In The News: FDA Approve Wider Use of Fish Oil Drug

Advisory Panel Recommends FDA Approve Wider Use of Fish Oil Drug

A study published in the New England Journal of Medicine in early 2019 showed remarkable benefits in people taking higher-doses (4,000 mg/day) of a fish oil drug that consisted only of EPA.¹

There was a 25% reduction in a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina in those using this fish oil drug.

The study observed several other benefits including:¹

• Cardiovascular death reduced by 20%
• Fatal or nonfatal heart attacks reduced by 31%
• Fatal or nonfatal stroke reduced by 28%
• Urgent or emergent coronary revascularization reduced by 35%
• Hospitalization for unstable angina reduced by 32%

This fish oil drug (Vascepa^®) is marketed to doctors as fish oil that lowers triglycerides without raising LDL cholesterol.²

To the physician, this may sound appealing compared to a competitive fish oil drug called Lovaza^®, which contains EPA and DHA.

What is troubling, however, is that patients taking the EPA-only fish oil drug (Vascepa^®) are unlikely to take other fish oil supplements. This ignores the important role of the DHA component of the omega-3 family on life-sustaining processes, especially brain and eye health.

The estimated out-of-pocket cost, assuming no insurance coverage, is about $300 a month for this EPA-only fish oil drug.

This is 7-times higher than what a comparable amount of EPA+DHA can be obtained for from dietary supplements.

A panel of experts unanimously recommended in November 2019 that the FDA allow wider use of this fish-oil-based drug.³

Editor’s Note: The media provided favorable coverage to the FDA’s scientific advisory panel’s endorsement of this fish oil drug, but often omitted that these same omega-3 potencies are available as low cost supplements that don’t require a prescription.

References

1. N Engl J Med. 2019 Jan 3;380(1):11-22.
2. Available at: https://www.vascepa.com/. Accessed November 18, 2019.
3. Available at: https://www.fda.gov/media/132471/download. Accessed November 18, 2019.

Frailty in Older Adults Linked with Decreased Nutrient Levels

Lower blood levels of several nutrients are associated with a greater risk of frailty among older adults, reported an article in The Journal of the American Medical Directors Association.*

Participants included 4,068 people in The Irish Longitudinal Study on Ageing who were aged 50 or older. They underwent frailty assessments using three different instruments, and their blood samples were tested for folate, vitamin B12, vitamin D, lutein, and zeaxanthin.

“Frailty is characterized by multisystem loss of physiological reserve, systemic decompensation in response to stressors, and increased risk of adverse outcomes including falls, disability, and mortality,” the authors stated.

The instruments used to measure participants’ frailty were the Frailty Phenotype, the Frailty Index, and the FRAIL Scale (fatigue, resistance, ambulation, illnesses, and loss of weight).

“Models were adjusted for sociodemographic, lifestyle, health, and seasonal factors,” researchers explained.

Increases in frailty using all three methods of assessment were associated with lower levels of lutein, zeaxanthin and vitamin D. Pre-frailty was associated with lower levels of lutein and vitamin D.

Editor’s Note: “Our data suggest that low micronutrient status has potential as an easily modifiable marker and intervention target for frailty,” the authors concluded.

*J Am Med Dir Assoc. 2019 Aug 7.

Increased Omega-3 Linked to Decreased Asthma Symptoms

A study published in the International Journal of Environmental Research and Public Health found that higher levels of omega-3 fatty acids are associated with a lower risk of asthma symptoms.*

The participants were 642 employees of a fish processing factory, who had a higher-than-average intake of fish.

Of these individuals, 8% currently had asthma, 11% had asthma symptoms, and 26% experienced nonspecific bronchial hyperresponsiveness (a hallmark of asthma also associated with COPD).

Participants’ blood samples were analyzed for levels of omega-3 and omega-6 fatty acids.

“We found that certain types of omega-3 (from marine oils) were significantly associated with a decreased risk of having asthma or asthma-like symptoms by up to 62%.

High omega-6 consumption (from vegetable oils), on the other hand, was associated with an increased risk by up to 67%,” said coauthor Dr. Andreas Lopata.

This study corroborates previous data showing most people need to increase omega-3s and reduce dietary intake of omega-6 fats.

Editor’s Note: “Asthma incidence has nearly doubled in the past 30 years and about half of asthma patients do not get any benefit from the drugs available to treat it. So, there’s a growing interest in non-drug treatment options,” Dr. Lopata asserted.

*Int J Environ Res Public Health. 2018 Dec 25;16(1).

Antidepressant Drug Side Effect Relieved by Pycnogenol

Pycnogenol, a compound occurring in maritime pine bark, helps lower the incidence of sexual dysfunction occurring as a side effect of antidepressant therapy, according to a study reported in Physiology International.*

The investigation included 20 men and 47 women diagnosed with a depressive episode or recurrent depressive disorder who had responded to treatment with escitalopram (sold under brand name Lexapro^®), a selective serotonin reuptake inhibitor (SSRI) antidepressant.

Participants were randomized to receive either 50 mg of Pycnogenol daily, in combination with escitalopram, or escitalopram only, for four months.

At the first visit and during subsequent monthly examinations, the subjects were evaluated for depressive episode severity, sexual function, blood pressure and other factors.

During the study, depression significantly declined in both groups. After a month of treatment, those who received Pycnogenol experienced a significant improvement in sexual function scores, while in the group that received escitalopram only, scores remained unchanged.

Editor’s Note: The effects associated with Pycnogenol in this study are based on its ability to improve endothelial function via its antioxidant, vasodilatory, anticoagulant and anti-inflammatory actions, researchers said.

*Physiol Int. 2019 Mar 1;106(1):59-69.

Selenium Lowers Risk of Hospital ICU Mortality

Results of a meta-analysis reported in the journal Medicine found a lower risk of mortality among intensive care unit (ICU) patients who were given selenium, an antioxidant mineral.*

For the meta-analysis, researchers selected 19 randomized, controlled trials that included 3,341 critically ill patients. Intravenous selenium was given to 1,694 individuals, while 1,647 were in the control group. Except for four of the trials, daily doses of selenium varied during the duration of each trial. Treatment duration ranged from 4.1 days to more than 28 days.

Patients who received selenium had a 14% lower risk of dying during the trial, compared to those who received a placebo or no treatment.

When the nine trials that reported length of ICU stay were analyzed, no significant difference was observed between those people who received selenium and the control subjects. However, selenium supplementation was associated with a shorter total hospital stay.

Editor’s Note: The authors concluded that, “The current evidence suggests that the use of selenium could cause reduction in overall mortality and may shorten the hospital length-of-stay in critically ill patients.”

*Medicine (Baltimore). 2019 May; 98(20): e15473.