Patient-oriented evidence that matters: POEMs by ProQuest

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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]).

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									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      mortality in high-risk patients                at the start of the study, and outcomes                            unpublished studies.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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