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  1. Article ; Online: The Metabolism of the New Benzodiazepine Remimazolam.

    Schmalix, Wolfgang / Petersen, Karl-Uwe / Pesic, Marija / Stöhr, Thomas

    Current drug metabolism

    2024  

    Abstract: Background: Remimazolam (RMZ) is a novel ultrashort-acting benzodiazepine used for sedation by intravenous administration. The pharmacophore of RMZ includes a carboxyl ester group sensitive to esterase- mediated hydrolysis, which is the primary path of ... ...

    Abstract Background: Remimazolam (RMZ) is a novel ultrashort-acting benzodiazepine used for sedation by intravenous administration. The pharmacophore of RMZ includes a carboxyl ester group sensitive to esterase- mediated hydrolysis, which is the primary path of metabolic elimination. However, for the sake of drug safety, a deeper and broader knowledge of the involved metabolic pathways and the evolving metabolites is required. Information is needed on both humans and experimental animals to evaluate the possibility that humans form harmful metabolites not encountered in animal toxicity studies.
    Objective: The current study aimed at identifying the mechanisms of remimazolam's metabolism and any potential clinically significant metabolites.
    Method: Using tissue homogenates from various animals and humans, the liver was identified as the tissue primarily responsible for the elimination of RMZ. CNS7054, the hydrolysis product of remimazolam, was identified as the only clinically relevant metabolite. Using bacterial or eukaryotic over-expression systems, carboxylesterase 1 (CES1) was identified as the iso-enzyme predominantly involved in RMZ metabolism, with no role for carboxylesterase 2. Using a variety of inhibitors of other esterases, the contribution to elimination mediated by esterases other than CES1 was excluded.
    Results: Besides tissue carboxylesterases, rodents expressed an RMZ esterase in plasma, which was not present in this compartment in other laboratory animals and humans, hampering direct comparisons. Other pathways of metabolic elimination, such as oxidation and glucuronidation, also occurred, but their contribution to overall elimination was minimal.
    Conclusion: Besides the pharmacologically non-active metabolite CNS7054, no other clinically significant metabolite of remimazolam could be identified.
    Language English
    Publishing date 2024-03-21
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 2064815-7
    ISSN 1875-5453 ; 1389-2002
    ISSN (online) 1875-5453
    ISSN 1389-2002
    DOI 10.2174/0113892002301026240318060307
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article: Efficacy of remimazolam versus midazolam for procedural sedation: post hoc integrated analyses of three phase 3 clinical trials.

    Dao, Van-Anh / Schippers, Frank / Stöhr, Thomas

    Endoscopy international open

    2022  Volume 10, Issue 4, Page(s) E378–E385

    Abstract: Background and study ... ...

    Abstract Background and study aims
    Language English
    Publishing date 2022-04-14
    Publishing country Germany
    Document type Journal Article
    ZDB-ID 2761052-4
    ISSN 2196-9736 ; 2364-3722
    ISSN (online) 2196-9736
    ISSN 2364-3722
    DOI 10.1055/a-1743-1936
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  3. Article ; Online: A population pharmacokinetic model of remimazolam for general anesthesia and consideration of remimazolam dose in clinical practice.

    Masui, Kenichi / Stöhr, Thomas / Pesic, Marija / Tonai, Tomohiro

    Journal of anesthesia

    2022  Volume 36, Issue 4, Page(s) 493–505

    Abstract: Background: Remimazolam besylate is a novel short-acting benzodiazepine. An appropriate pharmacokinetic model of remimazolam is desirable in anesthesia practice. The aim of the study was to develop a pharmacokinetic model using plasma samples from ... ...

