VIEWS: 2 PAGES: 2 CATEGORY: Medicine POSTED ON: 6/13/2010
Dronedarone reduces first hospitalizations but not mortality in high-risk patients Clinical question Does dronedarone improve clinical outcomes in high-risk patients with atrial fibrillation? Patients with severe or decompensated heart failure, permanent atrial fibrillation, acute myocarditis, and bradycardia were also excluded (a previous study in patients with severe heart failure found increased mortality with dronedarone [N Engl J Med. 2008;358(25):2678-2687]).
POEMs0509.qxp 4/24/09 1:57 PM Page 56 Patient-oriented evidence that matters POEMs Dronedarone reduces first not described, but analysis was by in- although important, is poorly described hospitalizations but not tention to treat, groups were balanced and could have missed important mortality in high-risk patients at the start of the study, and outcomes unpublished studies. Rather than use Clinical question Does dronedarone were blindly adjudicated. Once en- the published data, these authors ob- improve clinical outcomes in high-risk rolled, patients currently in atrial fibril- tained the patient-specific data from the patients with atrial fibrillation? lation underwent anticoagulation and studies and pooled them. Four trials Bottom line Dronedarone will prevent cardioversion. Patients were followed met their inclusion criteria and each one hospitalization for every 14 high- up for at least 12 months, with a mean provided data for nearly 3,000 patients, risk, older patients with intermittent follow-up of 21.5 months. Approxi- 1,289 of whom were randomized to atrial fibrillation treated for 2 years. mately 30% of patients in each group receive placebo and 1,678 to receive There is no impact on all-cause mortali- discontinued taking the study drug or aspirin. The mean age was 58 years ty, and adverse effects were more com- placebo prematurely. There was no dif- and approximately 60% of the patients mon in the dronedarone group (num- ference in all-cause mortality between were men. At the end of the studies, ber needed to treat to harm = 25). groups: 5% for dronedarone versus 6% approximately 93% of the patients in (Level of evidence = 1b) for placebo. The primary benefit was each group had been followed up and Synopsis Dronedarone is a cousin to a reduction in first hospitalizations adherence to study medication was amiodarone, modifed to reduce tissue for atrial fibrillation (14.6% vs 21.9%; higher than 80%. The median length accumulation and hopefully toxicity. In P < .001; number needed to treat = of follow-up in the studies was 33 this study, 4,628 patients at 551 centers 14). Discontinuation because of ad- months. The authors did not use a true (not more than 9 per center) were ran- verse events—including bradycardia, intention-to-treat approach to analyzing domized to receive either 400 mg twice QT interval prolongation, GI symp- the data. In general, this tends to inflate a day or matching placebo. Patients toms, and increased serum creatinine— the estimates of benefit. Patients taking were included in the study if they had was more common in the dronedarone aspirin were less likely to have a recur- ECGs confirming both atrial fibrilla- group (12.7% vs 8.1%). rent adenoma on follow-up colonos- tion or flutter and normal sinus rhythm Hohnloser SH, Crijns HJ, van Eickels M, et al; ATHENA copy (33%) than those taking placebo in the previous 6 months. They also Investigators. Effect of dronedarone on cardiovascular events in (37%; number nee
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