Flavored Lansoprazole Suspension In Pediatric GERD Study:
Jeffrey Phillips PharmD, David Parson MD, Steven Fitts MD, Matthew Bettag MD, Barbara Wilder MSN, Leslie Martin BS; University of Missouri, Columbia MO;
Carolina ENT, Greenville SC; Pediatric; Gastroenterology and Nutrition, Spokane WA
Pediatric gastroesophageal reflux disease (GERD) is difficult to treat for several reasons including:
An unflavored PPI suspension was developed at the University of Missouri for use in critically ill patients in 1990 known as simplified omeprazole suspension (SOS) and in 1995 simplified lansoprazole suspension (SLS). ChocoBase was developed to flavor SOS and SLS and was then used in children suffering from manifestations of pediatric GERD. Use of the ChocoBase/PPI suspension has become more common over the past three years in various sites around the United States. This study evaluates ChocoBase/Prevacid® suspension in pediatric GERD from three centers across the U.S.
Evaluate the use of ChocoBase/Prevacid® in children with difficult GERD and it’s manifestations regarding:
Study Design of the Flavored Lansoprazole suspension in pediatric GERD study:
Multicenter evaluative study, “difficult” GERD patients.
Pediatric Gastroenterology and Nutrition, Spokane WA S Fitts, MD, Pediatric Gastroenterology. Carolina ENT, Greenville SC D Parsons MD, ENT University of Missouri, Columbia MO M Bettag, MD ENT.
All patients received ChocoBase/Prevacid®
Outcomes evaluations were performed at periodic intervals after treatment with ChocoBase/Prevacid® initiated.
2. Safety Evaluation Adverse Effects:
3. Tolerability Evaluation:
Data were collected on 60 subjects selected from a larger group of patients at each of three sites:
Spokane WA (n=13)
Greenville SC (n=21)
Columbia MO (n=26)
60/60 patients had symptoms, clinical exam and history consistent with GERD.
43/60 had a definitive diagnosis (e.g. clinical diagnosis + pH study, laryngoscopy)
The age that GERD was identified ranged from birth to 14 years.
20 female and 40 male.
The mean age that ChocoBase/Prevacid® was started was 21.5 months.
The overall mean dose to get significant symptom control was 2.6 mg/kg.
Those patients under 1 yr of age required a disproportionately higher dosage.
Children less than 4 months required the highest dosage 5 + 1.9 mg/kg (mean + s.d.)
I. EFFICACY EVALUATION
Significant Improvement w/Resolution: 47/60 = 78%
Some improvement (still some symptoms): 2/60 = 3%.
No change: 7/60 = 12%
Did not tolerate or worsened: 1/60 = 2% (would not take medication)
II. SAFETY EVALUATION
Adverse Effects highly likely or probable: 3 loose stools.
2 resolved with continued dosing
1 required discontinuation (moderate)
No serious or life threatening adverse events.
Child took the medication readily and without difficulty.
Child refused medication sometimes.
Child completely refused the medication.
45 of 60 children received once daily dosing: 15 of 60 used twice daily dosing (most often those < 1 yr of age)
DISCUSSION of the Flavored Lansoprazole suspension in pediatric GERD study:
Pediatric GERD is difficult to treat and is often associated with extraesophageal manifestations. Patients in this study had the following extraesophageal manifestations (in no order):
Most patients had three symptoms associated with their GERD. Mothers were most frequently involved in the care of the patient and reported significant family stress related to the GERD symptoms.
Doses required to resolve symptoms were in the range of 2 to 4 mg /kg/day in most children. These values are similar to those reported by Israel, D and Hassall, E in studies of omeprazole in children. Data also support that very young children need the highest doses (mg/kg) and this is consistent with the findings of this study.
Conclusion of the Flavored Lansoprazole suspension in pediatric GERD study:
In children with “difficult” GERD and extraesophageal manifestations this study finds that: