adverse effects of dronedarone

Rebuilding value of antiarrhythmic therapy for atrial fibrillation by improving forecast. Note the adverse effects of dronedarone described.

Proven for over 500 days of the antiarrhythmic agent dronedarone in Germany in Practice: antiarrhythmic drug dronedarone as a first for non-permanent atrial fibrillation studies, a reduction in cardiovascular hospitalizations or death from any cause shown. This led to the recommendation of the European Society of Cardiology (European Society of Cardiology, ESC). Dronedarone was as a treatment option of choice for the maintenance of sinus rhythm in patients with non-permanent atrial fibrillation (AF) (except for patients with chronic heart failure NYHA class III / IV or unstable - decompensation within the last month - heart failure NYHA class II) included in the ESC guidelines.

• antiarrhythmic drug dronedarone reduced first cardiovascular-related hospitalizations or death from any cause

• As a first-line therapy in patients with non-permanent AF in the ESC guidelines included

• Quality of life and avoidance of hospitalization as new therapeutic target in the ESC guidelines

In addition, the guidelines recommend a single antiarrhythmic drug dronedarone to reduce cardiovascular hospitalizations in patients with non-permanent AF and cardiovascular risk factors. (1) in Germany were treated over 70,000 patients since approval of dronedarone (Multaq ®). "The treatment histories allow important conclusions for the future proper use in practice, explained Prof. Dr. Dieter pair, Director of Medical and Scientifc Affairs at Sanofi-Aventis Germany GmbH during the press conference the company on 9 June 2011 in Frankfurt am Main. "The correct use of dronedarone in patients for whom it is suitable, we continue to be a very important concern," said pair. "We have therefore supported by the doctors at the start of the therapy management of patients: not only with the technical information but also with an information card to the most important security-related topics. . This allows the attending physician a quick overview on the proper use of dronedarone adverse effects, interactions, cautions, and additional warnings and recommendations, "At the same time, the clinical research program will continue to dronedarone: The multinational, randomized, double-blind, Phase IIIb study Pallas is said to more than 10,000 patients with permanent atrial fibrillation, the potential clinical benefit of dronedarone in the reduction of major cardiovascular adverse effects events assessed. (2)

AF increases the risk for stroke victims, heart failure and death, leading to an increased risk for cardiovascular morbidity and mortality contributes. (3,4,5) "The most common rhythm disturbance also reduces the quality of life significantly," said Prof. Dr. Hendrik Bonnemeier, Kiel. "With the approval of dronedarone and its positive effects, including the hospitalization get the antiarrhythmic therapy on a new importance," stated Bonnemeier. The prevention of hospital stays has as goal of therapy of VHF therapy found its way into the new ESC guidelines also provide security in the rhythm control over its effectiveness. (1) "hospitalization frighten many patients and is thus also the associated organizational effort for those affected can not be underestimated," says cardiologist. That aspect of the quality of life as a patient-relevant endpoint closer and closer to the center is a welcome move, so Bonnemeier further.

"The addition of new therapeutic target has not been recently made possible by the results of the ATHENA trial with Multaq, which was first shown to have an antiarrhythmic agent, a reduction of the combined endpoint of mortality and hospitalization," said Prof. Dr. Andreas Goette, Paderborn, co-author of ESC AF guidelines. A recent indirect comparison analysis examined the differences between the antiarrhythmic therapy options dronedarone, amiodarone, sotalol, flecainide and propafenone for treatment of AF. (7) "A comparison of antiarrhythmic drugs with each other exhibited at dronedarone tend to have fewer side effects than other drugs that can sometimes even suggest an increase in mortality: Especially dangerous proarrhythmia were with taking dronedarone significantly reduced," concluded Götte. (6) "dronedarone shows that also in the comparative analysis of a tolerable side effect profile." (6), dronedarone reduced in the ATHENA study (7) the combined endpoint of cardiovascular hospitalization or death compared to placebo, a statistically significant 24 percent (31.9 vs percent. 39.4 percent, p <0.001). The cardiovascular mortality was reduced by 29 percent (p = 0.03) .7 "The prognosis of patients with Dronedarontherapie also improved at a later relapse VHF," Goette discussed. ". This also proves the wisdom of the purely based ECG assessment of an antiarrhythmic drug to depart" The subgroup of patients with coronary heart disease in which many antiarrhythmic drugs are adverse effects, benefited to a particular degree of treatment with dronedarone: A post-hoc analysis this subgroup showed a reduced risk by 27 percent for the primary endpoint of cardiovascular-related hospitalization or Tod.8 A further subgroup analysis of a lowered stroke risk by 34 percent resulted in dronedarone. (9) "The results of the indirect comparison analysis, the data support the reduction in stroke risk," said Goette. (6)

