Characteristics and completeness of spontaneous reports by reporter's role in Germany: An analysis of the EudraVigilance database using the example of opioid ‐associated abuse, dependence, or withdrawal
AbstractSpontaneous reporting is based on the experience of all healthcare professionals (HCPs) but also consumers/non-HCPs and therefore reveals a broad picture of a drug's adverse reactions. Recent studies found substantial differences between reports from these varying sources including the reports' completeness. Using the example of opioid-associated abuse, dependence, or withdrawal, this study analyzed the completeness and characteristics of spontaneous reports from Germany focusing on the reporter. Based on EudraVigilance data, we included all cases of abuse, dependence, or withdrawal associated with opioids indicate...
Source: Pharmacology Research and Perspectives - March 24, 2023 Category: Drugs & Pharmacology Authors: Kathrin Jobski, Carsten Bantel, Falk Hoffmann Tags: SHORT REPORT Source Type: research

Cognitive and negative symptoms in schizophrenia with L ‐Carnosine adjuvant therapy – A randomized double‐blind placebo‐controlled study
AbstractThe antioxidant L-Carnosine is reported to improve negative and cognitive symptoms in Schizophrenia. A randomized double-blind placebo-controlled study was planned to study the effectiveness of adjuvant L-Carnosine therapy in patients with Schizophrenia. 100 eligible patients with predominant negative symptoms as measured by scale for assessment of negative symptoms (SANS total score  ≥ 60) and Schizophrenia diagnosis (International Classification of Disorder-Tenth Edition, ICD-10) were recruited. They were randomly allocated to receive a fixed dose of either 400 mg L-Carnosine or identical placebo for 3...
Source: Pharmacology Research and Perspectives - March 23, 2023 Category: Drugs & Pharmacology Authors: Hema Tharoor, Sindhu Maran, Antra K. Chandan, Manikandan Pari, Shruti Rao, Jothilakshmi Durairaj Tags: ORIGINAL ARTICLE Source Type: research

A pharmacokinetic drug –drug interaction study between rosuvastatin and emvododstat, a potent anti‐SARS‐CoV‐2 (COVID‐19) DHODH (dihydroorotate dehydrogenase) inhibitor
Emvododstat (PTC299) was found to be a potent inhibitor of immunomodulatory and inflammation-related processes by the inhibition of dihydroorotate dehydrogenase (DHODH) to reduce SARS-CoV-2 replication. This drug interaction study was performed to determine whether emvododstat was an inhibitor of breast cancer resistance protein (BCRP) transporters in humans using a BCRP substrate, rosuvastatin. Drug interaction studies showed that emvododstat was an in vitro inhibitor of BCRP transporters.  The 90% CIs for AUC and Cmax indicated no apparent PK interaction between the BCRP substrate rosuvastatin and emvododstat. Furthermo...
Source: Pharmacology Research and Perspectives - March 21, 2023 Category: Drugs & Pharmacology Authors: Terri L. Morton, Oscar L. Laskin, Diksha Kaushik, Lucy Lee, Jiyuan Ma, Allan Kristensen, Kylie O'Keefe, Lee Golden, Matthew Klein, Ronald Kong Tags: ORIGINAL ARTICLE Source Type: research

A randomized, double ‐blind, single‐dose study to assess bioequivalence of MB02 biosimilar after manufacturing iteration and reference bevacizumab
This study demonstrates the PK, safety, and immunogenicity similarity and bioequivalence of MB02-SP, MB02-DM, and the reference product bevacizumab. (Source: Pharmacology Research and Perspectives)
Source: Pharmacology Research and Perspectives - March 14, 2023 Category: Drugs & Pharmacology Authors: C. Schwabe, A. Cole, A. Espigares ‐Correa, M. E. Beydon, A. Florez‐Igual, J. Queiruga‐Parada Tags: ORIGINAL ARTICLE Source Type: research

The prescribing safety assessment: Looking to the future
(Source: Pharmacology Research and Perspectives)
Source: Pharmacology Research and Perspectives - March 13, 2023 Category: Drugs & Pharmacology Authors: Ellen Haslam, Kurt Wilson, Lynne Bollington, Simon Maxwell Tags: COMMENTARY Source Type: research

Evaluation of the effects of isoproterenol on arrhythmia recurrence following catheter ablation in patients with atrioventricular nodal re ‐entrant tachycardia: A randomized controlled clinical trial
According to the findings, the presence or absence of isoproterenol administration for arrhythmia re-induction after ablation did not ameliorate the treatment outcomes and arrhythmia recurrence following radiofrequency ablation in atrioventricular nodal re-entrant tachycardiapatients. However, further clinical trials with larger sample sizes and longer duration of follow-up are necessary to confirm our findings. AbstractWe aimed to determine the effects of isoproterenol on arrhythmia recurrence in atrioventricular nodal re-entrant tachycardia (AVNRT) patients treated with catheter ablation. The present randomized controlle...
Source: Pharmacology Research and Perspectives - March 1, 2023 Category: Drugs & Pharmacology Authors: Neda Vahid  Lotfabadi, Saeed Mehrabi, Alireza Heidari‐Bakavoli, Negar Morovatdar, Mohammad Tayyebi, Vafa Baradaran Rahimi Tags: ORIGINAL ARTICLE Source Type: research

Highlights of basic and clinical pharmacology from Africa
(Source: Pharmacology Research and Perspectives)
Source: Pharmacology Research and Perspectives - February 28, 2023 Category: Drugs & Pharmacology Authors: Vanessa Steenkamp Tags: EDITORIAL Source Type: research

Pharmacokinetic study on the effect of ligustrazine –tangeretin co‐administration on the pharmacokinetics of ligustrazine and its potential mechanism in rats
This study provides theoretical guidance for the clinical prescription of ligustrazine- and tangeretin-containing herbs. (Source: Pharmacology Research and Perspectives)
Source: Pharmacology Research and Perspectives - February 28, 2023 Category: Drugs & Pharmacology Authors: Dandan Liu, Yunjiao Liu, Xian Qian, Junwei Yang, Chengjian Li, Lingfeng Zhu, Jin Zhou Tags: ORIGINAL ARTICLE Source Type: research

Safety, tolerability, and pharmacokinetics of a single ascending subcutaneous dose of GSK3772847 in healthy participants
AbstractThe aim of this study was to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GSK3772847, compared with placebo administered subcutaneously (SC) in healthy participants, including cohorts of Japanese and Chinese participants. This was a single-center, randomized, placebo-controlled, double-blind, single ascending dose study. Following a screening period of up to 28  days, eligible participants were assigned to one of four cohorts receiving a single dose of GSK3772847 70 mg (cohort 1) or 140 mg (cohorts 2, 3, and 4) or placebo SC. In cohorts 1 and 2, participants were rand...
Source: Pharmacology Research and Perspectives - February 27, 2023 Category: Drugs & Pharmacology Authors: Eleni Pefani, Sally Stone, Chang ‐Qing Zhu, Carol Nunn, David Fairman Tags: ORIGINAL ARTICLE Source Type: research

Reported hepatotoxicity and hepatotoxicity guidance in the product information of protein kinase inhibitors in oncology registered at the European Medicines Agency
AbstractProtein kinase inhibitors (PKIs) used in oncology can induce severe and even fatal hepatotoxicity. Several PKIs are registered within a certain class to target a specific kinase. No systematic comparison of the reported hepatotoxicity and clinical guidance for monitoring and management of hepatotoxic events between the various PKI summaries of product characteristics (SmPC) is yet available. A systematic analysis of data on 21 hepatotoxicity parameters obtained from the SmPCs and European public assessment reports (EPARs) of European Medicines Agency-approved antineoplastic PKIs (n = 55) has been conducted. The m...
Source: Pharmacology Research and Perspectives - February 27, 2023 Category: Drugs & Pharmacology Authors: Marc Maliepaard, Yoran S. Faber, Mark T. J. Bussel Tags: ORIGINAL ARTICLE Source Type: research