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Original

Relationship between serum bepridil concentration and corrected QT interval 

Kazuki Matsui, Yutaro Mukai, Kota Sakakura, Kyoichi Wada, Tsutomu Nakamura, Atsufumi Kawabata, Nobue Terakawa, Naoki Hayakawa, Kengo Kusano, Kouichi Hosomi, Satoshi Yokoyama, and Mitsutaka Takada

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Volume 59 (2021) p. 63 - 70

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 59 – No. 1/2021 (63-70)

Relationship between serum bepridil concentration and corrected QT interval 

Kazuki Matsui¹#²#³, Yutaro Mukai³, Kota Sakakura³, Kyoichi Wada⁴, Tsutomu Nakamura⁴, Atsufumi Kawabata², Nobue Terakawa³, Naoki Hayakawa³, Kengo Kusano⁵, Kouichi Hosomi⁶#⁷, Satoshi Yokoyama⁶#⁷, and Mitsutaka Takada¹#⁶#⁷

¹Division of Cardiovascular Drugs, Therapy, Kindai University Graduate School of Pharmacy, ²Laboratory of Pharmacology and Pathophysiology, Faculty of Pharmacy, Kindai University, Higashi-Osaka, ³Department of Pharmacy, National Cerebral and Cardiovascular Center, Suita, ⁴Education and Research Center for Clinical Pharmacy, Osaka University of Pharmaceutical Sciences, Takatsuki, ⁵Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Suita, ⁶Division of Clinical Drug Informatics, Kindai University Graduate School of Pharmacy, and ⁷Division of Clinical Drug Informatics, School of Pharmacy, Kindai University, Higashi-Osaka, Japan
Objective: Bepridil prolongs the QT interval and can induce torsade de pointes. Although increased bepridil concentration may be a primary cause of prolonged QT, the relationship between serum bepridil concentration and prolonged QT remains unclear. We investigated the relationship between serum bepridil concentration and the corrected QT (QTc) interval in patients treated with bepridil.
Materials and methods: A retrospective study was performed at the National Cerebral and Cardiovascular Center in Japan. Patients with atrial fibrillation who were treated with bepridil from January 2014 to December 2015 were enrolled in the study. Serum bepridil concentrations and electrocardiogram data collected more than 21 days after the initiation of bepridil were used for analysis.
Results: A total of 60 patients were included in this study. There was a significant difference in mean QTc interval before and after initiation of bepridil (p < 0.0001). A significant relationship was observed between bepridil dose (p = 0.014) or serum bepridil concentration (p < 0.001) and QTc interval. Additionally, a significant relationship was observed between serum bepridil concentration and ΔQTc (p = 0.034). In the study, 4 patients developed QTc prolongation ≥ 500 ms after the initiation of bepridil. Serum bepridil concentration in this group was significantly higher compared with the group that did not display prolonged QTc (973 ± 651 vs. 526 ± 310 ng/mL, p = 0.01).
Conclusion: This study revealed that the QTc interval was significantly associated with serum bepridil concentration. Serum bepridil concentration beyond a therapeutic range may be a critical risk factor for developing QTc prolongation.Correspondence to:
Mitsutaka Takada, PhD
Division of Clinical Drug Informatics
Kindai University Graduate School of Pharmacy
Higashi-Osaka, Osaka, 577-8502, Japan
Email:  takada@ phar.kindai.ac.jp

Original

Discontinuation of oral amphotericin B therapy does not influence the pharmacokinetics of tacrolimus in heart transplant patients 

Megumi Ikura, Tsutomu Nakamura, Takaya Uno, Kazuki Nakagita, Hiromi Takenaka, Sachi Matsuda, Ryosuke Oda, Kyoichi Wada, Yuji Hattori, Osamu Seguchi, Masanobu Yanase, Naoki Hayakawa, and Norihide Fukushima

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Volume 59 (2021) p. 566 - 571

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 59 – No. 8/2021 (566-571)

Discontinuation of oral amphotericin B therapy does not influence the pharmacokinetics of tacrolimus in heart transplant patients 

Megumi Ikura¹, Tsutomu Nakamura², Takaya Uno¹, Kazuki Nakagita¹, Hiromi Takenaka¹, Sachi Matsuda¹, Ryosuke Oda¹, Kyoichi Wada², Yuji Hattori¹, Osamu Seguchi³, Masanobu Yanase³, Naoki Hayakawa¹, and Norihide Fukushima³

