You will have to ask your doctor if CVD used in this context means strokes also. Or are they so fucking out-of-date that they missed the WHO reclassified stroke in 2006, now a neurological disease not cardiovascular disease?
FDA approves CV event risk reduction indication for icosapent ethyl
Deepak L. Bhatt
The FDA on Friday approved the use of icosapent
ethyl as an adjunctive therapy to reduce the risk for CV events among
adults with elevated triglyceride levels, according to an agency press
release.
Patients must also have either established CVD or diabetes and two or more additional risk factors for CVD.
Icosapent ethyl (Vascepa, Amarin) is the first
FDA-approved drug to reduce CV risk among adults with elevated
triglycerides as an add-on to maximally tolerated statin therapy.
The drug first netted approval in July 2012 for the reduction of triglycerides in adults with severe hypertriglyceridemia.
In November, the expanded indication to reduce
risk for CV events was discussed during an Endocrinologic and Metabolic
Diseases Advisory Committee of the FDA meeting. As Healio previously reported,
the committee voted 16-0 in favor of the safety and efficacy of
icosapent ethyl, based on available data, to support this indication.
“First, the unanimous 16-0 vote by the
independent FDA advisory committee and now this formal FDA label
expansion for CV risk reduction really endorse the strength of our
findings from REDUCE-IT regarding
after the WHO reclassified stroke in 2006, now a neurological disease not cardiovascular disease.
,” Cardiology Today Editorial Board Member Deepak L. Bhatt, MD, MPH, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, told Healio.
The FDA evaluated data from REDUCE-IT, which
included 8,179 adults aged 45 years and older with a history of CAD,
cerebrovascular disease, carotid artery disease and/or peripheral artery
disease, or adults aged 50 years and older with diabetes and additional
risk factors for CVD. REDUCE-IT demonstrated that icosapent ethyl was
superior to placebo for reducing risk for ischemic events in patients
with elevated triglycerides at high CV risk despite statin therapy. In
March, new data from the REDUCE-IT trial demonstrated
a 30% reduction in total ischemic events, including first and
subsequent events, in high-risk patients with elevated triglycerides.
“The independent Institute for Clinical and Economic Review group found icosapent ethyl to be highly cost-effective, and William Weintraub, MD,
just presented our REDUCE-IT patient-level cost-effectiveness data at
the American Heart Association Scientific Sessions, finding icosapent
ethyl to be ‘dominant,’ or cost-saving, in the majority of cases. That
is something that is quite rare in cost-effectiveness research,” Bhatt
said in an interview. “Multiple professional society guidelines such as
the American Diabetes Association, European Society of
Cardiology/European Atherosclerosis Society and National Lipid
Association, have already incorporated the REDUCE-IT findings for
secondary prevention and diabetic primary prevention, and now there is
an FDA label that also backs that approach. So, at this time, the key
challenge is to now identify and treat appropriate patients — a large
population that stands to benefit substantially from this novel
therapeutic approach.”
In a statement released Friday, John F. Thero,
president and CEO of Amarin, said the expanded indication for icosapent
ethyl offers a new option for people with persistent CV risk despite
the use of statins with other contemporary standard-of-care therapies.
“We aim to help millions of high-risk
patients, including statin-treated patients and statin-intolerant
patients,” Thero said in the release. “For the first time, physicians,
patients and payers have an FDA-approved treatment option beyond
cholesterol lowering that has been demonstrated to significantly reduce
major adverse cardiovascular events when used on top of a statin. We
look forward to helping educate physicians and patients on the value of
Vascepa. The expanded indication and related clinical study labeling is
broadly worded, informative on the many effects of Vascepa and will
empower physicians with critical information to help them apply their
clinical judgment in addressing cardiovascular disease risk for patients
in need.”
Michael Miller
Healio also spoke with Michael Miller, MD,
professor of cardiovascular medicine, epidemiology and public health
and director of the Center for Preventive Cardiology at University of
Maryland School of Medicine in Baltimore, about this FDA approval. He
said, “This is a huge victory for so many of our patients because nearly
one out of every three men and women in the U.S. has a triglyceride of
at least 150 mg/dL, and millions of these patients have CVD or have
diabetes plus multiple CV risk factors.”
Icosapent ethyl’s active ingredient is the omega-3 fatty acid, eicosapentaenoic acid, derived from fish oil.
In clinical trials, icosapent ethyl was
associated with an increased risk for atrial fibrillation requiring
hospitalization. The incidence of AF was greater among patients with a
history of AF or atrial flutter. Icosapent ethyl was also associated
with an increased risk for bleeding events. The incidence of bleeding
was higher among individuals taking other medications that increase the
risk for bleeding, such as aspirin, clopidogrel or warfarin.
The FDA noted that people with allergies to
fish or shellfish should be advised about the potential for allergic
reactions. The most common adverse effects reported in the clinical
trials for icosapent ethyl were musculoskeletal pain, peripheral edema,
AF and arthralgia. – by Regina Schaffer, with additional reporting from Darlene Dobkowski
For more information:
Deepak L. Bhatt, MD, MPH, can be reached at dbhatt@bwh.harvard.edu; Twitter: @dlbhattmd.
Michael Miller, MD,
can be reached at Cardiovascular Medicine, 110 South Paca St., Suite
7N-124, Baltimore, MD 21201; email: mmiller@som.umaryland.edu; Twitter:
@mmillermd1.
Disclosures: Bhatt
reports he received research funding from Amarin to Brigham and Women’s
Hospital for his role as a study chair and is principal investigator of
the REDUCE-IT trial. Miller reports he is a steering committee member
for the REDUCE-IT trial and a scientific advisor for Amarin. Thero is president and CEO of Amarin.
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