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

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    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.)