Efficacy and safety profile of dronedarone in clinical practice. Results of the Magdeburg Dronedarone Registry (MADRE study)

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.2012.06.056

Cited by 17 publications

(21 citation statements)

References 17 publications

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“…It should be noted that the recently approved amiodarone replacement drug, dronedarone, has also been shown to have antiparasitic activity in vitro (Benaim et al, 2012), raising the possibility that it may be effective in vivo against these parasites and be a less toxic alternative to amiodarone. This hope may be premature even though dronedarone was Food and Drug Administrationapproved after reports of an improved safety profile (Hohnloser et al, 2009), because more recent studies cast doubt on its safety (Said et al, 2012). Should additional studies show dronedarone to truly be safer than amiodarone, particularly during short-term use against parasitic agents, it could, in theory, be tested for antifungal activity by itself and in combination with antifungal drugs, in particular compound 4.…”

Section: Discussionmentioning

confidence: 99%

Synthesis and Antifungal Activity of Derivatives of 2- and 3-Benzofurancarboxylic Acids

Hejchman

Ostrowska

Maciejewska

et al. 2012

J Pharmacol Exp Ther

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Section: Discussionmentioning

confidence: 99%

Synthesis and Antifungal Activity of Derivatives of 2- and 3-Benzofurancarboxylic Acids

Hejchman

Ostrowska

Maciejewska

et al. 2012

J Pharmacol Exp Ther

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“…There are many potential reasons for changes and discontinuations in AAD therapy, including failure to control AF, emerging evidence for safety or effectiveness, non-adherence, and adverse events. 19–21 Additional research is needed to understand the reasons for these changes and discontinuations, as well as their impact on overall AF management, especially in relation to health care utilization.…”

Section: Discussionmentioning

confidence: 99%

Antiarrhythmic Drug Use in Patients <65 Years With Atrial Fibrillation and Without Structural Heart Disease

LaPointe¹,

Dai²,

Thomas³

et al. 2015

The American Journal of Cardiology

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Little is known in clinical practice about antiarrhythmic drug (AAD) use in atrial fibrillation (AF) patients (particularly younger ones) that do not have structural heart disease. Using the MarketScan® database, we identified patients <65 years of age without known coronary artery disease or heart failure who had an AAD prescription claim (Class Ic drug, amiodarone, sotalol, or dronedarone) after their first AF encounter. A multinomial logistic regression model was created to assess factors associated with using each available AAD, compared with using Class Ic drugs before and after dronedarone was marketed in the United States. Additionally, we used the Kaplan Meier method to determine the rates of change in AAD use and discontinuation during the year post-AAD initiation. Of 8562 AF patients, 35% received Class Ic drugs, 34% amiodarone, 24% sotalol, and 7% dronedarone. The median patient age was 56 (IQR 49, 61) and 34% were female. Both before and after dronedarone was marketed, there was a statistically significant lower likelihood of Class Ic drug use versus other AAD use with increasing age, inpatient index AF encounter, and prior or concomitant anticoagulation therapy. During the 1 year post-AAD initiation, the AAD change rate was 14% for Class Ic drugs, 8% amiodarone, 17% sotalol, and 18% dronedarone (p<0.001); the AAD discontinuation rate was 40% for Class Ic drugs, 52% amiodarone, 40% sotalol, and 69% dronedarone (p<0.001). In conclusion, we found extensive use of amiodarone that may be inconsistent with guideline recommendations, and unexpectedly high rates of AAD discontinuation.

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“…Few studies have assessed the use or associated outcomes of dronedarone in clinical practice, and to our knowledge, only one study assessed the impact of dronedarone on hospitalizations. 13,24,25 Kim et al compared the mean number of AF, cardiovascular, and all-cause hospitalizations in AF patients before and after the initiation of dronedarone. There was a statistically significantly lower mean number of AF, cardiovascular, and all-cause hospitalizations in the 1 year after dronedarone initiation compared to the 1 year before dronedarone was approved for market.…”

Section: Discussionmentioning

confidence: 99%

Comparisons of Hospitalization Rates Among Younger Atrial Fibrillation Patients Receiving Different Antiarrhythmic Drugs

LaPointe

Dai

Thomas

et al. 2015

Circ: Cardiovascular Quality and Outcomes

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Background Antiarrhythmic drugs (AADs) are used to reduce the frequency, severity, and duration of atrial fibrillation (AF) events, which should reduce hospitalizations; however, little is known about the associations between different AADs and hospitalization—particularly among younger AF patients without structural heart disease. Methods and Results Using MarketScan® claims data, we identified AF patients without coronary artery disease (CAD) or heart failure who received their first AAD prescription (amiodarone, sotalol, dronedarone, or Class Ic) within 14 days post-first AF encounter. The primary outcome was time from first AAD prescription to AF hospitalization and secondary outcomes included time to cardiovascular and all-cause hospitalizations. We used inverse probability-weighted estimators to adjust for differences in treatment allocation in the Cox proportional hazards model for each outcome. Among 8562 AF patients with a median age of 56 years (IQR 49,61), risk of AF hospitalization was greater with dronedarone than Class Ic (HR 1.59; 95% CI 1.13–2.24), amiodarone (HR 2.63;1.77–3.89), and sotalol (HR 1.72;1.17–2.54), but lower with amiodarone versus Class Ic (HR 0.68;0.57–0.80) and sotalol (HR 0.63;0.53–0.75). Risk of cardiovascular hospitalization was lower with amiodarone than Class Ic (HR 0.80;0.70–0.92), but not non-AF cardiovascular hospitalization (HR 1.26;1.01–1.57). There was no difference in all-cause hospitalization between amiodarone, Class Ic, and sotalol. Conclusions Differences in hospitalization rates were found between AADs in younger AF patients without structural heart disease. Amiodarone had the lowest risk of AF hospitalization and dronedarone had the greatest risk. Additional research is needed to better understand associations between AADs and hospitalization risk.

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Efficacy and safety profile of dronedarone in clinical practice. Results of the Magdeburg Dronedarone Registry (MADRE study)

Cited by 17 publications

References 17 publications

Synthesis and Antifungal Activity of Derivatives of 2- and 3-Benzofurancarboxylic Acids

Synthesis and Antifungal Activity of Derivatives of 2- and 3-Benzofurancarboxylic Acids

Antiarrhythmic Drug Use in Patients <65 Years With Atrial Fibrillation and Without Structural Heart Disease

Comparisons of Hospitalization Rates Among Younger Atrial Fibrillation Patients Receiving Different Antiarrhythmic Drugs

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