PMID- 8886215
OWN - NLM
STAT- MEDLINE
DCOM- 19970123
LR  - 20131121
IS  - 1078-4519 (Print)
IS  - 1078-4519 (Linking)
VI  - 25
IP  - 9 Suppl
DP  - 1996 Sep
TI  - Two comparative endoscopic evaluations of Naprelan.
PG  - 30-6
AB  - This paper describes the results of two endoscopic studies of Naprelan 
      (Wyeth-Ayerst Laboratories, Philadelphia, Pennsylvania), a controlled-release 
      formulation of naproxen sodium. In one study, 19 healthy male subjects received 
      either 2 controlled release Naprelan 500-mg tablets once daily or 1 Naprosyn 
      (naproxen; Syntex Laboratories, Inc., Palo Alto, California) 500-mg tablet BID. 
      At baseline, all subjects had gastroduodenal endoscopy scores of 0 on both the 
      Lanza and Euler scales. Although the trend favored Naprelan, differences in Lanza 
      and Euler scale elevations were not statistically significant. Eight of 10 
      subjects in the Naprelan group and 7 of 9 subjects in the Naprosyn group reported 
      a total of 27 adverse events (AEs). In the second study, healthy subjects 
      received Naprelan 1,000 mg once daily, Naprosyn 500 mg BID, and film-coated 
      aspirin 650 mg QID. In the stomach, there was a significant difference in favor 
      of Naprelan over aspirin (P = 0.0001) and in favor of Naprosyn over aspirin (P = 
      0.0001). Fewer erosions were seen in the duodenum than in the stomach. In the 
      duodenum, there was a significant difference in favor of Naprelan over Naprosyn 
      (P = 0.0236), and in favor of Naprelan over aspirin (P = 0.0086), but the 
      difference between Naprosyn and aspirin was not significant (P = 0.6643). Of the 
      23 subjects who received medication, 12 reported AEs: 8 while receiving aspirin, 
      3 while receiving Naprosyn, and 1 while receiving Naprelan. Differences in the 
      number of erosions and ulcers seen following each of the periods of drug 
      administration favored Naprelan and the Intestinal Protective Drug Absorption 
      System.
FAU - Hawkey, C
AU  - Hawkey C
AD  - Department of Medicine, University Hospital, Queens Medical Centre, Nottingham, 
      United Kingdom.
FAU - O'Morain, C
AU  - O'Morain C
FAU - Murray, F
AU  - Murray F
FAU - McCarthy, C
AU  - McCarthy C
FAU - Tierney, D
AU  - Tierney D
FAU - Devane, J
AU  - Devane J
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Am J Orthop (Belle Mead NJ)
JT  - American journal of orthopedics (Belle Mead, N.J.)
JID - 9502918
RN  - 0 (Anti-Inflammatory Agents, Non-Steroidal)
RN  - 0 (Delayed-Action Preparations)
RN  - 57Y76R9ATQ (Naproxen)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Anti-Inflammatory Agents, Non-Steroidal/administration & dosage/adverse 
      effects/*pharmacology
MH  - Cross-Over Studies
MH  - Delayed-Action Preparations
MH  - Digestive System/*drug effects
MH  - Double-Blind Method
MH  - Endoscopy, Gastrointestinal
MH  - Humans
MH  - Male
MH  - Naproxen/administration & dosage/adverse effects/*pharmacology
MH  - Peptic Ulcer/chemically induced
MH  - Single-Blind Method
EDAT- 1996/09/01 00:00
MHDA- 1996/09/01 00:01
CRDT- 1996/09/01 00:00
PHST- 1996/09/01 00:00 [pubmed]
PHST- 1996/09/01 00:01 [medline]
PHST- 1996/09/01 00:00 [entrez]
PST - ppublish
SO  - Am J Orthop (Belle Mead NJ). 1996 Sep;25(9 Suppl):30-6.