Study review: yet another Lipitor study

This continues a series I've begun recently that discusses studies that have emerged over the past 10 years relevant to heart scan scoring and reversal of coronary atherosclerotic plaque.

The St. Francis Heart Study from St. Francis Hospital, Roslyn, New York, was released in 2005. This was yet another study that set out to determine whether Lipitor exerted a slowing effect on coronary calcium scores. This time, Lipitor (atorvastatin), 20 mg per day, was combined with vitamin C 1 g daily, and vitamin E (alpha-tocopherol) 1,000 U daily, vs. placebo. A total of 1,005 asymptomatic men and women, age 50 to 70 years, with coronary calcium scores 80th percentile or higher for age and gender
participated in the study.

After four years, heart scan scores in the placebo group increased 73%, compared to 81% in the treatment group. Statistically, the cocktail of drug, vitamins C and E had no effect on heart scan scores.

Other findings included:

--Participants experiencing heart attack and other events during the study showed greater progression of scores than those not experiencing heart attack: score increase of 256 vs. increase of 120.

--While treatment did not reduce the number of heart attacks and events overall, participants with starting heart scan scores >400 did show a benefit: 8.7% with events on treatment (20 of 229) vs. 15.0% with placebo (36 of 240).

(Note what is missing from the treatment regimen: efforts to raise HDL (starting average HDL 51 mg/dl); reduce triglycerides (starting average 140 mg/dl); identify those whose LDL was false elevated by lipoprotein(a); omega-3 fatty acids from fish oil; correction of other factors like vitamin D deficiency.)


Are we pretty in agreement that just taking Lipitor and following an American Heart Association low-fat diet is an unsatisfactory answer to gain control over coronary plaque growth? No slowing of heart scan score growth seen in the St. Francis Heart Study and similar studies is consistent with the 25-30% reductions in heart attack witnessed in large clinical trials. Yes, heart attack and related events are reduced, but not eliminated--not even close.

And when you think about it, it should come as no surprise that the simple strategy studied in the St. Francis Heart Study failed to completely control plaque growth. Lipitor and statin drugs exert no effect on small LDL particles, barely raise HDL cholesterol at all, and have no effect on Lp(a), factors that increase heart scan scores substantially.

Though these discussions have frightened some people because of the suggestion that increasing heart scan scores are inevitable and unavoidable, they shouldn't. It really should not be at all shocking to learn that taking one drug all by itself should cure coronary heart disease.

Instead, findings like those of the St. Francis study should cause us to ask: What could be done better? How can we better impact on heart scan scores and how can we further reduce heart attack, particularly in people with higher heart scan scores?

My answer has been the Track Your Plaque program, a comprehensive effort to 1) address all causes of coronary plaque, and then 2) correct all the causes.

Comments (6) -

  • Anonymous

    12/3/2007 10:59:00 PM |

    Dr Davis, What would be your reaction to another Dr's blog site quoting the latest NCEP report of 9/07 that lowering LP(a) is not necessary unless it is in the 80-90th percentile? He also states that the report says raising HDL is only an "option" but not a proven deterrent. I don't have the credentials to argue this point but.... I certainly want to disagree with him.   Over&Out

  • Dr. Davis

    12/4/2007 2:53:00 AM |

    If the question is whether this physician is properly reiterating NCEP guidelines, he is right.

    I regard NCEP as being as least 10 years behind the times and a consensus opinion driven as much by big science as big pharma.

    It is also based on outcome studies, what I would call "body count" studies, rather than studies based on surrogate measures like heart scans. If we wish to wait for people to die in order to understand whether a treatment works or not, then his comments hold water. If our desire is to not gamble our lives away waiting for consensus opinions, then taking reasonable action based on available data is, in my view, a more rationale approach.

  • Anonymous

    12/4/2007 3:12:00 AM |

    The problem with following surrogate markers is they are just that.  The danger is illustrated well with the Torcetrapib story:  the drug did raise HDL the surrogate marker but the trial had to be halted because adverse events were so high.  It made "sense" to raise HDL and it is not clear what the exact mechanism of the excess deaths are (elevation in BP which the drug caused or ?).  Random controlled trials are still the best way to move forward no matter how long or messy they may be.

    On the subject of people having to decide in real time what treatment strategy they want to follow I believe one can make informed guesses but ultimately people should realize they are only guesses and may or may not prove to be correct.

  • Dr. Davis

    12/4/2007 3:29:00 AM |

    Yes, I agree with your second statement.

    However, I think we're talking apples and oranges here.

    With torcetrapib, we're not talking surrogate markers, but introducing a foreign substance with generally unknown extent of effects. With heart scanning, we're talking about a surrogate measure of the disease, and one certainly far closer to the disease than the rather "distant" HDL-to-event relationship.

  • Lipitor Prescription Information

    11/10/2008 8:45:00 PM |

    My name is Giulia White and i would like to show you my personal experience with Lipitor.

