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Pharmacology the Journal of Clinical The Journal of Clinical Pharmacology http://jcp.sagepub.com/ Gender Is an Important Determinant of the Disposition of the Loop Diuretic Torasemide Ulrike Werner, Dierk Werner, Svetlana Heinbüchner, Bernhard Graf, Hüseyin Ince, Stefan Kische, Petra Thürmann, Jörg König, Martin F. Fromm and Oliver Zolk J Clin Pharmacol 2010 50: 160 originally published online 23 November 2009 DOI: 10.1177/0091270009337514 The online version of this article can be found at: http://jcp.sagepub.com/content/50/2/160 Published by: http://www.sagepublications.com On behalf of: American College of Clinical Pharmacology Additional services and information for The Journal of Clinical Pharmacology can be found at: Email Alerts: http://jcp.sagepub.com/cgi/alerts Subscriptions: http://jcp.sagepub.com/subscriptions Reprints: http://www.sagepub.com/journalsReprints.nav Permissions: http://www.sagepub.com/journalsPermissions.nav >> Version of Record - Jan 28, 2010 OnlineFirst Version of Record - Nov 23, 2009 What is This? Downloaded from jcp.sagepub.com at UNIVERSITAETSBIBLIOTHEK on February 13, 2013 TITLE Gender Is an Important Determinant of the Disposition of the Loop Diuretic Torasemide Ulrike Werner, PhD, Dierk Werner, MD, Svetlana Heinbüchner, MD, Bernhard Graf, MD, Hüseyin Ince, MD, Stefan Kische, MD, Petra Thürmann, MD, Jörg König, PhD, Martin F. Fromm, MD, and Oliver Zolk, MD Signals from pharmacovigilance studies indicate that significant influence on torasemide pharmacokinetics. women are at higher risk for adverse drug reactions (ADRs) Using cell lines expressing OATP1B1, the authors identified due to diuretics. Despite the long-term use of torasemide, torasemide as OATP1B1 substrate (Km = 6.2 µM) with a there are few studies investigating gender differences of significant reduction of uptake by the 521C-variant. Taken torasemide pharmacokinetics in the hospital setting. together, gender differences in torasemide pharmacokinet- Therefore, torasemide pharmacokinetics were investigated ics are likely to contribute to a higher rate of ADRs in in 90 patients (45 women, 45 men) during steady-state con- women, which has, for example, been observed in a German ditions. Torasemide elimination was significantly reduced Pharmacovigilance Project with 66% of hospitalizations in women compared with men (eg, body-weight-normalized due to torasemide ADRs occurring in women. area under the concentration-time curve: 42.1 ± 20.4 vs 30.9 ± 10.3 kg•h/L; P < .001). Among the investigated Keywords: Gender; torasemide; loop diuretics; OATP1B1 genetic factors [SLC22A11(OAT4), SLCO1B1(OATP1B1), Journal of Clinical Pharmacology, 2010;50:160-168 CYP2C9], only the SLCO1B1c.521T>C polymorphism had a 2010 the American College of Clinical Pharmacology emale patients are at higher risk for adverse drug differences in the frequency of hospital admissions Freactions (ADRs) than male patients are.1-6 A caused by ADRs secondary to the use of diuretics.7,8 recent analysis of the German pharmacovigilance In that study, two-thirds of serious ADRs related to database, for example, demonstrated gender-specific diuretics occurred in women.7,8 The underlying mechanisms for these observa- tions have not been elucidated so far. Besides the From the Institute of Experimental and Clinical Pharmacology and concomitant use of medications, gender-specific dif- Toxico logy, University of Hamburg, Germany (Dr U. Werner); Department ferences in pharmacokinetics have been proposed.4,5 of Cardiology, Hospital Stift Bethlehem, Ludwigslust, Germany (Dr Indeed, in a recent pilot study, we identified gender D. Werner); Department of Cardiology, Helios-Hospital Schwerin, Germany as a potential determinant of torasemide pharma- (Dr Heinbüchner, Dr Graf); Department of Cardiology, University of cokinetics.9 Rostock, Rostock, Germany (Dr Ince, Dr Kische); Philipp Klee-Institute of Clinical Pharmacology, Helios-Hospital Wuppertal, University of Witten/ Pharmacokinetic studies performed in healthy Herdecke, Germany (Dr Thürmann); and Institute of Experimental and volunteers suggest that torasemide is completely Clinical Pharmacology and Toxicology, Friedrich-Alexander-University absorbed with little intersubject variation. Its metab- Erlangen-Nuremberg, Erlangen, Germany (Dr König, Dr Fromm, Dr Zolk). olism and excretion, however, largely differ between Drs U. Werner and D. Werner contributed equally to this study. Submitted individuals. for publication: January 29, 2009; revised version accepted April 17, Extrarenal elimination accounts for about 80% of 2009. Address for correspondence: Ulrike Werner, PhD, Institute of Experimental and Clinical Pharmacology and Toxicology, University the total clearance of torasemide, partly through Medical Center Hamburg-Eppendorf, Martinistr 