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Faye Spencer, Boise, ID, April 2017
“I think your site has helped a lot of patients.”Dr. Hugh G. Calkins, MD Johns Hopkins,
Baltimore, MD
2022 AF Symposium Abstract: Inhaler Can Stop A-Fib Attack in Minutes
This abstract further elaborates on an 2021 AF Symposium Spotlight session by Dr. Jeremy Ruskin of Massachusetts General Hospital. He showed safety data from the InCarda Phase 2 study (INSTANT) which he thought very promising. This abstract details a small clinical trial.
This InCarda inhaler is an incredible medical innovation for A-Fib patients! (It’s still in development.)
Imagine: A patient is having an A-Fib episode. The patient self-administers the InCarda inhaler, it produces a flecainide-containing aerosol which the patient inhales. This results in a rapid absorption of flecainide via the lungs into the heart.
It can terminate an A-Fib attack in as little as 8 minutes. (The tablet form of Flecainide takes around 1−3 hours to work.)
For more read my short report: Trial II of InCarda Orally Inhaled Flecainide.
(Finally) A Head-to-Head Comparison of Anticoagulants for A-Fib: Eliquis vs Xarelto
The most commonly prescribed direct-acting anticoagulants (DOACs) for A-Fib patients are Eliquis (generic name: apixaban) and Xarelto (generic name: rivaroxaban).
Direct-acting anticoagulants (DOACs) were introduced in the early 2010s, but most of the testing has been against warfarin, not against other DOACs. Finally, thanks to the researchers of two retrospective studies, A-Fib patients now have a head-to-head comparison of Eliquis versus Xarelto.
Study 1: Stroke and Bleeding Risks
A recent retrospective study (Fralick, M. et al) looked at 6 years of prescription data for atrial fibrillation patients from the Nationwide Healthcare Claims Database (NPIC). A-Fib patient group sizes were matched (39,351 each). Mean age was 69 years, 40% were women and follow up was 288–291 days.
Significant Findings
1. Eliquis patients had significantly lower rates of stroke or systemic embolism (6.6 vs 8.0 events per 1000 person-years) compared to Xarelto.
2. Eliquis patients had a significantly lower incidence of major bleeding, defined as gastrointestinal bleeding or intracranial hemorrhage (12.9 vs 21.9 events per 1000 person-years).
Researchers Conclusion (Fralick, M. et al): In routine care, adults with atrial fibrillation prescribed apixaban had a lower rate of both ischemic stroke or systemic embolism and bleeding compared with those prescribed rivaroxaban.
Study 2: Stroke and Bleeding Risks
A second retrospective study (Ray, W. et al) looked at 581,451 atrial fibrillation patients 65 years or older who were enrolled in Medicare from 2013–2018. A-Fib patient group sizes were Rivaroxaban, 227,572 and Apixaban, 353,879. Follow up was for 4 years, through November 30, 2018. Mean age was 77.0 years; 50.2% were women (291 966).
Significant Findings
1. Xarelto patients had more hemorrhagic events including fatal extracranial bleeding (1.4 vs 1.0 per 1000 person-years)
2. Xarelto had more nonfatal extracranial bleeding (39.7 vs 18.5 per 1000 person-years)
3. Xarelto had more fatal ischemic/hemorrhagic events (4.5 vs 3.3 per 1000 person-years)
4. Xarelto had more “total mortality” (44.2 vs 41.0 per 1000 person-years)
Researchers Conclusions and Relevance (Ray, W. et al): Among Medicare beneficiaries 65 years or older with atrial fibrillation, treatment with rivaroxaban compared with apixaban was associated with a significantly increased risk of major ischemic or hemorrhagic events.
Eliquis vs Xarelto…and the Winner is…
Eliquis (apixaban)! In routine care, Eliquis was found to be both more effective and safer than Xarelto.
As patients, we should pay particular attention to the fact that Eliquis had significantly lower incidence of major bleeding (gastrointestinal bleeding or intracranial hemorrhage) than Xarelto (12.9 vs 21.9 events). And that Xarelto had increased nonfatal extracranial bleeding (39.7 vs 18.5 events) compared to Eliquis.
These differences in bleeding weren’t just “statistically significant” but were really alarming. Major, red flag warning important. Particularly for older people who are more prone to bleeding problems.
Be Your Own Best Patient-Advocate
Whether or not to take anticoagulants and which one is one of the most difficult decisions you and your doctor must make.
All the results cited above were “significant” and should be taken into account when choosing an anticoagulant.
