ZIB

Hits per page

hits 1 - 2 | 2 hits

Sorting

Electronic Resource

QT interval monitoring during clinical studies with mizolastine, a new H1 antihistamine (1999)

Delauche-Cavallier, M. C. ; Chaufour, S. ; Guérault, E. ; [et al.]

Oxford BSL : Blackwell Science Ltd

Clinical & experimental allergy 29 (1999), S. 0

add to mindlist on the mindlist

Details

ISSN: 1365-2222

Source: Blackwell Publishing Journal Backfiles 1879-2005

Topics: Medicine

Notes: Some H1 antihistamines are at risk for rare but severe dysrhythmias due to an effect on the ventricular repolarization.〈section xml:id="abs1-2"〉〈title type="main"〉ObjectiveTo present an overview of the QT interval monitoring performed during the clinical development of mizolastine, a new selective second-generation H1 antihistamine.〈section xml:id="abs1-3"〉〈title type="main"〉MethodsThe ECGs database analysis of clinical studies conducted in volunteers and patients is summarized and focused on the results of reported studies and studies specifically designed for the assessment of the effect of mizolastine on cardiac repolarization, through the QT interval measurements. Mizolastine was orally administered up to 75 mg single dose and 40 mg repeated dose in healthy volunteers (i.e. 7.5 and 4 times the recommended dose, respectively) and at a dose of 10 or 15 mg in patients.〈section xml:id="abs1-4"〉〈title type="main"〉ResultsIn healthy volunteers, no increased incidence of QTc values 〉440 msec or ΔQTc ≥40 msec were recorded compared to placebo. No dose-related increase in QTc interval was observed. The ECG parameters were not modified by the co-administration of mizolastine with digoxin, diltiazem and erythromycin, when compared to the effect of each co-administered drug alone. In patients, the mean QTc interval changes from baseline did not significantly differ from placebo. In comparative studies vs. loratadine a similar incidence of out of range values was observed with mizolastine and loratadine.〈section xml:id="abs1-5"〉〈title type="main"〉ConclusionECG monitoring of volunteers and patients included in clinical studies conducted with mizolastine showed no significant effect of mizolastine on cardiac repolarization.

Type of Medium: Electronic Resource

URL: http://dx.doi.org/10.1046/j.1365-2222.1999.0290s3206.x

Permalink

Library	Location	Call Number	Volume/Issue/Year	Availability

Others were also interested in ...

Paper (German National Licenses)

Fulltext

Electronic Resource

Efficacy and safety of the 200–300 mg sustained release formulation of diltiazem administered once daily in patients with stable angina (1995)

Trimarco, B. ; Radzik, D. ; Neveux, E. ; [et al.]

Springer

European journal of clinical pharmacology 47 (1995), S. 493-496

add to mindlist on the mindlist

Details

ISSN: 1432-1041

Keywords: Diltiazem ; sustained release formulation ; calcium channel blocker ; stable angina ; efficacy ; adverse events

Source: Springer Online Journal Archives 1860-2000

Topics: Chemistry and Pharmacology , Medicine

Notes: Abstract The aim of this multicentre randomised double blind study was to compare the efficacy and safety of the 200–300 mg sustained release diltiazem formulation administered once daily (200–300 SR) with standard diltiazem (D) given three or four times daily to patients with stable angina. Patients aged 59 years, with a reproducible exercise test on placebo, were randomised to 4 weeks of treatment with 200–300 SR (n=70) or D (n=74). The initial dosage was 200 mg in the 200–300 SR group and 60 mg t.i.d. in the D group, increased to 300 mg once daily or 60 mg q.i.d., respectively, if ergometric parameters, which were always measured at the end of the dosing period, had not improved after two weeks. After 4 weeks of treatment, the antianginal efficacy at rest was comparable in the 200–300 SR and the D group; there was a prolongation of the total duration of exertion of 14% and 18% respectively (P〈0.01 vs placebo for both groups with no intergroup difference). A dose-effect relation was found with both formulations. The 200–300 SR formulation gave full 24 hour anti-ischaemic protection when administered once daily. Its efficacy and safety were comparable to those of standard diltiazem t.i.d. or q.i.d. in patients with stable angina. The once daily administration should improve treatment compliance.