Steve Borzak, MD
Steve Borzak, MD

By Steve Borzak, MD, FACC

The British Medical Journal published several papers this week detailing concerns about the bleeding risk of pradaxa (dabigatran), a coumadin substitute used for stroke risk reduction in atrial fibrillation.  In the first article, investigative journalist Deborah Cohen describes unpublished drafts of a manuscript which was eventually published in the Journal of the American College of Cardiology in 2013 describing the bleeding profile of pradaxa.  Ms. Cohen details company concerns (in both the draft manuscript and in company emails obtained through freedom of information act applications) raising the issue of more variability in plasma levels than would be expected or desired, and the wish of the company to not provide details about this variability.  A second paper published by Thomas Moore and associates from the Institute for Save Medication Practices (a drug safety watchdog group) detail similar concerns about wide biologic variability in plasma levels and its effect on bleeding risk.
The two papers do raise the concern that potentially valuable pharmacokinetic and pharmacodynamic data was not published and could have contributed to the general knowledge base.  However, balanced conclusions about the matter appear to be the following:  1.  Neither paper offers any new data or offers substantial evidence that the bleeding risk of pradaxa is any different today compared to yesterday.  2.  Pradaxa has been subject to one of the most exhaustive postmarketing surveillance reviews ever by the FDA, and the bleeding risk after launch is identical to that published in the pivotal trial.  3.  These new papers fall under the general rubric of “bad drugs sell papers,” meaning that anything pertaining to drug safety, particularly if there can be insinuations made about a cover-up or conspiracy, draws great interest.  Bottom line: pradaxa is a safe and useful drug with a potential for harm like other anticoagulants.  Don’t stop any drug without seeing your prescribing physician.

Steve Borzak, MD, FACC
He completed a Cardiology Fellowship at the Brigham and Women’s Hospital & Harvard Medical School in Boston, MA from 1988 to 1991.
Before joining Florida Cardiology Group in 2001, Dr. Borzak was Associate Division Head of Cardiology at Henry Ford Hospital, Michigan, where he directed the Coronary Care Unit, conducted dozens of research studies and contributed extensively to cardiovascular literature. Dr. Borzak has received numerous teaching awards during his tenure, and he is currently a faculty member at Nova Southeastern College of Medicine, Fort Lauderdale, Florida.

Steve Borzak, MD
Steve Borzak, MD

By Steve Borzak, MD, FACC

Liver Damage: Worry About Your Supplement, not Your Statin

In a leading story on December 22, 2013, The New York Times featured new research showing an alarming rise in serious liver damage attributed to supplement use.  In a careful study, over 800 patients were analyzed who had liver damage severe enough to consider transplantation.  An alarming trend over time attributed an increasing percentage of these serious cases to supplement use.  It is clear that the unregulated nature of supplement manufacture and use is a key cause.  It should be noted that in 2012, the FDA updated its packaging requirements for statin-based cholesterol-lowering drugs, to no longer require or even suggest monitoring liver enzymes.  This is because in the 30-year history of statin use in the US, there have been no cases of statin-induced serious liver injury.  The FDA pointed out that much more harm was caused by inappropriately interrupting statins (with a resultant spike in heart attack, stroke and vascular death) than any and all manifestations of liver injury.

Here is the full article link in NY Times.

Steve Borzak, MD, FACC
He completed a Cardiology Fellowship at the Brigham and Women’s Hospital & Harvard Medical School in Boston, MA from 1988 to 1991.
Before joining Florida Cardiology Group in 2001, Dr. Borzak was Associate Division Head of Cardiology at Henry Ford Hospital, Michigan, where he directed the Coronary Care Unit, conducted dozens of research studies and contributed extensively to cardiovascular literature. Dr. Borzak has received numerous teaching awards during his tenure, and he is currently a faculty member at Nova Southeastern College of Medicine, Fort Lauderdale, Florida.

Steve Borzak, MD
Steve Borzak, MD

By Steve Borzak, MD, FACC

This week saw the publication of yet another study showing that daily vitamins did nothing to reduce the risk of heart attack, stroke and vascular disease.  This particular study, TACT, also tested chelation therapy and found a modest benefit.  In this analysis, very high doses of antioxidants were no better than placebo in reducing the chance of vascular events.

There are now a large collection of studies looking at daily multivitamins which have all concluded that in otherwise healthy people, the addition of a multivitamin is worthless at preventing MI, stroke or cardiac death, and almost certainly not likely to have a meaningful reduction in the incidence of cancer.

We can conclude that daily multivitamins are not helpful in general.  There are some specific areas where we should be cautious:

  • a specific combination of anti-oxidant vitamins (the “AREDS formula”) has been shown to slow the progression of macular degeneration in patients with advanced drusen or early macular degeneration
  • pregnant women should take folic acid supplements to prevent neural tube defects
  • vitamin D remains controversial.  It may be very important for bone disease.  There is no good quality data showing that vitamin D reduces vascular events, though the theory has been proposed.  Large-scale studies are underway to see if vitamin D supplementation reduces vascular events, and we should await the results of these studies before using vitamin D for THIS purpose.
Steve Borzak, MD, FACC
He completed a Cardiology Fellowship at the Brigham and Women’s Hospital & Harvard Medical School in Boston, MA from 1988 to 1991.
Before joining Florida Cardiology Group in 2001, Dr. Borzak was Associate Division Head of Cardiology at Henry Ford Hospital, Michigan, where he directed the Coronary Care Unit, conducted dozens of research studies and contributed extensively to cardiovascular literature. Dr. Borzak has received numerous teaching awards during his tenure, and he is currently a faculty member at Nova Southeastern College of Medicine, Fort Lauderdale, Florida.
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We plan to update periodically here and on the Facebook for valuable information about our practice so that we can keep our patient well-informed. We also plan to prepare a series of documents outlining the important pertinent patient education information on certain common cardiac conditions, various tests and procedures, diagnoses and treatment. Here you will find the collections of “Frequently Asked Questions” (FAQs) on variety of important topics.