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| |  Cafcit (Caffeine Citrate) Safe, Effective For Apnea In Premature Infants COLUMBUS, OH -- July 11, 2000 -- A new study, conducted in nine U.S. neonatal intensive care units to evaluate Cafcit® (caffeine citrate) in the treatment of premature infants suffering from apnea of prematurity, revealed that the treatment is both safe and effective in reducing apnea of prematurity attacks. This first-ever placebo-controlled study concluded that caffeine citrate proved significantly better than placebo in reducing apnea of prematurity episodes in infants between 28 to 32 weeks post-conception. Cafcit treatment, which was studied for a maximum of 10 to 12 days, significantly eliminated apnea of prematurity events on day two of treatment. Apnea of prematurity is defined as cessation of breathing for periods of 20 seconds or longer, with or without bradycardia or cyanosis, which can result in severe neurological damage and sometimes death. Apnea of prematurity may occur in 80 percent of pre-term infants weighing less than 2.2 pounds at birth. The American Academy of Pediatrics and the U.S. Birth Cohorts estimate that there are more than 150,000 infants born each year who will be diagnosed and treated for AOP. This multicenter study was a 10- to 12-day, randomized, double-blind, placebo-controlled trial, with an open-label rescue phase. Pre-term infants, 28 to 32 weeks post-conceptual age, who had six or more apnea episodes (>20 seconds in duration) within 24 hours, were eligible for the study. A total of 85 infants were randomly assigned to two groups: 46 received caffeine citrate and 39 placebo. Specifically, the study demonstrated that caffeine citrate treatment significantly eliminated apnea events on day two of treatment [percent of patients with zero apnea events: 26.7 percent (caffeine citrate) vs. 8.1 percent (placebo), p=0.03]. The mean number of days with zero apnea events was 3.0 in the caffeine citrate group and 1.2 in the placebo group. The mean number of days with a 50 percent reduction from baseline in apnea events was 6.8 in the caffeine citrate group and 4.6 in the placebo group. Overall, this double-blind clinical trial found that adverse events were similar between Cafcit and placebo. Adverse events described in published literature include CNS stimulation, cardiovascular effects, gastrointestinal effects, alterations in serum glucose and renal effects. Six cases of necrotizing enterocolitis (NEC) developed among the 85 infants studied. Five of the six patients with NEC were randomized to -- or had been exposed to -- caffeine citrate treatment. "This is the first time a placebo-controlled study of caffeine citrate has been conducted for the treatment of apnea of prematurity," said the Medical Director of the study Allen Erenberg, M.D., Professor of Pediatrics, Head of the Section of Neonatology and Developmental Biology, University of Arizona Health Sciences Center, Tuscon AZ. "This study has shown that Cafcit is significantly more effective than placebo in reducing the number of apneic episodes by at least 50 percent, as well as eliminating apnea in more than 25 percent of treated infants." The study notes in the introduction that caffeine citrate has been used to treat AOP since the 1970s, however hospital pharmacies were required to compound the caffeine citrate solution, which resulted in some incorrectly prepared formulations. Some of these mixtures resulted in overdoses, which were responsible for most reported adverse events associated with caffeine citrate. Recently, two dosage forms of Cafcit have been approved by the U.S. Food and Drug Administration for the short-term treatment of apnea of prematurity (AOP) in infants between 28 and <33 weeks gestational age. In September 1999, Cafcit (caffeine citrate) Injection was approved. In April 2000, Cafcit (caffeine citrate) Oral Solution was approved, which can be used in both hospital and home settings. CAFCIT, one of only three drugs approved by the FDA for neonatal use, is distributed by Roxane Laboratories, Inc. Results from this study have been published in this month's issue of Pharmacotherapy, a monthly peer-reviewed medical journal. The study was conducted by the Caffeine Citrate Study Group and supported by O.P.R. Development, Inc.
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