Advanced Mediterranean Diet

MedPageToday reported October 8, 2010, that Abbott is voluntarily removing Meridia from the U.S. market.  I had written on September 8 about the higher incidence of stroke and heart attack in Meridia users who had underlying cardiovascular disease.

Meridia, also known as sibutramine, has an estimated 100,000 users in the U.S.  Abbott recommends that they stop taking the drug and consult their physicians about other weight-loss programs.

Here are a some options I like:

1. Advanced Mediterranean Diet
2. Ketogenic Mediterranean Diet
3. Low-Carb Mediterranean Diet

This would be a good time for Meridia ex-users to review “Prepare to For Weight Loss.”

Steve Parker, M.D.

The weight-loss drug sibutramine (Meridia) should be withdrawn from the U.S. market, suggests an editorialist in the September 2, 2010, New England Journal of Medicine.  Based on a clinical study in the same issue, it’s more accurate to conclude that sibutramine shouldn’t be prescribed for people who aren’t supposed to be taking it in the first place.

Sibutramine is sold in the U.S. as Meridia and has been available since 1997.  Judging from the patients I run across, it’s not a very popular drug.  Why not?  It’s expensive and most people don’t lose much weight.

The recent multi-continent SCOUT trial enrolled 9,800 male and female study subjects at least 55 years old (average age 63) who had either:

1. History of cardiovascular disease (here defined as coronary artery disease, stroke, or peripheral artery disease)
2. Type 2 diabetes plus one or more of the following: high blood pressure, adverse cholesterol levels, current smoking, or diabetic kidney disease.
3. Or both of the above (which ended up being 60% of the study population)`.

Here’s a problem from the get-go.  For years, Meridia’s manufacturer and the U.S. Food and Drug Administration have told doctors they shouldn’t use the drug in patients with history of cardiovascular disease.  It’s not the scary “black box warning,” but it’s clearly in the package insert of full prescribing information.

Half the subjects were randomized to sibutramine 10 mg/day and the other half to placebo.  All were instructed in diet and exercise aiming for a 600 calorie per day energy deficit.  They should lose about a pound a week if they followed the program.  Average follow-up was 3.4 years.

What Did the Researchers Find?

Forty percent of both drug and placebo users dropped out of the study, a very high rate.

As measured at one year, the sibutramine-users averaged a weight loss of 9.5 pounds (4.3 kg), the majority of which was in the first 6 weeks.  After the first year, they tended to regain a little weight, but kept most of it off.

Death rates were the same for sibutramine and placebo.

Sibutramine users with a history of cardiovascular disease had a 16% increase in non-fatal heart attack and stroke compared to placebo.  To “cause” one heart attack or stroke in a person with known cardiovascular disease, you would have to treat 52 such patients.

Folks in the “diabetes plus risk factor(s)” group who took sibutramine had no increased risk of heart attack or stroke.

So What?

Average weight loss with sibutramine isn’t much.  Nothing new there.  [Your mileage may vary.]

People with cardiovascular disease shouldn’t take sibutramine.  Nothing new there.

An FDA advisory panel reviews sibutramine in mid-September.  Are they likely to recommend withdrawal of the drug from the marketplace?  No.  They’ll remind doctors not to use it in patients with cardiovascular disease, and perhaps phrase that as a “black box warning.”

Steve Parker, M.D.

Reference:  James, W. Philip, et al.  Effect of sibutramine on cardiovascular outcomes in overweight and obese subjects.  New England Journal of Medicine, 363 (2010): 905-917.

HealthDay TV has a short video about oleocanthol, a component of olive oil that may help prevent Alzheimer Disease.  Olive oil is the predominant form of fat in the traditional Mediterranean diet.  The Mediterranean diet is associated with lower rates of Alzheimer Disease and longer survival in Alzheimer patients.

 Steve Parker, M.D.

This healthy lifestyle blog based on the Mediterranean diet is reproduced by syndication at Amazon.com.  To view it, click here.

Many of my blog posts show up at Amazon.com followed by long lists of hyperlinks to websites selling drugs or other products or services.  These links are not in the original posts and, as far as I know, I am not responsible for them.

Note that I do not endorse any of the products, services, or companies promoted by these hyperlinks.  I recommend you not click on them.

You can subscribe to the uncontaminated original blog by RSS.

I am working with Amazon to eliminate the problem.

  Steve Parker, M.D.

Update Jan. 15, 2009:  Spam appeared at the Amazon.com syndication today, three days after my original posting.  Please ignore and don’t click any hyperlinks that appear after this line.

A few small scientific studies suggest that eating cinnamon will improve blood glucose and cholesterol levels.  One of the studies involved rats.  That’s all some people need to start using cinnamon as a medicinal.  I’ve seen it used to treat or prevent diabetes.

