Lovaza no help for atrial fibrillation

Atrial fibrillation (AF) is common, yet there remains an unmet medical need for additional treatment options. Current pharmacological treatments have limited efficacy and significant adverse events.

To evaluate the safety and efficacy of prescription omega-3 fatty acids (prescription omega-3) for the prevention of recurrent symptomatic AF, a prospective, randomized, double-blind, placebo-controlled, parallel-group multicenter trial involving 663 US outpatient participants with confirmed symptomatic paroxysmal (n = 542) or persistent (n = 121) AF, with no substantial structural heart disease, and in normal sinus rhythm at baseline was performed.

Lovaza (a prescription omega-3) at 8 grams/day or placebo were given for the first 7 days; prescription omega-3 (4 g/d) or placebo thereafter through week 24. At 24 weeks, in the paroxysmal AF stratum, 129 of 269 participants (48%) in the placebo group and 135 of 258 participants (52%) in the prescription group had a recurrent symptomatic AF or flutter event. In the persistent AF stratum, 18 participants (33%) in the placebo group and 32 (50%) in the prescription group had documented symptomatic AF or flutter events. There was no difference between treatment groups for recurrence of symptomatic AF in the paroxysmal stratum. JAMA 11/12/2010

Among participants with paroxysmal AF, 24-week treatment with prescription omega-3 compared with placebo did not reduce recurrent AF over 6 months.

Bonnie - maybe they should have used another omega-3 supplement for this study. I have never been a supporter of Lovaza because it contains trans-fat, to which experts have agreed that there is no safe level. What's worse is that as recently as last year, partially hydrogenated vegetable oil was posted on Lovaza's label (go to page 12). Now, it is not listed (see page 7). We contacted GlaxoSmithKline, the manufacturer of Lovaza and pharmaceutical goliath. They could not tell us why partially hydrogenated vegetable oil was not on the label, because the formula had not changed.

I'll tell you why. If GSK wanted to change the formula, they would probably have to put in a new application for FDA approval. It is much easier to change words on a label.

Does this surprise you?