TABLE OF CONTENTS
- Briefing Document by Hugo Gallo-Torres, M.D., Ph.D.
- Sample of a Written Request for Proton-Pump Inhibitors Used to Treat Gastroesophageal Reflux Disease
- Usage data for proton-pump inhibitors in pediatrics
- Letter from George D. Ferry, M.D.
List of References
Gastroesophageal reflux disease in pediatrics
- Faubion, WA, Zein, NN. Gastroesophageal reflux in infants and children. Mayo Clinic Proc. 1998; 73:166-173.
- Orenstein, SR. Management of supraesophageal complications of gastroesophgeal reflux disease in infants and children. The American Journal of Medicine. 2000; 108(4A):139S-143S.
- Vandenplas,Y, SacrJ
-Smits,L. Continous 24-hour esophageal pH monitoring in 285 asymptomatic infants 0-15 months old. Journal of Pediatric Gastroenterology and Nutrition. 1987; 6(2):220-224.
- Thach, BT. Reflux associated apnea in infants: Evidence for a laryngeal chemoreflex. The American Journal of Medicine. 1997; 103(5A): 120S-124S.
Gastroesophageal reflux in neonates
- Jadcherla, SR. Gastroesophageal reflux in the neonate. Clinics in Perinatology. 2002; 29(1):135-158.
- Newell, SJ, Booth, IW, Morgan, MEI, et.al. Gastro-oesophageal reflux in preterm infants. Archives of Disease in Childhood, 1989;64:780-786.
- Marino, AJ, Assing, E, Carbone, MT, et.al. The incidence of gastroesophgeal reflux in preterm infants. Journal of Perinatology. 1995; 15(5):369-371.
- Kimball, AL, Carlton, DP. Gastroesophgeal reflux medications in the treatment of apnea in premature infants. The Journal of Pediatrics. 2001;138(3): 355-360.
- Page, M, Jeffery, H. The role of gastro-oesophgeal reflux in the aetiology of SIDS. Early Human Development. 2000; 59:127-149.
- Barrington, KJ, Tan, K, Rich, W. Apnea at discharge and gastro-esophgeal reflux in the preterm infant. Journal of Perinatology. 2002; 22:8-11.
Respiratory and supraesophageal manifestations of gastroesophageal reflux
- Menon, AP, Schefft, GL, Thach, BT. Apnea associated with regurgitation in infants. The Journal of Pediatrics. 1985; 106(4):625-629.
- Orlando, R. Mechanisms of reflux-induced epithelial injuries in the esophagus. The American Journal of Medicine. 2000; 108(4A):104S-107S.
- Richter, JE. Gastroesophgeal reflux disease and asthma: The two are directly related. The American Journal of Medicine. 2000; 108(4A):153S-158S.
- Holloway, RH. Esophageal body motor response to reflux events: Secondary peristalsis. The American Journal of Medicine. 2000; 108(4A):20S-26S.
- Peter, CS, Sprodowski, N, Bohnhorst, B, et.al. Gastroesophageal reflux and apnea of prematurity: No temporal relationship. Pediatrics. 2002; 109(1): 8-11.
- FDA Ethics Working Group Consensus Statement on the Pediatric Advisory Subcommittee’s November 15, 1999 Meeting. (www.fda.gov/cder/pediatric/ethics-statement.htm) (accessed 4/29/02).
- FDA Pediatric Ethics Working Group Consensus Statement on Pediatric Advisory Subcommittee’s September 11, 2000 Meeting. (www.fda.gov/cder/pediatric/ethics-statement.htm). (accessed 4/29/02).
Special study designs: Randomized-withdrawal trials
- Temple, RJ. Special study designs: Early escape, enrichment, studies in non-responders. Commun. Statist. Theory Meth. 1994; 23(2):499-531.
Choice of control group in clinical studies
- Guidance For Industry: E 10 Choice of Control Group and Related Issues in Clinical Trials. Food and Drug Administration. May 2001.
- Temple, R, Ellenberg, S. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 1: Ethical and scientific issues. .Annals of Internal Medicine. 2000; 133(6):455-463.
- Ellenberg, S, Temple, R. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 2: Practical issues and specific cases. Annals of Interanl Medicine. 2000; 133(6): 464-475.
- Temple, RJ. When are clinical trials of a given agent vs. placebo no longer appropriate or feasible? Controlled Clinical Trials. 1997; 18:613-620
Pharmacology of proton-pump inhibitors
- James, LP. Pharmacology for the gastrointestinal tract. Clinics in Perinatology. 2002; 29(1):115-133.
- Wolfe, MM, Sachs, G. Acid suppression: Optimizing therapy for gastroduodenal ulcer healing, gastroesophageal reflux disease, and stress-related erosive syndrome. Gastroenterology. 2000; 118:S9-S31.
- Richardson, et.al. Proton pump inhibitors in GI disorders. Drugs. 1998; 56(3):308-334.
- Sachs, G, Shin, JM, Briving, C, et.al. The pharmacology of the gastric acid pump: The H+, K+ ATPase. Annual Review of Pharmacology and Toxicology. 1995; 33:277-305.