If you are taking Xarelto, you should talk with your doctor about switching to Eliquis.
Learn all you can about your health conditions. A well-informed patient is welcomed by your doctors and healthcare caregivers. (If not, consider changing doctors.)
• Dawwas, G.K. et al. Apixaban Versus Rivaroxaban in Patients With Atrial Fibrillation and Valvular Heart Disease—A Population-Based Study. Annals of Internal Medicine, 18 October 2022. https://www.acpjournals.org/doi/10.7326/M22-0318 https://doi.org/10.7326/M22-0318
2022 AF Symposium Abstract: Trial II of InCarda Orally Inhaled Flecainide
2022 AF Symposium
Abstract: Trial II of InCarda Orally Inhaled Flecainide
Background: This abstract further elaborates on an 2021 AF Symposium Spotlight session by Dr. Jeremy Ruskin of Massachusetts General Hospital. He showed safety data from the InCarda Phase 2 study (INSTANT) which he thought very promising. This abstract details a small clinical trial.
Flecainide is a Class IC anti-arrhythmic that is prescribed daily in tablet form for many A-Fib patients. It can also be used as a “Pill in the Pocket” therapy.
The InCarda inhaler from InCarda Therapeutics, Inc., is a different delivery system, is portable, and used only as needed.
Inhaler For Rapid Absorption of Flecainide
When an A-Fib patient self-administers the InCarda inhaler, it produces a flecainide-containing aerosol when the patient inhales. This results in a rapid absorption of flecainide via the lungs into the heart.
It can terminate an A-Fib attack in as little as 8 minutes.
The tablet form of Flecainide takes around 1−3 hours to work.
The InCarda inhaler can be used like a Pill-In-The-Pocket therapy. This would free many A-Fib patients from daily use of Flecainide. This is a good thing, because Flecainide, like most antiarrhythmic drugs, can have bad side effects and be poorly tolerated over time.
Phase II Trials
InCarda inhaler from InCarda Therapeutics, Inc.
In a Phase II clinical trial of the inhaler, 97 patients received 120 mg of flecainide acetate oral inhalation solution (FleclH) during an 8-minute inhalation period.
Inhalation Safety Measures: Safety was evaluated based on peak plasma concentrations of flecainide, maximum QRS prolongation, cardiovascular events (CVEs) and adverse events. (Patients who did not convert to sinus were offered alternative treatment. They didn’t experience any adverse consequences.)
The Conversion Rate: At 90 minutes post-dose, the conversion rate to normal sinus rhythm was 47.5%, and the median time to conversion was 14.6 minutes from start of inhalation.
There were no significant safety differences in patients converting to normal sinus rhythm and those who didn’t.
The authors concluded, “Inhalation of 120 mg of flecainide (FleclH) was safe, and the efficacy was similar to that reported for oral and IV administration.”
Editor’s Comments
This InCarda inhaler is an incredible medical innovation for A-Fib patients! Imagine having an A-Fib episode and just using your flecainide inhaler to get you out of it in just 8 to 14 minutes! Think of how liberating that would be!
In clinical trial, the flecainide inhaler is testing just as effective as the tablet form−but currently the inhaler only works for patients about 50% of the time.
Many A-Fib patients would say that’s still a lot better than having to take flecainide as a tablet every day.
I’m hoping the dosage and formula will be adjusted to work better and more consistently.
Other Possibilities: Can the InCarda system be eventually used with other anti-arrhythmic drugs? Can it be used for anticoagulant delivery as well? The possibilities seem endless.
If you find any errors on this page, email us. Y Last updated: Tuesday, February 22, 2022
Return to 2022 AF Symposium Reports
A-Fib Patients: Vazalore to Replace Aspirin
In 2014, Aspirin was removed from the AHA/ACC/HRS Guidelines for the Management of Patients with Atrial Fibrillation. (See my 2020 Update: Aspirin No Longer Recommended as First-Line Therapy for Stroke.)
There hasn’t been innovation in the mechanism of Aspirin delivery in over 50 years.
Not only is Aspirin proved relatively ineffective as an anticoagulant but it causes increased risk of gastrointestinal (GI) bleeding, ulcers, nose bleeds, wet macular degeneration, and hemorrhagic stroke.
For secondary prevention patients (after a heart attack), nearly 25% with a history of GI issues reported discontinuing aspirin against medical advice because of “stomach issues”.
Vazalore: Delivers Aspirin in a New Form
Vazalore Aspirin Therapy from PLx Pharma
In March 2021, the U.S. FDA approved the medication, Vazalore (PLx Pharma), a capsule containing aspirin and protective fatty substances called liposomes.
