Effects of supratherapeutic doses of ebastine and terfenadine on the QT interval

Gillen, Michael; Miller, Barry; Chaikin, Philip; Morganroth, Joel

doi:10.1046/j.0306-5251.2001.01345.x

Cited by 38 publications

(25 citation statements)

References 14 publications

(12 reference statements)

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“…Compared with placebo, mean heart rate increased significantly with ebastine (increase of 8-10 beats/min; P £ 0.002), but not with terfenadine (76). Ebastine was associated with a decrease in uncorrected QT interval, which was consistent with the increased heart rate seen in these groups.…”

Section: Cardiac Safetysupporting

confidence: 75%

“…It has been reported that BazettÕs formula may be inaccurate at describing the relationship between QTc and RR intervals, and it is possible that this formula overcorrected for heart rate in this study, leading to the significant difference in Bazett-corrected QTc interval seen in the ebastine 100 mg group (76). Additional analysis of the data from this study confirmed that the outcome for ebastine depended on the particular correction used, whereas results for terfenadine were largely independent of the formula (77).…”

Section: Cardiac Safetysupporting

confidence: 70%

“…The change in QTc with ebastine 100 mg (+10.3 ms) was statistically significantly greater than that seen with placebo (P = 0.0034); however, it was significantly less than that seen with terfenadine (+18.0 ms; P < 0.05). In addition, when QTc was corrected using the Friderica formula, there was no significant difference between either dose of ebastine and placebo, whereas terfenadine caused a significantly greater change in QTc interval than ebastine or placebo (P < 0.0001) (76). No recipients of ebastine experienced an increase in QTc interval of >10% (75).…”

Section: Cardiac Safetymentioning

confidence: 99%

“…The effects of supratherapeutic doses of ebastine on the ECG were assessed in a randomized, investigatorblinded, four-way cross-over study in 32 healthy male volunteers (76). Volunteers received ebastine 60 and 100 mg once-daily (three and five times the maximum recommended dose), terfenadine 180 mg twice daily (three times the recommended dose) and placebo, for 7 days each, with treatment periods separated by a 13-day washout period.…”

Section: Cardiac Safetymentioning

confidence: 99%

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Ebastine in allergic rhinitis and chronic idiopathic urticaria

Sastre

2008

Allergy

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Histamine is a key mediator in the development of allergy symptoms, and oral H1‐antihistamines are among the most widely used treatments for symptomatic relief in conditions such as allergic rhinitis and chronic urticaria. Ebastine is a second‐generation antihistamine which has been shown to be an effective treatment for both seasonal and perennial allergic rhinitis. In controlled clinical trials in adult and adolescent patients with allergic rhinitis, ebastine 10 mg once‐daily improved symptoms to a significantly greater extent than placebo and to a similar extent as loratadine 10 mg and cetirizine 10 mg (both once‐daily), while ebastine 20 mg proved to be more effective than these two comparator antihistamines. In addition, ebastine was significantly more effective than placebo at relieving the symptoms of chronic idiopathic urticaria. Ebastine provides efficacy throughout the 24‐h dosing interval with once‐daily administration and clinical benefit is seen from the first day of treatment. Small studies have found beneficial effects for ebastine in patients with other disorders, including cold urticaria, dermographic urticaria, atopic asthma, mosquito bites and (in combination with pseudoephedrine) the common cold. In addition to the regular ebastine tablet, a fast‐dissolving tablet (FDT) formulation, which disintegrates in the mouth without the aid of a drink, is also available. It has been shown to be bioequivalent to the regular tablet, and to be significantly more effective than desloratadine at reducing histamine‐induced cutaneous wheals. A number of patient surveys demonstrated that the majority of individuals who tried the fast‐dissolving formulation reported it to be convenient for use, fast‐acting and preferred it to their previous antihistamine medication. Perhaps most importantly, a large proportion of patients indicated that they would prefer to use this new formulation in the future. Ebastine has a rapid onset of action and it can be administered once‐daily, with or without food. Dose modifications are not needed in elderly patients, or in those with renal or mild to moderate hepatic impairment. Ebastine is generally well‐tolerated, and clinical studies showed that at usual therapeutic doses of 10 and 20 mg once‐daily, it had no clinically relevant adverse effects on cognitive function and psychomotor performance or on cardiovascular function. In conclusion, ebastine is an effective and generally well‐tolerated treatment for allergic rhinitis and chronic idiopathic urticaria. In addition to the regular tablet formulation, ebastine is available as a FDT, providing a treatment option that is particularly convenient for patients.

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Section: Cardiac Safetysupporting

confidence: 75%

Section: Cardiac Safetysupporting

confidence: 70%

Section: Cardiac Safetymentioning

confidence: 99%

Section: Cardiac Safetymentioning

confidence: 99%

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Ebastine in allergic rhinitis and chronic idiopathic urticaria

Sastre

2008

Allergy

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“…However, no significant QT c increase was observed in dose ranging studies [67,69]. In a study aiming to compare the effects of supratherapeutic doses of ebastine and terfenadine on the QT interval, ebastine at doses up to five times the recommended therapeutic dose did not cause clinically relevant changes in QTc interval [70].…”

Section: Ebastinementioning

confidence: 98%

Adverse Systemic Reactions of Antihistamines: Highlights in Sedating Effects, Cardiotoxicity and Drug Interactions

Kus¹

2005

CMCAIAA

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Antihistamines are already among the most frequently used pharmaceutical compounds and with the predictable increase of the prevalence of atopic disease, even more patients are expected to use them in future. Though the common belief on their safety has existed since some decades, they, including the over the counter ones, might potentially bear serious side effects. Thus , the following article focuses on the adverse effects of antihistamines by summarizing the current data mainly on central nervous system and cardiovascular side effects. Meanwhile, less common side effects, and important issues like their use in pregnancy and lactation are also included. Updated information is provided on drug interactions and overdose situations along with their management. As a finalstep, pitfalls in choosing suitable antihistamine/s in special circumstances to avoid adverse effects are also covered.

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Effect of Enzyte on QT and QTc Intervals

Phillips¹,

Sullivan²,

Snyder³

et al. 2010

Arch Intern Med

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deaths. Passengers who were reported to be unconscious were 33 times more likely to require diversion and 234 times more likely to die during flight. Passengers who required the use of an AED were 35 times more likely to be diverted. Diagnostic category was associated with diversions but not deaths. Neurological (39.1%), cardiac (23.9%), and obstetric and/or gynecological (13.0%) problems accounted for most of the diversions. Obstetric and/or gynecological cases had a diversion rate of 10.7%, which was higher than the rate for neurological (2.5%) or cardiac (4.4%) cases.

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Effects of supratherapeutic doses of ebastine and terfenadine on the QT interval

Cited by 38 publications

References 14 publications

Ebastine in allergic rhinitis and chronic idiopathic urticaria

Ebastine in allergic rhinitis and chronic idiopathic urticaria

Adverse Systemic Reactions of Antihistamines: Highlights in Sedating Effects, Cardiotoxicity and Drug Interactions

Effect of Enzyte on QT and QTc Intervals

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