Key result
FDA criteria miss ~83% of mitral DIVHD cases in benfluorex-exposed patients.
Cohort (n=1,376)
Yes
Answers are grounded in this paper and cite their sources.
Prospective multicentre study reveals FDA criteria misclassify drug-induced valvular heart disease after benfluorex exposure, highlighting the need for combined morphological valve assessments.
AIMS: The Food and Drug Administration (FDA) criteria for diagnosis of drug-induced valvular heart disease (DIVHD) are only based on the observation of aortic regurgitation ≥ mild and/or mitral regurgitation ≥ moderate. We sought to evaluate the diagnostic value of FDA criteria in a cohort of control patients and in a cohort of patients exposed to a drug (benfluorex) known to induce VHD. METHODS AND RESULTS: This prospective, multicentre study included 376 diabetic control patients not exposed to valvulopathic drugs and 1000 subjects previously exposed to benfluorex. Diagnosis of mitral or aortic DIVHD was based on a combined functional and morphological echocardiographic analysis of cardiac valves. Patients were classified according to the FDA criteria [mitral or aortic-FDA(+) and mitral or aortic-FDA(-)]. Among the 376 control patients, 2 were wrongly classified as mitral-FDA(+) and 17 as aortic-FDA(+) (0.53 and 4.5% of false positives, respectively). Of those exposed to benfluorex, 48 of 58 with a diagnosis of mitral DIVHD (83%) were classified as mitral-FDA(-), and 901 of the 910 patients (99%) without a diagnosis of the mitral DIVHD group were classified as mitral-FDA(-). All 40 patients with a diagnosis of aortic DIVHD were classified as aortic-FDA(+), and 105 of the 910 patients without a diagnosis of aortic DIVHD (12%) were classified aortic-FDA(+). Older age and lower BMI were independent predictors of disagreement between FDA criteria and the diagnosis of DIVHD in patients exposed to benfluorex (both P ≤ 0.001). CONCLUSIONS: FDA criteria solely based on the Doppler detection of cardiac valve regurgitation underestimate for the mitral valve and overestimate for the aortic valve the frequency of DIVHD. Therefore, the diagnosis of DIVHD must be based on a combined echocardiographic and Doppler morphological and functional analysis of cardiac valves.
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Maréchaux et al. (2014) conducted a cohort in Drug-induced valvular heart disease (DIVHD) (n=1,376). Benfluorex exposure (evaluated by FDA criteria vs combined functional and morphological echocardiographic analysis) vs. Diabetic control patients not exposed to valvulopathic drugs was evaluated on Diagnostic agreement between FDA criteria and combined functional/morphological echocardiographic diagnosis of mitral or aortic DIVHD. FDA criteria missed 83% (48/58) of mitral DIVHD cases and falsely classified 12% (105/910) of non-DIVHD patients as aortic-FDA(+) in benfluorex-exposed patients.
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