Efficacy and safety profile of dronedarone in clinical practice. Preliminary results of the Magdeburg Dronedarone Registry

Said, Samir M.; Esperer, Hans D.; Kluba, Kathrin; Genz, Conrad; Wiedemann, Anne K.; Boenigk, Hagen; Herold, Joerg; Schmeißer, Alexander; Braun-Dullaeus, Ruediger C.

doi:10.1016/j.ijcard.2012.03.133

Cited by 9 publications

(5 citation statements)

References 6 publications

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“…In summary, the data we present, as well as those reported in the PALLAS study, do not confirm prior results, which had suggested a good safety profile of dronedarone. Nonetheless, dronedarone seems to be useful in selected patient groups.…”

Section: Discussioncontrasting

confidence: 99%

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Which Patient is Most Likely to Benefit From Dronedarone? Analysis From the Magdeburg Dronedarone Registry (MADRE Study)

Said

Esperer

Kluba

et al. 2013

The Journal of Clinical Pharmacology

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Based on an analysis of the Magdeburg Dronedarone Registry data we sought to determine which patients could benefit from dronedarone therapy regarding rhythm control. The study included 191 patients (85 women) aged 63 ± 10 years with a history of paroxysmal or persistent AF and a follow-up of 14 ± 5 months. The total AF recurrence rate was 67% and lone AF was significantly more often associated with AF recurrences than non-lone AF (84% vs. 62%, P = .01). Arterial hypertension, treated coronary artery disease, and diabetes mellitus were not significantly related to AF recurrences (64%, 67%, 58% resp. P = .3). Response rate to dronedarone in patients with slightly increased left atrial size was significantly greater than in patients with normal or markedly increased left atrial size (47%, 16%, 27% resp., P = .001). The rate of adverse effects was 32% in the study sample, and was significantly lower in patients with lone AF as compared to those with non-lone AF (11% vs. 37%, P = .002). The body mass index was a predictor neither of response rate nor adverse effects. The results suggest that dronedarone is more effective in patients with non-lone AF and slightly increased left atrial size.

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Section: Discussioncontrasting

confidence: 99%

“…However, two trials using dronedarone were prematurely terminated because of excess mortality among the patients in the active therapy . Additionally, a complex spectrum of effects and adverse effects has been recently reported …”

mentioning

confidence: 99%

Which Patient is Most Likely to Benefit From Dronedarone? Analysis From the Magdeburg Dronedarone Registry (MADRE Study)

Said

Esperer

Kluba

et al. 2013

The Journal of Clinical Pharmacology

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“…In conclusion, the safety profile of dronedarone is not completely known, and it has been questioned in recent systematic reviews and meta‐analyses . Our findings add to the body of evidence concerning cardiovascular, hepatic and pulmonary risks and suggest the need to reconsider the risk/benefit ratio of this new antiarrhythmic drug.…”

Section: Discussionmentioning

confidence: 76%

Dronedarone‐associated acute renal failure: evidence coming from the Italian spontaneous ADR reporting database

Biagi

Venegoni²,

Melis

et al. 2013

Brit J Clinical Pharma

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Aim To describe cases of acute renal failure (ARF) and of renal failure (RF) from dronedarone retrieved in the general population during post‐marketing surveillance through the Italian spontaneous ADR reporting database. Methods A case by case analysis was performed. Reports codified with the System Organ Class (SOC) term ‘urinary system disorders’ of the ADR terminology of the World Health Organization associated with dronedarone treatment were selected. Results Out of 124 069 ADR reports, in 55 of them dronedarone was listed as the suspected drug. Among these reports, we identified four cases of ARF, two of RF and three cases of increase of blood creatinine submitted by physicians between October 2010 and December 2011. The patient age was from 61 to 84 years and most cases occurred within the first 13 days of initiation of dronedarone therapy (range 6 days – 2 months). Only one patient received a co‐suspected drug labelled for causing ARF. In all reports but one, positive dechallenge was reported. Conclusions Clinicians should be made aware of the risk of ARF/RF associated with dronedarone and of the need to screen patients appropriately for ARF/RF risk factors before starting dronedarone therapy.

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“…Therefore, a wide variety of potential ECG alterations can be expected. In fact, QT-interval prolongation, increased frequency of ventricular premature beats, and episodes of atrial flutter have all been reported as potentially proarrhythmic side effects of dronedarone ( 2 , 3 ). However, increased QRS duration has not so far been documented.…”

Section: Discussionmentioning

confidence: 99%

“…Dronedarone is a derivate of the potent antiarrhythmic drug amiodarone that was designed to have less toxic side effects ( 1 ). Although dronedarone was approved following reports of an improved safety profile, more recent studies have cast doubt on its safety ( 1 - 2 - 3 ). However, dronedarone is still held to be less proarrhythmic than comparable compounds, although its proarrhythmia potential in humans has not been sufficiently evaluated ( 1 ).…”

Section: Introductionmentioning

confidence: 99%

Marked Prolongation of QRS Duration after Initiation of Dronedarone Therapy

Genz

Esperer

Schmeißer

et al. 2014

Heart International

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Dronedarone is a relatively new antiarrhythmic drug and is held to be less proarrhythmic than comparable compounds, although its proarrhythmia potential in humans has not been sufficiently evaluated. We describe a so far unreported dronedarone effect, namely a significant alteration of both the morphology and the duration of the QRS complex on the electro cardiogram in a 41-year old patient with symptomatic paroxysmal atrial fibrillation.

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Efficacy and safety profile of dronedarone in clinical practice. Preliminary results of the Magdeburg Dronedarone Registry

Cited by 9 publications

References 6 publications

Which Patient is Most Likely to Benefit From Dronedarone? Analysis From the Magdeburg Dronedarone Registry (MADRE Study)

Which Patient is Most Likely to Benefit From Dronedarone? Analysis From the Magdeburg Dronedarone Registry (MADRE Study)

Dronedarone‐associated acute renal failure: evidence coming from the Italian spontaneous ADR reporting database

Marked Prolongation of QRS Duration after Initiation of Dronedarone Therapy

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