Vancomycin is commonly used as a treatment for neonatal infections. However, there is a lack of consensus establishing the optimal vancomycin therapeutic regimen and defining the most appropriate PK/PD parameter correlated with the efficacy. A recent guideline recommends AUC–guided therapeutic dosing in treating serious infections in neonates. However, in clinical practice, trough serum concentrations are commonly used as a surrogate PKPD index for AUC24. Despite this, target serum concentrations in a neonatal population remain poorly defined. The objective is to describe the relationship between therapeutic regimens and the achievement of clinical or pharmacokinetic outcomes in the neonatal population. The review was carried out following PRISMA guidelines. A bibliographic search was manually performed for studies published on PubMed and EMBASE. Clinical efficacy and/or target attainment and the safety of vancomycin treatment were evaluated through obtaining serum concentrations. A total of 476 articles were identified, of which 20 met the inclusion criteria. All of them evaluated the target attainment, but only two assessed the clinical efficacy. The enormous variability concerning target serum concentrations is noteworthy, which translates into a difficulty in determining which therapeutic regimen achieves the best results. Moreover, there are few studies that analyze clinical efficacy results obtained after reaching predefined trough serum concentrations, this information being essential for clinical practice.

Migraine is considered one of the most disabling diseases. Currently, there are few studies on clinical migraine treatment based on sex-related differences, despite the important role of sex in migraine. Our aim was to evaluate gender bias in published clinical trials on monoclonal antibodies (erenumab, galcanezumab, fremanezumab and eptinezumab). We performed a systematic review of controlled clinical trials of erenumab, galcanezumab, fremanezumab and eptinezumab, searching the PubMed/MEDLINE database for articles published before December 2021. The search identified 760 articles, 25 of which met the inclusion criteria. Of all the patients included in these trials, 85.1% were women. Only one study had female lead authors. Two of the 25 studies included a sex-based analysis of the primary endpoint. None of the articles discussed the results separately for men and for women. The proportion of men recruited in trials is scarce and more studies are needed to guarantee the safety and tolerability of monoclonal antibodies used in male migraine. As observed in our study, despite the high number of women recruited, only 2 studies analysed the results separately by sex. Thus, a potential risk of gender bias was found in these clinical trials.

Vancomycin is used to treat a wide variety of infections within the pediatric population. In adults, continuous infusion of vancomycin (CIV) has been evaluated as an alternative to intermittent infusion of vancomycin (IIV) with potential advantages. In children, the use of CIV is increasing; however, data is currently limited. The objective is to provide efficacy and safety evidence for CIV within this population. The review was carried out following PRISMA guidelines. A bibliographic search was performed for studies on PubMed and EMBASE. Clinical trials and observational studies that reported clinical efficacy and/or target attainment of CIV in pediatrics were included. Articles were reviewed to assess their design and target population, characteristics of vancomycin treatment and the main findings in terms of safety and efficacy. A total of 359 articles were identified, of which seven met the inclusion criteria. All of them evaluated the target attainment, six assessed safety but only three assessed clinical efficacy. The best administration method for this antibiotic within the pediatric population is still unknown due to limited evidence. However, studies conducted thus far suggest pharmacokinetic advantages for CIV. Further investigation is required, in particular for studies comparing IIV with CIV for clinical efficacy and toxicity outcomes.

Background and Importance Monoclonal antibodies (mAb) against calcitonin gene related peptide (anti-CGRP) and its receptor (anti-CGRP-receptor) are effective in the prophylaxis of migraine. However, studies to determine effectiveness and safety on switching between them in non-responders are scarce. Aim and Objectives To evaluate the real-world clinical effectiveness and safety of mAb switch in migraine patients. Material and Methods Retrospective cohort study of adult patients who switched between mAb in a tertiary hospital from December 2019 until September 2022. Sociodemographic and clinical data were recorded. Outcome measures: the reduction of Headache Impact Test (HIT-6) scale punctuation and the reduction of monthly migraine days. Results We analysed 147 patients treated with anti-CGRP or anti-CGRP-receptor. Among these, 20 patients (13.6%) switched between mAb and had at least one follow-up visit after switching. 16 patients (80%) suffered from chronic migraine (CM) with a baseline median days of migraine a month of 15 [13-24], median Regicor scale of 2% [1-3%] and median HIT-6 of 67 [62.5-72.3]. 19 (95%) were female. Out of these 20 patients, 15 (75%) started with Erenumab and 5 (25%) with Galcanezumab. First mAb switching was performed after a median of 7.4 months treatment [5.9-11.8] (12 from Erenumab to Galcanezumab; 3 from Erenumab to Fremanezumab; 2 from Galcanezumab to Erenumab and 3 from Galcanezumab to Fremanezumab). 5 patients required a second switch, and one received a third mAb. Reasons for first switching: 12 (60%) non-response, 7 (35%) loss of response and 1 (5%) adverse event. 1 patient (5%) discontinued mAb treating during the study period due to lack of effectiveness. Median reduction in HIT-6 after first and second switching was-2 [-11.5-0],and -3.5 [-11.8-0], respectively. Median reduction of monthly migraine days after first, and second switching was -4.15 [-7-0] and-4.8 [-6.5 to -0.6], respectively. Constipation (38.7%) and itchiness (3.2%) were the most frequent adverse events during the study period. Conclusion and Relevance Our findings in 20 treatment-resistant patients indicated that switching between CGRP mAbs could be beneficial to some non-responders to a initial mAb. Conflict of Interest No conflict of interest