Major Finding: Relative risk of risperidone inefficacy is lower among pediatric patients (0.43), compared with adults (0.64).
Data Source: Meta-analysis of 30 studies with 872 pediatric patients and 2,655 adults.
Disclosures: Dr. Maayan said he has received research support from Eli Lilly and Pfizer. The current study had no funding source.
BOCA RATON, FLA. – The efficacy and tolerability of risperidone differ between pediatric and adult patients, according to a meta-analysis of 32 double-blind, placebo-controlled trials.
For pediatric prescribers of risperidone, there is good news, mixed news, and not-so-good news, Dr. Lawrence A. Maayan said.
“The good news is study-defined efficacy: Treatment did better than placebo for both children and adults, but significantly better in children,” said Dr. Maayan, a child and adolescent psychiatrist at the Nathan S. Kline Institute for Psychiatric Research at New York University in Orangeburg, N.Y.
Of the studies that included data on efficacy, Dr. Maayan and his colleagues compared 12 studies of 872 pediatric patients with 18 such trials of 2,655 adults. They found that a relative risk of inefficacy was lower among children and adolescents (0.43), compared with adults (0.64). The difference was most pronounced in schizophrenia, which favored pediatric patients (RR, 0.34), compared with adults (RR, 0.62).
“By this metric, risperidone works better in children than in adults. It is reassuring to a pediatric prescriber,” Dr. Maayan said in an interview at his poster. Risperidone is manufactured by Ortho-McNeil-Janssen.
The meta-analysis also included populations with bipolar disorder, subaverage intelligence/disruptive behavior disorders, posttraumatic stress disorder, autism/pervasive developmental disorder, and Alzheimer's dementia. The 32 studies comprised 1,184 children and adolescents (72% male, 65% white) and 3,909 adults (53% male, 85% white).
There was some mixed news regarding adverse events, Dr. Maayan said. For example, “children and adults did about equally” with discontinuation. A total of 26 studies assessed all-cause discontinuation and discontinuation because of inefficacy or intolerability/side effects.
There were no age-group differences in all-cause discontinuation between pediatric and adult patients, Dr. Maayan said. Although pediatric patients had a lower risk (RR, 0.60) compared with adults (RR, 0.77), the magnitude of the difference between risperidone and placebo groups was not statistically different between age groups, “which is reassuring.”
Pediatric patients also had a lower risk for discontinuation because of treatment inefficacy (RR, 0.30), compared with adults (RR, 0.52), Dr. Maayan said. “Children were able to continue [risperidone] just as well as adults.”
However, children were more likely to report at least one adverse event during risperidone treatment (RR, 1.30), compared with adults (RR, 1.01).
“The not-so-good news was raw weight gain: It was about the same in children as in adults,” Dr. Maayan said. “Two kilograms in a 40-year-old is different than a 2-kg gain in a 10-year-old.”
Dr. Maayan and his associates assessed weight gain as a percentage of baseline body weight. “The kids gained about three times as much.” Weight gain was 5.7% for children, vs. 1.5% for adults, a significant difference.
Counsel and talk to patients and families about this increased risk of weight gain with risperidone treatment as part of a full disclosure of benefits and risks, Dr. Maayan advised.