    Abstract Background: Remimazolam besylate is a novel short-acting benzodiazepine. An appropriate pharmacokinetic model of remimazolam is desirable in anesthesia practice. The aim of the study was to develop a pharmacokinetic model using plasma samples from patients anesthetized with remimazolam. Influence of patient characteristics, context-sensitive decrement-times, and dose regimens were also examined.
    Methods: Data were obtained from four trials on patients, and seven trials on healthy volunteers. The characteristics of 416 male and 246 female subjects were as follows: age, 18-93 years; body weight, 34-149 kg; and American Society of Anesthesiologists physical status (ASA-PS), I-IV. 2231 arterial and 3200 venous samples were used for the final model. The equilibration rate constant between arterial plasma and effect-site was estimated using the concept of time to peak effect. The final model was used to generate context-sensitive decrement times and dose regimens for general anesthesia.
    Results: A three-compartment model plus virtual venous compartment with allometric scaling of adjusted body weight (ABW), age, sex, and ASA-PS as covariates were selected as the final model. Elimination clearance was lower in males, and in subjects with higher ABW and ASA-PS scores. Approximately 10% or 20% higher dose rate was necessary in females than in males or ASA-PS I/II than III/IV patient. The context-sensitive half-time for effect-site concentration in a 55-year-old, 70-kg, 170-cm male or female ASA-PS I/II patient after > 6-h infusion was 16.7 or 15.9 min.
    Conclusion: Remimazolam pharmacokinetic model for general anesthesia was successfully developed. ABW, ASA-PS, and sex has a considerable impact on the remimazolam concentration.
    MeSH term(s) Adolescent ; Adult ; Aged ; Aged, 80 and over ; Anesthesia, General ; Benzodiazepines ; Body Weight ; Female ; Humans ; Hypnotics and Sedatives ; Male ; Middle Aged ; Young Adult
    Chemical Substances Hypnotics and Sedatives ; Benzodiazepines (12794-10-4) ; remimazolam (7V4A8U16MB)
    Language English
    Publishing date 2022-06-16
    Publishing country Japan
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1107821-2
    ISSN 1438-8359 ; 0913-8668
    ISSN (online) 1438-8359
    ISSN 0913-8668
    DOI 10.1007/s00540-022-03079-y
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 3408: Show issues Location:
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  4. Article: Efficacy of remimazolam versus midazolam for procedural sedation: post hoc integrated analyses of three phase 3 clinical trials

    Dao, Van-Anh / Schippers, Frank / Stöhr, Thomas

    Endoscopy International Open

    2022  Volume 10, Issue 04, Page(s) E378–E385

    Abstract: Background and study aims: Remimazolam is an ultra-short acting, fast onset/fast offset benzodiazepine for intravenous use in procedural sedation, general anesthesia, and Intensive Care Unit sedation. The aim of this work was to compare the efficacy of ... ...

    Abstract Background and study aims: Remimazolam is an ultra-short acting, fast onset/fast offset benzodiazepine for intravenous use in procedural sedation, general anesthesia, and Intensive Care Unit sedation. The aim of this work was to compare the efficacy of remimazolam versus midazolam dosed according to medical practice (real-world midazolam) and midazolam dosed according to US prescribing information (on-label midazolam) for procedural sedation.
    Patients and methods: This post hoc analysis was performed using integrated data from three randomized, placebo, and active (midazolam) controlled, phase 3 clinical trials in patients undergoing colonoscopy and bronchoscopy. Statistical comparisons between treatment groups, without adjustment for potential confounding factors, were exploratory and observational in nature.
    Results: The mean ± SD dose of midazolam in the real-world midazolam group was 6.2 ± 3.1 mg, compared with 3.5 ± 1.5 mg in the on-label midazolam group. remimazolam showed significantly shorter time from first dose to start of procedure (median 3 minutes) compared to on-label midazolam (median 8 minutes). Recovery time from end of procedure to fully alert was significantly shorter for remimazolam (median 6 minutes) than real-world midazolam (median 14 minutes), enabling earlier transfer of patients from the procedure room to the recovery area with a lower requirement for patient monitoring. The onset and recovery times with remimazolam showed significantly less inter-patient variability than with on-label midazolam and real-world midazolam, respectively. Patients treated with remimazolam received significantly less fentanyl for analgesia (78.2 ± 28.4 µg) than did those treated with real-world midazolam (113.6 ± 60.1 µg) and on-label midazolam (92.5 ± 40.0 µg).
    Conclusions: Remimazolam offers advantages over midazolam in terms of faster recovery and less fentanyl requirement, which may facilitate increased procedural throughput in clinical practice.
    Language English
    Publishing date 2022-04-01
    Publisher Georg Thieme Verlag KG
    Publishing place Stuttgart ; New York
    Document type Article
    ZDB-ID 2761052-4
    ISSN 2196-9736 ; 2364-3722 ; 2196-9736
    ISSN (online) 2196-9736
    ISSN 2364-3722 ; 2196-9736
    DOI 10.1055/a-1743-1936
    Database Thieme publisher's database

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  5. Article ; Online: Target-controlled Infusion of Remimazolam in Healthy Volunteers Shows Some Acute Tolerance.

