Volume 47, No. 1/2009(January)
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 Int. Journal of Clinical Pharmacology and Therapeutics
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Therapeutics
Proton pump inhibitors for prevention of bleeding episodes in cardiac patients with dual antiplatelet therapy – between Scylla and Charybdis?
Abstract
D. Trenk
Herz-Zentrum Bad Krozingen, Bad Krozingen, Germany
Guidelines from national and international cardiac societies recommend dual antiplatelet therapy with aspirin and thienopyridines (clopidogrel, ticlopidine) in patients with acute coronary syndrome and patients undergoing percutaneous coronary intervention. The most-feared complication of antiplatelet therapy is hemorrhage. Long-term treatment with aspirin increased bleeding rates compared to placebo and similar bleeding rates were observed on clopidogrel. Dual antiplatelet therapy increased hemorrhage with the dose of aspirin administered impacting on increased bleeding rates. Concomitant treatment with a proton pump inhibitor (PPI) decreased bleeding rates in patients on antiplatelet therapy. An analysis of medical and pharmacy databases indicated a more than 3-fold increase in the incidence of myocardial infarction within 12 months after starting treatment with clopidogrel in patients on concomitant treatment with a PPI. This might be attributed to a drug-drug interaction between PPIs and clopidogrel because recent clinical studies showed that treatment with the PPI omeprazole attenuated the antiplatelet effect of clopidogrel most likely by inhibiting the formation of the active metabolite which carries the antiplatelet activity of the drug. Therefore, sufficiently powered prospective clinical studies in cardiac patients on dual antiplatelet therapy investigating the potential drug interaction between PPIs and the antiplatelet effect of clopidogrel are awaited eagerly.Correspondence to:
Dr. D. Trenk; Department of Clinical Pharmacology, Herz-Zentrum Bad Krozingen, Suedring 15, 79189 Bad Krozingen, Germany
Email: dietmar.trenk@herzzentrum.de
Pharmacotherapy Guidelines for the Aged
Pharmacotherapy guidelines for the aged by family doctors for the use of family doctors – Part C Special pharmocology
Abstract
Guidelines Group Hesse: Pharmacotherapy Guidelines by Family Doctors for Family Doctors – F.W. Bergert, D. Conrad, K. Ehrenthal, J. Feßler, J. Gross, K.Gundermann, B. Kluthe, W. Lang Heinrich, A. Liesenfeld, P.G. Loew, E. Luther, R. Pchalek, J
General practitioners, Association of Statuatory Health Insurance Physicians in Hesse [Kassenärztliche Vereinigung in Hessen (KVH) Frankfurt (Main)], Germany
Part C of the guideline is preceded by Part B General Pharmacology IJCPT. 2008; 46: 600 – 617. Included in Part C are practical guidelines for improving the therapy of some age-specific diseases and problems commonly encountered in general practice. The article in this issue is dedicated to the therapy of Dementia and M. Parkinson. Further guidelines for the other age specific diseases and problems named above will be published in the following issues of IJCPT. An important feature of these guidelines are the inclusion of Levels of Evidence and of the Strength of Recommendations for the therapy which are shown when reliable studies are available. (For both see levels of evidence at the end of this article.)Correspondence to:
PD Dr. L. von Ferber; Auf dem Ufer 7, 40593 Düsseldorf, Germany
Email: Liselotte.vonFerber@uni-duesseldorf.de
Bioavailability Section
Pharmacokinetics and bioequivalence of 20 mg omeprazole capsule in 24 healthy Korean male volunteers
Abstract
S.-Y. Rhim1, J.-H. Park2, Y.-S. Park2, M.-H. Lee3, K.-G. Hwang4, Y.-S. Kim5, L.M. Shaw6, Y.-S. Lee7 and J.-S. Kang2,8
1Division of Pediatric Surgery, Department of Surgery, College of Medicine, 2Department of Pharmacology, College of Medicine and Institute of Biomedical Science, Hanyang University, 3Department of Internal Medicine, College of Medicine, 4Department of Dentistry/Oral and Maxillofacial Surgery, College of Medicine, 5Department of Biochemistry and Molecular Biology, College of Medicine, Hanyang University, Seoul, South Korea, 6Department of Pathology and Lab Medicine, College of Medicine, University of Pennsylvania, Philadelphia, PA, USA, 7Department of Medical Zoology, College of Medicine, Kyunghee University, and 8Department of Bioengineering, College of Engineering, Hanyang University, Seoul, South Korea
