European journal of clinical pharmacology
-
Eur. J. Clin. Pharmacol. · Apr 2020
Meta AnalysisSufentanil versus fentanyl for pain relief in labor involving combined spinal-epidural analgesia: a systematic review and meta-analysis of randomized controlled trials.
To systematically compare the efficacy and safety of sufentanil versus fentanyl for pain relief in labor involving combined spinal-epidural analgesia (CSEA), a systematic review and meta-analysis of randomized controlled trials targeting parturients requesting labor analgesia was conducted. ⋯ Existing evidence suggests that compared with fentanyl, sufentanil used for analgesia in combined spinal-epidural during labor is more effective in extending the duration of spinal analgesia, and may be safer for the infant. There was overall low clinical and statistical heterogeneity among the included studies. For all outcomes, variations caused by heterogeneity across trials were acceptable. Thus the findings of this meta-analysis may provide additional evidence for future clinical practices of pain relief in labor involving CSEA. Stronger evidence supporting this conclusion will require data from more high-quality and multicenter randomized controlled trials.
-
Eur. J. Clin. Pharmacol. · Apr 2020
Clinical TrialIntake of aspirin prior to metamizole does not completely prevent high on treatment platelet reactivity.
Metamizole can sterically inhibit aspirin (ASA) from binding to cyclooxygenase 1 (COX1). It is recommended that ASA should be taken 30 min prior to metamizole to maintain the irreversible inhibition of arachidonic acid (AA)-induced platelet aggregation. We aimed to analyse the inhibitory effect of ASA and metamizole on AA-induced platelet aggregation over the course of the day. ⋯ Co-medication of ASA and metamizole significantly influences platelet inhibition with variations during the day and can cause HTPR in patients taking ASA prior to metamizole or simultaneously.
-
Eur. J. Clin. Pharmacol. · Mar 2020
Randomized Controlled TrialSafety, pharmacokinetic and pharmacodynamic properties of single ascending dose and continuous infusion of remimazolam besylate in healthy Chinese volunteers.
The aim of the present study was to evaluate the safety, pharmacokinetic (PK) and pharmacodynamic (PD) properties of remimazolam besylate following single ascending dose (SAD) and continuous infusion in healthy Chinese volunteers. ⋯ Remimazolam was safe and well tolerated in healthy Chinese participants. Based on the phase I clinical study, we suggest that remimazolam besylate demonstrates greater sedation and quicker recovery from sedation than midazolam.
-
Eur. J. Clin. Pharmacol. · Sep 2019
Regulatory characteristics and pivotal study design of US Food and Drug Administration approval of drugs for major vs. minor cancer.
We aimed to investigate the regulatory approval of drugs for cancers by the US Food and Drug Administration based on the cancer type (major vs. minor), including the use of expedited development programs and duration from Investigational New Drug application (IND) to marketing approval. ⋯ Drugs targeting minor cancers have frequently utilized the expedited development programs; thus, efficiently shortening time to approval. As many of such drugs are approved based on non-comparative pivotal studies, meticulous evaluation and follow-up should be performed for such drugs after their approval.
-
Eur. J. Clin. Pharmacol. · Aug 2019
Randomized Controlled TrialEffect of itraconazole, food, and ethnic origin on the pharmacokinetics of ivosidenib in healthy subjects.
To assess the effect of ethnicity, food, and itraconazole (strong CYP3A4 inhibitor) on the pharmacokinetics of ivosidenib after single oral doses in healthy subjects. ⋯ No ivosidenib dose adjustment is deemed necessary for Japanese subjects. High-fat meals should be avoided when ivosidenib is taken with food. When co-administered with strong CYP3A4 inhibitors, monitoring for QT interval prolongation (a previously defined adverse event of interest) is recommended and an ivosidenib dose interruption or reduction may be considered. CLINICALTRIALS.GOV : NCT03071770, NCT02579707, and NCT02831972.