Amarin on Monday presented new findings from the REDUCE-IT cardiovascular outcomes trial at the American College of Cardiology (ACC) annual scientific session showing that Vascepa (icosapent ethyl) provided a significant 30-percent risk reduction in total cardiovascular events, compared to placebo, in the study's statin-treated patient population. "These data…extend the scope of consistent effects of Vascepa beyond a patient's first cardiovascular event to all subsequent cardiovascular events, including cardiovascular death," the company said.
The study involved 8179 adults who were already on stable statin therapy, but still had elevated triglyceride levels and either cardiovascular disease or diabetes with other cardiovascular risk factors. Patients were randomised to receive Vascepa twice daily or a placebo containing mineral oil, and were followed for a median 4.9 years.
Last November, Amarin unveiled detailed results confirming earlier top-line data that had shown Vascepa was associated with a significant 25-percent relative risk reduction in first occurrence of major adverse cardiovascular events (MACE) on a five-point primary composite endpoint. The findings also showed that the fish-oil-derived drug was linked to significant relative risk reductions in each component of the MACE composite, including cardiovascular death, heart attack, stroke, coronary revascularisation and hospitalisation for unstable angina. However, some questioned at the time whether the benefits of Vascepa might have been exaggerated, citing blood test changes that were seen in the placebo arm.
In the latest analysis, which was also published in the Journal of the American College of Cardiology, investigators evaluated patients' total cardiovascular events during the median follow-up of 4.9 years, including first and all subsequent occurrences of MACE. For patients taking Vascepa, first events were reduced by 25 percent, second events by 32 percent, third events by 31 percent and fourth or more events were cut by 48 percent. Amarin said the 30-percent risk reduction in total cardiovascular events translates to about 159 MACE prevented for every 1000 patients treated for five years with Vascepa, including the prevention of roughly 12 cardiovascular deaths, 42 heart attacks, 14 strokes, 76 coronary revascularisations and 16 episodes of hospitalisation for unstable angina.
The company also reported a 28-percent reduction of total events in the key secondary goal of three-point MACE in the intent-to-treat population, consisting of a composite of cardiovascular death, non-fatal heart attack and non-fatal stroke. There were no new safety-related results from REDUCE-IT reported with the updated analysis.
Amarin suggested that the latest findings "will position Vascepa well in pharmacoeconomic analyses planned to be conducted and reported in 2019." Meanwhile, lead study author Deepak Bhatt said "with this drug, we are not only preventing that first heart attack, but potentially the second stroke and maybe that third fatal event," adding that "prevention of such subsequent cardiovascular events could improve patient outcomes and quality of life and may lower the total cost burden of medical care."
Vascepa was approved by the FDA in 2012 to reduce triglyceride levels in adults with severe hypertriglyceridaemia, with Amarin later reaching an agreement with the regulator to allow it to promote the treatment for off-label uses. Analysts anticipate the product to generate sales of more than $350 million this year, climbing to $1 billion by 2023.
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