A recent meta-analysis published in Diabetes Care examined five randomized, controlled clinical trials testing the cinnamon theory.  “Randomized, controlled trials” are the gold standard in testing whether a drug or other treatment is effective.  Even better is if the trial is “double-blind,” meaning neither the study subjects NOR investigators know during the study if the subject is getting the drug versus a placebo.  “Randomized” means that all qualified study participants are randomly assigned either to placebo or the drug/treatment being tested.

W.L. Baker and colleagues found five well-designed studies in the literature involving 282 people who were given cinnamon - from one to six grams daily - for at least three months.

Their findings?

Cinnamon does not appear to improve [hemoglobin] A1c, fasting blood glucose, or cholesterol in patients with type 1 or 2 diabetes.

So enjoy cinnamon for the flavor but without expectations it will improve glucose or cholesterol levels.

Now, Drs. Roizen and Oz in their book, YOU - on a Diet, write that cinnamon helps with weight control in overweight people.  If you know of clinical studies that support that claim, please share with us.

Steve Parker, M.D.

Reference:  Baker, W.L., et al.  Effect of cinnamon on glucose control and lipid parameters.  Diabetes Care, 31 (2008): 41-43.

An article published today in the Los Angeles Times reported results of the JUPITER trial:  Daily use of a specific statin drug in apparently healthy people reduced by 50% the chances of heart attack and stroke over two years.  Furthermore, the odds of undergoing heart angioplasty or coronary artery bypass surgery were also reduced by 50%, and the odds of death by any cause were reduced by 20%.

The Jupiter trial enrolled men over 50 and women over 60 with normal cholesterol levels but elevated high-sensitivity C-reactive protein.  The study was terminated after two years of follow-up.  The study drug was rosuvastatin, manufactured by AstraZeneca and sold in the U.S. as Crestor at a cost of $3.45 per day (U.S.), according to the LA Times.

Do not assume that the drug’s beneficial effects demonstrated in JUPITER are a class effect applicable to all statin drugs such as Lipitor, Zocor, and Mevacor.  If they are, let those drug manufacturers spend the time and money to prove it.

Critics of the study say that widespread similar use of statins in healthy middle-aged and older individuals would cost $9 billion a year in the U.S.

Who can wrap their brain around $9 billion a year?  The recent U.S. Wall Street bail-out was $700 billion.  The U.S. government just gave insurance company AIG another $40 billion.  So $9 billion is chicken scratch, right?

Again according to the LA Times article, Dr. Mark Hlatky of Stanford University calculated the NNT - the number needed to treat - to prevent one heart attack, stroke or death over two years.  That number is 120.  In other words, to prevent one heart attack, stroke, or death over two years, 119 people have to take the drug daily for two years, with no benefit to them.  At the outset of this preventive “treatment,” a given individual has less than a one percent chance of benefiting from treatment over the next two years.

At $3.45 per day, the drug costs $2,518 for two years.  This doesn’t include the cost of physician visits and blood monitoring for toxicity.  At the end of two years, what do you do?  Your doctor is likely to recommend taking the drug indefinitely.

Does this sound like a good deal to you?  Will you be that lucky one out of 120 to benefit?  Can you think of better ways to spend your $2,518 over the next two years?

Would you consider other ways to prevent heart attack, stroke, and death, such as losing excess weight, quitting smoking, getting regular exercise, and switching to a traditional Mediterranean diet?

Popping a pill is easier, no doubt.

Let’s say you decided to spend your $2,518 on something other than Crestor.  But your health insurance will pay for it.  Would you take the pill then?

Remember, AstraZeneca isn’t going to give the drug away for free.  They’ve spent millions on development and testing.  Someone has to pay for it, whether it’s you, your health insurer, or your employer.  If the latter two pay, won’t that be reflected in higher insurance premiums or lower paychecks?

Steve Parker, M.D.

Additional resources:

Ridker, Paul, et al.  Rosuvastin to Prevent Vascular Events in Men and Women With Elevated C-Reactive Protein.  New England Journal of Medicine, online November 9, 2008.  DOI: 10.1056/NEJMoa0807646

Hlatky, Mark.  Expanding the Orbit of Primary Prevention - Moving Beyond JUPITER.  New England Journal of Medicine, online November 9, 2008.  DOI: 10.1056/NEJMe0808320

O’Riordan, Michael.  JUPITER hits New Orleans:  Landmark study shows statins benefit healthy individuals with high CRP levels.  HeartWire, November 9, 2008.

Szwarc, Sandy.  In-depth skeptical analysis at Junkfood Science.  Ms. Szwarc spent more effort analyzing the JUPITER study than 99.9% of Crestor-prescribing physicians ever will.

The European Medicines Agency today suspended prescription-writing for the weight-loss drug rimonabant, sold in Europe since 2006 as Acomplia.

Why?  Too many psychiatric side effects.

About a year ago, the Food and Drug Administration rejected the manufacturer’s request to sell it in the U.S., citing psychiatric concerns.

Consider caloric restriction and physical activity as an alternative.  Not as easy as popping a pill, but effective nevertheless, with psychiatric benefits.

Steve Parker, M.D.