The Real-World Routine Use of Caffeine Citrate in Preterm Infants: A European Postauthorization Safety Study

Autores de IIS La Fe

• Pilar Sáenz González

  Autor

Participantes ajenos a IIS La Fe

• Lista, G
• Fabbri, L
• Polackova, R
• Kiechl-Kohlendorfer, U
• Papagaroufalis, K
• Ferrari, F
• Lasagna, G
• Carnielli, VP
• Peyona PASS Grp

Grupos

• Perinatología

Abstract

Background: Caffeine citrate is the treatment of choice for apnea of prematurity (AOP). Regulatory agencies have requested real-world data on drug utilization and safety, a postauthorization safety study, of a pharmaceutical-grade caffeine citrate, Peyona (R), to confirm its benefit for preterm infants. Objectives: To investigate the clinical use, outcomes, and safety profile of this pharmaceutical-grade caffeine citrate in the routine treatment of preterm infants with a gestational age (GA) <37 weeks. Methods: We conducted a multicenter, noninterventional, prospective study in five European countries. Patients eligible for study enrollment were <37-week GA neonates who received treatment with the pharmaceutical-grade caffeine citrate and whose parents had given informed consent. Results: A total of 506 preterm infants were enrolled from 21 institutions. The pharmaceutical-grade caffeine citrate doses were administered intravenously, orally, or via both routes. The main indication of use was AOP treatment (58%) followed by AOP prophylaxis (37%). Median treatment duration was 21 days. The primary cause of study termination was AOP resolution (n = 407; 80%). Hundred and six patients (21%) required supplemental oxygen on day 28; 48 patients (9.5%) had bronchopulmonary dysplasia at 36 weeks' postmenstrual age. Twenty-three adverse drug reactions were observed in 21 neonates (4.2%); the most frequent was tachycardia (2.3%) and only one (seizures) was considered serious. Thirty-one patients (8.1%) had hepatic or renal functional impairment; the side effects were manageable, and these patients also benefitted from treatment. Conclusions: The use of this caffeine citrate is safe for the management of AOP in a real-world setting. (C) 2016 S. Karger AG, Basel

Keywords

• Preterm infants; Caffeine citrate; Apnea