ASTRAZENECA PRESENTS NEW PHASE III CRESTOR DATA CONFIRMING EXCITING POTENTIAL

21-Mar-2001

AstraZeneca today presents Phase III clinical trial results of its superstatin, Crestor (rosuvastatin - previously known as ZD4522), at the American College of cardiology (ACC), in Orlando, Florida. The data show that:

CRESTOR 5 and 10mg both significantly reduce LDL-C more than atorvastatin 10mg, simvastatin 20mg or pravastatin 20mg

CRESTOR 5 and 10mg both bring more patients to their target cholesterol levels (NCEP guidelines) than atorvastatin 10mg, simvastatin 20mg or pravastatin 20mg

CRESTOR 5 and 10mg are both significantly more effective at increasing HDL-C than atorvastatin 10mg, and similar to simvastatin 20mg and pravastatin 20mg

CRESTOR 5 and 10mg both produce good reductions in triglycerides, as seen with atorvastatin 10mg, simvastatin 20mg and pravastatin 20mg

These newly announced phase III studies confirm the results of the phase II dose ranging programme in which CRESTOR demonstrated dose-dependent reductions in LDL-C of up to 65%

CRESTOR is well tolerated and has a safety profile comparable to placebo at 5mg and 10mg, and at doses up to 80mg CRESTOR has a safety profile comparable to atorvastatin. Superior Efficacy

Data from two of the trials involving over 1,000 patients, show a significantly better reduction in LDL-C (a major marker for the development of cardiovascular disease), with CRESTOR compared to three currently available statins. These data show that CRESTOR (10mg) lowered LDL-C by 49 percent whereas simvastatin (20mg) lowers LDL-C by 37 percent and pravastatin (20mg) by 28 percent. Against atorvastatin, CRESTOR (10mg) reduces LDL-C by 43 percent whereas atorvastatin (10mg) lowers LDL-C by 35 percent.

In addition to LDL-C lowering, these data show that CRESTOR 10mg increases HDL-C (sometimes referred to as ‘good’ cholesterol) more than atorvastatin (12 percent increase vs. 8 percent increase respectively) and to a similar extent compared to simvastatin and pravastatin.

"These data confirm our confidence in the future potential of Crestor as a new statin," said Dr Hamish Cameron, Vice President and Head of the AstraZeneca Cardiovasular Therapy Area.

Greater numbers of patients to guidelines

Current research suggests that a significant number of patients receiving therapy fail to achieve their LDL-C goal. However, the CRESTOR studies show there are significantly greater numbers of patients, in each individual risk category, achieving target LDL-C levels. In the comparative trial of CRESTOR 5mg or 10mg versus atorvastatin 10mg, almost 30 per cent more high-risk patients on CRESTOR reach their target LDL-C levels compared with atorvastatin. These data show that CRESTOR 10mg brings 47 percent of high risk patients to their target LDL-C level (as defined by the National Cholesterol Education Program Expert Panel), whereas atorvastatin 10mg brings only 19 percent of patients to their goal.

"These findings are crucial because the majority of patients are initiated and remain on a statin at the lowest available dose, which is why so many fail to reach their goal, so it is logical to give that patient the most effective statin available", stated Dr Michael Davidson, President of the Chicago Centre for Clinical Research, and Principal Investigator for the atorvastatin comparative study.

Similar findings were seen when CRESTOR 5mg or 10mg was compared with pravastatin 20mg or simvastatin 20mg. CRESTOR 10mg brings 67 percent of high risk patients to their target LDL-C level, whereas only 7 percent of patients receiving pravastatin 20mg and 19 percent of patients receiving simvastatin 20mg achieve their target LDL-C levels.

"Even when taken at either 5 or 10mg, rosuvastatin enables most patients to reach target LDL-C levels at a lower dose than the dose recommended in international guidelines. This will provide a tremendous additional weapon in the global fight against coronary heart disease," stated Philip Barter, Professor of Cardiology at the Royal Adelaide Ho

https://www.chemeurope.com/en/news/2114/astrazeneca-presents-new-phase-iii-crestor-data-confirming-exciting-potential.html