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Should Multaq Be Used To Treat AF? This Physician Answers With A Resounding “No”

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.

*This blog post was originally published at Dr John M*


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One Response to “Should Multaq Be Used To Treat AF? This Physician Answers With A Resounding “No””

  1. Aaron Emmel, PharmD, BCNSP says:

    Nice post. I saw the barrage of propaganda touting this as the “safer” amiodarone as well. Problem is, as you pointed out, not only does it not work very well but it doesn’t appear to be too safe. Bad in heart failure, reports of liver failure, more QT prolongation, now reports of kidney injury…

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Richmond, VA – In an effort to simplify inpatient medical billing, one area hospitalist group has determined that “altered mental status” (ICD-9 780.97) is the most efficient code for use in any patient work up.

“When you enter a hospital, you’re bound to have some kind of mental status change,” said Dr. Fishbinder, co-partner of Area Hospitalists, PLLC. “Whether it’s confusion about where your room is located in relationship to the visitor’s parking structure, frustration with being woken up every hour or two to check your vital signs, or just plain old fatigue from being sick, you are not thinking as clearly as before you were admitted. And that’s all the justification we need to order anything from drug and toxin screens, to blood cultures, brain MRIs, tagged red blood cell nuclear scans, or cardiac Holter monitoring. There really is no limit to what we can pursue with our tests.”

Common causes of mental status changes in the elderly include medicine-induced cognitive side effects, disorientation due to disruption in daily routines, age-related memory impairment, and urinary tract infections.

“The urinalysis is not a very exciting medical test,” stated Dr. Fishbinder. “It doesn’t matter that it’s cheap, fast, and most likely to provide an explanation for strange behavior in hospitalized patients. It’s really not as elegant as the testing involved in a chronic anemia or metabolic encephalopathy work up. I keep it in my back pocket in case all other tests are negative, including brain MRIs and PET scans.”

Nursing staff at Richmond Medical Hospital report that efforts to inform hospitalists about foul smelling urine have generally fallen on deaf ears. “I have tried to tell the hospitalists about cloudy or bloody urine that I see in patients who are undergoing extensive work ups for mental status changes,” reports nurse Sandy Anderson. “But they insist that ‘all urine smells bad’ and it’s really more of a red herring.”

Another nurse reports that delay in diagnosing urinary tract infections (while patients are scheduled for brain MRIs, nuclear scans, and biopsies) can lead to worsening symptoms which accelerate and expand testing. “Some of my patients are transferred to the ICU during the altered mental status work up,” states nurse Anita Misra. “The doctors seem to be very excited about the additional technology available to them in the intensive care setting. Between the central line placement, arterial blood gasses, and vast array of IV fluid and medication options, urosepsis is really an excellent entré into a whole new level of care.”

“As far as medicine-induced mental status changes are concerned,” added Dr. Fishbinder, “We’ve never seen a single case in the past 10 years. Today’s patients are incredibly resilient and can tolerate mixes of opioids, anti-depressants, anti-histamines, and benzodiazepines without any difficulty. We know this because most patients have been prescribed these cocktails and have been taking them for years.”

Patient family members have expressed gratitude for Dr. Fishbinder’s diagnostic process, and report that they are very pleased that he is doing everything in his power to “get to the bottom” of why their loved one isn’t as sharp as they used to be.

“I thought my mom was acting strange ever since she started taking stronger pain medicine for her arthritis,” says Nelly Hurtong, the daughter of one of Dr. Fishbinder’s inpatients. “But now I see that there are deeper reasons for her ‘altered mental status’ thanks to the brain MRI that showed some mild generalized atrophy.”

Hospital administrators praise Dr. Fishbinder as one of their top physicians. “He will do whatever it takes to figure out the true cause of patients’ cognitive impairments.” Says CEO, Daniel Griffiths. “And not only is that good medicine, it is great for our Press Ganey scores and our bottom line.”

As for the nursing staff, Griffiths offered a less glowing review. “It’s unfortunate that our nurses seem preoccupied with urine testing and medication reconciliation. I think it might be time for us to mandate further training to help them appreciate more of the medical nuances inherent in quality patient care.”

Dr. Fishbinder is in the process of creating a half-day seminar on ‘altered mental status in the inpatient setting,’ offering CME credits to physicians who enroll. Richmond Medical Hospital intends to sponsor Dr. Fishbinder’s course, and franchise it to other hospitals in the state, and ultimately nationally.

***

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