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  In the first article, investigative journalist Deborah Cohen describes unpublished drafts of a manuscript which was eventually published in the Journal of the American College of Cardiology in 2013 describing the bleeding profile of pradaxa.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.
Steve Borzak, MD
Steve Borzak, MD

By Steve Borzak, MD, FACC

After 9 years, the American Heart Association and American College of Cardiology published new guidelines for the evaluation and management of elevated cholesterol guidelines.  Upon publication, they immediately generated controversy, such that the New York Times opined in an editorial that Americans without established vascular disease “should probably wait until the heart organizations reassess their risk calculator.”  What happened?

Noncontroversial parts of the guideline.  The new guidelines emphasize that treating people with established vascular disease or diabetes—so-called high-risk individuals—is extremely well established, and that lowering LDL cholesterol with statins has been repeatedly shown to reduce death, stroke, heart attack, and the need for stenting or bypass surgery.  The guidelines also acknowledge that patients without vascular disease or diabetes, but who have very high cholesterol levels, with LDL in excess of 190—so-called familial hypercholesterolemia—ought to be treated with statins.

The Four Groups.  The guidelines identify four separate treatment groups.  The first includes individuals with any evidence of atherosclerotic disease, for instance, having had a heart attack, stents, angioplasty, bypass surgery, having peripheral vascular or carotid disease, a stroke, and the like.  The second group includes individuals without vascular disease but with an untreated LDL cholesterol of 190 or more.  The third group includes diabetics without vascular disease and less than 75 years old.  The last group are otherwise healthy individuals with LDL > 70 and < 190 and with a 10 year risk of vascular events > 7.5%.  All four groups, in the estimation of the guidelines, justify treatment with a statin.

Gone are the targets.  One surprising part of the guidelines is the emphasis on treating high-risk individuals with a potent statin drug but without a specific target.  Previous guidelines emphasized an LDL below 100, or optionally below 70 for high-risk individuals.  The new guidelines no longer mention a target for several reasons.  First, none of the studies was conducted with a specific LDL or total cholesterol target.  Rather, the large clinical trials that make up the proof of benefit all used fixed doses of statins.  Thus, since the studies did not use targets, it is not rational or proven that treating to a specific target is worthwhile.  For example, a high risk individual may have an untreated LDL of 95.  The old guidelines would not emphasize treatment, and certainly not with a potent statin, but the new guidelines recognize that treating such an individual is important and worthwhile, and would importantly reduce the chance of future adverse events.  The point is to treat the patient, and not the number.

Second, avoiding targets leads to more personalized and individualized treatment.  A low risk individual with a high LDL may remain untreated, while a high risk individual should be aggressively treated, without much concern for the high-risk individual’s LDL level either before or after treatment.  Since we know extremely well that potent statins reduce risk, whatever the starting LDL level, the starting and ending LDL levels do not really inform treatment in any meaningful way.

So should we check blood tests in patients on statins?  The FDA previously recommended that liver enzymes should no longer be checked periodically in statin-treated patients, because the accumulated experience over decades has shown the drugs to be nontoxic to the liver, and because most liver enzyme elevations in statin patients are due to something besides the statin.  The new guidelines would suggest that since a given statin dose has both a predictable effect on the LDL, and more importantly a predictable effect on reducing cardiac events, that monitoring LDL (and other lipid parameter) levels is a distraction and might only lead to adding relatively ineffective therapy (e.g., niacin, fish oil, or fenofibrate).  Nonetheless, some doctors have said that blood tests reinforce positive feelings about taking the medication and verifies compliance.

The risk calculation.  The most controversial part of the guideline is the recommendation to apply a new risk calculator to an otherwise healthy or low-risk individual.  If the estimated risk exceeds 7.5% chance of an event in the coming 10 years, then the guideline recommends treatment.   The new risk calculator replaces the Framingham score, a risk method derived from the Framingham Heart Study, which has been in use for decades.  So what is so controversial?  Upon publication of the guidelines, it became clear that the new calculator would recommend treating a large number of people not currently being treated.  This was felt by some to be controversial.  Moreover, shortly after publication, a pair of Harvard researchers applied the new risk score to several data sets and concluded that the score overestimated risk in these populations, sometimes by twofold or more.  The pair suggested that calculation of risk may have changed in the several decades since the Framingham score was derived, and that more work needed to be done to insure the accuracy of the new risk calculator.