    I have taken for 9 years. I am 60 years old. I took 20 mg for 9 years and I told numerous physicians about my pain and stiffness and was told that I had arthritis and to keep taking it. I left it at home by accident when we went on vacation and within 3 days, the pain in my legs began to go away. After 2 weeks I knew it was a very dangerous medication. I went to my new physician and he wanted me to try Pravachol. Afer 4 days on it, I was in a fog and thought I had the flu. I have been off it for just 36 hours and feel better. I am an RN and should have known that I was experiencing side effects with Lipitor, but you listen to your Doctor because you trust him. I now tell my patients to trust what their bodies are telling them. Statins can't be good for anyone but the drug companies!!!!!!!!!! They keep lowering the recommended levels so that almost everyone is considered to have "high" cholesterol. If someone is 30 and on this for 30 or 40 years there is not telling what the long term effects will be.

    I have experienced some of these side effects-
    Joint and Muscle Pain / Stiffness.

    I hope this information will be useful to others,
    Giulia White

  • buy jeans

    11/3/2010 8:47:11 PM |

    (Note what is missing from the treatment regimen: efforts to raise HDL (starting average HDL 51 mg/dl); reduce triglycerides (starting average 140 mg/dl); identify those whose LDL was false elevated by lipoprotein(a); omega-3 fatty acids from fish oil; correction of other factors like vitamin D deficiency.)

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Why do I need a prescription for Olava?

Why do I need a prescription for Olava?

Imagine this:





What is OLAVA?

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Why Do I Need a Prescription for OLAVA?

Studies show that olive oil contains essential fatty acids, "good" fats that:



--Contain natural compounds your body needs for good health but can't produce on its own.

--Has antioxidants that may provide protection from heart disease.



So, it is common for people to ask why they need a prescription for OLAVA if it is made from a natural ingredient--olive oil. It's time to get the facts about OLAVA. Learn why OLAVA is different from olive oil you can buy at a store.



OLAVA Is an FDA-Approved Medication

OLAVA is the only FDA-approved medicine made from olive oil that's proven, along with diet, to reduce risk for heart disease


The FDA enforces standards to make sure that prescription medications like OLAVA are safe, effective, and quality controlled.


The way OLAVA is manufactured is reviewed and approved by the FDA.


OLAVA uses a 10-step purification process that helps remove lead and other environmental toxins that can be present in olive oil.


Each 1-gram capsule of OLAVA contains 1000 mg of pure olive oil.


The FDA-approved dose of OLAVA is 4 capsules per day. It could take up to 2 tablespoons per day of regular olive oil to provide the same amount of active ingredients proven to lower heart disease risk.




What Else You Should Know About Olive Oil

Regular olive oil has not been approved by the FDA to treat any specific disease like heart disease.



Olive oil doesn't have specific dosing information; it has a food label.



Olive oil does not go through an FDA-approved manufacturing process.





Talk to Your Doctor About OLAVA

If you have very heart disease, you may need a prescription medicine, along with diet, to treat your condition. Talk to your doctor about OLAVA. Print a trial offer to use on your first prescription of OLAVA.

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Gastric emptying: When slower is better

Gastric emptying: When slower is better

When it comes to the Internet and Nascar, speed is good: The faster the better.

But when it comes to gastric emptying (the rate at which food passes from the stomach and into the duodenum and small intestine), slower can be better.

Slower transit time for foods passing through the stomach leads to lower blood sugar, lower blood glucose area under-the-curve (AUC), i.e., reduced blood glucose levels over time. Lower postprandial (after-eating) blood sugars can reduce cardiovascular risk. It can lead to a reduction in net calorie intake and weight loss.

Strategies that can slow gastric emptying include:

--Minimizing fluids during a meal--Drinking a lot of fluids, e.g., water, accelerates gastric emptying by approximately 20%.

--Cinnamon--While the full reason to explain Cassia cinnamon's blood glucose-reducing effect has not been completely worked out, part of the effect is likely to due slowed gastric emptying. Thus, a 1/4-2 teaspoons of cinnamon per day can reduce postprandial blood sugar peaks by 10-25 mg/dl.

--Vinegar--Two teaspoons of vinegar in its various forms slows gastric emptying. The effect is likely due to acetic acid, the compound shared by apple cider vinegar, white vinegar, red wine vinegar, Balsamic vinegar, and other varieties.

--Increased fat content--Fat is digested more slowly and slows gastric emptying time, compared to the rapid transit of carbohydrates.

Not everybody should slow gastric emptying. Diabetics with a condition called diabetic gastroparesis should not use these methods, as they can further slow the abnormal gastric emptying that develops as part of their disease, making a bad situation worse.

However, in the rest of us with normal gastric emptying time, a delay in gastric emptying can reduce blood sugar and induce satiety, effects that can work in your favor in reducing cardiovascular risk.

Comments (18) -

  • Anonymous

    2/21/2010 10:17:43 PM |

    What about fiber?  

    For what it's worth, I recently discovered Chia seeds, which are high in Omega-3 and fiber.  Mixed 15 grams with 8 oz water, and you get a gel that's easy to slurp down.  The taste is neutral, too.

  • Anonymous

    2/21/2010 11:21:09 PM |

    I wonder what kind of effect supplemental digestive enzymes what have in gastric emptying.

