Tuesday, October 14, 2008

Jupiter Study- What does it really mean??

Dr. Steven Horvitz- Reading between the Lines:
Bringing you healthcare information you can trust!

The following is part of the abstract from the New England Journal of Medicine.
You will be hearing alot of information in the press about the benefits of cholesterol drugs, otherwise known as statins, especially Crestor, which was the drug used in this study.

From the New England Journal Of Medicine:
n engl j med 359;21 www.nejm.org november 20, 2008
Increased levels of the inflammatory biomarker high-sensitivity C-reactive protein
predict cardiovascular events. Since statins lower levels of high-sensitivity C-reactive protein as well as cholesterol, we hypothesized that people with elevated high-sensitivity C-reactive protein levels but without hyperlipidemia might benefit from statin treatment.

We randomly assigned 17,802 apparently healthy men and women with low-density
lipoprotein (LDL) cholesterol levels of less than 130 mg per deciliter (3.4 mmol per
liter) and high-sensitivity C-reactive protein levels of 2.0 mg per liter or higher to
rosuvastatin, 20 mg daily, or placebo and followed them for the occurrence of the
combined primary end point of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from cardiovascular causes.
In this trial of apparently healthy persons without hyperlipidemia but with elevated
high-sensitivity C-reactive protein levels, rosuvastatin significantly reduced the incidence of major cardiovascular events. (ClinicalTrials.gov number, NCT00239681.)


The Jupiter (Justification for the Use of Statins in Prevention) study, another multimillion dollar study paid for by a pharmaceutical company, this time AstraZenaca.

AstraZeneca wants to justify that Crestor, a statin cholesterol lowering drug, be used in people with normal cholesterol as well as high cholesterol by the outcomes data in the Jupiter study.

Let's take a closer look.

The Jupiter study focused more on testing for inflammation in arteries, via high-sensitivity C-reactive protein as a criteria for inclusion. They want to prove that Crestor would lower inflammation in the arteries and thereby lower major cardiovascular events.

For each year of treatment out of 100 people, 0.17 in the Crestor group versus 0.37 in the placebo group had a heart attack, or an absolute difference of 0.2%. So it would take 500 people a year to take the drug to prevent one heart attack each year. Yet, up to 3% of people may get muscle or liver damage from the drug. That is 1 out of every 33 people.

So every year, 1 in 500 benefit, and 1 in 33 get side effects.

I would also like to follow the money trail and find out who is paying for the interpretations of the study. Below is the long list of consulting agreements to the pharmaceutical industry engaged in by the authors of the study and the funding by AstraZeneca below. This can also be found at the end of study. I have highlighted and underlined pertinent areas for emphasis.

Dr. Ridker reports receiving grant support from AstraZeneca, Novartis, Merck, Abbott, Roche, and Sanofi-Aventis; consulting fees or lecture fees or both from AstraZeneca, Novartis, Merck, Merck–Schering-Plough, Sanofi-Aventis, Isis, Dade Behring, and Vascular Biogenics; and is listed as a coinventor on patents held by Brigham and Women’s Hospital that relate to the use of inflammatory biomarkers in cardiovascular disease, including the use of high-sensitivity C-reactive protein in the evaluation of patients’ risk of cardiovascular disease. These patents have been licensed to Dade Behring and AstraZeneca.

Dr. Fonseca reports receiving research grants, lecture fees, and consulting fees from AstraZeneca, Pfizer, Schering-Plough, Sanofi-Aventis, and Merck;

Dr. Genest, lecture fees from AstraZeneca, Schering-Plough, Merck–Schering-Plough, Pfizer, Novartis, and Sanofi-Aventis and consulting fees from AstraZeneca, Merck, Merck Frosst, Schering- Plough, Pfizer, Novartis, Resverlogix, and Sanofi-Aventis.

Dr.Gotto reports receiving consulting fees from Dupont, Novartis, Aegerion, Arisaph, Kowa, Merck, Merck–Schering-Plough, Pfizer, Genentech, Martek, and Reliant; serving as an expert witness; and receiving publication royalties.

Dr. Kastelein reports receiving grant support from AstraZeneca, Pfizer, Roche, Novartis,
Merck, Merck–Schering-Plough, Isis, Genzyme, and Sanofi-Aventis; lecture fees from AstraZeneca, GlaxoSmithKline, Pfizer, Novartis, Merck–Schering-Plough, Roche, Isis, and Boehringer Ingelheim; and consulting fees from AstraZeneca, Abbott, Pfizer, Isis, Genzyme, Roche, Novartis, Merck, Merck–Schering-Plough, and Sanofi-Aventis.

Dr. Koenig reports receiving grant support from AstraZeneca, Roche, Anthera, Dade Behring and GlaxoSmithKline; lecture fees from AstraZeneca, Pfizer, Novartis, GlaxoSmithKline, DiaDexus, Roche, and Boehringer Ingelheim; and consulting fees from GlaxoSmithKline, Medlogix, Anthera, and Roche.

Dr. Libby reports receiving lecture fees from Pfizer and lecture or consulting fees from AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Merck, Pfizer, Sanofi-Aventis, VIA
Pharmaceuticals, Interleukin Genetics, Kowa Research Institute, Novartis, and Merck–Schering-Plough.

Dr. Lorenzatti reports receiving grant support, lecture fees, and consulting fees from Astra-Zeneca, Takeda, and Novartis;

Dr. Nordestgaard, lecture fees from AstraZeneca, Sanofi-Aventis, Pfizer, Boehringer Ingelheim, and Merck and consulting fees from AstraZeneca and BG Medicine;

Dr. Shepherd, lecture fees from AstraZeneca, Pfizer, and Merck and consulting fees from AstraZeneca, Merck, Roche, GlaxoSmithKline, Pfizer, Nicox, and Oxford Biosciences; and

Dr. Glynn, grant support from AstraZeneca and Bristol-Myers Squibb.

So do you think there may be a potential conflict of interest relevant to the Jupiter study?

There is more to heart disease than cholesterol and inflammation. While they may be useful markers for potential disease, they do not necessarily become the main cause of disease. If they were, then you would expect much better outcomes.
An analogy I use is that cholesterol is like smoke, and heart disease is like the fire. Cholesterol, like smoke is a warning sign we can spot easily. Using Crestor and other statin drugs can lower cholesterol, or "blow away the smoke". But it does very little to put out the fire or reduce heart disease. When I see alot of smoke, I try to find natural lifestyle changes in diet and exercise to put out the fire. When that occurs the smoke goes away!!
Steven Horvitz, D.O.
Board Certified Family Medicine
Founder of The Institute for Medical Wellness

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