New Data Examines The Effect Of Adding A Statin To Optimised Treatment For Patients With Advanced Heart Failure
New data from the CORONA study presented today at the American Heart Association 2007 Scientific Sessions in Orlando, US, showed that adding a statin to optimised heart failure treatment did not significantly improve the prognosis for patients with advanced heart failure because it could not reverse or prevent the deterioration of a failing heart.
Patients taking AstraZeneca’s CRESTOR™ (rosuvastatin) 10mg experienced an 8 percent reduction (p=0.12) in the combined primary endpoint of cardiovascular death or myocardial infarction or stroke, which was not statistically significant. This reduction was primarily driven by a decrease in atherosclerotic events, i.e. stroke and myocardial infarctions (post hoc analysis p=0.05) which is where statins have been proven to have benefit. In this study the majority of deaths were due to sudden death, or non-ischemic causes, which did not appear to be impacted by statin therapy. In addition, significantly fewer hospitalizations occurred in patients on CRESTOR compared to placebo, whether due to any cause (p=0.007), cardiovascular causes (p<0.001), or for worsening heart failure (p=0.01).
“The CORONA results represent a major advancement in medical research and understanding of patients with advanced heart failure, they clearly differ from patients without heart failure in their response to statin treatment†said lead investigator Prof. John Kjekshus, Department of Cardiology, Rikshospitalet University Hospital, Oslo, Norway. “We added a highly effective statin on top of an optimal treatment regimen. Our findings suggest the major cause of death in these patients was likely not to be related to atherosclerotic events, where benefit with statins in non-heart failure patients has been demonstrated, but instead may have been caused by the deterioration of failing heart muscle damaged beyond repair. CORONA underscores the need for early intervention in the progression of atherosclerosis to prevent one of its worst consequences, heart failure.â€
“The CORONA study was a novel and challenging study and demonstrates our commitment to advancing medical knowledge by investigating the effects of CRESTOR in challenging patient populations with unmet medical need. The CORONA study included patients with advanced heart failure on optimal treatment who were not candidates for statin therapy in the view of the investigators and which sought to answer the question of whether or not statins provide additional benefit or might even be harmful in this population. As a result of this study, AstraZeneca has provided new scientific information to help answer these important questions,†said Elisabeth Bjork, Global Medical Science Director for CRESTOR.
CORONA (COntrolled ROsuvastatin MultiNAtional Study in Heart Failure) was a long-term, randomised, placebo-controlled study of more than 5,000 patients with chronic, symptomatic, systolic heart failure (NYHA II-IV) of ischaemic origin. The study was designed to evaluate the effects of adding CRESTOR 10 mg to optimised treatment (including multiple medications) on cardiovascular mortality and morbidity and overall survival in patients whom investigators felt did not need lipid-lowering therapy.
CRESTOR 10 mg was well tolerated in over 2,500 patients during the study, with a safety profile similar to placebo. The frequency and type of adverse events were comparable in all treatment groups throughout the study. CORONA was conducted in 21 countries.
CORONA is a part of AstraZeneca’s extensive GALAXY clinical trials programme, designed to address important unanswered questions in statin research. Currently, more than 69,000 patients have been recruited from 55 countries worldwide to participate in the GALAXY Programme.
CRESTOR has now received regulatory approvals in over 90 countries. Over 11 million patients have been prescribed CRESTOR worldwide. Data from clinical trials and real world use shows that the safety profile for CRESTOR is in line with other marketed statins. CRESTOR worldwide sales for the nine months of 2007 reached $1,997 million