    Vellinga, Remco / Koomen, Jeroen V / Eleveld, Douglas J / Stöhr, Thomas / Pesic, Marija / Struys, Michel M R F / Colin, Pieter J

    Anesthesiology

    2023  Volume 140, Issue 2, Page(s) 207–219

    MeSH term(s) Humans ; Anesthesia, General ; Benzodiazepines/pharmacology ; Healthy Volunteers ; Hypnotics and Sedatives/pharmacology ; Infusions, Intravenous
    Chemical Substances Benzodiazepines (12794-10-4) ; Hypnotics and Sedatives ; remimazolam (7V4A8U16MB)
    Language English
    Publishing date 2023-10-28
    Publishing country United States
    Document type Clinical Trial ; Journal Article
    ZDB-ID 269-0
    ISSN 1528-1175 ; 0003-3022
    ISSN (online) 1528-1175
    ISSN 0003-3022
    DOI 10.1097/ALN.0000000000004811
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: A miniature pig model of pharmacological tolerance to long-term sedation with the intravenous benzodiazepines; midazolam and remimazolam.

    Io, Toshiro / Saunders, Rob / Pesic, Marija / Petersen, Karl-Uwe / Stoehr, Thomas

    European journal of pharmacology

    2021  Volume 896, Page(s) 173886

    Abstract: As a new and ultra fast-acting IV benzodiazepine, pharmacological tolerance may be anticipated during long-term treatment with remimazolam e.g. in intensive care. In this context, tolerance is particularly relevant for withdrawal syndrome. However, apart ...

    Abstract As a new and ultra fast-acting IV benzodiazepine, pharmacological tolerance may be anticipated during long-term treatment with remimazolam e.g. in intensive care. In this context, tolerance is particularly relevant for withdrawal syndrome. However, apart from primates, existing models of sedative tolerance are unsuitable for remimazolam due to its excessive metabolic clearance (i.e. in rodents) or paradoxical responses (in dogs). Pigs are a well-established model species, especially for in-vivo drug safety studies, and appear a well suited as model for evaluation of remimazolam. In a series of experiments from dose-range-finding bolus and infusion studies through to 28-day continuous level sedation, we established a viable model of intravenous benzodiazepine sedation in NIBS micropigs to compare tolerance development during 28 days sedation with either midazolam or remimazolam. Dose increases after 28 days were lower for remimazolam (0 to 3-fold) than for midazolam (2 to 4-fold) and recovery times were approximately 40% faster for remimazolam vs midazolam. Tolerance to remimazolam is therefore likely in long-term human sedation and may be less than that seen for midazolam.
    MeSH term(s) Administration, Intravenous ; Animals ; Benzodiazepines/administration & dosage ; Consciousness/drug effects ; Dose-Response Relationship, Drug ; Drug Tolerance ; Hypnotics and Sedatives/administration & dosage ; Male ; Midazolam/administration & dosage ; Models, Animal ; Recovery of Function ; Swine ; Swine, Miniature ; Time Factors
    Chemical Substances Hypnotics and Sedatives ; Benzodiazepines (12794-10-4) ; remimazolam (7V4A8U16MB) ; Midazolam (R60L0SM5BC)
    Language English
    Publishing date 2021-01-23
    Publishing country Netherlands
    Document type Comparative Study ; Journal Article
    ZDB-ID 80121-5
    ISSN 1879-0712 ; 0014-2999
    ISSN (online) 1879-0712
    ISSN 0014-2999
    DOI 10.1016/j.ejphar.2021.173886
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 522: Show issues Location:
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  7. Book: Analyse und Beschreibung des mechanischen Werkstoffverhaltens von presshärtbaren Bor-Manganstählen

    Stöhr, Thomas

    (Bericht aus dem Lehrstuhl für Fertigungstechnologie ; Fertigungstechnik - Erlangen ; 235)

