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Cholesterol Drug Halves Heart Attack and Stroke in Early Test
– Reported, September 01 2014
An experimental cholesterol-lowering drug from Sanofi and Regeneron Pharmaceuticals cut roughly in half the number of heart attacks and strokes in a clinical trial, researchers reported on Sunday.
The result is not conclusive, because the analysis was done retrospectively, but the study provides the first evidence that targeting a protein known as PCSK9 could reduce cardiovascular risks for millions of patients.
The drug, alirocumab, is from a new class of medicines, which are also being developed by Amgen and Pfizer. They lower LDL, the so-called bad cholesterol, in a new way and are expected to reap multibillion-dollar sales.
The finding is likely to spur enthusiasm about the drugs, which could reach the market next year, although specialists said it remained subject to confirmation in a much larger trial.
Sanofi and Regeneron said in July that nine studies had shown consistent LDL reductions with alirocumab, which is injectable. But details from four of those trials have only now been reported at the European Society of Cardiology’s annual meeting in Barcelona.
The encouraging cardiovascular findings came from an interim safety analysis of one of these studies showing patients on alirocumab were less prone to a combination of cardiovascular events, including cardiac death, heart attack, stroke and chest pain requiring hospitalization.
Both groups of patients received conventional anti-cholesterol statin pills in addition to alirocumab or a placebo. Among the alirocumab group, 1.4 percent of patients suffered a major cardiovascular event compared with 3.0 percent of those in the placebo group.
The 2,341-patient study, called Odyssey Long Term, is expected to conclude early next year, but researchers said the early sign of effectiveness was clearly positive.
‘To have this result emerge so quickly in this study is very encouraging,’ said Dr. Jennifer Robinson, a cardiologist at the University of Iowa, who led the study.
No other drug maker has previously released data suggesting reduced cardiovascular risk from PCSK9 inhibitors.
Dr. Patrick T. O’Gara of the Brigham and Women’s Hospital in Boston and president of the American College of Cardiology said that the finding was ‘biologically plausible,’ but that the retrospective nature of the analysis necessitated caution.
‘It’s so much wished-for that we must be careful,’ he said.