As liquid-filled capsules, Vazalore delivers Aspirin differently. The special complex inside the capsule allows for targeted release of aspirin, limiting its direct contact with the stomach.
Vazalore works four times faster than aspirin, with 71% less injury. It’s absorbed five times better than aspirin. It comes in low-dose (81 mg) and full-strength (325 mg) versions.
Aspirin Continues as “Secondary” Prevention
“Secondary prevention” refers to those who have already had a stroke or heart attack; the goal is to prevent another.
While no longer recommended as an anticoagulant for Atrial Fibrillation patients, Aspirin still has a roll to play in cardiac health.
Aspirin is recommended for a “secondary” prevention of recurrence of a heart attack. It significantly reduces the risk for a second heart attack or stroke. (Translation: If you’ve already had a heart attack or stroke, you may be on traditional Aspirin to prevent a second event.)
Editor’s Comments
It’s too early to tell how Vazalore compares to the use of DOACs (Direct-Acting Oral Anticoagulants).
But for those who have to take Aspirin (such as people with stents), Vazalore seems like a major game changer and medical breakthrough. It’s a way to get the benefits of aspirin without the bad side effects such as GI bleeding, ulcers, etc.
Now that Vazalore is FDA approved, let’s wait and see how it performs in practice as compared to clinical trials.
Are you on Vazalore? If you have been taking Vazalore for your Atrial Fibrillation, would you share your impressions? Email me and let me know about your experience.
A-Fib & Anticoagulants: Bleeding Risk If combined with OTC meds, Supplements
More than a third (33%) of people taking anticoagulants also take at least one nonprescription drug daily or most days of the week. This combination can cause dangerous side effects.
If you are taking an anticoagulant, such as Eliquis, Xarelto, Pradaxa or Savaysa, be aware that taking it along with some over-the-counter drugs and supplements can cause dangerous internal bleeding.
These over-the-counter drugs include painkillers such as aspirin, Advil (ibuprofen), and Tylenol (acetaminophen) and dietary supplements such as fish oil, turmeric, ginger and other herbs.
Internal Bleeding Risk: NOACs/DOACs Hard to Measure
The older anticoagulant, warfarin, required regular blood tests of INR (International Normalized Ratio) to measure how much warfarin was actually working in a patient’s blood to prevent a stroke.
But the newer anticoagulants (NOACs, DOACs), such as Eliquis, Xarelto, Pradaxa or Savaysa, aren’t normally measured by anticoagulation clinics or health care professionals using standardized tests such as INR. (The FDA, under pressure for new anticoagulants, approved the NOACs without there being any established or universally recognized method of determining their clot preventing effectiveness.)
Be aware that your doctor probably doesn’t test to see how much your NOAC is actually working in you. They hope it is, but doesn’t know for sure. Blood levels of your NOAC depends on factors such as how well or how poorly your kidneys are functioning.
Not all of your NOAC may actually be working for you. Pradaxa, for example, is 80% cleared by the kidneys. This means there may be lower anticoagulant levels in your blood stream, and a lot of your clot prevention is being flushed away by your kidneys. (Eliquis, Xarelto and Savaysa fare better with only 25%, 33% and 35% being cleared by the kidneys, respectively.)
Check With Your Doctor About Increased Internal Bleeding Risk
If you take an anticoagulant along with over-the counter drugs and supplements, ask your doctor which combinations to avoid. But be aware that many doctors are clueless about natural dietary supplements.
(Don’t ask them how effectively your NOAC is working in you. They probably don’t know and can’t easily test for that.)
Magnesium IV to Stop A-Fib
We have long advocated the benefits of Magnesium for A-Fib. (See Magnesium Long-Life Insights for A-Fib Patients.)
Intravenous Delivery: A recent randomized controlled double-blind study found that Magnesium delivered directly into the bloodstream (Intravenous, i.e., IV) can produce both rate and rhythm control when used for A-Fib patients in the emergency room (ER).
The Good News: This study from the University of Monastir, Tunisia, found Magnesium IV is the fastest way to improve Magnesium levels and is very effective in restoring A-Fib patients to normal sinus rhythm.
The Bad News: In U.S. emergency rooms, Magnesium IV is not a standard treatment for A-Fib patients (though it may be used prior to cardioversion). (Dr. Julian Whitaker in Newport Beach, CA performs this therapy (www.drwhitaker.com).)
One of our Advisory Board members wrote me about his large facility’s experience with Magnesium IVs, “A few years ago we tried and stopped because of futility.”
