Tramadol Induced QTc-Interval Prolongation: Prevalence, Clinical Factors and Correlation to Plasma Concentrations

Author(s): Guillermo A. Keller, María C.V. Etchegoyen, Nicolás Fernandez, Nancy M. Olivera, Patricia N. Quiroga, Waldo H. Belloso, Roberto A. Diez, Guillermo Di Girolamo.

Journal Name: Current Drug Safety

Volume 11 , Issue 3 , 2016

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Abstract:

In recent years, several cases of torsade de pointes have been associated with many opioids. However, to present no cases have been reported with tramadol.

Objective: To evaluate the effect of tramadol on QT-interval in the clinical setting.

Research Design and Methods: Medical history and comorbidities predisposing to QT interval prolongation were registered for patients requiring medical assistance that involved tramadol administration. Ionograms and ECGs were performed at baseline and intratreatment; QT interval was analyzed after correction with Bazzet, Fridericia, Framinghan and Hogdes formula.

Results: 115 patients were studied (50.4% males) All patients had received tramadol 150-400 mg/day during 3.0-5.0 days at the moment of intratreatment control. Plasma concentrations of tramadol were 201-1613 ng/mL. Intratreatment electrocardiographic control, as mean ± SD (range), showed QTcB 372±32 (305 to 433), QTcFri 356±37 (281 to 429), QTcFra 363±33 (299 to 429), QTcH 362±30 (304 to 427), ΔQTcB 26±40 (-73 to 110), ΔQTcFri 24±48 (-97 to 121), ΔQTcFra 22±42 (-81 to 109) and QTcH 22±38 (-68 to 110) ms. QTc interval presents high correlation with plasma tramadol concentrations (for QTc, R>0.77). Renal failure was associated with a relative risk for ΔQTc > 30 ms of 1.90 (IC95% 1.31-2.74) and for ΔQTc > 60 ms of 4.74 (IC95% 2.57-8.74). No patient had evidence of arrhythmia during the present study.

Conclusion: Tramadol produces QTc interval prolongation in good correlation with plasma drug concentrations; renal failure is a risk factor for higher concentration and QT prolongation by tramadol.

Keywords: Tramadol, QT-interval prolongation, torsade des pointes, arrhythmia, adverse drug reaction.

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Article Details

VOLUME: 11
ISSUE: 3
Year: 2016
Page: [206 - 214]
Pages: 9
DOI: 10.2174/1574886311666160225150405
Price: $65

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