In conclusion, the familiar message reinforced by the new guidelines is that statins are safe and effective and a potent one should be used in adequate doses for at-risk individuals.  This message is not new.  Gone is the idea of a target LDL for treatment, which while familiar, is not evidence based.  The controversy surrounding the new risk calculator and its accuracy will not be resolved soon, but should not be a distraction from the take-home message: don’t miss an opportunity to reduce your risk of vascular events with a group of the safest and most effective drugs we have.

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.

Fish oil is one of the most frequently used supplements.  Recent data have questioned its efficacy, as well as raised concerns about its safety.

Fish oil supplementation arose as an idea from population-based studies which found lower than expected rates of coronary heart disease in populations, such as eskimos, for a given level of serum cholesterol.  Subsequent investigation in other populations showed that fatty fish in the diet seemed to be inversely correlated with lower rates of coronary disease, with higher fish consumption associated with lower rates.  Mechanistic studies suggested that oils that are rich in omega-3 fatty acids, such as occur in fatty fish, may reduce triglycerides, have an anti-platelet effect, and have been hypothesized to reduce atherosclerosis.  Sounds good….but do they really work?

The first and only large clinical trial, the GISSI prevention study, compared about 15,000 patients randomized to supplementation with either olive oil, or a high-quality omega-3 preparation currently available in the US as Lovaza (but not comparable to the fish oil supplements currently available over the counter).  This study showed no difference in mortality, a slight decrease in the rate of sudden death, and no difference in heart attack.  Fish oil therefore became incorporated into guidelines and popular use, because there were no safety concerns.  However, the study was performed before the widespread use of statins.  Since statins are so safe and effective, and not only reduce total and LDL cholesterol but also reduce death, stroke, heart attack, stenting, and bypass surgery, what is the role of fish oil in a person who takes statins?

Recent data, including a high-quality meta-analysis, has shown that fish oil in statin-treated groups of patients has no beneficial effect and may be associated with a slight risk of bleeding.

We would therefore make the following suggestions:

  • Statins are the primary strategy for reducing risk of vascular events in both low and high risk patients
  • Fish oil adds very little beneficial for patients on statins
  • Because of the bleeding risk, fish oil should be avoided in patients on Coumadin, xarelto, pradaxa and eliquis, and possibly in patients on aspirin plus either Plavix, effient or brillinta
  • Hi-dose fish oil (4 g of lovaza) can lower triglycerides if they are significantly elevated (> 500)
  • As always, ask your cardiologist and internist about whether this drug is good for you or not

Dr. Steven Borzak

Cardiologist TODAY!
– See a Board Certified Cardiologist Now

There is no need to wait for a new cardiology consultation. If you are looking for a cardiologist and need an office consultation today in Palm Beach County, FL, FCG has a NEW service where you can see a board certified cardiologist TODAY.  Just call our office and get seen today.

If you have been referred by your PCP and are waiting to see a cardiologist, or you are in need of a cardiologist for your existing cardiac condition or you are looking for a cardiologist for the first time then you can call today. Our practice is designed to have a board certified cardiologist available to see you for an office consultation today and every day from 9 am to 5 pm.

FCG’s Cardiologist TODAY for

  • New cardiology consultation
  • Chest pain Evaluation
  • High Blood pressure Issues
  • Difficulty in controlling cholesterol
  • Existing cardiac condition and looking for a new cardiologist
  • General Cardiac Exam
  • Cardiac Conditioning program
  • Weight Management
  • and More …

 

Florida Cardiology Group thanks you for selecting us for your cardiovascular needs. The values of ethical, compassionate and state of the art cardiovascular care are the foundation of our practice. We not only take great care in treating past and present cardiac illnesses but we also strongly believe in the philosophy of prevention of future cardiovascular disease. State of the art cardiology practice covering wide range of cardiovascular diseases. Located in South Florida.

We are currently updating our website and online information. Please visit us soon to find the new information on the website. In the meantime please visit us on the Facebook and like us on our Florida Cardiology Facebook.

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.