Objective: A randomized, two-way, crossover bioequivalence study in 24 healthy Korean male volunteers was conducted to compare bioequivalence of two brands of 20 mg omeprazole capsules, Hutex omeprazole® (Hutex Pharm Co. Korea) as a test and Yuhan Losec™ (Yuhan Co. Ltd., Korea) as a reference drug. Volunteers and methods: Subjects were administered single dosage of 1 capsule of 20 mg of each formulation with 240 ml of water after 10 hs overnight fasting on 2 treatment days separated by one-week washout period. After dosing, serial blood sampling was held during 9 hs. Plasma was analyzed for omeprazole by a validated HPLC method with ultraviolet detection in the range of 10 ~ 1,000 ng/ml with the lowest limit of quantification of 10 ng/ml. Results: Several pharmacokinetic (PK) parameters were determined from the plasma samples, and data from reference and test formulations in the plasma were represented such as AUC0-t (1,223.3 vs 1,284.3 ng × h/ml), AUC0-¥ (1,311.1 vs 1,410.0 ng × h/ml), Cmax (598.7 vs 598.1 ng/ml), tmax (1.9 vs 1.9 h), t1/2 (1.3 vs 1.4 h) and Ke (0.67 vs 0.67 h–1), respectively. AUC0-t, AUCC-¥ and Cmax were tested for bioequivalence after log-transformation of plasma data. PK parameters with 90% confidence interval (CI) of test/reference ratio based on ANOVA analysis were 0.961 ~ 1.135 for AUC0-t, 0.968 ~ 1.144 for AUCC-¥ and 0.951 ~ 1.117 for Cmax. Conclusions: PK parameters with 90% CI were within the bioequivalence range of 80 – 125% of FDA statistical limit. Therefore, both omeprazole formulations were bioequivalent during fasting state in these healthy Korean male volunteers.Correspondence to:
Prof. J.S. Kang, MD, PhD; Department of Pharmacology, College of Medicine, Institute of Biomedical Science, Department of Bioengineering, College of Engineering, Hanyang University, Seoul 133-791, South Korea
Email: jskang@hanyang.ac.kr
2008 CESAR: Annual Meeting – Extended Abstracts
Preface – Combining clinical, translational and basic cancer drug research: The 2008 CESAR annual meeting
Abstract
J. Brockmöller, D. Sehrt, and M.E. Scheulen
2008 CESAR: Annual Meeting – Extended Abstracts
Modulation of the efficacy of temozolomide and dacarbazine melanoma treatment by DNA-repair factors in vivo and in vitro
Abstract
L. Boeckmann, K.-M. Thoms, R. Gutzmer, C. Has, M. Kunz, C. Kuschal, P. Laspe, D. Struever and S. Emmert
2008 CESAR: Annual Meeting – Extended Abstracts
Characterization of transcriptional regulation of 5-HT<sub>3B</sub> in rat PC-12 cells: the role of glucocorticoids
Abstract
K. Bokelmann, J. Brockmöller and M.V. Tzvetkov
2008 CESAR: Annual Meeting – Extended Abstracts
Cyclosporin A, but not everolimus, inhibits DNA repair in human fibroblasts and lymphoblasts
Abstract
C. Kuschal, K.-M. Thoms, T. Mori, N. Kobayashi, L. Böckmann, P. Laspe and S. Emmert
2008 CESAR: Annual Meeting – Extended Abstracts
Activity of NAD(P)H oxidase in relation to genotypes: Comprehensive genetic mapping of single nucleotide polymorphisms (SNPs) in the p22<sup>phox</sup> subunit
Abstract
M. Hoffmann, M. Schirmer, M. Tzvetkov and J. Brockmöller
2008 CESAR: Annual Meeting – Extended Abstracts
Possible changes in the genomic features of tumor tissues over the last 150 years
Abstract
K. Schmücker, B. Herrmann and S. Hummel
2008 CESAR: Annual Meeting – Extended Abstracts
Classical resistance mechanisms
2008 CESAR: Annual Meeting – Extended Abstracts
Molecular mechanisms of drug resistance
Abstract
R.M. Mader, W.M. Schmidt, G.G. Steger and G. Krupitza
2008 CESAR: Annual Meeting – Extended Abstracts
Influence of the hOCT2 inhibitor cimetidine on the cellular accumulation and cytotoxicity of oxaliplatin
Abstract
I. Buß, G.V. Kalayda, P. Marques-Gallego, J. Reedijk and U. Jaehde
2008 CESAR: Annual Meeting – Extended Abstracts
Plasma and cellular pharmacokinetics of doxorubicin after intravenous infusion of Caelyx™/Doxil<sup>®</sup> in patients with hematological tumors
Abstract
H. Richly, M. Grubert, M.E. Scheulen and R.A. Hilger
2008 CESAR: Annual Meeting – Extended Abstracts
Pharmacokinetic study of sodium trans[tetrachlorobis(1H-indazole)-ruthenate (III)]/-indazole hydrochloride (1:1.1) (FFC14A) in patients with solid tumors
Abstract
M.M. Henke, H. Richly, A. Drescher, M. Grubert, D. Alex, D. Thyssen, U. Jaehde, M.E. Scheulen and R.A. Hilger
2008 CESAR: Annual Meeting – Extended Abstracts
Pharmacokinetics of sorafenib in patients with renal impairment undergoing hemodialysis
Abstract
R.A. Hilger, H. Richly, M. Grubert, S. Kredtke, D. Thyssen, W. Eberhardt, J. Hense, M. Schuler and M.E. Scheulen
2008 CESAR: Annual Meeting – Extended Abstracts
Pharmacokinetic study of S-1
Abstract
B. Mende, J. Krauss, D. Thyssen, S. Kredtke, M.E. Scheulen, D. Strumberg, A. Hanauske, L. Makris, P. Scigalla, P.D. Urrea and R.A. Hilger
2008 CESAR: Annual Meeting – Extended Abstracts
First-in-man and first-of-class-in-man clinical trials in oncology
