Forgive me if this has been posted before here, but I was at the prevacid manufacturer’s website and saw that in their own double blind study prevacid was found to be no more effective than a placebo..
What do you all think about this?
8.4 Pediatric Use
The safety and effectiveness of PREVACID have been established in
pediatric patients 1 to 17 years of age for short-term treatment of
symptomatic GERD and erosive esophagitis, however, PREVACID was not effective in
patients with symptomatic GERD 1 month to less than 1 year of age in a
multicenter, double-blind, placebo controlled study.
Neonate to less than 1 year of age The pharmacokinetics of lansoprazole were studied in pediatric patients
with GERD aged less than 28 days and 1 to 11 months. Compared to healthy adults receiving 30 mg, neonates had higher exposure (mean weight-based
normalized AUC values 2.04- and 1.88-fold higher at doses of 0.5 mg/kg/day and1 mg/kg/day, respectively). Infants aged 10 weeks had
clearance and exposure values that were similar to neonates. Infants
aged greater than 10 weeks who received 1 mg/kg/day had mean AUC values that were similar to adults who received a 30 mg dose.
Lansoprazole was not found to be effective in a U.S. and Polish 4 week
multicenter, double-blind, placebo-controlled, parallel-group study of
162 patients between one month and less than 12 months of age with
symptomatic GERD based on a medical history of
crying/fussing/irritability associated with feedings who had not responded to conservative GERD management
(i.e., non-pharmacologic intervention) for 7 to 14 days. Patients
received lansoprazole as a suspension daily (0.2 to 0.3 mg/kg/day in infants
10 weeks of age or 1.0 to 1.5 mg/kg/day in infants greater than 10
weeks or placebo) for up to 4 weeks of double-blind treatment.
The primary efficacy endpoint was assessed by greater than 50%
reduction from baseline in either the percent of feedings with a
crying/fussing/irritability episode or the duration (minutes) of a crying/fussing/irritability episode within one hour after feeding.
There was no difference in the percentage of responders between the
lansoprazole pediatric suspension group and placebo group (54% in both
groups).
There were no adverse events reported in pediatric clinical studies (1
month to less than 12 months of age) that were not previously observed
in adults.
Based on the results of the Phase 3 efficacy study, lansoprazole was
not shown to be effective. Therefore, these results do not support the
use of
lansoprazole in treating symptomatic GERD in infants.
.
If that were the case we’d be dosing at only 6mg per day
! The dose that works for us? 36mg per day
