CardioExchange Archive

October 16th, 2013

FDA Advisory Panel: No Expanded Indication for Vascepa Without Outcomes Trial

Larry Husten, PHD

An FDA advisory panel today failed to recommend an expanded indication for Vascepa, the purified EPA fish-oil product from Amarin. Vascepa is currently indicated only for the relatively small number of people with severe hypertriglyceridemia (>500 mg/dL). The proposed new indication would have greatly expanded the patient population eligible to receive Vascepa to the 20% of […]

---

September 11th, 2012

More Evidence That Omega-3 Supplements Don’t Work

Larry Husten, PHD

Once again researchers have failed to find any clinical benefit for omega-3 supplements. In a new meta-analysis and systematic review published in JAMA, Evangelos Rizos and colleagues analyzed 20 randomized controlled trials including  68,680 patients and found no significant effect on any of the endpoints: all-cause mortality: relative risk (RR) 0.96, CI 0.91 – 1.02 cardiac death: RR […]

---

July 27th, 2012

FDA Approves New Prescription Fish Oil Pill

Larry Husten, PHD

The FDA has approved a new prescription formulation of fish oils for treating very high triglyceride levels. The drug will be sold under the brand name Vascepa. According to Amarin, the manufacturer, it will be indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia (>500 mg/dL). Vascepa contains ultra-purified ethyl EPA, an […]

---

April 9th, 2012

Meta-Analysis: No Secondary CV Prevention Benefits for Omega-3 Fatty Acid Supplements

Larry Husten, PHD

A new meta-analysis published in the Archives of Internal Medicine finds no evidence to support claims of a beneficial effect of omega-3 fatty acid supplements on secondary CV prevention. Sang Mi Kwak and colleagues in the Korean Meta-analysis Study Group analyzed data from more than 20,000 patients with a history of CV disease who were randomized in […]

---

June 2nd, 2011

Small Study Suggests Possible Benefits of Fish-Oil Supplements for PCI Patients

Larry Husten, PHD

A small study from Poland raises the possibility that supplements containing omega-3 fatty acids may have beneficial effects when given to PCI patients already taking aspirin and clopidogrel. The investigator-initiated study randomized 54 PCI patients to either 1 g per day of n-3 PUFA daily or placebo for one month. The results have been published […]

---

November 15th, 2010

Omega-3s Fail to Show Benefits in Atrial Fibrillation

Larry Husten, PHD

In sharp contrast to earlier studies suggesting a positive effect, a large study of high-dose prescription omega-3 fatty acids found no evidence of benefit in treating atrial fibrillation. The trial, called the Efficacy and Safety of Prescription Omega-3 Acid Ethyl Esters (P-OM3) for the Prevention of Recurrent Symptomatic Atrial Fibrillation, included 663 patients with AF (542 […]

---