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CUSTOMER FEEDBACK:

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b) G.D. reports "Pure One lowered my high triglycerides. I started at 304 mg/dL taking 4 per day. I dropped 10% in 3 months and 29% in 10 months on the tharapy. I was so happy I sent you my doctor's results." , Wisconsin 2009.

c) P.K., customer from New York says "I'm diabetic so can't take fish oil at high levels, I discovered you because Pure One is diabetic-friendly. I take the DHA Therapy for my dyslipidemia, plus now I have a lower triglyceride score, thank you!", Brooklyn 2008.

The complete contents of Heartwire, a professional news service of WebMD, can be found at www.theheart.org, a Web site for cardiovascular healthcare professionals.

Study Highlights

The GISSI-HF was a randomized, double-blind, placebo-controlled trial conducted at 326 cardiology and 31 internal medicine centers in Italy.
The goal of GISSI-HF was to assess whether omega-3 PUFA could improve morbidity and mortality in a large population of patients with symptomatic heart failure of any cause.
Enrollment criteria were chronic heart failure of New York Heart Association class II to IV, irrespective of cause and left ventricular ejection fraction.
A concealed, computerized telephone randomization system was used to randomly assign participants to receive omega-3 PUFA 1 g (n = 3494) or placebo (n = 3481) daily.
Median follow-up was 3.9 years (interquartile range 3.0 - 4.5).
Main outcome measures were time to death and time to death or to hospitalization for CV cause.
Analysis was by intent-to-treat.
Death from any cause occurred in 955 (27%) patients in the omega-3 PUFA group and 1014 (29%) in the placebo group (adjusted hazard ratio [HR], 0.91; 95.5% confidence interval [CI], 0.833 - 0.998; P = .041).
Death or admission to hospital for CV reasons occurred in 1981 (57%) patients in the omega-3 PUFA group and 2053 (59%) in the placebo group (adjusted HR, 0.92; 99% CI, 0.849 - 0.999; P = .009).
To avoid 1 death, 56 patients needed to be treated for a median duration of 3.9 years.
To avoid 1 death or admission to hospital for cardiovascular reasons, 44 patients needed to be treated for a median duration of 3.9 years.
Gastrointestinal symptoms were the most frequent adverse effect in both groups.
The investigators concluded that treatment with omega-3 PUFA was simple, safe, and provided a small benefit in terms of mortality and admission to hospital for CV reasons in patients with heart failure in usual care.
GISSI-HF data on chronic heart-failure patients treated with rosuvastatin 10 mg were also presented at the ESC.
After 3.9 years, there was no significant difference between rosuvastatin vs placebo in either time to death or time to death or admission to the hospital for CV reasons.
Secondary end points also did not differ significantly between rosuvastatin vs placebo groups.
These findings were consistent in all subgroups analyzed, including older patients, those with left ventricular ejection more than 40%, and those with and without diabetes.
Treatment with rosuvastatin was associated with a 27% decrease in LDL cholesterol at 3 years, from 123 mg/dL at baseline to 90 mg/dL.
Exploratory analysis showed no treatment effect based on achieved LDL-cholesterol reductions.

Pearls for Practice

Omega-3 PUFA supplementation was associated with reduction in death from any cause and in death or admission to hospital for CV reasons in a large population of patients with symptomatic heart failure of any cause.
After 3.9 years, there was no significant difference between rosuvastatin 10 mg vs placebo in either time to death or time to death or admission to the hospital for CV reasons in all subgroups analyzed, including older patients, those with left ventricular ejection more than 40%, and those with and without diabetes.

Summary: From European Society of Cardiology (ESC) 2008 Congress*Information and statements regarding this supplement have not been evaluated by the Food and Drug Administration and are not intended to diagnose, treat, cure, or prevent any disease.

From Heartwire — a professional news service of WebMD

September 3, 2008 — Omega-3 fatty-acid supplementation improves morbidity and mortality in symptomatic heart-failure patients, while statins failed to have any beneficial effect in the same group of patients, two new studies have shown [1,2]. The long-term administration of omega-3 fatty acids reduced all-cause mortality and admission to the hospital for cardiovascular (CV) reasons, while there was no effect on these end points with 10-mg rosuvastatin (Crestor, AstraZeneca).

The Gruppo Italiano per lo Studio della Sopravvivenza nell'Infarto Miocardico Heart Failure (GISSI-HF) trial — which includes two nested studies designed to test the two hypotheses — was presented at the European Society of Cardiology (ESC) 2008 Congress and published online in The Lancet.

Speaking to the 9% reduction in all-cause mortality with omega-3 fatty acids in The Lancet, the GISSI-HF investigators write: "Although this moderate benefit was smaller than was expected, we should note that it was obtained in a population already treated with recommended therapies, was consistent across all the predefined subgroups, and was further supported by the findings of the per-protocol analysis."

Chair of the GISSI-HF steering committee, Dr Luigi Tavazzi (Fondazione IRCCS Policlinico San Matteo, Pavia, Italy), who presented the omega-3 fatty-acid data to the media during an ESC press conference, said the treatment is an "effective, safe, simple, and cheap" option for patients with chronic heart failure. In an editorial accompanying the published studies [3], Dr Gregg Fonarow (University of California, Los Angeles) echoed the sentiment, writing that while "questions remain about the mechanism of action, optimum dosing, and formulation, supplementation with n-3 polyunsaturated fatty acids [PUFA] should join the short list of evidence-based life-prolonging therapies for heart failure."

GISSI-HF, polyunsaturated fatty acids, and statins

The GISSI-HF project is a large-scale, randomized, double-blind study designed to investigate the effects of omega-3 fatty acids and statin therapy on mortality and morbidity in patients with symptomatic heart failure. In the PUFA study, investigators enrolled patients with chronic heart failure — NYHA class 2 - 4 regardless of cause and left ventricular ejection fraction — and randomized them to treatment with n-3 PUFA 1 g daily or placebo. Patients were followed for nearly four years, with the co-primary end points being death and death or admission to the hospital for cardiovascular reasons.

After 3.9 years of follow-up, treatment with the omega-3 fatty acids reduced the risk of mortality by 9% and mortality and admission to the hospital for cardiovascular causes by 8%. The absolute reduction in risk was small, just 1.8%, but investigators report that 56 patients would need to be treated to avoid one death and 44 patients would need to be treated to avoid one death or admission for cardiovascular reasons. A per-protocol analysis that included only patients who remained on treatment for the study duration confirmed the overall findings, showing that treatment cut the absolute risk by 3.3% compared with placebo, or a 14% relative risk reduction.