    2012  

    Author's details Thomas Stöhr
    Series title Bericht aus dem Lehrstuhl für Fertigungstechnologie
    Fertigungstechnik - Erlangen ; 235
    Keywords Fließen ; Karosserieblech ; Hochfester Stahl ; Vergütungsstahl ; Finite-Elemente-Methode ; Formhärten
    Language German
    Size 117 S., Ill., graph. Darst.
    Publisher Meisenbach
    Publishing place Bamberg
    Document type Book
    ISBN 9783875253467 ; 3875253469
    Database Library catalogue of the German National Library of Science and Technology (TIB), Hannover

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  8. Book ; Online: Bilanzierung von Rückstellungen nach BilMoG

    Stöhr, Thomas

    2012  

    Abstract: Hauptbeschreibung: Durch die Einführung des BilMoG erleben die deutschen Bilanzierungsregeln ihre fundamentalste Änderung seit dem Bilanzrichtliniengesetz von 1985. Zentrales Ziel des Gesetzgebers ist es, das deutsche Bilanzrecht im Vergleich zu den ... ...

    Abstract Hauptbeschreibung: Durch die Einführung des BilMoG erleben die deutschen Bilanzierungsregeln ihre fundamentalste Änderung seit dem Bilanzrichtliniengesetz von 1985. Zentrales Ziel des Gesetzgebers ist es, das deutsche Bilanzrecht im Vergleich zu den internationalen Regelungen wieder attraktiver zu gestalten. Die beschlossenen Änderungen sollen die Aussagekraft des HGB-Abschlusses erhöhen und damit eine "Antwort auf die IFRS geben". Die Gesetzgebung des BilMoG wurde geprägt von dem Gedanken, das verlorene Vertrauen in eine wirklichkeitsgetreue Darstellung der wirtschaftlichen Verhältnisse der Unt
    Keywords Wirtschaft Sonstiges
    Language German
    Size Online-Ressource (71 p.)
    Publisher Diplomica Verlag
    Publishing place Hamburg
    Document type Book ; Online
    Note Description based upon print version of record
    ISBN 9783863410339 ; 3863410335
    Database Library catalogue of the German National Library of Science and Technology (TIB), Hannover

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  9. Article ; Online: Impact of concurrent remifentanil on the sedative effects of remimazolam, midazolam and propofol in cynomolgus monkeys.

    Kops, Maren S / Pesic, Marija / Petersen, Karl-Uwe / Schmalix, Wolfgang A / Stöhr, Thomas

    European journal of pharmacology

    2020  Volume 890, Page(s) 173639

    Abstract: Drug-drug interactions can substantially change pharmacological effects of the individual substances involved. For the use of sedatives or anaesthetics, having knowledge of the extent and characteristics of such interactions is crucial for ensuring the ... ...

    Abstract Drug-drug interactions can substantially change pharmacological effects of the individual substances involved. For the use of sedatives or anaesthetics, having knowledge of the extent and characteristics of such interactions is crucial for ensuring the proper protection of patients undergoing any kind of sedation. Remimazolam is a new ultra-short acting benzodiazepine that is currently under development for intravenous use in procedural sedation and general anaesthesia. It exhibits a fast onset and fast offset which enables a more rapid recovery than currently available drugs in that class, such as midazolam. The purpose of this study was to more closely investigate the sedative properties and pharmacodynamic drug-drug interaction potential of remimazolam with the opioid analgesic remifentanil and compare it with other commonly used sedatives - midazolam and propofol. For this purpose, six Cynomolgus monkeys received escalating doses of remimazolam, propofol, and midazolam intravenously without or with concurrent remifentanil. Sedation was evaluated using a general sedation scale that included monitoring exploratory and avoidance behaviour, responses to sensory stimuli, posture and gait, and eyelid position as endpoints. Based on the results, sedative doses were calculated to allow evaluation of pharmacological drug-drug interaction with remifentanil. Remimazolam induced dose-dependent and consistent sedative effects in each endpoint tested and showed a high degree of synergism with remifentanil. Midazolam showed a comparable synergism while the interaction between propofol and remifentanil was less pronounced.
    MeSH term(s) Administration, Intravenous ; Analgesics, Opioid/administration & dosage ; Analgesics, Opioid/pharmacology ; Animals ; Benzodiazepines/administration & dosage ; Benzodiazepines/pharmacology ; Cross-Over Studies ; Drug Interactions ; Hypnotics and Sedatives/administration & dosage ; Hypnotics and Sedatives/pharmacology ; Macaca fascicularis ; Male ; Midazolam/administration & dosage ; Midazolam/pharmacology ; Propofol/administration & dosage ; Propofol/pharmacology ; Remifentanil/administration & dosage ; Remifentanil/pharmacology
    Chemical Substances Analgesics, Opioid ; Hypnotics and Sedatives ; Benzodiazepines (12794-10-4) ; remimazolam (7V4A8U16MB) ; Remifentanil (P10582JYYK) ; Midazolam (R60L0SM5BC) ; Propofol (YI7VU623SF)
    Language English
    Publishing date 2020-10-14
    Publishing country Netherlands
    Document type Comparative Study ; Journal Article
    ZDB-ID 80121-5
    ISSN 1879-0712 ; 0014-2999
    ISSN (online) 1879-0712
    ISSN 0014-2999
    DOI 10.1016/j.ejphar.2020.173639
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 522: Show issues Location:
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  10. Article ; Online: Potential strategy for assessing QT/QTc interval for drugs that produce rapid changes in heart rate: Electrocardiographic assessment of the effects of intravenous remimazolam on cardiac repolarization.

