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Newsletters June 2010 - Jefferson Cardiology Happenings

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How Effective and Safe is Multaq?

There is always much excitement and publicity when a new drug is brought to the market with claims of increased safety. There may also be concerns when questions are raised about the effective-ness coupled with the new steep price. Two statements of commentary appear in the April 13 issue of the American Col-lege of Cardiology addressing the role of Multaq.

Multaq is a medication given to patients who have had atrial fibrillation, the most common rhythm disorder, to maintain normal rhythm. It is universally agreed that amiodarone is the most effec-tive medication available to maintain normal rhythm in patients who have atrial fibrillation. However, amiodarone has a number of potential side effects. Multaq has been touted as a safer version of amiodarone. Is this really true and is Mul-taq as effective?

In the commentary written by well- known cardiologists from Cedar-Sinai Medical Center in Los Angeles, a UCLA affiliate, four studies were pooled to-gether. In the combined results of persons with a history of atrial fibrillation 43% of patients treated with Multaq had a recur-rent event compared to 54% of placebo treated patients. In these patients, quinidine maintained normal rhythm in 50%. On the other hand, analysis of 11 studies demonstrated that amiodarone was three times as successful in maintaining normal rhythm than placebo.
Another study, DIONYSOS, directly compared Multaq and amiodarone for maintenance of normal rhythm for six months in patients with a history of atrial fibrillation. During this time 58% of amiodarone patients maintained normal rhythm compared to 37% taking Multaq. Also 10.4% of patients were intolerant of Multaq and 13% intolerant of amiodarone which was not significant statistically.

In an accompanying editorial from Denmark, a conclusion was reached that Multaq does not represent a step forward based on efficacy. This decision was based on the previously mentioned study from Cedars-Sinai and analysis of other studies. The ANDROMEDA study was stopped prematurely because of excess mortality with Multaq and the ATHENA study demonstrated positive benefit.

How safe is Multaq? Findings in the ANDROMEDA study demonstrated increased mortality that appeared related to increased heart failure. For this reason, the FDA warned that Multaq is not to be given to patients with heart failure or recent onset of heart failure. Also there does not appear to be evidence that Mul-taq reduces mortality. Also, at a retail cost of $9 a day or $3285 per year, ques-tion is raised how this is cost effective compared with generic amiodarone.

The major side effects of Multaq are diarrhea, nausea, vomiting and rash. Multaq has not been shown to create threatening heart rhythms and causes a temporary change in blood tests measur-ing kidney function. Multaq has not been shown to have the thyroid, lung or neu-rologic side effects of amiodarone. The authors concluded that Multaq has a small statistically insignificant tolerability advantage compared to amiodarone.

What is the role for Multaq? Previously established guidelines of the American College of Cardiology, American Heart Association, and European Society of Cardiology list first line drugs for patients with no or minimal structural heart disease including hypertension and these drugs include Flecainide, propafenone, and sotalol based on safety and efficacy in this population. Second line agents for patients without structural heart disease include amiodarone and dofetilide. Multaq could be given to amiodarone intolerant patients. Among coronary patients without heart failure, Multaq could be given as an alternative to amiodarone. Among coronary patients with heart failure, amiodarone and dofetilide are recommended and Multaq is not recommended. In short the authors believe that Multaq can be an alternative to amiodarone in patients without heart failure. To date, concerns remain regarding the limited efficacy of Multaq and the limited or insignificant reduction of side effects coupled with a large multiple in cost.

Surgery vs. Endovascular Repair for Aneurysms

In recent years more abdominal aortic aneurysms have increasingly been done by placing endovascular devices through a catheterization technique. How effective and safe is this compared with surgical treatment?
In the May 20, 2010 issue of the New England Journal of Medicine there are several studies evaluating these techniques. In a randomized study from England there was greater 30-day mortality with surgery at 4.3% compared with 1.8%. Patients were followed up to 8 years. By that time there was no difference in survival between the two groups. In part the leveling of mortality was due to late fatal endograft failure. The rates of graft-related complications and repeat procedures exceeded surgical complications and accounted for increased cost with endovascular devices. Similar outcomes were seen in a Dutch study.

Staff News

Happy Birthday

Please join us in wishing our senior partner, Dr. Bramowitz a very happy birthday. Congratulations to both of you.

Happy Father’s Day
We at JCA would like to wish all the Fathers of our practice a very happy and safe Father’s Day.

A publication of Jefferson Cardiology Association
Alan D. Bramowitz, M.D. | Michael S. Nathanson, M.D. | Gennady Geskin, M.D.

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