Explanipedia

Venlafaxine reduces hot flashes in hormone receptor-positive breast cancer patients receiving tamoxifen: a prospective single‑arm, open‑label trial Open

Riko Sato, Ryotaro Kamohara, Tomohei Matsuo, Sawa Aya, Mai Okazaki , et al. · 2025

Background We conducted a prospective, singlearm, openlabel trial to evaluate venlafaxine efficacy and safety in hormone receptor-positive breast cancer patients on tamoxifen experiencing moderatetosevere hot flashes. Methods Twenty patien…

Bleeding Risk in the Early Postoperative Period after Atrial Fibrillation Ablation with Anticoagulant Therapy Using Dabigatran Etexilate Open

Yasuyuki Takashima, Kosuke Doki, Yasutoshi Shinoda, Yuki Komatsu, Hiro Yamasaki , et al. · 2025

The bleeding risk associated with dabigatran etexilate (DABE) dosing remains unclear in patients undergoing catheter ablation for atrial fibrillation (AF) because these patients were excluded from the pivotal clinical trial of DABE. This s…

EFFECTS OF MULTIPLE NEUROPSYCHIATRIC MEDICATIONS DURING PREGNANCY ON NEONATAL ABSTINENCE SYNDROME (SECOND REPORT) Open

Masaru Nakagawa, Kosuke Doki, Mana Obata‐Yasuoka, Hiromi Hamada, Daisuke Hitaka , et al. · 2025

Background Neonatal abstinence syndrome (NAS) is characterized by withdrawal symptoms in neonates because of the discontinuation of transplacental drug transfer after delivery. Although the use of neuropsychiatric drugs in pregnant women i…

Naldemedine for Opioid-Induced Constipation in Patients With Cancer: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial Open

Jun Hamano, Takahiro Higashibata, Takaomi Kessoku, Shinya Kajiura, Mami Hirakawa , et al. · 2024

PURPOSE Opioid-induced constipation is the most frequent and non–self-limiting adverse effect of opioid analgesia, reducing adherence and interfering with pain relief. This clinical trial aimed to clarify the preventive effect of naldemedi…

Assessment of Blood Prostaglandin E2 Metabolite Levels among Infants Born Preterm with Patent Ductus Arteriosus: A Prospective Study Open

Motomichi Nagafuji, Satoshi Fujiyama, Kosuke Doki, Ryota Ishii, Yuki Okada , et al. · 2024

Serum PGEM concentrations in preterm infants were associated with maternal histologic chorioamnionitis, but not hsPDA development. IBU treatment response was associated with higher blood IBU concentrations, but not PGEM concentrations.

Impact of Hepatitis B Surface and Core Antibody Levels on Hepatitis B Virus Reactivation Open

Maki Ohkubo, Emiko Seo, Kosuke Doki, Yoshiharu Suzuki, Ikuo Sekine , et al. · 2024

Hepatitis B virus reactivation (HBV-R) is a serious complication that can occur in patients with resolved HBV infection during cancer chemotherapy. We examined the levels of HBV surface antibody (HBsAb) and HBV core antibody (HBcAb) to ass…

Utilizing the dry spot method to monitor the concentrations of biologic agents in breast milk Open

Yuji Mukai, Kosuke Doki, Yoshiharu Suzuki, Masato Homma · 2023

To the Editor: We read with great interest the recent article by Saito et al., who developed a method to quantify six biologic agents in dried milk spots.1 The study provides new insights into the pharmacokinetic properties of these biolog…

Impact of hepatitis B surface and core antibody levels on hepatitis B virus reactivation Open

Maki Ohkubo, Emiko Seo, Kosuke Doki, Yoshiharu Suzuki, Ikuo Sekine , et al. · 2023

Hepatitis B virus reactivation (HBV-R) is a serious concern during cancer chemotherapy in patients with resolved HBV infection. We examined the levels of HBV surface (HBsAb) and core antibodies (HBcAb) to assess the incidence of HBV-R in p…

