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Update in Cardiology

Peter H. Stone, MD
[+] Article and Author Information

From Brigham and Women's Hospital, Boston, Massachusetts.


Potential Financial Conflicts of Interest: None disclosed.

Requests for Single Reprints: Peter H. Stone, MD, Cardiovascular Division, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115; e-mail, pstone@partners.org.


Ann Intern Med. 2005;143(10):737-743. doi:10.7326/0003-4819-143-10-200511150-00011
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This Update will cover the highlights of an extraordinary year in cardiology. Papers included in the update examined important research in the areas of unstable and stable coronary artery syndromes, risk factors for atherosclerotic disease, heart failure, cardiomyopathy, arrhythmias, peripheral vascular disease, and valvular heart disease.

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No Title
Posted on November 30, 2005
Daniel M. Musher
Baylor College of Medicine, Michael E. DeBakey VAMC, Houston, TX
Conflict of Interest: None Declared

To the Editor:

As an infectious disease specialist, I read the current "Update in Cardiology" [1] with surprise. Of 15 articles cited, 3 (20%) dealt with one specific drug, atorvastatin. Peter H. Stone, the author of the update claimed that he had no conflict of interest. Yet, with the vast number of drug studies and the intense competition in the cardiology field, I found 3 citations on atorvastatin to be remarkably disproportionate.

My simple search on PubMed of "˜PH Stone' and "˜atorvastatin' yielded 3 articles.[2-4] The research for all of these articles was supported, in part, by unrestricted grants from Pfizer, the manufacturer of atorvastatin.

This is a major conflict of interest. In an update presented at an ACP Annual Meeting and then published in the Annals, Dr. Stone should have specified his conflicts of interest and should have gone out of his way not to favor articles on a drug he has studied. It is difficult to imagine how he can justify citing 3 articles on atorvastatin when he discusses only 15 articles from the entire cardiology literature for 2004.

Daniel M. Musher, M.D., F.A.C.P. Professor of Medicine Baylor College of Medicine Chief of Infectious Diseases Michael E. DeBakey Veterans Affairs Medical Center, Houston, Texas

References

1. Stone PH. Update in Cardiology. Ann Intern Med 2005;143:737-743

2. Kinlay S, Timms T, Clark M, et al. Comparison of effect of intensive lipid lowering with atorvastatin to less intensive lowering with lovastatin on C-reactive protein in patients with stable angina pectoris and inducible myocardial ischemia. Am J Cardiol 2002;89:1205-7

3. Stone PH, Lloyd-Jones DM, Johnstone M, et al. Vascular basis for the treatment of myocardial ischemia study: trial design and baseline characteristics. Am Heart J 2004;147:875-82

4. Stone PH, Lloyd-Jones DM, Kinlay S, et al. Effect of intensive lipid lowering, with or without antioxidant vitamins, compared with moderate lipid lowering on myocardial ischemia in patients with stable coronary artery disease: the Vascular Basis for the Treatment of Myocardial Ischemia Study. Circulation 2005;111:1747-55

Conflict of Interest:

None declared

Response
Posted on December 1, 2005
Peter H. Stone
Brigham and Women's Hospital
Conflict of Interest: None Declared

I acknowledge that I should have disclosed my potential conflicts of interest in my Cardiology Update, but I did not do so because, after careful thought, I considered that they were either not sufficiently current or not of sufficient relationship to the content of my presentation to warrant inclusion. My 3 articles cited by Dr. Musher (1-3) as representing research studies supported by Pfizer were, in fact, all from a single NHLBI-funded RO-1 study, "The Vascular Basis for the Treatment of Myocardial Ischemia" (the design manuscript [1], the primary endpoint manuscript [2], and a small database study [3]). Only a small proportion of supplemental funding for that NHLBI clinical trial was provided by Pfizer, and there had not been funding from Pfizer for that study for more than 2 years prior to my Cardiology Update. Since that clinical trial was completed my relationship with Pfizer has been minimal.

The year 2004 was indeed extraordinary in cardiology in that research published that year dramatically expanded the understanding of the "lipid hypothesis" and clarified the role of inflammation in the clinical and anatomic manifestations of coronary atherosclerosis. Statin studies published specifically in 2004 were also unique in that they compared an intensive regimen of atorvastatin with a less intense regimen of another statin, enabling an evaluation of comparative efficacy based on magnitude of lipid-lowering or the specific agent used. In contrast, earlier studies of the clinical benefit of individual statins utilized only placebo controls. The landmark atorvastatin studies I cited for 2004 provided critical information concerning optimal goals of lipid-lowering (4) and critical correlation relating anatomic improvement in coronary atherosclerosis from lipid-lowering with statins to the clinical benefit of lipid-lowering therapy with statins (5). The results from these 2 atorvastatin studies led to revised recommendations of lipid-lowering goals by the National Cholesterol Education Program's Adult Treatment Panel III. A third innovative atorvastatin study expanded the role of lipid-lowering in primary prevention, and was terminated prematurely because an interim analysis found a significant benefit in the active treatment group (6). The apparent disproportion of atorvastatin studies in 2004 was based on the fact that the majority of important studies in lipid-lowering that year utilized atorvastatin. My focus on lipid-lowering studies was balanced by a presentation of a broad spectrum of cardiology topics: coronary revascularization strategies in stable and unstable coronary syndromes, new pharmacologic therapy and device therapy for heart failure, management strategies for atrial fibrillation, public use of automatic external defibrillators, management strategies of high-risk coronary patients undergoing non-cardiac surgery, percutaneous carotid stenting, and percutaneous heart valve implantation.

In order to provide complete disclosure of any perception of a potential financial conflict of interest I have now revised my disclosure statement:

"Dr. Stone received research grants from Pfizer (not active) and Boston Scientific Corporation (active), served on a now-defunct advisory board for CV Therapeutics, and has served on an advisory board for Pfizer (not active). He has received honoraria from Pfizer for several speaking engagements."

Sincerely yours,

Peter H. Stone, M.D.

1. Stone PH, Lloyd-Jones DM, Johnstone M, et al. Vascular basis for the treatment of myocardial ischemia study: trial design and baseline characteristics. Am Heart J. 2004;147:875-82.

2. Stone PH, Lloyd-Jones DM, Kinlay S, et al. Effect of intensive lipid-lowering, with or without antioxidant vitamins, compared with moderate lipid lowering on myocardial ischemia in patients with stable coronary artery disease: the Vascular Basis for the Treatment of Myocardial Ischemia Study. Circulation 2005;111:1747-55.

3. Kinlay S, Timms T, Clark M, et al. Comparison of effect of intensive lipid lowering with atorvastatin to less intensive lowering with lovastatin on C-reactive protein in patients with stable angina pectoris and inducible myocardial ischemia. Am J Cardiol 2002:89:1205-7.

4. Cannon CP, Braunwald E, McCabe CH, et al. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med. 2004; 350: 1495-504.

5. Nissen SE, Tuzcu EM, Schoenhagen P, et al. Effect of intensive compared with moderate lipid-lowering therapy on progression of coronary atherosclerosis: a randomized controlled trial. JAMA 2004;291:1071-80.

6. Colhoun HM, Betteridge DJ, Durrington PN, et al. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study. Lancet 2004;364:685-96.

Conflict of Interest:

see letter

Atorvastatin and diabetes
Posted on March 10, 2006
Ferran Bejarano-Romero
Institut Català de la Salut. Servicio de Atención Primaria Reus-Altebrat. Tarragona, Spain
Conflict of Interest: None Declared

We would like to do some comments about Stone's update in cardiology published on your paper on November the 15th. In the analysis about the study CARDS, he only offers some results and his conclusion quotes almost literally the one of the same study: "The debate should now focus on whether any patients can reliably be identify as being sufficiently low risk for this safe and efficacious treatment to be withheld".

CARDS study evaluates the hypothesis that treatment with statines is effective on primary prevention of diabetes type 2, with cholesterol bounded to LDL proteins levels of < 160 mg/dl and triglycerides of < 600 mg/dl. Nevertheless, patients included were not only diabetics. They had, at least, another cardiovascular risk factor besides diabetes. In fact, 84 % had hypertension, 22 % were smokers, 30 % had retinopathy, and 17 % had albuminuria in some degree. In short, they were patients with high risk of having a cardiovascular disease. Therefore, the great majority would be candidate of receiving a hypolipemiant treatment with statines before the beginning of this trial.

With an average age of 60 years old, using Framinghan formula, we can calculate that the coronary risk of these patients in 10 years was between 16 % and 37 % for men at the beginning of the study. The coronary risk in ten years for women was between 13 % and 27 %.

Facing a patient with high cardiovascular risk, the correct management is a global treatment of all this risk factors. The CARDS exposition does not seem to consider this circumstance. So, arterial blood pressure was approximately about 143/80 mmHg at the end of the study. There is no mention of how many patients received ACE inhibitors and angiotensin II antagonist during the monitoring (44 % at the beginning). The management of diabetes could not be energetic judging the evolution of metabolic controls, with an HbA1c increase from 7.84 to 8.2 % at the end of the trial. Finally, it does not referee about the effectiveness of a hypothetic intervention on smoking.

Conclusions that Stone exposes about CARDS do not seem correct for us. He extrapolates the results of the study to all diabetic population, when the results are only applicable to patients of great cardiovascular risk. It reaffirms the calculation of cardiovascular risk as a valid method to identify subjects that would have more benefit with a hypolipemiant treatment, including patients with diabetes.

REFERENCES

1. Stone PH. Update in cardiology. Ann Intern Med 2005; 143: 737- 743.

2. Colhoun HM, Betteridge DJ, Durrington PN, Timan GA, Neil HAW, Livingstone SJ et al, on behalf of the CARDS investigators. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial. Lancet 2004; 364: 685-696.

3. Wilson PW, D'Agostino RB, Levy D, Belanger AM, Silbershatz H, Kannel WB. Prediction of coronary heart disease using risk factor categories. Circulation 1998; 97: 1837-1847.

Conflict of Interest:

None declared

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