Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Showing posts with label icosapent ethyl. Show all posts
Showing posts with label icosapent ethyl. Show all posts

Friday, March 19, 2021

Icosapent ethyl cuts stroke events in high-risk patients

Hell this was already approved by the FDA, why more research?

FDA approves CV event risk reduction indication for icosapent ethyl January 2020

 The latest here:

Icosapent ethyl cuts stroke events in high-risk patients

The triglyceride-lowering drug icosapent ethyl reduced stroke incidence in high-risk patients taking statins, according to research presented at the American Stroke Association’s virtual International Stroke Conference.

Deepak L. Bhatt

“Compared with placebo, icosapent ethyl 4 g per day significantly reduced first and total strokes by 28% and 32%, respectively, and significantly reduced first and total ischemic strokes each by 36%, without increasing hemorrhagic stroke in statin-treated patients with elevated CV risk,” Cardiology Today Intervention Section Editor Deepak L. Bhatt, MD, MPH, executive director of interventional cardiology programs at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, said during a presentation.

Heart and Brain two 2019 Adobe
Source: Adobe Stock

In the REDUCE-IT trial, 8,179 patients, 70.7% with atherosclerotic CVD requiring secondary prevention and 29.3% with diabetes and at least one CV risk factor, were randomly assigned to icosapent ethyl (Vascepa, Amarin) 4 g per day or to a placebo, Bhatt said.

To qualify for the trial, patients had to have triglyceride levels of 135 mg/dL to 499 mg/dL and LDL levels of 40 mg/dL to 100 mg/dL.

Researchers found that at 5 years, first fatal or nonfatal stroke occurred in 2.4% of the icosapent ethyl group and 3.3% of the placebo group (HR = 0.72; 95% CI, 0.55-0.93; P = .01) with a relative risk reduction of 28%, an absolute risk reduction of 0.9% and a number needed to treat of 114.

According to researchers, for every 1,000 patients treated with icosapent ethyl for 5 years, nearly 14 fatal or nonfatal strokes were prevented (RR = 0.68; 95% CI, 0.52-0.91; P = .008).

First-event ischemic strokes occurred in 2% of the icosapent ethyl group and 3% of the placebo group, a 36% reduction (HR = 0.64; 95% CI, 0.49-0.85; P = .002), the researchers wrote in an abstract.

Hemorrhagic stroke occurred at low rates with no meaningful difference for icosapent ethyl vs. placebo (0.3% vs. 0.2%, respectively; P = .55), the researchers wrote in an abstract.
In his presentation, Bhatt noted that across multiple subgroups, there were generally consistent reductions in ischemic stroke.

“Pure eicosapentaenoic acid-based treatment with icosapent ethyl represents a novel approach to stroke reduction,” Bhatt said during the presentation.

 

Thursday, January 16, 2020

FDA approves CV event risk reduction indication for icosapent ethyl

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.

Tuesday, December 11, 2018

REDUCE-IT: Icosapent ethyl reduces ischemic events in high-risk patients

Maybe in a couple of decades our researchers will finally have stroke put into the neurological disease category instead of the cardiovascular category.  Until then you will need to monitor CVD research. The WHO reclassified stroke in 2006, now a neurological disease not cardiovascular disease. So only 12 years of incompetency. 

REDUCE-IT: Icosapent ethyl reduces ischemic events in high-risk patients


Deepak L. Bhatt
Deepak L. Bhatt
CHICAGO — In patients with elevated triglycerides at high CV risk despite statin therapy, icosapent ethyl was superior to placebo for reducing risk for ischemic events, according to results of the anticipated REDUCE-IT trial.
The trial of icosapent ethyl (Vascepa, Amarin Pharmaceuticals), a pharmaceutical-grade omega-3 fatty acid, enrolled 8,179 patients (median age, 64 years; 71% men) who had fasting triglycerides 135 mg/dL to 499 mg/dL despite taking statins and who had established CVD (70.7%) or diabetes plus other risk factors (29.3%). Patients were assigned icosapent ethyl 2 g twice daily or placebo and followed for a median of 4.9 years. All had LDL levels ranging from 41 mg/dL to 100 mg/dL.

Reduction in CV events
The primary endpoint of CV death, nonfatal MI, nonfatal stroke, coronary revascularization or unstable angina occurred less often in the icosapent ethyl group compared with the placebo group (17.2% vs. 22%; HR = 0.75; 95% CI, 0.68-0.83; P = .00000001; absolute difference, 4.8%; 95% CI, 3.1-6.5; number needed to treat to prevent one primary endpoint event = 21; 95% CI, 15-33), Cardiology Today’s Intervention Chief Medical Editor 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, reported at the American Heart Association Scientific Sessions.
Treatment with icosapent ethyl significantly reduced cardiovascular events, including a 20% reduction in cardiovascular death, a 31% reduction in heart attack, a 28% reduction in stroke and a low rate of adverse events,” Bhatt said during a presentation. “There was a consistent benefit across all subgroups, including in the primary and secondary prevention cohorts.”
The key secondary endpoint, defined as CV death, nonfatal MI or nonfatal stroke, was also lower in the icosapent ethyl group (11.2% vs. 14.8%; HR = 0.74; 95% CI, 0.65-0.83; P = .0000006; absolute difference, 3.6%; 95% CI, 2.1-5; number needed to treat to prevent one key secondary endpoint event = 28; 95% CI, 20-47).
The researchers also performed hierarchical testing of additional ischemic endpoints. In this analysis, the rates of the additional ischemic endpoints, including death from CV causes, were also lower in the icosapent ethyl group (4.3% vs. 5.2%; HR = 0.8; 95% CI, 0.66-0.98).
Carl E. Orringer
Carl E. Orringer
“The highly significant reductions in the primary and secondary cardiovascular endpoints in the presence of relatively modest effects of blood lipids and lipoproteins suggest the possibility that other properties of this drug such as the antithrombotic or anti-inflammatory effects” could have prompted the results, Carl E. Orringer, MD, FACC, FNLA, associate professor of medicine at University of Miami Miller School of Medicine, said during a discussant presentation at the press conference.

