Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

ESC Congress 2004: Dronedarone is effective and well-tolerated in the prevention of atrial fibrillation recurrence

30.08.2004


On behalf of the Steering Committee of the American-Australian-African trial with DronedarONe In atrial fibrillation or flutter patients for the maintenance of Sinus rhythm



ADONIS trial findings presented at the European Society of Cardiology Congress in Munich

The findings of the “American-Australian-African trial with DronedarONe In atrial fibrillation or flutter patients for the maintenance of Sinus rhythm” (ADONIS) trial, announced today at the annual meeting of the European Society of Cardiology in Munich, Germany showed that the new anti-arrhythmic agent, dronedarone, is highly effective in the prevention of atrial fibrillation or atrial flutter recurrence, serious disorders of cardiac rhythm, and is well-tolerated by patients. ADONIS is part of the clinical investigation program on the novel multi-channel blocker, dronedarone, in this patient population, which also includes the European trial EURIDIS (EURopean trial In atrial fibrillation or flutter patients receiving Dronedarone for the maIntenance of Sinus rhythm).


The ADONIS trial involved 625 patients in 115 centers in the US, Canada, Argentina, Australia and South Africa. The study compared the efficacy and safety of dronedarone to placebo in patients who had already had at least one ECG-documented atrial fibrillation or flutter in the three month period prior to randomization and who were in sinus rhythm for at least one hour at the time of randomization. Using 2:1 randomization in order to optimize the assessment of safety parameters, patients received either 400 mg bid of dronedarone (n=417)or placebo (n=208) for a period of 12 months. The primary endpoint of ADONIS was the time from randomization to the first adjudicated recurrence of atrial fibrillation or flutter (AF/AFL) within the 12 month study period. All recurrences of AF/AFL had to last for at least ten minutes and were confirmed by two consecutive electrocardiograms (ECGs) or Trans-Telephonic Electrocardiographic Monitoring (TTEM) tracings recorded approximately 10 minutes apart and both showing atrial fibrillation or flutter.

“ADONIS demonstrated that dronedarone is a highly effective and well tolerated agent in the prevention of both symptomatic and asymptomatic recurrences of AF/AFL,” said Bramah N. Singh, MD, PhD, Professor of Medicine, Department of Medicine, Cardiology Division, UCLA Medical School and Chairman of the ADONIS trial Steering Committee. “Dronedarone was also shown to be effective in decreasing the heart rate of patients with AF recurrences and the drug’s cardiac tolerability was good with no cases of torsades de pointes,” he added.

The ADONIS study showed that the median time from randomization to a first adjudicated AF/AFL recurrence was 2.7-fold longer in the dronedarone group than in the placebo group. Dronedarone significantly decreased the risk of a first recurrence of AF/AFL within the 12-month study period by 27.5% compared to placebo (log-rank test p=0.0017).

Most initial AF/AFL recurrences were symptomatic in both groups of patients. Overall incidence of adverse events was comparable in the two groups (73% in the placebo arm and 80% in the dronedarone group, (p = ns)) and dronedarone also displayed good cardiac tolerability, with no cases of torsades de pointes.

“The results of the ADONIS and EURIDIS trials show remarkable consistency for both the antiarrhythmic efficacy as well as the safety of dronedarone,” said Stefan Hohnloser MD, PhD, Professor of Medicine, Department of Internal Medicine J.W. Goethe University, Frankfurt, Germany and member of the EURIDIS trial Steering Committee. “Given the relatively poor benefit-to-risk ratios of currently available anti-arrhythmic therapies, the results of the EURIDIS and ADONIS trials appear to position dronedarone as a promising option for cardiac rhythm space and rate control in atrial fibrillation,” he added.

Camilla Dormer | alfa
Further information:
http://www.escardio.org

More articles from Health and Medicine:

nachricht Millions through license revenues
27.04.2017 | Rheinische Friedrich-Wilhelms-Universität Bonn

nachricht New High-Performance Center Translational Medical Engineering
26.04.2017 | Fraunhofer ITEM

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Making lightweight construction suitable for series production

More and more automobile companies are focusing on body parts made of carbon fiber reinforced plastics (CFRP). However, manufacturing and repair costs must be further reduced in order to make CFRP more economical in use. Together with the Volkswagen AG and five other partners in the project HolQueSt 3D, the Laser Zentrum Hannover e.V. (LZH) has developed laser processes for the automatic trimming, drilling and repair of three-dimensional components.

Automated manufacturing processes are the basis for ultimately establishing the series production of CFRP components. In the project HolQueSt 3D, the LZH has...

Im Focus: Wonder material? Novel nanotube structure strengthens thin films for flexible electronics

Reflecting the structure of composites found in nature and the ancient world, researchers at the University of Illinois at Urbana-Champaign have synthesized thin carbon nanotube (CNT) textiles that exhibit both high electrical conductivity and a level of toughness that is about fifty times higher than copper films, currently used in electronics.

"The structural robustness of thin metal films has significant importance for the reliable operation of smart skin and flexible electronics including...

Im Focus: Deep inside Galaxy M87

The nearby, giant radio galaxy M87 hosts a supermassive black hole (BH) and is well-known for its bright jet dominating the spectrum over ten orders of magnitude in frequency. Due to its proximity, jet prominence, and the large black hole mass, M87 is the best laboratory for investigating the formation, acceleration, and collimation of relativistic jets. A research team led by Silke Britzen from the Max Planck Institute for Radio Astronomy in Bonn, Germany, has found strong indication for turbulent processes connecting the accretion disk and the jet of that galaxy providing insights into the longstanding problem of the origin of astrophysical jets.

Supermassive black holes form some of the most enigmatic phenomena in astrophysics. Their enormous energy output is supposed to be generated by the...

Im Focus: A Quantum Low Pass for Photons

Physicists in Garching observe novel quantum effect that limits the number of emitted photons.

The probability to find a certain number of photons inside a laser pulse usually corresponds to a classical distribution of independent events, the so-called...

Im Focus: Microprocessors based on a layer of just three atoms

Microprocessors based on atomically thin materials hold the promise of the evolution of traditional processors as well as new applications in the field of flexible electronics. Now, a TU Wien research team led by Thomas Müller has made a breakthrough in this field as part of an ongoing research project.

Two-dimensional materials, or 2D materials for short, are extremely versatile, although – or often more precisely because – they are made up of just one or a...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Expert meeting “Health Business Connect” will connect international medical technology companies

20.04.2017 | Event News

Wenn der Computer das Gehirn austrickst

18.04.2017 | Event News

7th International Conference on Crystalline Silicon Photovoltaics in Freiburg on April 3-5, 2017

03.04.2017 | Event News

 
Latest News

Bare bones: Making bones transparent

27.04.2017 | Life Sciences

Study offers new theoretical approach to describing non-equilibrium phase transitions

27.04.2017 | Physics and Astronomy

From volcano's slope, NASA instrument looks sky high and to the future

27.04.2017 | Earth Sciences

VideoLinks
B2B-VideoLinks
More VideoLinks >>>