Health and Nutrition

June 30, 2010

Treating Depression With Omega-3: Encouraging Results from Largest Clinical Study

Filed under: Uncategorized — Doc Joe @ 3:28 pm

ScienceDaily (June 21, 2010) — The use of Omega-3 supplements is effective among patients with major depression who do not have anxiety disorders, according to a study directed by Dr. François Lespérance of the Centre de recherche du Centre hospitalier at the Université de Montréal (CRCHUM), head of CHUM’s Department of Psychiatry and a professor at the Université de Montréal.

The study was published June 15 in the online Journal of Clinical Psychiatry.

This was the largest study ever conducted assessing Omega-3’s efficacy in treating major depression. It was carried out in conjunction with researchers from centres affiliated with the UdM’s Réseau universitaire intégré de santé (RUIS), from McGill University, Université Laval in Quebec City and Queen’s University in Kingston, Ontario. The study was supported by the European firm isodisnatura, the Fondation du CHUM and the CRCHUM.

Initial analyses failed to clearly demonstrate the effectiveness of Omega-3 for all patients taking part in the study. Other analyses, however, revealed that Omega-3 improved depression symptoms in patients diagnosed with depression unaccompanied by an anxiety disorder. Efficacy for these patients was comparable to that generally observed with conventional antidepressant treatment.

From October 2005 to January 2009, 432 male and female participants with major unipolar depression were recruited to take part in this randomized, double-blind study (neither patients nor researchers knew which capsules patients received). For eight weeks, half of the participants took three capsules per day of OM3 Emotional Balance, a fish oil supplement containing high concentrations of eicosapentaenoic acid (EPA). The other half took three identical capsules of a placebo consisting of sunflower oil, flavoured with a small quantity of fish oil. In contrast with typical clinical studies designed to assess the effectiveness of antidepressants, this study included a high proportion of patients with complex and difficult-to-treat conditions, including patients resistant to conventional antidepressant treatments and patients also suffering from an anxiety disorder. The aim was to assess the value of Omega-3 supplementation in a group of individuals more like those treated in outpatient clinics.

Need to assess the impact of Omega-3 supplements

Some 11% of men and 16% of women in Canada will suffer from major depression at some point in their lives, making this disorder one of our society’s leading public health issues. Depression, which is now the world’s fourth leading cause of morbidity and death is expected to move up to the number two position by 2020. “Despite significant progress in neuroscience over the past two decades, depression is difficult to treat,” Dr. Lespérance noted. In view of the large number of patients who stop taking their medications in the first few months of treatment and those who refuse such treatment due to fear of stigmatization or side effects, it comes as no surprise that a large number of patients suffering from major depression use alternative treatments offered outside the healthcare system. “Many of these treatments have not been adequately evaluated. That is why it was important to assess the efficacy of Omega-3, one of the most popular alternative approaches,” he added.

Epidemiological and neurobiological studies have suggested that a relative deficit in polyunsaturated fatty acids of the Omega-3 group may predispose individuals to psychological disorders such as depression. Further, several preliminary clinical studies based on small numbers of patients have suggested that Omega-3 supplements with high concentrations of EPA can help to reduce symptoms of depression among patients who fail to respond to an initial antidepressant treatment. These studies have not, however, convinced the entire scientific community. A broader study was needed to acquire further knowledge about the properties and efficacy of high-quality Omega-3 supplements among patients suffering from major depression.

“We are proud that OM3 Emotional Balance, with its high concentration of EPA at unexcelled levels of purity delivers the dose of EPA needed for effective treatment,” said Claire Bertin, head pharmacist for isodisnatura, the laboratory producing the Omega-3 supplement used in the study.

It is important to note that the study assessed use of Omega-3 for eight weeks, at doses of 1050 mg of EPA and 150 mg of DHA each day. It is currently unknown whether taking higher doses or taking supplements over a longer period would yield different results.

These encouraging results show that use of EPA is effective among patients with unipolar depression unaccompanied by an anxiety disorder. Additional research directly comparing Omega-3 with conventional antidepressants could more clearly confirm their usefulness for patients suffering from depression.

Story Source:

The above story is reprinted (with editorial adaptations by ScienceDaily staff) from materials provided by Centre hospitalier de l’Université de Montréal, via EurekAlert!, a service of AAAS.

Journal Reference:

  1. François Lespérance, Nancy Frasure-Smith, Elise St-André, Gustavo Turecki, Paul Lespérance, Stephen R. Wisniewski. The Efficacy of Omega-3 Supplementation for Major Depression: A Randomized Controlled Trial. Journal of Clinical Psychiatry, 2010; DOI: 10.4088/JCP.10m05966blu

Avandia heart risks reported ahead of FDA hearing

Filed under: Uncategorized — Doc Joe @ 3:44 am

By Lindsey Tanner, AP Medical Writer

CHICAGO — A new study led by a federal drug safety expert ties the controversial diabetes drug Avandia
to a higher risk of heart problems, strokes and deaths in older adults, and says it is more  dangerous than a rival drug, Actos.

The study, a huge review of Medicare records, comes two weeks ahead of a Food and Drug  Administration hearing on Avandia’s safety. The lead
author, David Graham, is an FDA scientist who wants the pill banned.

As many as 100,000 heart attacks, strokes, deaths and cases of heart failure may be due to Avandia
since it came on the market in 1999, Graham said in an interview with The Associated Press.

Harms from Avandia are great enough to “put you in a hospital or in a cemetery,” he said.

Editors at the Journal of the American Medical Association rushed to release the study online on
Monday, so the information would be available before the July 13-14 hearing, a spokeswoman said.

Avandia is a once-blockbuster drug for Type 2 diabetes, the most common form of the disease and
the kind often tied to obesity. Avandia and Actos are pills that help the body make better use of insulin, a
key digestive hormone.

The American Heart Association issued a statement reminding patients not to stop taking any medicine
without talking with their doctors first. The new study is not definitive enough to prove harm but
“deserves serious consideration” and should be discussed between patients and their doctors, the
statement says.

Avandia has been under a cloud since May 2007, when a review of dozens of studies suggested it may
raise the risk of heart attacks and heart-related deaths. Warnings were added to its label, and the
American Diabetes Association told patients to avoid using it until safety questions were resolved.

The FDA and Congress have held meetings on the drug but it has remained on the market, still used by
hundreds of thousands of Americans.

Avandia’s maker, the British company  GlaxoSmithKline PLC, maintains that its drug is safe.
A spokeswoman said the new study has limitations, and that the company looks forward to a full
discussion of evidence at the FDA hearing.

The study involved 227,571 Medicare patients, average age 74, who started on Actos or Avandia
from July 2006 through June 2009 and were followed for three years on average.

Avandia patients were 27% more likely to suffer strokes, 25% more likely to develop heart failure and
14% more likely to die than those on Actos, researchers found.

There were 2,593 heart attacks, heart failure cases, strokes and deaths among the 67,593 Avandia
users, and 5,386 of those problems among the 159,978 people taking Actos. Just dividing these
numbers to compare side effect rates can’t be done, though, because people were on the drugs for
differing lengths of time.

Unlike studies in younger patients that implicated Avandia, heart attack risks were similar in both
groups in the Medicare study. Sudden cardiac deaths are much more common in older adults, and
whether Avandia affects heart risks differently in older versus younger patients is unknown, the
researchers note.

The findings suggest that if 60 people were treated with Avandia for one year, one extra case of heart
failure, stroke or death would occur that could have been avoided if they’d taken Actos instead, Graham

“The evidence is overwhelming,” he said. “There is not a single study where those two drugs are
compared where Avandia doesn’t look worse than Actos. How many studies do you have to do before
you come to your senses?”

The study was observational, with the researchers examining data on patients whose doctors had
prescribed Avandia or Actos. That’s less rigorous than studies that randomly assign patients to take
different drugs, and therefore cannot prove that the drug is riskier.

But Alvin Powers, a diabetes specialist at Vanderbilt University, called it “important information that’s
consistent with prior studies,” even if it is not definitive. He said he doesn’t prescribe Avandia
because of uncertainty over its safety.

Another AMA journal, Archives of Internal Medicine, on Monday released online an expanded analysis by
the same authors who did the original one in 2007; both suggest higher heart risks for Avandia.

At its hearing next month, the FDA plans to examine the latest safety data and air internal disagreement
among its scientists over what should be done.

At the FDA’s request, Glaxo began a big study last year comparing heart and stroke risks in patients on
Avandia or Actos, made by Japan’s Takeda Pharmaceuticals. It aims to enroll thousands of
patients, but an editorial in JAMA about the Medicare study says it would be unethical to let the study

The editorial, by David Juurlink of the University of Toronto, says it is hard to understand why patients
and doctors would choose Avandia when a safer alternative exists. He led a previous study of elderly
diabetics in Ontario that also found higher risks with Avandia versus Actos.

June 28, 2010

Vitamin D and Cardiovascular Prevention

Filed under: Uncategorized — Doc Joe @ 2:12 pm

M. Adnan Nadir 1 , Benjamin R. Szwejkowski 1 & Miles D. Witham 2
1Department of Clinical Pharmacology, Centre for Cardiovascular and Lung
Biology, Division of Medicine, University of Dundee, Ninewells Hospital,
Dundee, UK 2Department of Ageing and Health, Centre for Cardiovascular and
Lung Biology, Division of Medicine, University of Dundee, Ninewells
Hospital, Dundee, UK

Vitamin D has been known to medical science for almost a century. Yet, it is
only in the last 15 years that we have realized that the biological effects
of vitamin D extend far beyond the control of calcium metabolism. Recent observational evidence suggests strong links between low vitamin D levels and a range of cardiovascular conditions, including stroke, myocardial infarction, hypertension, and diabetes. Interventional studies are beginning
to explore whether vitamin D supplementation can modify vascular health and prevent cardiovascular disease. This article reviews the physiology and function of vitamin D, examines the current observational and intervention data in cardiovascular disease, and discusses future research and current practice recommendations.

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