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  • 1995-1999  (2)
  • individual metabolism/sensitivity  (1)
  • therapeutic equivalence  (1)
  • 1
    Electronic Resource
    Electronic Resource
    Prolongation of the PQ interval as a measure of therapeutic inequivalence between two formulations of diltiazem (1995)
    Springer
    European journal of clinical pharmacology 48 (1995), S. 45-49 
    Details
    ISSN: 1432-1041
    Keywords: Diltiazem ; PQ interval ; ECG ; bioequivalence ; therapeutic equivalence
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract We studied the use of atrioventricular (AV) conduction time to assess the therapeutic equivalence of two diltiazem formulations in 20 volunteers in a double-blind, cross-over trial. ECG recording was carried out before and at several intervals after drug administration, and prolongation of the PQ interval (ΔPQ) was taken as a pharmacodynamic response. In addition, diltiazem plasma concentrations were determined in 8 subjects. The effect of diltiazem increased proportionally with the plasma concentration and could be detected up to 10 h after administration. The area under the effect-time curve (AUEC0–10), the peak effect (Emax), and the effect mean residence time (MRTE) showed significant differences. In contrast to the pharmacodynamics, the pharmacokinetic profiles of diltiazem do not vary to the same extent. We conclude that the formulations are therapeutically different. Furthermore, at the administered dose, ΔPQ appears to be a sensitive measure for assessing the electrophysiological properties of diltiazem.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00202171
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    Paper (German National Licenses)
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  • 2
    Electronic Resource
    Electronic Resource
    Age-dependent differences in the anticoagulant effect of phenprocoumon in patients after heart valve surgery (1997)
    Springer
    European journal of clinical pharmacology 52 (1997), S. 31-35 
    Details
    ISSN: 1432-1041
    Keywords: Key words Phenprocoumon ; Thromboembolism prophylaxis; anticoagulant drugs ; age-dependence ; postoperative dosage requirement ; individual metabolism/sensitivity
    Source: Springer Online Journal Archives 1860-2000
    Topics: Chemistry and Pharmacology , Medicine
    Notes: Abstract Objective: An enhanced response to warfarin and an increased risk of major bleeding has been observed in older patients. The reason for this increase in sensitivity remains unknown. It could be due to pharmacodynamic reasons, pharmacokinetic reasons, or both. Methods: We therefore followed an anticoagulant regimen with phenprocoumon in 19 older (76 years) and 19 younger patients (50 years) following heart valve replacement. INR values were determined frequently. At the 4th and around the 24th day after starting treatment with phenprocoumon, we also measured the total and unbound plasma concentration of phenprocoumon. Results: The dose requirement to obtain the desired anticoagulant effect was significantly lower in the older patients than in the younger patients (26.3 vs. 37.3 μg · kg−1 · day−1). The total plasma concentration (2.19 vs. 2.43 μg · ml−1), the percentage unbound drug in the plasma (0.61 vs. 0.64%) and the unbound plasma concentration (13.8 vs. 15.1 ng · ml−1) did not differ significantly between older and younger patients. The dose-adjusted INR (INR/dose) was higher in the older patients (110 vs. 67) but the INR adjusted for the unbound plasma concentration (INR/Cuss) which reflects the intrinsic sensitivity to the drug, was not significantly different (192 vs. 173). However, the older patients had an about 30% significantly lower metabolic clearance based on unbound drug (84 vs. 115 ml · kg−1 · h−1). Conclusions: Older patients (〉 70 years) require a dose approximately 30% lower than younger patients (〈 160␣years). Pharmacokinetic reasons (reduced metabolic clearance) are mainly responsible for the lower dose requirement of the older patients after heart valve surgery.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/s002280050245
    Library Location Call Number Volume/Issue/Year Availability
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    Paper (German National Licenses)
    Fulltext
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