  • Dr. William Davis

    2/22/2010 12:46:00 AM |

    Hi, Ted--

    Great results! there are some data on fenugreek, but we have not used it in any systematic way. Perhaps we should give it a try,.

  • Seedeater

    2/22/2010 3:06:08 AM |

    Chia is a remarkable food.  3:1 n3 to n6 ratio, and absolutely complete protein, missing no amino acids.

    Check it out:

    http://www.nutritiondata.com/facts/nut-and-seed-products/3061/2

  • mongander

    2/22/2010 3:34:36 AM |

    "If eating one gram a day of cinnamon reduces blood glucose levels 20 percent, then three grams or six grams will reduce it a lot more. Wrong.

    Researchers from the U.S. Department of Agriculture, including Dr. Richard A. Anderson, and Agricultural University, Peshawar, Pakistan, gave these doses of cinnamon to volunteers. Some 60 volunteers divided into six groups participated. Three of these groups got the three different doses and three groups received a placebo.

    They found that less than one-teaspoon—one gram—of cinnamon worked as well as higher doses."

    C Leigh Broadhurst, PhD explains how to make a cinnamon water extract.
    http://www.mendosa.com/cinnamon.htm

  • Anonymous

    2/22/2010 8:44:59 AM |

    Good thing too. Cassia is also high in toxins like coumarin.  I eat true cinnamon every day, I don't know if it works like Cassia, but it's so tasty it just must be doing some good!

  • 2 Quick

    2/22/2010 5:40:58 PM |

    Hi, Dr. Davis: I'm a long-time fan of your blog & LEF articles. I'm wondering if you can help. My husband (50 y.o., thin but muscular) is in extremely good health except for one thing: he is a very light sleeper (genetic, it seems). The insomnia is caused by his extremely fast transit time--exactly 12 hours, no more, no less--which means that if he eats more than one meal a day, it wakes him up in middle of the night. He doesn't drink during meals, he takes plenty of cinnamon, has taken apple cider vinegar (which, perversely, sped up his digestion), and because he is allergic to gluten, eats a high fat, high protein diet. He's tried adding fiber but that hasn't helped. (As you can imagine, his fast transit time leads to awkward social situations!) We're at wits end. Any help you can give us would be greatly appreciated!

  • DrStrange

    2/22/2010 8:30:15 PM |

    I have found that all of these work very well for some people and NONE of them works for everyone.  Some will great effect at lowering bg w/ some botanical while another person will have no effect whatsoever w/ same substance.

  • Anonymous

    2/24/2010 4:40:33 AM |

    2 quick - additional food intolerances?  has he tried a few weeks without fiber - counter-intuitive but could help.

  • 2 Quick

    2/24/2010 2:30:50 PM |

    Hi Anonymous,

    No, my husband does not suffer from any other food intolerance.

    That increase in fiber was a one-time, disastrous experiment. For the past several years my husband's diet has been free of fiber (except for the occasional bowl of berries and cream). This has helped his digestion tremendously but it has not slowed down his transit time...Frown

  • Dr. William Davis

    2/24/2010 6:40:30 PM |

    2 Quick--

    Sorry, but beyond wheat elimination, I have no specific insights.

    Occasionally, iodine deficiency will show up with odd gastrointestinal phenomena.

  • mongander

    2/24/2010 11:59:21 PM |

    You might try taking the probiotic, Culturelle, for a few weeks.  It causes your stools to bulk up.  It stopped a prolonged case of diarrhea for me. I know diarrhea is not your husband's problem but maybe Culturelle will normalize his digestion.

    Alternate day fasting might reset him.  I just started an alternate day fast.  Yesterday was my 1st day of fasting and it increased my transit time from 24 hr to 48 hr.  I know one day is too soon to make a judgment.
    http://www.ajcn.org/cgi/content/abstract/86/1/7

  • Anonymous

    2/25/2010 9:11:43 PM |

    What's the time frame arround meals in which luquids should be avoided? Does it include hot liquids like soup or tea and coffee?

  • Anonymous

    2/28/2010 8:14:24 PM |

    What a great resource!

  • Anonymous

    3/28/2010 7:17:29 PM |

    Smaller, more frequent meals is a better approach to limiting AUC and peaks. Slowing gastric emptying just invites acid reflux.

  • Anonymous

    6/1/2010 9:41:13 AM |

    Having trouble reconciling something on this topic:  Magnesium supplementation can supposedly be helpful in glucose control (as mentioned in past blog comments).  Yet my understanding is that it's mag's ability to *increase* the gastric emptying rate which causes the loose-stools side effects at high doses.

    I'm especially interested in any thoughts on this apparent contradiction because my pre-meal cinnamon supplementation seemed to lose its great benefit on postprandial glucose just about the time I triple my magnesium dose to 1200 mg (about 10 days ago).  Coincidence?

  • buy jeans

    11/3/2010 8:42:17 PM |

    Not everybody should slow gastric emptying. Diabetics with a condition called diabetic gastroparesis should not use these methods, as they can further slow the abnormal gastric emptying that develops as part of their disease, making a bad situation worse.

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