin has demonstrated regression of such plaque build-up, otherwise known as atherosclerosis, in a major clinical study, according to AZ.

The plaque is caused by the collection of cholesterol, inflammatory cells and fibrous tissue forms in artery walls. If it ruptures it can block blood flow to critical organs, such as the heart or the brain.

Patients on the ASTEROID (A Study To Evaluate the Effect of Rosuvastatin On Intravascular Ultrasound-Derived Coronary Atheroma Burden) study undertook treatment with Crestor for two years, receiving 40mg doses once-daily. An open label, single-arm, blinded endpoint study, it involved 507 patients who had all undergone coronary angiography as well as having shown evidence of CAD.

Plaque volume in the target coronary artery was measured using intravascular ultrasound (IVUS) imaging at the initial catheterisation and after two years of treatment. Data from the 349 patients with 'evaluable IVUS data' found a 0.79% (median) reduction in percent atheroma volume in the entire target vessel; a 9.1% (median) reduction in total atheroma volume in the most diseased 10mm segment of the target vessel, and a 6.8% (median) reduction in total atheroma volume in the entire target vessel.

Overall these changes were associated with a 53% reduction in low-density lipoprotein cholesterol (LDL-C) and a 15% increase in high-density lipoprotein cholesterol (HDL-C).

'The data from this study - demonstrating that Crestor regressed plaque in the arteries of four out of five patients - is an important new finding,' said Dr Howard Hutchinson, vice president of clinical research for AZ. 'We see this as underscoring the benefits of aggressively managing cholesterol levels, both LDL and HDL, to reduce the burden of atherosclerosis.'

The ASTEROID study is part of AZ's GALAXY programme, which is 'designed to address important unanswered questions in statin research and to investigate the impact of Crestor on cardiovascular risk reduction and patient outcomes'.

Crestor is currently indicated for the treatment of lipid disorders, but not for atherosclerosis. The trial results could thus push Crestor's future worldwide sales, which totalled $1.3bn in 2005.