Summary
To better understand outcomes in postpartum patients who receive peripartum anaesthetic interventions, we aimed to assess quality of recovery metrics following childbirth in a UK‐based multicentre cohort study. This study was performed during a 2‐week period in October 2021 to assess in‐ and outpatient post‐delivery recovery at 1 and 30 days postpartum. The following outcomes were reported: obstetric quality of recovery 10‐item measure (ObsQoR‐10); EuroQoL (EQ‐5D‐5L) survey; global health visual analogue scale; postpartum pain scores at rest and movement; length of hospital stay; readmission rates; and self‐reported complications. In total, 1638 patients were recruited and responses analysed from 1631 (99.6%) and 1282 patients (80%) at one and 30 days postpartum, respectively. Median (IQR [range]) length of stay postpartum was 39.3 (28.5–61.0 [17.7–513.4]), 40.3 (28.5–59.1 [17.8–220.9]), and 35.9 (27.1–54.1 [17.9–188.4]) h following caesarean, instrumental and vaginal deliveries, respectively. Median (IQR [range]) ObsQoR‐10 score was 75 ([62–86] 4–100) on day 1, with the lowest ObsQoR‐10 scores (worst recovery) reported by patients undergoing caesarean delivery. Of the 1282 patients, complications within the first 30 days postpartum were reported by 252 (19.7%) of all patients. Readmission to hospital within 30 days of discharge occurred in 69 patients (5.4%), with 49 (3%) for maternal reasons. These data can be used to inform patients regarding expected recovery trajectories; facilitate optimal discharge planning; and identify populations that may benefit most from targeted interventions to improve postpartum recovery experience.
IntroductionAzilsartan is an angiotensin II receptor blocker indicated for the treatment of patients with hypertension. The efficacy and safety of azilsartan are established in adults, but have not been evaluated in pediatric patients, nor has its pharmacokinetic profile been determined in pediatric patients.MethodsIn this phase 3, open-label, multicenter study, we investigated the pharmacokinetics and safety of single doses of azilsartan in six Japanese patients with hypertension, aged 9–14 years. The dose of azilsartan was 5 mg for three patients weighing less than 50 kg, with mean body weight at baseline of 27.5 kg, and 10 mg for three patients weighing at least 50 kg, with mean body weight at baseline of 65.9 kg.ResultsMean maximum plasma concentration (Cmax) of azilsartan was 888.3 and 831.3 ng/mL and median time to maximum concentration (Tmax) of unchanged azilsartan was 3.0 and 4.0 h, in the 5-mg and 10-mg groups, respectively. Mean areas under the plasma concentration–time curve (AUC) from 0–24 h post-dose (AUC0–24) and 0 h to infinity (AUC0–inf) were 6350.3 and 6635.7 ng h/mL, respectively, in the 5-mg group, and 6871.7 and 7433.3 ng h/mL, respectively, in the 10-mg group. Both doses were well tolerated; no treatment-emergent adverse events considered to be related to azilsartan occurred during the study.ConclusionOur data suggest that pediatric patients weighing less than 50 kg may have approximately 2-fold greater exposure to azilsartan than those weighing at least 50 kg at the same dose. Exposure to azilsartan in children weighing at least 50 kg is comparable to that in healthy adults at the same dose.Trial RegistrationClinicalTrials.gov identifier, NCT02451150.FundingTakeda Pharmaceutical Co. Ltd.
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