Bottom Line: So it’s an interesting research study, but don’t look for a Magnesium IV if you end up in the ER with an A-Fib episode.
Side Effects of Flecainide: An A-Fib Patient’s Perspective
Carol, from Salem, Oregon, wrote me to share how taking the antiarrhythmic drug, flecainide, affected her.
Flecainide, an antiarrhythmic medication, works by slowing electrical signals in the heart to stabilize the heart rhythm.
“When I initially started taking flecainide for my A-Fib, I experienced annoying visual disturbances, especially when there was a difference between a light and dark environment such as a stage or when going from a light to a dark room. I would see afterimages, many of them. For example, in a theater I’d see my hands clapping, but I’d see many of them as if in a time lapse still photo. Over time that effect got better.
But other side effects developed.
…Here it goes again. I plan to call the Cardiologist as soon as the office opens. I have the following symptoms:
• Irregular heartbeat
• stomach discomfort (bloating)
• rash and hives
• hair loss
• anxiety (my shoulders are practically making contact with my ears)
• sleep problems
• increased sweating
• annoying visual disturbances
These are all listed on the package insert as possible side effects.
However, I am not ready to say they were caused by flecainide as I have had lifelong problems with allergies and digestive issues. Except for the visual disturbances…
I was on flecainide for 12 years―and it mostly worked well―until it didn’t anymore.”
Carol Baumann,
Salem, Oregon
Editor’s Comments
One of the most frequently prescribed antiarrhythmic drugs is flecainide acetate (Tambocor). Flecainide has been around a long time (1985) and is only available as a generic drug.
Instead of a daily dose, fecainide can be used as a “Pill-In-The-Pocket” treatment i.e., taking an antiarrhythmic med at the time of an A-Fib attack.
Flecainide carries an FDA “Black Box Warning” which is the most serious the FDA issues. A Black Box Warning alerts doctors and patients that a drug has potentially dangerous effects.
As with almost all antiarrhythmic drugs, flecainide is known for bad side effects.
To read a detailed description of flecainide, its uses and side effects, see fecainide at MedlinePlus/Drugs, Herbs and Supplements (U.S. National Library of Medicine).
Don’t Want to Take Anticoagulants? Three Alternatives for A-Fib Patients
With Atrial Fibrillation, you are 4–5 times more likely to have an A-Fib (ischemic) stroke. Taking an anticoagulant helps prevent an A-Fib stroke and may give you peace of mind.
The negative side is that all anticoagulants are high-risk medications and inherently dangerous. You bruise easily, cuts take a long time to stop bleeding. You can’t participate in any contact sports. Bleeding events are common complications. There is an increased risk of developing a hemorrhagic stroke and gastrointestinal bleeding. See Risks of Life-Long Anticoagulation.
(Most EPs are well aware of the risks of life-long anticoagulation.)
Don’t want to take anticoagulants? What’s the alternative? Remove the reason you need an anticoagulant!
Three Alternatives to Taking Anticoagulants
Anticoagulants are used with high-risk Atrial Fibrillation patients for the prevention of clots and stroke.
The best way to deal with the increased risk of stroke and side effects of anticoagulants is to no longer need them. Here are three options:
RF Catheter ablation
#1 Alternative: Get rid of your A-Fib.
As electrophysiologist (EP) and prolific blogger Dr. John Mandrola wrote: “…if there is no A-Fib, there is no benefit from anticoagulation.”
Action: Request a catheter ablation procedure. Today, you can have an ablation immediately (called ‘first-line therapy’). You don’t have to waste a year on failed drug therapies. See Catheter Ablation Reduces Stroke Risk Even for Higher Risk Patients
Placing Watchman in LAA
#2 Alternative: Close off your Left Atrial Appendage (LAA).
The Left Atrial Appendage is where 90%-95% of A-Fib clots originate. Closing off the LAA provides similar protection against having an A-Fib (ischemic) stroke as being on an anticoagulant.
Action: Request a Watchman device. The Watchman device is inserted to close off your LAA and keep clots from entering your blood stream. See Watchman Better Than Lifetime on Warfarin
Natural blood thinners
#3 Alternative: Consider non-prescription blood thinners
Perhaps you can benefit from an increase in natural blood thinners such as turmeric, ginger and vitamin E or, especially, the supplement Nattokinase.
Action: Ask your doctor about your CHA2DS2-VASc score (a stroke risk assessor). If your score is a 1 or 2 (out of 10), ask if you could take a non-prescription approach to a blood thinner. See FAQ: “Are natural blood thinners as good as prescription blood thinners?”
