Navigation Links
Experimental Drug for Irregular Heart Rhythm Raises Death Risk: Study

MONDAY, Nov. 14 (HealthDay News) -- A once-promising drug for a common and dangerous form of irregular heart rhythm actually seems to raise the odds for patient death, a new study finds.

The drug, dronedarone, had seemed effective against the non-chronic, "intermittent" form of atrial fibrillation in prior trials. But in the newer trial -- involving patients with ongoing, "permanent" atrial fibrillation -- use of dronedarone was tied to a doubling of the patients' death risk. The trial was cancelled early due to concerns over the drug's safety.

Atrial fibrillation is a heart rhythm disorder affecting about 2.7 million Americans that often occurs with age and can raise risks for stroke. In people with intermittent atrial fibrillation, the heart may return to normal rhythm on its own. But it does not do so in people with the more permanent form, who usually receive medications to control their heart rate.

One expert said the new study provides valuable guidance to doctors and patients.

"Rather than being a failure (which it is for the drug), this study is a 'win' for the cardiology community, in that it has tested and shown that this agent should not be used in such a fashion," said Dr. Stephen Green, associate chairman of the department of cardiology at North Shore University Hospital in Manhasset, N.Y.

The study was slated for presentation Monday at the annual meeting of the American Heart Association in Orlando, Fla. It is also being published simultaneously in the New England Journal of Medicine.

Dronedarone is currently used to treat intermittent atrial fibrillation but is not approved for treatment of the permanent form of the condition. This study was designed to investigate if dronedarone would benefit patients 65 and older with permanent atrial fibrillation, but it was halted after enrolling only 30 percent of the intended 10,800 patients.

Compared to those taking a placebo, patients who took dronedarone were 2.2 times more likely to suffer a major vascular event such as stroke, heart attack, systemic blood clot or cardiovascular death, the researchers found.

There were 21 cardiovascular deaths in the dronedarone group and 10 in the placebo (control) group; 13 deaths linked to arrhythmias (heart rhythm disorders) in the dronedarone group and four in the control group; and 22 strokes in the drug group versus nine in the control group.

The researchers also found that dronedarone increased the risk of hospitalization for heart failure and that the nearly one-third of patients in the dronedarone group who had been taking the heart rhythm drug digitalis had a 36 percent rise in their digitalis blood levels.

That suggests that an "increase in digitalis played a causative role in the increased risk of cardiovascular death," lead author Dr. Stuart J. Connolly, a professor of cardiology at McMaster University in Hamilton, Canada, said in an American Heart Association news release. "But this does not explain the increase in stroke or heart failure," he added.

Still, "the message is that the drug dronedarone should not be used for permanent atrial fibrillation," Connolly said.

Green agreed. "The pertinent points are: Antiarrhythmic agents have traditionally had a difficult risk/benefit ratio, and large-scale studies are useful to choose the correct patient for the correct drug," and, "it is important to trial agents for non-FDA-approved indications, rather than use them indiscriminately," he explained.

More information

The U.S. National Heart, Lung, and Blood Institute has more about atrial fibrillation.

-- Robert Preidt

SOURCES: Stephen Green, M.D., associate chairman, department of cardiology, North Shore University Hospital, Manhasset, N.Y.; Nov. 14, 2011, New England Journal of Medicine, online; American Heart Association, news release, Nov. 14, 2011

Copyright©2010 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. Experimental Drug Slims Obese Monkeys
2. Experimental Psoriasis Drug Bests Older Treatment
3. Experimental Vaccine Shows Promise for Lung Cancer: Study
4. Experimental vaccine protects monkeys from blinding trachoma
5. Experimental MS Drug Shows Promise
6. Researchers create new experimental vaccine against chikungunya virus
7. Experimental Drug Promising Against Tough-to-Treat Asthma
8. University Hospitals Case Medical Center to begin clinical trial on experimental anti-TB drug
9. Experimental Drug Might Help Fight Alzheimers After All
10. Experimental Drug Bests Chemo in Non-Small Cell Lung Cancer Study
11. Experimental Vaccine Seems to Cure Prostate Cancer in Mice
Post Your Comments:
Related Image:
Experimental Drug for Irregular Heart Rhythm Raises Death Risk: Study
(Date:11/25/2015)... ... 2015 , ... For the first time, Vitalalert is donating half of its ... The partnership between the two groups began in 2014 with Vitalalert pledging a portion ... International was founded in 1954 and is an international Christian-based health organization whose mission ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... across the country to celebrate their sobriety and show through pictures what a ... and after” photos this Thanksgiving with the hashtag #FacesOfGratitude on their Facebook, Twitter, ...
(Date:11/25/2015)... ... ... On November 25, 2015, officials of Narconon Arrowhead , the drug rehabilitation ... new cutting edge recovery program that has been 50 years in the making. ... with the purpose to free addicts from the symptoms and negative behaviors of addiction. ...
(Date:11/25/2015)... , ... November 25, 2015 , ... The McHenry County ... recent successful appellate decision obtained by Attorneys Francisco J. Botto and Alex C. Wimmer. ... Illinois Workers’ Compensation Comm’n, 2015 IL App (2d) 130884WC. , According to court documents, ...
(Date:11/25/2015)... ... November 25, 2015 , ... Smiles by Stevens ... Bruxism, and moderate facial wrinkling. While many patients are aware of the benefits of ... success Botox® delivers to those suffering with discomfort, soreness, and pain as a result ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... 26, 2015 --> ... approach blends immunotherapy with Bremachlorin-photodynamic therapy for advanced cancer. ... blends immunotherapy with Bremachlorin-photodynamic therapy for advanced cancer. ... blends immunotherapy with Bremachlorin-photodynamic therapy for advanced cancer. ... found that immunotherapy can be efficiently combined with photodynamic ...
(Date:11/26/2015)... and Markets ( ) has announced the addition of ... - Rise in Cardiac Disorders and Growing Awareness among People ... Boston scientific and others. ... others. --> The market is dominated by ... scientific and others. Asia ...
(Date:11/26/2015)... DUBLIN , November 26, 2015 /PRNewswire/ ... the addition of the "2016 Future ... Drugs of Abuse Testing Market: Supplier Shares, ... report to their offering. --> ... of the "2016 Future Horizons and ...
Breaking Medicine Technology: