AstraZeneca has decided to stop the Rosuvastatin (Crestor) JUPITER clinical trial early based on a recommendation from an Independent Data Monitoring Board and the trial’s Steering Committee due to overwhelming efficacy.
Rosuvastatin was found to be more beneficial than placebo at reducing cardiovascular morbidity and mortality, the JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin) researchers said.
The JUPITER study began in 2003 and involved more than 15,000 patients, at least 50 years old, who had no history of MI, stroke or arterial revascularisation and LDL cholesterol levels below
120mg/dL, according to the London-based AstraZeneca. The participants were randomly assigned to receive either 20 mg rosuvastatin daily or placebo.
The study was halted because participants given a placebo had an increased risk of cardiovascular disease events and death, according to the investigators.
The JUPITER team has initiated activities to close this large multi-centre study. More than 15,000 trial participants will be scheduled by their investigator for final assessments at over 1,200 sites in 26 countries. Data from the visits will be collected and reviewed to allow complete analysis and final results of the study to be published once the analysis is complete.
AstraZeneca also noted that JUPITER is one study from a global research initiative known as the GALAXY program, which has now recruited more than 64,000 patients from 55 countries worldwide, to investigate the impact of Crestor on cardiovascular risk reduction and patient outcomes.