First Multi-National Outcomes Study To Examine The Effect Of Adding A Statin To Optimised Treatment For Patients With Advanced Heart Failure

Main Category: Cardiovascular / Cardiology
Also Included In: Stroke / Neuroprotection;  Statins
Article Date: 06 Nov 2007 - 1:00 PDT

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The first prospective outcomes study (CORONA*) that examined the effect of adding a statin to optimised treatment for patients with advanced heart failure has been presented at the American Heart Association 2007. Patients taking 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

CORONA also showed that significantly fewer hospitalisations occurred in patients on rosuvastatin 10mg compared to placebo, whether due to any cause (p=0.007), cardiovascular causes (p<0.001), or for worsening heart failure (p=0.01).

Dr Jay Wright, Consultant Cardiologist, Liverpool said "These results need to be considered in light of the impact of device implantation during the study period. The study population recruited was at a low risk of atherosclerotic events, nevertheless, we have seen a positive outcome in reduction of myocardial infarction and stroke, but the primary endpoint did not meet statistical significance. Statin treatment in heart failure patients is common, but we did not previously know whether adding a statin would impact mortality in patients with advanced heart failure. CORONA has demonstrated that you can reduce hospitalisations which could have a positive cost implication."

Dr George Kassianos, GP, Bracknell and Fellow of The European Society of Cardiology said "This study was conducted in a challenging heart failure population where the benefit of statins was previously unproven. CORONA has highlighted that there is a need for early intervention in the progression of atherosclerosis, preventing one of its worst consequences - heart failure. Furthermore, it is particularly encouraging that we can help to keep these patients out of hospital".

CORONA was a long-term, randomised, placebo-controlled study of 5,011 patients with chronic, symptomatic, systolic heart failure (NYHA II-IV) of ischaemic origin. The study was designed to evaluate the effects of adding rosuvastatin 10mg to optimised treatment (including multiple medications) on cardiovascular mortality and morbidity and overall survival in patients who were not indicated a statin.

Rosuvastatin 10mg 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.

Elisabeth Bjork, Global Medical Science Director for CRESTOR said "The CORONA study was a challenging study and demonstrates our commitment to advancing medical knowledge by investigating the effects of rosuvastatin in a particularly challenging patient population with unmet medical need."

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.

Reference

Kjekshus, J et al. COntrolled ROsuvastatin multiNAtional trial in heart failure (CORONA). A randomised, double-blind, placebo controlled study in patients with heart failure comparing CRESTOR 10mg with placebo on cardiovascular mortality and morbidity and overall survival. Presented at the American Heart Association (AHA) Annual Meeting 2007, Orlando, Florida, USA at 10:45 on Monday 5th November 2007

*CORONA (Controlled Rosuvastatin MultiNAtional Study in Heart Failure)

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.

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4 Good Index.

http://www.astrazeneca.com