The recent and widely reported death of actor James Gandolfini highlights the need to aggressively address the known risk factors for heart attack and sudden cardiac death.
“Omega-3 deficiency is one of these well-validated and easily-modifiable risk factors for heart disease,” Dr. George Jackowski, chairman and CSO of Pivotal Therapeutics (OTCQX:PVTTF; CNSX:PVO), says in an interview with BioTuesdays.com.
“With our Western diet, we do not achieve the omega-3 blood levels that are known to be protective and therefore, we should encourage the use of a prescription omega-3 capsule under medical supervision formulated for the correction of an omega-3 deficiency,” he adds.
“This fact is compounded by a misunderstanding on the part of consumers that over-the-counter (OTC) products deliver the same benefits as prescription omega-3. OTC products do not have the same high purity, formulation and concentration to provide the same biological effects as prescription only omega-3s,” Dr. Jackowski says.
“Most consumers are unaware that they would have to consume on average up to 12, one-gram capsules of OTC omega-3 to equal the daily dose of a prescription omega-3 product formulated for the correction of an omega-3 deficiency.”
Omega-3 fatty acids, also known as polyunsaturated fatty acids, are believed to be essential to health and development, even though they are not produced by the body. The most important omega-3 fatty acids in fish oil are eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which are abundant in species such as salmon, mackerel, halibut, sardines, tuna, and herring.
Most studies suggest that prescription fish oil can lower triglyceride levels in the body by more than 30%, but their beneficial effects might not stop there. New evidence suggests that EPA and DHA can lower blood pressure, increase HDL or “good cholesterol” and slow the progression of heart disease.
Heart disease is the number one cause of death in men and women in the U.S., claiming approximately one million lives annually. Even with the widespread use of statin drugs such as Lipitor and Crestor to control cholesterol, an estimated 80 million Americans have heart disease, which can include coronary artery disease, or atherosclerosis, and arrhythmia, or abnormally fast or slow heartbeat.
Pivotal’s lead product, VASCAZEN, is a FDA-regulated, ultra-pure, specially formulated medical food product for the clinical dietary management of omega-3 deficiency in patients with cardiovascular disease, including high triglycerides. Each capsule of VASCAZEN contains 680 mg of EPA and 110 mg of DHA. According to FDA regulations, VASCAZEN can be used only under a physician’s supervision and is available by prescription only in the U.S.
Dr. Jackowski says the recommended four capsules a day dose of VASCAZEN delivers the optimal amount of EPA and DHA. “Those levels cannot be reasonably achieved through a normal diet of fatty fish alone to elevate and sustain omega-3 in patients to levels associated with reduced risk for sudden cardiac death,” he contends.
Drug makers, including AstraZeneca, GlaxoSmithKline and Amarin, are betting the market for their prescription-only, fish-oil pills will follow the success of blockbuster selling statins such as Lipitor and Crestor. The aim is to tackle the conditions that can lead to heart disease by coupling triglyceride treatments with cholesterol-lowering pills.
Dr. Jackowski says there’s no reason in this day and age why anyone should die of an acute heart attack or arrhythmia prior to getting proper medical help. “Yet, 50% of people with normal cholesterol are still dying of sudden death. The only thing out there that can reduce sudden death is omega-3 in the right dose, purity and blend of EPA and DHA.”
In an open label study in 2011, Pivotal identified more than 80% of cardiovascular disease patients as omega-3 deficient.
He explains that 75 years ago, Prof. Hugh Sinclair of Oxford University suggested that coronary artery disease, or blockages in coronaries, was due to a deficiency of essential fatty acids, which have turned out to be omega-3 and is now referred to as EPA/DHA.
“So when cardiology was in its infancy, conventional wisdom was already linking the disease to a metabolic deficiency that can lead to high blood pressure; a change in the lipid profile in blood, with LDL “bad cholesterol” going up and HDL “good cholesterol” going down; and triglycerides increasing along with inflammation,” he adds.
Today, with the advances in modern medicine, he points out that the standard of care for cardiovascular disease has shifted from a focus on dietary deficiencies to treating the symptoms – lipids and hypertension – with prescription drugs.
On the dietary side, he says studies have linked a lower rate of mortality with the so-called “Mediterranean diet,” which recommends a low consumption of meat and meat products, a high consumption of fruits and vegetables, a moderate-to-high consumption of fish and a moderate consumption of dairy products.
“And the studies showing an impact of omega-3 on sudden death correlate with levels of omega-3 in blood,” he adds. “So patients with high levels of circulating omega-3 tend to have lower levels of cardiac mortality.”
Specifically, he points to a study in the Annals of Internal Medicine last April which found a 29% reduction in total mortality, especially coronary heart disease death, in older adults who had high levels of circulating omega-3 in the body. Researchers believe that coronary heart disease patients who have high levels of omega-3 in the body have so-called “stable plaque,” while those with no omega-3 have “vulnerable plaque,” which tends to break off from blood vessel walls and cause heart attacks.
“Even if we correct lipid-risk factors so that LDL is at normal levels, 50% of these people still have heart attacks and sudden death, so there’s more to it than just correcting lipids; it may be as simple as our Western diet,” he suggests. “And the group that is obese, diabetic and hypertensive are the ones at greater risk of arrhythmia and death.”
In April, Pivotal announced that in its REVEAL trial, VASCAZEN corrected omega-3 deficiency in patients with heart disease and also achieved statistical significance in various secondary endpoints in patients with elevated triglycerides of greater than 200mg/dL and less than 500mg/dL. The positive data were presented at the American Heart Association’s Arteriosclerosis, Thrombosis and Vascular Biology 2013 Scientific Sessions in May.
“VASCAZEN is an important treatment option for correcting omega-3 deficiency, thereby reducing cardiovascular disease risk factors, including high triglycerides, in patients who do not meet the current criteria for pharmaceutical treatment of high triglycerides,” Dr. Jackowski says.