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®, 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.

The Real-World Routine Use of Caffeine Citrate in Preterm Infants: A European Postauthorization Safety Study / Lista, Gianluca; Fabbri, Laura; Polackova, Renáta; Kiechl-Kohlendorfer, Ursula; Papagaroufalis, Konstantinos; Saenz, Pilar; Ferrari, Fania; Lasagna, Giovanna; Carnielli, Virgilio P.. - In: NEONATOLOGY. - ISSN 1661-7800. - STAMPA. - 109:3(2016), pp. 221-227. [10.1159/000442813]

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

Carnielli, Virgilio P.
2016-01-01

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®, 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.
2016
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11566/233750
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