Key result
Drug administration in everyday clinical practice resulted in QTc >450/470 ms in 9.9% of patients, with significant associations for furosemide, clarithromycin, and betalactamase inhibitors.
Why the study?
What is the prevalence and what are the clinical factors associated with drug-induced QTc prolongation in everyday clinical practice?
Observational (n=1,270)
Yes
What is the prevalence and what are the clinical factors associated with drug-induced QTc prolongation in everyday clinical practice?
Drug-induced QTc prolongation is frequent in everyday clinical practice and is associated with specific clinical factors and commonly used drugs like clarithromycin and furosemide.
Supports safety of therapeutic dextropropoxyphene dosing on QTc; leaves open risk at higher doses or in vulnerable patients.
OBJECTIVE: The actual prevalence of drug induced QTc prolongation in clinical practice is unknown. Our objective was to determine the occurrence and characteristics of drug-induced QT prolongation in several common clinical practices. Additionally, a subgroup of patients treated with dextropropoxyphene of particular interest for the regulatory authority was analysed. RESEARCH DESIGN AND METHODS: Medical history and comorbidities predisposing to QT interval prolongation were registered for 1270 patient requiring medical assistance that involved drug administration. Three ionograms and ECGs were performed: baseline, intra- and after treatment; QT interval was corrected with Bazzet formula. RESULTS: Among patients, 9.9% presented QTc >450/470 ms, 3% QTc > 500 ms, 12.7% ΔQTc >30 ms and 5.2% ΔQTc >60 ms. QTc prolongation associated with congestive heart failure, ischemic cardiopathy, diabetes, renal failure, arrhythmias, hypothyroidism, and bradycardia. At univariate analysis, clarithromycin, haloperidol, tramadol, amiodarone, glyceryl trinitrate, amoxicillin + clavulanic acid, amoxicillin + sulbactam, ampicillin + sulbactam, fentanyl, piperacillin + tazobactam, and diazepam prolonged QTc. Prolongation remained significantly associated with furosemide, clarithromycin, glyceryl trinitrate and betalactamase inhibitors after multivariate analysis. CONCLUSION: QT interval prolongation in everyday practice is frequent, in association to clinical factors and drugs that can be easily identified for monitoring and prevention strategies.
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Keller et al. (2015) conducted an observational in Patients requiring medical assistance involving drug administration (n=1,270). Drug administration was evaluated on QTc >450/470 ms. Drug administration in everyday clinical practice resulted in QTc >450/470 ms in 9.9% of patients, with significant associations for furosemide, clarithromycin, and betalactamase inhibitors.
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