Rationale and design of a multicenter, double-blinded, randomized, placebo-controlled trial to investigate the effects of naldemedine on opioid-induced constipation for patients with cancer pain: A study protocol Open

Takahiro Higashibata, Jun Hamano, Takaomi Kessoku, Shinya Kajiura, Mami Hirakawa , et al. · 2022

Increased serum amiodarone concentration in hypertriglyceridemic patients: Effects of drug distribution to serum lipoproteins Open

Naoaki Hashimoto, Kosuke Doki, Satoru Kawano, Kazutaka Aonuma, Masaki Ieda , et al. · 2021

Amiodarone and its main metabolite, desethylamiodarone (DEA), are highly distributed to serum lipoproteins such as very‐low‐density lipoprotein (VLDL) and low‐density lipoprotein (LDL), which are the carriers of triglyceride and cholestero…

Survey of Description Formats of Medication Notebook Open

Ayako Yamaguchi, Yoshiharu Suzuki, Nozomi Taya, Erika Isaka, Kosuke Doki , et al. · 2021

Medication notebook is an important information tool for patients and healthcare providers, but the description formats have not been standardized. As standardization of the prescription formats for the medication, the Ministry of Health, …

A Case of Rhabdomyolysis Associated with Combination Treatment with Rosuvastatin and Bezafibrate for A Single Kidney Patient: A Case Report Open

Erika Isaka, Shuya Kandori, Tomomi Hosono, Kosuke Doki, Hiroyuki Nishiyama , et al. · 2021

Precautionary warnings for rhabdomyolysis from the coadministration of HMG-CoA reductase inhibitors (statins) and fibric acid derivatives (fibrates) have been well publicized so far. However, contraindications for the coadministration of s…

Applications of PBPK Modeling and Simulations in The Clinical Pharmacology Field: Lessons from Several Case Studies Open

Chie Emoto, Kosuke Doki, Yuki Matsumoto, Shinichi Kijima, Mikiko Nakamura , et al. · 2020

The utilization of a physiologically-based pharmacokinetic (PBPK) model has become prevalent, especially in drug development by pharmaceutical companies. The regulatory agencies in the US and Europe have already issued guidelines while the…

A Follow-Up Report of an Infant Born to a Mother Receiving Tamoxifen Open

Yuki Okada, Daisuke Hitaka, Takahiro Kido, Yu Kanai, K. Konishi , et al. · 2020

Tamoxifen, an estrogen receptor antagonist, is contraindicated in pregnant women due to its teratogenic activity. In the present study, we report the case of an infant whose mother received tamoxifen for breast cancer while unaware of the …

Involvement of Renal Efflux Transporter MATE1 in Renal Excretion of Flecainide Open

Kosuke Doki, Sándor Apáti, Takeshi Sakata, Masato Homma · 2019

Flecainide, an anti-arrhythmic drug, undergoes renal excretion through active renal tubular secretion in addition to passive glomerular filtration. The contribution of renal uptake and efflux transporters in active renal tubular secretion …

Assessing Potential Drug–Drug Interactions Between Dabigatran Etexilate and a P‐Glycoprotein Inhibitor in Renal Impairment Populations Using Physiologically Based Pharmacokinetic Modeling Open

Kosuke Doki, Sibylle Neuhoff, Amin Rostami‐Hodjegan, Masato Homma · 2019

Plasma concentrations of dabigatran, an active principle of prodrug dabigatran etexilate ( DABE ), are increased by renal impairment ( RI ) or coadministration of a P‐glycoprotein inhibitor. Because the combined effects of drug–drug intera…

Indoxyl Sulphate is Associated with Atrial Fibrillation Recurrence after Catheter Ablation Open

Fumi Yamagami, Kazuko Tajiri, Kosuke Doki, Masayuki Hattori, Junya Honda , et al. · 2018

A Simple Spectrophotometric Assay for Determination of Selenium Concentration in the Hospital Preparation Open

Miyabi Ito, Saori Shimada, Naoyuki Yokota, Kosuke Doki, Masato Homma · 2018

A simple spectrophotometric assay was developed for quantitative determination of selenium in selenium injection which is a hospital preparation for patients with selenium deficiency. Aliquots of the samples (500 µL) added 20 µL of 2.5 M f…