"Practical experience with dronedarone confirm the benefit-risk ratio of the study data," said the practicing cardiologist Dr. Ralph Bosch, Ludwigsburg. Besides antiarrhythmic it show frequency-reducing effects. (11), thyroid and lung function in question side effects, such as fear under administration of amiodarone were in Dronedaroneinnahme to placebo. (7.10) is important as with any drug, on strict compliance with the recommendations for use and contraindications to respect and deal with the specifics of the drug, so Bosch. Thus, the increase in plasma creatinine dronedarone. In this case, a new reference value is determined if the increase is seven days after initiation of treatment not more than ten percent. (10) "It is important that the treating physician prior to deal with this phenomenon is so ACE inhibitors or angiotensin II receptor antagonists are not sold unnecessary," said Bosch. Just as in patients treated with amiodarone should be done with a liver Dronedarongabe Monitoring: Liver function tests before starting treatment, then monthly and then during the first six months and in the ninth and twelfth month and perform at periodic intervals. (10) "A good patient education about the monitoring, but also the prognostic utility of the agent and the temporary nature of gastrointestinal side effects, for example, can have a positive impact on its compliance," recommended Bosch. It was also important that patients realize that potential VHF recurrences not affect the prognosis of improvement, so Bosch continues.

References

1) The Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology. European Heart Journal 2010th doi: 10.1093/eurheartj/ehq278. Guidelines for the management of atrial fibrillation.

2) adverse effects of dronedarone 

3) Lloyd-Jones et al. Lifetime Risk for Development of Atrial Fibrillation: The Framingham Heart Study. Circulation. 2004, 110:1042-1046.

4) Fuster V et al. ACC / AHA / ESC 2006 guidelines for the management of patients with atrial fibrillation. European Heart Journal (2006) 27, 1979-2030.

5) Benjamin EJ, et al. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation 1998 Sep 8, 98 (10) :946-52.

6) Freemantle N, et al. Indirect comparison analysis between dronedarone, amiodarone, sotalol, flecainide and propafenone for treatment of atrial fibrillation. Euro Pace 2011; 13:329-345.

7) SH Loser Hohn et al. ATHENA Investigators. Effect of dronedarone on cardiovascular events in atrial fibrillation. N Engl J Med 2009; 360 (7) :668-78.

8) HJGM Crijns et al. Effects of dronedarone on clinical outcomes in patients with atrial fibrillation and coronary heart disease: insights from the ATHENA study. EUR Heart J 2009; 30 (Abstract Suppl): 450

9) AJ Connolly et al. Analysis of Stroke in ATHENA: A Placebo-Controlled, Double-Blind, Parallel Arm Trial to Assess the Efficacy of dronedarone 400 mg BID for the Prevention of Cardiovascular Hospitalization or Death from any cause in patients with Atrial Fibrillation / Atrial Flutter. Circulation 2009; 120:1174-1180.

10) Reference Information Multaq at:.

11) Singh BN, Connolly SJ, Crijns HGJM, Roy D, Kowey PR, Capucci A, et al. (Members of the Steering Committee), for the EURIDIS and ADONIS Investigators: Dronedarone for maintenance of sinus rhythm in atrial fibrillation or flutter. N Engl J Med 2007; 357:987-99.

12) Ring Borg A et al. Costs of atrial fibrillation in five European countries: results from the Euro Heart Survey on atrial fibrillation. Euro Pace. 2008 Apr, 10 (4): 403-11. Epub 2008 Mar 7th