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Are you "JUPITER-ed" out??


The Jupiter trial is a large well conducted study which has been exhaustively covered on theheart.org as well as other websites. The study has had very little impact on clinical practice now 3 months after presentation and publication of the data. There is little discussion amongst patients or primary care physicians about the use of CRP for the Jupiter to find patient subset.

The trial has validated CRP as a useful biomarker for patient’s in an intermediate risk range and having this "objective" criteria may help convince some patient’s to except statin therapy white otherwise have been reticent

This trial seems to demonstrate safety and efficacy of rosuvastatin that puts it solidly in the family of the other statin medications and gives me more confidence to use this therapy especially in patients who need 50% or more LDL lowering to achieve a desired goal.

Guidelines for application of this trial and CRP in general are eagarly awaited .  (last updated in 2003)

References:

Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein.

Ridker PM, Danielson E, Fonseca FA, Genest J, Gotto AM Jr, Kastelein JJ, Koenig W, Libby P, Lorenzatti AJ, MacFadyen JG, Nordestgaard BG, Shepherd J, Willerson JT, Glynn RJ; JUPITER Study Group. N Engl J Med. 2008 Nov 20;359(21):2195-207.

Expanding the Orbit of Primary Precention: Moving beyond Jupiter. Hlatky, MA. N Engl J Med. 2008 Nov 20; 359(21): 2280-2282.

CommentsCommentaires

It seems that this study was stopped at the most advantages point at least from a marketing standpoint . This despite the fact that a doubling of new cases of diabetes was seen in this study. The absolute benefit was small and to draw conclusions about long term use based on a study stopped so early just does not seem logical. The fact that such a low number formally dropped out but a large number were not taking their pills at studies end should at least arouse attention.
Posted by Vince, Mar 04, 2009 Publié le Vince, 03.04.2009

Dr. Ridker responded to these concerns on the NEJM website: 

 

If the "protective" effect on diabetes incidence reported in WOSCOPS is treated as hypothesis-generating, then a summary of published hypothesis-testing trials demonstrates that all statins modestly increase the risk of diabetes, with no heterogeneity according to potency. In our study, many of the patients in whom diabetes developed were obese or had an impaired fasting glucose level, groups in which large reductions in vascular events were associated with rosuvastatin.

The independent data and safety monitoring board for our trial followed rigorous principles3 in its prespecification that early termination of the study because of an observed benefit would require proof beyond a reasonable doubt. Members of the board were experienced in monitoring publicly and privately funded trials and viewed the trial's prespecified statistical boundary as only one component required for proof. Although the formal statistical boundary was conservative and evaluated only after accrual of ample data, the board elected to continue the trial for an additional 6 months after the boundary was crossed. Data that were accrued thereafter independently confirmed both the magnitude and statistical significance of the apparent benefit. We thus respectfully disagree with Pierard and Davis. The board appropriately protected the interests of society and the trial participants and provided a valid estimate of the treatment effect.4

The evaluation by Koller et al. ignores the significant reduction in death from any cause that we observed. If death from any cause is added to our primary composite outcome (a standard approach to account for competing risks), then the absolute risk difference increases and the number needed to treat declines.


Posted by surfer, Jul 24, 2009 Publié le surfer, 07.24.2009

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About Dr Seth Bilazarian
Seth Bilazarian MD has been a Clinical and Interventional Cardiologist at Pentucket Medical Associates in Massachusetts since 1993. He is board certified in Internal Medicine, Cardiovascular Medicine, Nuclear Cardiology, Vascular Ultrasound, Interventional Cardiology, and Vascular and Endovascular Medicine.

Dr Bilazarian performs coronary and peripheral interventions at Lahey Clinic and Massachusetts General Hospital. He has been an investigator in the interventional laboratory for new devices including drug-eluting stents, distal protection devices, imaging devices (OCT and InfraRed), and anticoagulant pharmacotherapy.

Dr Bilazarian is an active participant in clinical trials in congestive heart failure, hypertension, coronary disease prevention, prediabetes management, anemia, atrial fibrillation, and anticoagulation/antiplatelet therapies in the outpatient setting. He has authored numerous papers and book chapters in clinical cardiology. He was appointed as a physician advisor to the circulatory device panel of the FDA in 2008.
About this blog
My intent is to create a forum for dialogue on issues pertinent to private practice cardiology around topics such as:

  • Integration of new data and guidelines on inpatient and outpatient practice in clinical and interventional cardiology
  • Practice approaches to the extra clinical issues in dealing with managed care insurers
  • Strategies for navigating the restrictions of pharmacy benefits managers (PBMs) on pharmacologic therapies for our patients
  • Experiences with restrictions on testing and imaging
The video blog (VLOG) will provide an opportunity to share broadly different approaches to the common conundrums we face in caring for patients. My hope is that this forum will provide useful data points for practice outside of tertiary and academic centers and a look inside community hospitals and physician’s practice patterns in the office, starting with mine.