Physiologically based pharmacokinetic modelling to guide drug delivery in older people Open

Manoranjenni Chetty, Trevor N. Johnson, Sebastian Polak, Farzaneh Salem, Kosuke Doki , et al. · 2018

Use of Pharmacogenetic Information for Therapeutic Drug Monitoring of an Antiarrhythmic Drug Open

Kosuke Doki · 2018

Antiarrhythmic drugs require therapeutic drug monitoring (TDM) to avoid adverse effects such as proarrhythmia. However, TDM is not necessarily used to adjust the dosage of antiarrhythmic drugs because there is a lack of information regardi…

Implications of intercorrelation between hepatic CYP3A4‐CYP2C8 enzymes for the evaluation of drug–drug interactions: a case study with repaglinide Open

Kosuke Doki, Adam S. Darwich, Brahim Achour, Aleksi Tornio, Janne T. Backman , et al. · 2018

Aims Statistically significant positive correlations are reported for the abundance of hepatic drug‐metabolizing enzymes. We investigate, as an example, the impact of CYP3A4–CYP2C8 intercorrelation on the predicted interindividual variabil…

Predictive performance of physiologically-based pharmacokinetic model for amiodarone and its active metabolite: evaluation using therapeutic drug monitoring data from Japanese patients Open

Naoaki Hashimoto, Kosuke Doki, Kazutaka Aonuma, Masato Homma · 2018

Backgrounds: Therapeutic drug monitoring (TDM) of amiodarone (AMD) and its active metabolite, mono-desethyl-amiodarone (DEA), is practically conducted to avoid adverse effects because of large inter-individual variabilities in their pharma…

Implications of inter-correlation between hepatic CYP3A4-CYP2C8 enzymes for the evaluation of drug-drug interactions: a case study with repaglinide and gemfibrozil Open

Kosuke Doki, Adam S. Darwich, Brahim Achour, Aleksi Tornio, Janne T. Backman , et al. · 2018

Virtual bioequivalence for achlorhydric subjects: The use of PBPK modelling to assess the formulation-dependent effect of achlorhydria Open

Kosuke Doki, Adam S. Darwich, Nikunjkumar Patel, Amin Rostami‐Hodjegan · 2017

Majority of bioequivalence studies are conducted in healthy volunteers. It has been argued that bioequivalence may not necessarily hold true in relevant patient populations due to a variety of reasons which affect one formulation more than…

P277Indoxyl sulfate levels predict recurrences after catheter ablation of atrial fibrillation Open

Fumi Yamagami, Kazuko Tajiri, Kosuke Doki, Kenji Kuroki, Takeshi Machino , et al. · 2017

LA dilatation and atrial fibrillation (AF) onset in pts with CHF .There is none study focused on wheather the incidence of AF in CHF pts with enlarged LA could be affected by electrical and/or mechanical dyssynchrony in this particular gro…

Guidelines for Therapeutic Drug Monitoring of Cardiovascular Drugs Clinical Use of Blood Drug Concentration Monitoring (JCS 2015)　― Digest Version ― Open

Kazutaka Aonuma, Tsuyoshi Shiga, Hirotsugu Atarashi, Kosuke Doki, Hirotoshi Echizen , et al. · 2017

CQ2 Does blood drug concentration monitoring of antiarrhythmic drugs help reduce ADRs in patients with arrhythmia who are receiving antiarrhythmic drugs?.............. 588 CQ3 Can we shorten the time to achieve an optimal dosage regimen by…

<b>A Survey on Trial Site Visit Activities of Clinical Research Associates: A Consideration Toward Improving the Efficiency of Clinical Trials </b> Open

Minami Iimura, Kosuke Doki, Saori Shimada, Hideo Tsurushima, Akira Matsumura , et al. · 2015

Clinical trial sponsors have been requested to improve the on-site visit activities of clinical research associates (CRA) in Japan, because their activities are less efficient compared with those in the European Union and the United States…

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