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Fluvastatin Reduced Risk Of Serious Cardiac Events

Fluvastatin Reduced Risk Of Serious Cardiac Events In Patients Following First Angioplasty - JAMA Published First Prospective Study In This Patient Population -

ROTTERDAM, June 25 /PRNewswire-AsiaNet/ --

Results of the landmark Lescol Intervention Prevention Study (LIPS) published in today's edition of the Journal of the American Medical Association (JAMA) demonstrated that cholesterol-lowering medication fluvastatin 80mg reduced the risk of fatal and serious nonfatal cardiac events by 22 per cent in patients with average cholesterol levels after undergoing a first angioplasty.(1)

"LIPS identified a new treatment strategy for patients undergoing percutaneous coronary intervention (PCI) procedures, such as an angioplasty, to open blocked coronary arteries. The results clearly support the early use of lipid-lowering therapy fluvastatin in these patients, regardless of their cholesterol levels, to help prevent future cardiac events, including heart attacks and bypass surgery," said Patrick WJC Serruys, MD, PhD, Professor of Interventional Cardiology at Erasmus Medical Centre, University Hospital, Rotterdam, and LIPS Principal Investigator.

The study demonstrated that early treatment with fluvastatin post-PCI would be both cost effective and socially beneficial by preventing one fatal or non-fatal major adverse cardiac event in every 19 people treated for four years.1 The fact that the study population had a mean LDL cholesterol level of 132 mg/dL [3.4 mmol/L] within the upper end of the normal range suggests that the decision to begin statin therapy should be based on an overall risk assessment of a patient and not just baseline cholesterol levels.

There were 1.8 million PCI procedures worldwide in 2001, and the number is increasing by eight per cent annually. Approximately 90 per cent of patients who undergo these procedures receive immediate relief from the chest pain known as angina, but 66 per cent of them die or have a serious cardiac event, such as a heart attack, within the next 10 years. In the U.S., where each year more than one million patients undergo procedures such as angioplasty, as many as 40 per cent will have a heart attack or undergo a second procedure within five years following their first successful angioplasty.(2)

"The LIPS findings were clinically significant and showed how the outcomes of post-PCI patients can be markedly improved with fluvastatin therapy," Professor Serruys said. "LIPS is the only statin study in this high-risk patient population, and the data will have lasting implications on the treatment of the post-PCI patient population."

LIPS is the first prospectively designed, double-blind, placebo-controlled study to evaluate the effect of a statin, specifically fluvastatin, exclusively in patients who had undergone their first PCI. The four-year study followed 1677 patients recruited from 57 centres in 10 countries. Major adverse cardiac events were defined as cardiac death, nonfatal heart attack, coronary artery bypass grafting, or repeat PCI.(1)

In addition to the 22 per cent reduction in serious adverse cardiac events (p=0.013), the LIPS study demonstrated fluvastatin 80mg (40mg twice daily) provided a greater benefit in certain high-risk patients compared to placebo. Patients with diabetes (12 per cent of the total study population) experienced a 47 per cent reduction in the risk of experiencing a serious cardiac event, as compared to placebo (p=0.041). Additionally, patients with multi-vessel disease, meaning they had blockages in more than one artery (37 per cent of the total study population), experienced a 34 per cent reduction in their risk of a major cardiac event (p=0.011).(1) Interestingly, patients with unstable angina in the fluvastatin arm of the study experienced a greater risk reduction than patients with stable angina (28 per cent versus 20 per cent, respectively). Patients treated with or without stents during their first PCI experienced similar benefits from fluvastatin therapy.(1)

LIPS also yielded important long-term safety data in this high-risk patient population. In LIPS there were no significant elevations of creatine phosphokinase (CPK), a possible side effect of cholesterol-lowering statin therapies and an indication of muscle breakdown.(1) Professor Serruys noted "fluvastatin was used in this study because of its established safety profile and pleiotropic effects." The LIPS data support other research in this area suggesting that treatment with statins may have a positive impact on a number of other aspects of arterial plaque buildup, including the migration of cells and the function of endothelial tissue.(3)

LIPS was sponsored by Novartis Pharma AG, manufacturers of fluvastatin.

Erasmus MC is the new Rotterdam university medical centre in which the Faculty of Medicine and Health Sciences of the Erasmus University Rotterdam and the University Hospital Rotterdam, including Sophia Children's Hospital and Daniel den Hoed Cancer Centre have formalised their co-operation. Erasmus MC focuses on research into health and disease combining its internationally recognised expertise in the fields of Clinical sciences, Health sciences and Biomedical sciences. Research aims to contribute to medical knowledge and knowledge of health systems, to better health condition and training of students, MD's and others.

1 Patrick WJC Serruys, MD, PhD, et al. Fluvastatin for Prevention of Cardiac Events Following Successful First Percutaneous Coronary Intervention. JAMA. 2002; 287:3215-3222.
2 Ruygrok PN, de Jaegere PT, van Domburg RT, et al. Clinical outcome 10 years after attempted percutaneous transluminal coronary angioplasty in 856 patients. J Am Coll Cardiol 1996;27:1669-77.
3 Vaughan CJ, Gotto AM Jr, Basson CT. The evolving role of statins in the management of atherosclerosis [review]. J Am Coll Cardiol. 2000;35:1-10.


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