Cardiovascular PharmacologyCardiovascular Safety of FexofenadineHCl
Section snippets
Methods
To avoid inter-reader variability, all electrocardiographs were read by a single cardiologist, who was blinded to the treatment assignment. The electrocardiographs were analyzed by RR and QT intervals by means of a standard, automated process. All QTc measurements were made on ≥3 successive QTc intervals, and a cycle was measured on the corresponding RR intervals. In general, the QTc measurements were made in lead II; however, occasionally another appropriate lead was selected if lead II was
Clinical trials in patients with seasonal allergic rhinitis
Two double-blind, randomized, 2-week placebo-controlled parallel studies were conducted with a total of 1,160 patients (870 received fexofenadine HCl and 290 received placebo) with SAR symptoms (Table I). 11, 12 Doses of 40, 60, 120, and 240 mg fexofenadine HCl twice daily were compared with placebo for a dosing period of 2 weeks. Electrocardiographs were collected before randomization and at 1 to 3 hours following the final dose, when plasma levels of fexofenadine were expected to be highest.
Discussion
Extensive electrocardiographic data from >2,100 patients who received fexofenadine HCl or placebo in controlled clinical trials demonstrates that fexofenadine does not increase QTc even when administered long-term in doses 10-fold that of the recommended dosage (60 mg twice daily). Moreover, no case of torsade de pointes ventricular tachycardia was observed in approximately 6,000 patients who received fexofenadine during clinical development of the drug.
The risk factor for ventricular
Acknowledgements
The authors thank Sheila Owens for assistance in the development of this manuscript.
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