The JUPITER trial will determine whether long-term treatment with Crestor decreases the rate of major cardiovascular events in patients with average LDL cholesterol and elevated C-reactive protein levels. AstraZeneca will have to show significant advantages to effectively differentiate Crestor from other statins that are already backed by comprehensive long-term safety and efficacy data.
AstraZeneca has announced the initiation of JUPITER (Justification for the Use of statins in Primary prevention: an Intervention Trial Evaluating Rosuvastatin), a 15,000-patient phase III trial.
The study will assess the long-term effects of Crestor (rosuvastatin) versus placebo in reducing the rate of major cardiovascular events in patients with average LDL cholesterol (<130mg/dL) and elevated levels of C-reactive protein (>/=2.0mg/dL).
Clinical trials have shown that there is an important correlation between C-reactive protein levels and the risk of developing future coronary events. This evidence has led to C-reactive protein being increasingly used as an effective indicator of cardiovascular risk. In January 2003, a joint panel from the American Heart Association and the Centre for Disease Prevention and Control announced the publication of recommendations for the use of C-reactive protein testing in practice.
Furthermore, this marker can be used to identify patients with normal LDL cholesterol levels that are at high risk of coronary events, in order to target primary prevention measures. In this way, C-reactive protein may help physicians to identify the patients that do not have any of the established cardiovascular risk factors but would benefit from pharmacological intervention.
The initiation of the JUPITER trial represents an attempt by AstraZeneca to differentiate Crestor from the already well-established statins. However, although this is the first trial to assess the benefits of statin therapy in lowering C-reactive protein in patients with normal LDL cholesterol levels, many of the first generation statins, such as simvastatin, pravastatin and lovastatin, have already gained support from long-term primary prevention trials.
Following the safety concerns and regularity delays that Crestor has faced in recent months, the results from this trial will have to be very convincing to enable AstraZeneca to position Crestor as the statin of choice in primary prevention, particularly considering results will not be available for some time.
Related Research: Datamonitor, "Market Dynamics: Anti-dyslipidemics - Third Generation Statins Superfluous to Market Requirements?" (DMHC1839)
You can download a FREE healthcare report from www.dmfreereports.com