AstraZeneca says it has decided to end a clinical trial of its blockbuster Crestor early because the cholesterol-lowering drug proved more beneficial than placebo in reducing cardiovascular morbidity and mortality.
The study, known as JUPITER, has been halted after a recommendation from an independent data monitoring board which believes, said AstraZeneca, that there is “unequivocal evidence of a reduction in cardiovascular morbidity and mortality” amongst patients who received Crestor (rosuvastatin) when compared to placebo.
The trial was designed to determine if treating patients with no evidence of pre-existing cardiovascular disease and low to normal LDL-C but elevated C-reactive protein (CRP) with Crestor once-daily would reduce major heart-risk events. The Anglo-Swedish drugmaker noted that CRP is a recognised marker of inflammation and is associated with an increased risk of atherosclerotic cardiovascular events.
Over 15,000 trial participants will now be scheduled by their investigator for final assessments at over 1,200 sites in 26 countries and the results of JUPITER will be published once an analysis is completed. The study forms part of AstraZeneca’s GALAXY programme, which has now recruited more than 64,000 patients to investigate the impact of Crestor on cardiovascular risk reduction.
News that the trial has been halted is a major boost for AstraZeneca as it further promotes the argument that Crestor can benefit healthy patients, as well as those with cardiovascular disease. Also the drug could benefit from the concerns that still surround Schering-Plough/Merck & Co’s Vytorin (ezetimibe and simvastatin; see today’s lead story) and recommendations from panellists at the American College of Cardiology meeting in Chicago who are saying that patients need to go back to statins.
Sales of Crestor have slipped slightly given that many doctors are now preferring to prescribe the generic version of Merck’s Zocor (simvastatin). It is also facing a number of patent challenges.
