Lescol Reduces Incidence Of Death, Myocardial Infarction In Angioplasty Patients
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Lescol Reduces Incidence Of Death, Myocardial Infarction In Angioplasty Patients

DORVAL, QC -- March 5, 1999 -- The January issue of the European Heart Journal reports that Novartis Pharmaceuticals Canada Inc.’s Lescol(R) (fluvastatin sodium) produced a reduction in the incidence of death and myocardial infarction (MI) in patients who underwent balloon angioplasty, a procedure in which plaque-clogged arteries are cleared.

The FLuvastatin Angiographic REstenosis (FLARE) study was designed to evaluate the ability of Lescol to reduce restenosis, which occurs when arteries previously cleared become re-blocked, after successful angioplasty. In common with other similar statin trials, treatment with Lescol did not affect the process of restenosis, and there was no difference in the incidence of the combined clinical endpoint (death, MI, coronary artery bypass graft surgery or need for additional revascularisation). However, there was a significantly lower combined incidence of death and MI in patients treated with Lescol 80 mg (40 mg, twice daily) 40 weeks following coronary balloon angioplasty.

"Patients who have undergone angioplasty are often at increased risk of additional coronary events. The FLARE study shows that fluvastatin therapy may have a role in improving the outcomes of patients who undergo these procedures," said Patrick Serruys, MD, Ph.D., chairman of the FLARE steering committee and professor of interventional cardiology at Erasmus University in Rotterdam, The Netherlands. "Based on these findings, there is a large-scale clinical study underway to confirm the ability of fluvastatin to reduce clinical events in post-angioplasty patients."

FLARE evaluated 1,054 patients at 33 centres in six countries. Patients were randomised to Lescol 80 mg (40 mg, twice daily) or placebo two weeks prior to scheduled balloon angioplasty and continued 26 more or less two weeks after successful angioplasty. Restenosis, as indicated by the loss of minimal luminal diameter, was measured using quantitative coronary angiography during follow-up at 26 more or less two weeks.

Treatment with Lescol resulted in a 37 percent LDL-C reduction at the angioplasty visit (two weeks) and 33 percent at week 26 which was maintained throughout the trial. There was no significant difference at baseline in demographic, angiographic or lipid parameters between the treatment and placebo groups. Patients in the study had a baseline LDL-C of less than 6 mmol/L (232 mg/dL).

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