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Sunday, 08/28/2016 3:49:05 AM

Sunday, August 28, 2016 3:49:05 AM

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Amarin Corporation (AMRN)
Case Study Highlights Potential Benefit of Switching from Lovaza to Vascepa

Key Takeaway
A case report was published recently describing the experience of a pt with persistent dyslipidemia and high CV risk switching from Lovaza to Vascepa. After >2 yrs on Vascepa, she showed improvement in lipid parameters, incl TG (-35%) and LDL-C (-69%), v. Lovaza. While the study was not a RCT, we believe it suggests that many pts on Lovaza/generic could stand to benefit if switched. We believe her continued improvement after >2 yrs bodes well for REDUCE-IT.

Recent Case Study of Patient with Persistent Dyslipidemia and High CV Risk Suggests Favorable Impact from Switching from Lovaza to Vascepa: Crandell published a case report in July describing his experience with switching a patient with persistent dyslipidemia and high cardiovascular (CV) risk from Lovaza to Vascepa (Crandell, J. R. Clin Med Insights Cardiol 2016, 10, 123-128). The patient was a 55-year-old, overweight female with a history of severe dyslipidemia and insulin resistance. This patient furthermore had a strong family of history of CV disease. Prior to initiation of Lovaza, the patient was on rosuvastatin 40 mg/day and ER niacin 1,500 mg/day, and had continued elevations of atherogenic lipids despite therapy, including: triglycerides (TGs) of 240 mg/dL and LDL-C of 161 mg/dL. It was decided that Lovaza at 4 g/day be added to her existing therapy, the only FDA-approved omega-3 fatty acid product at the time. Yet despite treatment with Lovaza for ~10 months, while her TGs fell to 182 mg/dL (-24%), her LDL-C remained persistently high at 168 mg/dL (+4%). Given her profile, it was decided that this patient be switched to Vascepa. After ~1 yr of Vascepa as add-on therapy, her TGs decreased to 130 mg/dL (-29% from Lovaza tx; -46% from baseline) and her LDL-C decreased to 80 mg/dL (-52% from Lovaza tx; -50% from baseline). After >2 yrs of Vascepa, her TGs decreased further to 119 mg/dL (-35% from Lovaza tx; -50% from baseline) and her LDL-C decreased to 52 mg/dL (-69% from Lovaza tx; -68% from baseline). The patient’s other lipid parameters trended favorably as well and full detail can be found in the publication.

Patient’s Experience Reminds Us that Lovaza and Vascepa are Not Interchangeable: The results of this case study are consistent with the experience of previous case studies of switching from Lovaza to Vascepa (Hassan, A. et al. Cardiol Ther 2015, 4, 83-93 (n=10); Kedia, A. W. et al. Postgrad Med 2015, 127, 869-73; Castaldo, R. S. Postgrad Med 2014,126, 268-273). This study’s results remind us that Lovaza and Vascepa, despite both being omega-3 fatty acid products, are not interchangeable. In this setting, an EPA alone formulation could have more favorable clinical effects on a mixed dyslipidemia patient with high CV risk than an EPA + DHA mixture, and this data suggests that many patients currently on Lovaza/Lovaza generic could stand to benefit if switched to Vascepa. We remind that this study was not a randomized controlled trial, therefore the results are not necessarily generalizable to the entire patient population.

Continued Improvement in Lipid Parameters After Long-Term Vascepa Treatment Bodes Well for REDUCE-IT: We view the long-term results of this patient’s Vascepa therapy (>2 yrs) as encouraging, because it suggests that Vascepa has benefits on lipid parameters that extend beyond what was achieved in the 12 wks in MARINE and ANCHOR. The study by Hassan et al. (n=10), for instance, only reported a treatment period of Vascepa for ~3.9-8.4 mo after Lovaza, and so this case report helps us understand Vascepa’s longer term effects. The median treatment time and follow-up in REDUCE-IT is ~4 years, therefore the 22% reduction in TGs and 6% reduction in LDL-C from Vascepa v. placebo in ANCHOR likely do not fully represent Vascepa’s potential clinical effect in REDUCE-IT.
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