Dr John M

cardiac electrophysiologist, cyclist, learner

  • Home
  • About
    • About Me
    • About the Blog
      • General Cardiology and Internal Medicine
    • Six Reasons why I Blog
    • What’s Electrophysiology?
    • ICD/Pacemaker
    • Electrophysiology Column / Medscape
    • Contact
  • Afib
    • AFib
    • AF in Athletes
    • The best tool to treat AF
    • Know your CHADS-VASC Score
    • 3 non-warfarin anticoagulants
    • AF ablation
      • 13 things to know about AF
      • Atrial Fib Ablation -2012 Update
      • Gender-Spec results of AF ablation
    • Female gender and stroke risk in AF
    • My AF Story
  • Heart Healthy
    • Heart Disease (by DrJohnM)
    • Healthy Living
    • Exercise
    • Nutrition
    • inflammation
  • Policy
    • Policy
    • Health Care
    • Health Care Reform
  • Doctoring
    • Doctoring
    • Knowledge
    • Reflection
    • General Medicine
      • Does your cholesterol level matter?
    • General Cardiolgy – Medicine
      • What is a normal heart rate?
      • Cardiology/Internal Med
      • General Cardiology
      • Athletic heart
        • The ECG of an athlete
      • General Medicine
      • Stroke
      • Statins
  • Cycling
    • DrJohnM on Cycling
    • How I became a bike racer
    • My top 12 Likes on Cycling
    • Cyclocross
      • A CX-Primer
    • Fitness
    • Athletic heart
    • The Mysterious Athletic Heart

Multaq continues to disappoint

July 8, 2011 By Dr John

What should I have told the doctor who recently asked me about dronedarone (Multaq)?

“Supposedly, it’s [Multaq] just like Amiodarone, but without the side effects?” he asked.

Gosh…Should I, or shouldn’t I?

I took a big cleansing breath, reminding myself to stay civil, as at least Sanofi-Aventis, the makers of Multaq, sponsor a cycling team. Then I gave him my long answer:

I started with the fact that Multaq barely made it through the approval process. One of the original studies with Multaq (ANDROMEDA), a randomized trial of Multaq in patients with severe heart failure, showed that patients who took the drug were twice as likely to die.

Multaq eventually won approval for use in patients without significant heart failure and mild forms of AF, based on the results of the ATHENA trial—which randomized 4628 patients with non-permanent AF to either standard therapy or standard therapy plus Multaq. The ATHENA investigators didn’t exactly say that Multaq works, rather they claimed that it reduced a composite of hospitalizations and death.

This started the marketing machine in motion, the likes of which I have not ever witnessed. Paid experts, “thought leaders,” as they are called, touted Multaq in endless venues—at special CME events, on the internet, at national meetings and of course, during evening dinners. There were posters, TV and magazine ads, lunches, breakfasts, key chains, and tee shirts, but not logo’d pens.

When doctors started using Multaq to treat AF they found that the drug did not suppress AF-episodes. Now, to be fair, no AF drug works much more than 50% of the time, but Multaq almost never works. Since it was approved, I have yet to see a single patient in which Multaq suppressed AF for more than 6 months.

Not only does Multaq not work in AF-suppression, the drug also causes significant side effects. More than a small number of patients report intolerable GI adverse effects—diarrhea and nausea are the most common. Additionally, the drug may cause excessive lowering of heart rate, and insomnia, both of which contribute to an AF patient’s chief complaint, fatigue.

Thus far, we could summarize Multaq as an expensive, aggressively marketed AF drug which doesn’t work and often makes people feel ill, though less frequently hospitalized.

“At least it was safe,” said the company.

Wrong.

A recent report suggested that Multaq may be associated with unpredictable and abrupt-onset liver failure. This was distressing enough, but yesterday, Sanofi announced that it was terminating its latest study, called the PALLUS trial–an investigation into whether Multaq would work as a rate-control drug in patients with permanent AF. The trial was stopped prematurely because of an increased rate of cardiovascular events in patients who took Multaq. Taken together, and along with the original ANDROMEDA trial, these reports suggest that Multaq isn’t a very safe drug.

Whew…

That was a long discussion for a doctor’s lounge question.

I could have just said, “I cannot recommend Multaq to my patients with AF.”

JMM

P.S. My colleague, Dr Wes Fisher has this outstanding, much more detailed and very professional summary of the Multaq debacle.

Here is a list of my previous posts on Multaq.

  • Email
  • LinkedIn
  • Facebook
  • Twitter
  • More
  • Reddit

Related posts:

  1. The first four months of a new era.
  2. In defense of Multaq…not really
  3. Dabigatran is approved
  4. Alas, a single success…

Filed Under: Atrial fibrillation

John Mandrola, MD

Welcome, Enjoy, Interact. john-mandrola I am a cardiac electrophysiologist practicing in Louisville KY. I am also a husband to a palliative care doctor, a father, a bike racer, and a regular columnist at theHeart.org | Medscape

My First Book is Now Available…

Email Newsletter

Search the Site

Categories

Find me on theheart.org | Medscape Cardiology

  • Electrophysiology commentary on Medscape/Cardiology

Mandrola on Medscape

  • My Medscape column on general medical matters

For patients...Educational posts

  • 13 things to know about Atrial Fibrillation — 2014
  • A new cure of AF
  • Adding a new verb to doctoring: To deprescribe is to do a lot
  • AF ablation — 2015 A Cautionary Note
  • AF Ablation in 2012–An easier journey?
  • Atrial Flutter — 15 facts you may want to know.
  • Benign PVCs: A heart rhythm doctor’s approach.
  • Caution with early Cardioversion
  • Decisions of 2 low-risk cases of PAF
  • Defining success in AF ablation in 2014
  • Four commonly asked questions on AF ablation
  • Inflammation and AF — Get off the gas
  • Ten things to expect after AF ablation
  • The medical decsion as a gamble
  • The most important verb in our health crisis
  • Wellness Requires Ownership

loading Cancel
Post was not sent - check your email addresses!
Email check failed, please try again
Sorry, your blog cannot share posts by email.