Friday, November 16, 2018

Fish-oil drugs protect heart health, two studies say

So this just proves that supplements likely don't contain the pure ingredients they list. As this earlier study found no use for Omega-3 supplementation. 

Marine n−3 fatty acids and prevention of cardiovascular disease and cancer

Supplements have no guarantee of purity. What do you expect when the fucking stupidity of the US Congress passes the Dietary Supplement Health and Education Act of 1994 (DSHEA): (DSHEA) defined dietary supplements as a category of food, which put them under different regulations than drugs.

 

Fish-oil drugs protect heart health, two studies say


Two major studies released Saturday provide evidence that medications derived from fish oil are effective in protecting people from fatal heart attacks, strokes and other forms of cardiovascular disease.
The large, multiyear research efforts tested different formulations and quantities of drugs made with Omega-3 fatty acids on two groups of people: one that suffered from cardiovascular disease or diabetes and another that represented the general population. Both studies found that people who took the drugs every day enjoyed protection against some heart and circulatory problems compared with those given a placebo.
In a look at another commonly consumed supplement, vitamin D, researchers found no effect on heart disease but saw a link to a decline in cancer deaths over time.
The research was released Saturday at the American Heart Association’s 2018 Scientific Sessions in Chicago and published in the New England Journal of Medicine.
About 43 million people in the United States take statins to lower LDL, or “bad,” cholesterol, and the drugs are credited with reducing the risk of heart attacks and strokes. But heart disease remains the leading killer of Americans. In recent years, a long, steady decrease in heart disease deaths has slowed. So researchers are seeking other ways to combat cardiovascular disease beyond known protective factors such as changes in diet, exercise and smoking habits.
One of the studies unveiled Saturday, named by the acronym REDUCE-IT, determined that people with cardiovascular disease who were already taking statins stood less chance of serious heart issues when they were also given two grams of the drug Vascepa (icosapent ethyl) twice a day.
The drug is a purified version of a fish-oil component that targets triglycerides, another type of fat in the blood. Elevated triglycerides can harden or thicken arteries, potentially leading to strokes and heart attacks. People who took the drug were compared with those who were given a placebo. The study involved more than 8,000 people.
The drug is made by Amarin Corp., which sponsored the research. In September, Amarin announced that the study had met its primary goals.
Deepak L. Bhatt, executive director of interventional cardiovascular programs at Brigham and Women’s Hospital in Boston, who led the study, said the results could change the practice of cardiology in the same way that the introduction of statins did more than 30 years ago.
“Honestly, I’ve been doing clinical trials for a long time. And I’ve not been involved in a trial that has this much potential to improve the lives of perhaps tens of millions of people,” Bhatt said.
In 2007, a large study in Japan determined that the same component of fish oil used in the REDUCE-IT study showed promise in protecting against cardiovascular problems. But that research did not compare the substance against a placebo, and was complicated by the large amount of fish in the typical Japanese diet.
The other fish-oil study released Saturday, called VITAL, looked at the effect of a different formulation of Omega-3 fatty acids in a drug called Lovaza. Researchers followed nearly 26,000 people for a median of more than five years. The results suggested that people given the drug were 28 percent less likely to suffer heart attacks than those given a placebo, and 8 percent less likely to have a variety of cardiovascular events. The effect was even more pronounced among African Americans, but the lead researcher said the results need further study before they can be relied upon.
People who ate fewer than 1.5 servings of fish weekly saw a drop in the number of heart attacks suffered when they increased their consumption of Omega-3s by taking the drug. The study did not find a decline in strokes.
JoAnne Manson, chief of the division of preventive medicine at Brigham and Women’s Hospital, who led the study, said it “further supports . . . the benefits of Omega-3 in heart health.”
Manson called the results “promising signals” about fish-oil consumption, but said they are not conclusive enough to compel people to begin taking the drug or fish-oil supplements. The study also showed that the medication is safe enough that people already taking fish oil have no reason to stop, she said in an interview.
People in the study were given 840 milligrams of the key fatty acids in fish oil each day, less than is found in a typical serving of salmon.
“We would encourage starting with more fish in the diet and having at least two servings a week,” Manson said. “One advantage of doing it through the diet . . . is that fish can replace red meat, saturated fat and processed food.”
Lovaza is manufactured by GSK, but is available in generic form. The study was sponsored by the National Institutes of Health.
The VITAL study also looked at vitamin D, which is often recommended to improve bone health in older women and for overall health in other people. It found that the vitamin had no effect on heart attacks or strokes and did not affect the incidence of cancer.
But vitamin D consumption may have some role in reducing the number of deaths from cancer two or more years later, the research showed. Manson suggested that vitamin D may help prevent cancers from metastasizing or becoming more invasive. But she said that idea needs more research.
She said people already taking modest amounts vitamin D, especially on the advice of doctors, have no reason to stop. But she warned against taking huge doses of the vitamin, such as 5,000 or 10,000 international units a day, unless a clinician recommends it, because the safety of that practice is not known.