Bottom Line
Whether or not to take anticoagulants (and which one) is one of the most difficult decisions you and your doctor must make. To stop taking an anticoagulant, talk to your doctor about alternatives:
• Catheter ablation
• LAA closure (Watchman device)
• Non-prescription blood thinners
These options may help you to no longer need an anticoagulant. As Dr. John Mandrola wrote: “…if there is no A-Fib, there is no benefit from anticoagulation.”
As an A-Fib patient, don’t settle for a lifetime on anticoagulants or blood thinners. Remember: You must be your own best patient advocate.
Unsafe Interaction Between Pradaxa and Common Calcium Channel Blockers
An observational study published in 2020 found that people with A-Fib taking two common rate control calcium channel blockers along with the anticoagulant Pradaxa had higher bleeding rates (GI bleeding, minor bleeding, and minor GI bleeding).
The study was an analysis of the potential drug-drug interaction between verapamil or diltiazem and DOACs.
The term DOAC has replaced use of NOAC.
The study was conducted using US population-based data (2010-2015) analyzed between January 1 and July 15, 2019. Data were obtained on 48,442 patients with nonvalvular atrial fibrillation who had received an index prescription of dabigatran, rivaroxaban, or apixaban.
Analysis was restricted to individuals with no history of kidney disease who were receiving standard doses of the DOACs.
Drug-Drug Interactions Found When Co-Administered
Researchers found that taking the drugs Verapamil and Diltiazem (rate control calcium channel blockers) along with the anticoagulant Pradaxa had higher bleeding rates.
Other anticoagulants such as Xarelto and Eliquis didn’t cause more bleeding. (Apixaban [Eliquis] had consistently lower bleeding event rates among all DOACs.)
(For you technical types, Dabigatran functions as a P-glycoprotein inhibitor (P-gp), an important protein that pumps many foreign substances, such as toxins and drugs, out of cells. Verapamil and diltiazem are also P-gp inhibitors.)
Pradaxa Data Compiled and Compared to Four Calcium Channel Blockers
The investigators compiled data from IBM Watson MarketScan Databases.
Comparisons were made between 1,764 Pradaxa (dabigatran etexilate) users taking verapamil or diltiazem versus 3,105 Pradaxa users taking amlodipine (a calcium channel blocker used primarily to lower blood pressure which isn’t a P-gp inhibitor). The overall bleeding rate was 52% higher compared to amlodipine.
In addition, comparisons were made between 1,793 Pradaxa users taking verapamil or diltiazem versus 3,224 Pradaxa users on metoprolol (a beta-blocker which isn’t a P-gp inhibitor). The overall bleeding rate was 43% higher compared to metoprolol.
Avoid Mixing Pradaxa with Verapamil & Diltiazem
The message of this study is clear. “Clinicians and patients may need to consider alternative DOAC therapy other than dabigatran” when using P-gp inhibitors such as verapamil and diltiazem. (Amiodarone is another P-gp inhibitor.) “It is not safe to combine dabigatran (Pradaxa) with P-glycoprotein (P-gp) inhibitors in people with atrial fibrillation (Afib)” regardless of kidney function.
What This Means to Patients
If you are taking the anticoagulant Pradaxa, along with Verapamil and Diltiazem (rate control calcium channel blockers), talk to your doctor about changing to another DOAC (and take a copy of this article with you).
Happily, there are several DOACs, so there’s seldom an overwhelming need to continue on Pradaxa (dabigatran). Eliquis (apixaban), for example, tested the best and is the safest of the DOACs.
Post Surgery―Develops A-Fib, Drug Therapy & Supplements Restore Sinus Rhythm
My name is Richard, male, and born in 1945. I am 5′ 9’’, weigh 167 lbs., and am a non-smoker. My exercise is walking about 1.5 miles a day, and I have a healthy diet.
Complications from an Appendectomy Surgery―Develops A-Fib
In April 2018 I was in the hospital for three weeks. I had two surgeries, first an appendectomy and 10 days later correction of a problem caused by the first surgery.
After the second surgery I developed A-Fib, with no prior history of it.
The only drug to bring me back to sinus rhythm was Amiodarone. I left the hospital with prescriptions for Amiodarone 100 mg a day and Metoprolol Tartrate 25 mg twice a day.
Amiodarone Damages Thyroid
Everything was under control for several months. Until I had blood work that revealed my Thyroid was not functioning. Amiodarone was removed, and… continue reading Richard’s personal A-Fib story.
