Dronedarone for atrial fibrillation: the limited reliability of clinical practice guidelines.

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.

Prealbumin serum concentrations as a useful tool in the assessment of malnutrition in hospitalized patients.

BACKGROUND: Protein-energy malnutrition (PEM) is a common condition among patients admitted to hospitals, and it is associated with a worse prognosis and increased mortality. Although several screening systems have been developed, PEM is still poorly recognized, and there is no consensus on which test is more reliable and feasible in clinical practice. Prealbumin (PAB) is a potential useful PEM marker because its serum concentrations are closely related to early changes in nutritional status. METHODS: We studied PEM prevalence and PAB serum concentrations in 108 hospitalized patients. The Detailed Nutritional Assessment (DNA) was used as the reference method to determine PEM. PAB performance was compared with that of 2 other methods, the Subjective Global Assessment (SGA) and the Prognostic Inflammatory and Nutritional Index score (PINI). RESULTS: According to the DNA reference method, 41% of patients were classified with mild malnutrition and 19% with severe malnutrition. PAB showed the best concordance with the standard DNA method (concordance index, 76.8%) and a good sensitivity/specificity profile (83.1%/76.7%) compared with SGA and PINI. CONCLUSIONS: We conclude that PAB could represent a feasible and reliable tool in the evaluation of malnutrition, especially in settings where it is difficult to obtain a more detailed and comprehensive nutritional assessment such as the DNA.