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Special Communication |

Dronedarone for Atrial Fibrillation The Limited Reliability of Clinical Practice Guidelines

Primiano Iannone, MD1; Enrico Haupt, MD1; Gaddo Flego, MD2; Paola Truglio, MD1; Monica Minardi, MD3; Simon Clarke, MD3; Nicola Magrini, MD4
[+] Author Affiliations
1Emergency Department, Tigullio Hospital, Lavagna, Italy
2Liguria Health Technology Assessment Network, Genova, Italy
3Emergency Department, Frimley Park Hospital, Frimley, England
4Drug Evaluation Unit, World Health Organization Collaborating Centre in Evidence-Based Research Synthesis and Guideline Development, Emilia Romagna Health and Social Care Agency, Bologna, Italy
JAMA Intern Med. 2014;174(4):625-629. doi:10.1001/jamainternmed.2013.14485.
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Concerns have been expressed about the reliability of clinical practice guidelines. We analyzed 3 guidelines from medical specialty societies about dronedarone hydrochloride, an antiarrhythmic drug related to amiodarone hydrochloride, for treatment of patients with atrial fibrillation. We compared the recommendations in these guidelines with the conclusions about dronedarone that we reached by applying the Grading of Recommendations Assessment, Development and Evaluation (GRADE) Method to the same evidence base. In our analysis, as a rate control drug, dronedarone was better than placebo only for a surrogate outcome (heart rate). As a rhythm control drug, dronedarone was associated with 13 (95% CI, −15 to 61) excess deaths per 1000 patients treated as compared with placebo. Compared with amiodarone, dronedarone was less effective (214 [95% CI, 130 to 294] more recurrences of atrial fibrillation per 1000 patients treated) and similarly tolerated (−28 [95% CI, −69 to 33] more serious adverse events requiring drug suspension per 1000 patients treated). Despite the limits of the evidence, all 3 guidelines recommended dronedarone for prevention of recurrences of atrial fibrillation; 2 of the guidelines recommended it as a rate control agent. Our findings raise questions about the reliability of these clinical practice guidelines, as well as the financial associations between many of the panel members and the manufacturer of dronedarone.

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Results of the Meta-analysis (Outcome: All-Cause Mortality) Excluding and Including the PALLAS Study

A, Excluding, and B, including the PALLAS study. Random-effects model showing the Mantel-Haenszel odds ratio. The DAFNE study did not contribute to the overall odds ratio because of the absence of events of interest. The ADONIS and EURIDIS studies were considered together because they had the same study design. Test for heterogeneity without PALLAS, I2 = 59%; with PALLAS, I2 = 64%.

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