¹Department of Pharmacy, National Cerebral and Cardiovascular Center, Suita, ²Education and Research Center for Clinical Pharmacy, Osaka University of Pharmaceutical Sciences, Takatsuki, and ³Department of Transplant Medicine, National Cerebral and Cardiovascular Center, Suita, Japan
Objective: Amphotericin B (AMPH-B) is used to prevent opportunistic infections associated with immunosuppressive therapy after heart transplantation (HTx), while the blood concentrations of tacrolimus (TAC) are carefully controlled. Although AMPH-B has the potential to inhibit TAC metabolism in in vitro studies, its interaction with clinically used AMPH-B oral suspension has not been investigated. In the present study, we examined whether oral AMPH-B therapy influences the pharmacokinetics of TAC in HTx patients.
Materials and methods: A retrospective study was performed at the National Cerebral and Cardiovascular Center in Japan. All patients with HTx enrolled in the study received standard triple-drug immunosuppression therapy including the regular release of TAC, mycophenolate mofetil, and prednisolone as well as prophylactic therapy with AMPH-B oral suspension. Patient characteristics and clinical laboratory data were collected from the electronic medical record system. Blood concentrations of TAC were used for pharmacokinetic analysis.
Results: A total of 14 patients were enrolled in the study. There were no statistically significant differences in the variables except for serum creatinine levels and eGFR before and after discontinuation of oral AMPH-B therapy. The dose and trough concentrations of TAC and the area under the time-concentration curve and apparent oral clearance calculated from its concentrations were not influenced by discontinuation of AMPH-B treatment.
Conclusion: The prophylactic treatment with AMPH-B oral suspension did not influence the pharmacokinetics of TAC and was demonstrated as a safe and easy method to prevent early post-HTx fungal infection.Correspondence to:
Tsutomu Nakamura, PhD, Professor
Education and Research Center for Clinical Pharmacy
Faculty of Pharmacy, Osaka Medical and Pharmaceutical University
4-20-1 Nasahara, Takatsuki 569-1094, Japan
Email: [email protected]

Case  Report

Pharmacokinetics and pharmacodynamics of amiodarone in patients with hypertriglyceridemia: Two case reports 

Takaya Uno, Kota Sakakura, Yutaro Mukai, Mitsutaka Takada, Takashi Noda, Kengo Kusano, and Naoki Hayakawa

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Volume 60 (2022) p. 515 - 520

Abstract

International Journal of Clinical Pharmacology and Therapeutics, Vol. 60 – No. 12/2022 (515-520)

Pharmacokinetics and pharmacodynamics of amiodarone in patients with hypertriglyceridemia: Two case reports 

Takaya Uno¹#², Kota Sakakura¹, Yutaro Mukai¹, Mitsutaka Takada², Takashi Noda³#⁴, Kengo Kusano⁴, and Naoki Hayakawa¹

¹Department of Pharmacy, National Cerebral and Cardiovascular Center, Suita, ²Division of Clinical Drug Informatics, Faculty of Pharmacy, Kindai University, Higashi-Osaka, ³Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine, Sendai, and ⁴Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan
Background: The antiarrhythmic drug amiodarone has noncardiac adverse effects, leading to restrictive therapeutic plasma ranges. Despite the significant positive correlation between triglyceride and amiodarone levels, the effect of fluctuations in amiodarone levels in patients with hypertriglyceridemia on amiodarone therapy has not been fully characterized. This study is the first to report on the effect of hypertriglyceridemia on the efficacy and safety of amiodarone therapy.
Case presentation: The first patient was a 58-year-old man with hypertriglyceridemia who was diagnosed with ventricular fibrillation (patient #1). The second patient with hypertriglyceridemia was a 72-year-old man with sustained ventricular tachycardia (patient #2). Both patients received implantable cardioverter-defibrillator therapy. During the study period, amiodarone and N-desethylamiodarone concentrations were measured 12 times in patient #1 and 26 times in patient #2. Triglyceride concentrations in patient #1 and patient #2 ranged from 102 to 765 mg/dL and from 125 to 752 mg/dL, respectively. For both patients, amiodarone dosage was maintained at 100 mg/day, and the administration of concomitant drugs that could affect amiodarone pharmacokinetics was neither initiated nor discontinued. However, amiodarone concentrations fluctuated (patient #1, 0.52 – 1.86 μg/mL; patient #2, 0.73 – 2.82 μg/mL). Although amiodarone concentrations fluctuated, neither of the patients had defibrillation shocks to stop the abnormal rhythm via an implantable cardioverter-defibrillator, and laboratory data showed that thyroid-stimulating hormone, free thyroxine, KL-6, and surfactant protein-D remained close to normal.
Conclusion: In patients with hypertriglyceridemia, it may be necessary for clinicians to pay more attention to the clinical symptoms along with fluctuations in amiodarone levels and accordingly adjust amiodarone dosage.Correspondence to:
Takaya Uno, PhD
Department of Pharmacy
National Cerebral and Cardiovascular Center
564-8565, Suita, Osaka, Japan
Email: [email protected]

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