Amarin Corp Plc (AMRN)

[sstyles]

On the flip side, Dr. Connie Newman, another AdCom member, is a huge proponent of statins.

See: https://med.nyu.edu/faculty/connie-newman

Hard to discern how she will come out in terms of the scope of the label.

From her bio:
My main interests are statin safety and intolerance and the effects of statins on cardiovascular disease. I have designed, conducted, and analyzed efficacy and safety data from large cardiovascular outcomes trials of statins in various populations, including patients with diabetes, stroke or transient ischemic attack (TIA), cardiovascular disease, and chronic kidney disease.

My research has involved the following:

evaluating the effects of atorvastatin 10 mg on heart attacks and stroke in about 2,500 patients with diabetes, as part of the steering committee of the Collaborative Atorvastatin Diabetes Study (CARDS)
analyzing safety data from the Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine, or SEARCH, and the Study of Heart and Renal Protection, or SHARP
performing meta-analyses of safety data from trials of statins, including a meta-analysis of cancer events and deaths in 27 randomized controlled trials of various statins in about 170,000 patients and meta-analyses of safety data from early clinical trials of atorvastatin
serving as a member of the Cholesterol Treatment Trialists’ Collaboration
In addition, I was a member of the steering committee of the Biochemical Efficacy and Safety Trial of Vitamin D, or BEST-D. This randomized double-blind trial in people older than 65 years evaluated the effects of one year of vitamin D treatment at either 4,000 IU or 2,000 IU per day, compared with placebo. Outcomes measured included levels of vitamin D, parathyroid hormone, and calcium; other safety parameters; and selected cardiovascular endpoints such as arterial stiffness, blood pressure, and lipids.

I am currently chair of the task force for the Endocrine Society’s clinical practice guideline on lipid management in patients with endocrine disorders, including type 1 and type 2 diabetes.

Previously, I studied mammary gland growth and development and the role of novel pituitary factors in primate and rodent models. My earlier clinical research focused on new therapies for the treatment of pituitary tumors, including the effects of somatostatin analogues in patients with acromegaly. I have also investigated the effects of growth hormone replacement on cardiopulmonary function in growth-hormone–deficient adults.


See: https://www.ncbi.nlm.nih.gov/pubmed/26318980?otool=nynyumlib&myncbishare=nynyumlib
Statin tolerability: In defence of placebo-controlled trials.

Tobert JA1, Newman CB2.
Author information
1
Nuffield Department of Population Health, University of Oxford, UK [e-mail].
2
Department of Medicine, Division of Endocrinology and Metabolism, New York University School of Medicine, USA.
Abstract
BACKGROUND:
Statin intolerance is a barrier to effective lipid-lowering treatment. A significant number of patients stop prescribed statins, or can take only a reduced dose, because of adverse events attributed to the statin, and are then considered statin-intolerant.
METHODS:
Examination of differences between statin and placebo in withdrawal rates due to adverse events - a good measure of tolerability - in statin cardiovascular outcome trials in patients with advanced disease and complex medical histories, who may be more vulnerable to adverse effects. The arguments commonly used to dismiss safety and tolerability data in statin clinical trials are examined.
RESULTS:
Rates of withdrawal due to adverse events in trials in patients with advanced disease and complex medical histories are consistently similar in the statin and placebo groups. We find no support for arguments that statin cardiovascular outcome trials do not translate to clinical practice.
CONCLUSIONS:
Given the absence of any signal of intolerance in clinical trials, it appears that statin intolerance in the clinic is commonly due to the nocebo effect causing patients to attribute background symptoms to the statin. Consistent with this, over 90% of patients who have stopped treatment because of an adverse event can tolerate a statin if re-challenged. Consequently, new agents, including monoclonal antibodies to proprotein convertase subtilisin/kexin type 9, will be useful when added to statin therapy but should rarely be used as a statin substitute.