52, 20146 Hamburg, metabolism by the genetically polymorphic cyto- 9-13 Germany; e-mail: [email protected]. chrome P450 enzyme CYP2C9. Moreover, polymor- DOI: 10.1177/0091270009337514 phisms in the gene encoding the organic anion 160 • J Clin Pharmacol 2010;50:160-168 Downloaded from jcp.sagepub.com at UNIVERSITAETSBIBLIOTHEK on February 13, 2013 PHARMACOKINETICS OF TORASEMIDE DEPEND ON GENDER Table I Patient Characteristics Gender Parameter Female (n = 45) Male (n = 45) P Diagnosis (hypertension/heart failure) 23/22 22/23 No. of all received drugs 8.0 ± 2.2 8.5 ± 2.3 .334a Age, y 72.1 ± 8.7 64.7 ± 9.4 <.001a BMI, kg/m2 29.0 ± 5.1 27.4 ± 4.5 .039a Serum creatinine, µmol/L 75.3 ± 33.6 83.2 ± 36.4 .321a 2 a CLCR, MDRD, mL/min/1.72 m 83.9 ± 47.2 95.0 ± 34.9 .035 CYP2C9 c.230T allele frequency 0.133 0.144 .829b CYP2C9 c.1075A allele frequency 0.078 0.056 .550b SLCO1B1 c.388G allele frequency 0.378 0.356 .757b SLCO1B1 c.521C allele frequency 0.200 0.156 .436b SLC22A11 g.-20166T allele frequency 0.589 0.567 .975b BMI, body mass index; CLCR, creatinine clearance. Number of all received drugs, age, BMI, serum creatinine, and CLCR are given as mean ± SD. Bold font indicates significant p-values. a. Mann-Whitney U test. b. Pearson chi-square. transporting polypeptide OATP1B1 (SLCO1B1), which in total oral torasemide clearance.14 Moreover, by mediates the hepatocellular uptake of drugs, have means of in vitro studies, we tested the hypothesis been reported to influence torasemide disposition.9,14 whether torasemide is indeed an OATP1B1 sub- Because torasemide is extensively bound to strate and whether cells expressing the 521C vari- plasma protein (>99%), very little of the drug enters ant have an impaired torasemide uptake. urine via glomerular filtration. Most of its renal clearance (approximately 20% of total clearance) METHODS occurs via active secretion by the proximal tubules into urine. Interindividual differences in renal clear- Study Design ance of torasemide have been partially explained by genetic variation in the luminally expressed organic An open-label pharmacokinetic study was performed anion transporter OAT4 (SLC22A11).14,15 in 90 patients with a primary diagnosis of arterial The objective of the present study was to quan- hypertension (n = 45) or NYHA Class II or III congestive tify the impact of gender on torasemide pharma- heart failure (n = 45). Pharmacokinetic data of 24 of cokinetics during steady state in the hospital setting. these patients have previously been reported.9 The Studies on determinants of torasemide pharmacoki- study was approved by the Ethics Committee of the netics in patients during steady-state treatment are Federal State of Mecklenburg–West Pomerania. Criteria largely missing. To address this issue, this study for inclusion were stable therapy with the diuretic was performed in a relatively large cohort of patients torasemide for at least 1 week. All patients received 10 on stable medication with torasemide for treatment mg of torasemide once daily. Only 1 of the included of arterial hypertension and/or symptomatic heart subjects took 20 mg of torasemide once daily for clinical failure (New York Heart Association [NYHA] Class reasons. After written informed consent was obtained, II-III). To assess the true gender-specific impact on all patients underwent a screening evaluation, which the intersubject variation of torasemide pharma- included laboratory tests. None of the patients had a cokinetics, we also considered as potential covari- history of additional liver disease or intrinsic kidney ates demographic factors (eg, body weight, kidney disease. Table I summarizes the patients’ characteristics function) as well as single-nucleotide polymor- including serum creatinine and creatinine clearance. phisms (SNPs) in the CYP2C9 (c.430C>T and All long-term medications (see Table II) were main- c.1075A>C intermediate/poor-metabolizer geno- tained at a constant dose during the entire study phase types), SLCO1B1 (c.388A>G and c.521T>C), and of 1 week. Blood samples were collected on the study SLC22A11 (g.-20166A>T) genes, which in concert day before and at 0.5, 1, 2, 4, 8, 12, and 24 hours after have been suggested to explain almost 50% variation torasemide administration in all patients. PHARMACOKINETICS 161 Downloaded from jcp.sagepub.com at UNIVERSITAETSBIBLIOTHEK on February 13, 2013 WERNER ET AL Table II Prescription Frequency of Comedications Site-Directed Mutagenesis in Male and Female Patientsa Both mutations (c.388A>G and c.521T>C) were Medication Women (n) Men (n) introduced into the vector pcDNA3.1-OATP1B1 by Acetylsalicylic acid 27 36 using the QuikChange site-directed Mutagenesis kit Allopurinol 7 5 from Stratagene (Amsterdam, the Netherlands) as Amlodipine 5 6 previously described.17
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