    Kleiman, Robert B / Darpo, Borje / Thorn, Michael / Stoehr, Thomas / Schippers, Frank

    British journal of clinical pharmacology

    2020  Volume 86, Issue 8, Page(s) 1600–1609

    Abstract: Aims: Remimazolam is a new, ultra-short-acting benzodiazepine developed for intravenous (IV) use during procedural sedation and in general anaesthesia. Two trials were conducted to characterize its effects on cardiac repolarization.: Methods: A ... ...

    Abstract Aims: Remimazolam is a new, ultra-short-acting benzodiazepine developed for intravenous (IV) use during procedural sedation and in general anaesthesia. Two trials were conducted to characterize its effects on cardiac repolarization.
    Methods: A thorough QT/QTc (TQT) study assessed electrocardiography effects of therapeutic and supratherapeutic doses of remimazolam and midazolam. To investigate whether RR-QT hysteresis effects due to rapid heart rate changes might have confounded the QTc assessments in the TQT trial, a second trial used continuous IV remimazolam infusion to achieve stable heart rates during periods of stable remimazolam plasma concentration.
    Results: During the TQT, both compounds produced a 10-20-beats/min increase in heart rate within 30 seconds, persisting for 5-10 minutes. Within 30 seconds, the upper bound of the 2-sided 90% confidence interval for the placebo-corrected change from baseline for QTcI (ΔΔQTcI) exceeded 10 ms for both doses of remimazolam (ΔΔQTcI 7.2 [3.2, 11.2] ms for the 10 mg dose and 10.4 [6.5, 14.3] ms for the 20 mg dose) as well as for the 7.5-mg dose of midazolam (8.2 [4.4, 12.1] ms). At 2 minutes after IV bolus, the upper bound of the 2-sided 90% confidence interval for ΔΔQTcI exceeded 10 ms only for the remimazolam 20-mg dose (6.3 [2.3, 10.2] ms). During the second study, during periods of stable heart rate, remimazolam had no clinically significant effect on QTc (peak ΔΔQTcI 3.4 [-1.1, 7.6] ms).
    Conclusion: Remimazolam does not prolong cardiac repolarization (QTc). The methods reported here may allow assessment of the QTc effects of other drugs given by IV bolus.
    MeSH term(s) Benzodiazepines ; Dose-Response Relationship, Drug ; Double-Blind Method ; Electrocardiography ; Heart Rate ; Humans ; Pharmaceutical Preparations
    Chemical Substances Pharmaceutical Preparations ; Benzodiazepines (12794-10-4) ; remimazolam (7V4A8U16MB)
    Language English
    Publishing date 2020-03-23
    Publishing country England
    Document type Journal Article
    ZDB-ID 188974-6
    ISSN 1365-2125 ; 0306-5251 ; 0264-3774
    ISSN (online) 1365-2125
    ISSN 0306-5251 ; 0264-3774
    DOI 10.1111/bcp.14270
    Database MEDical Literature Analysis and Retrieval System OnLINE

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