Evidence Table 10

Randomized controlled trials of nonsteroidal anti-inflammatory drug-induced ulcer treatment

Author
Year
Setting
Purpose
Age, Gender, Race, Other population characteristicsInterventionsControlNumber Screened/
Eligible/
Enrolled
Outcomes reported (results)Number of adverse effectsQuality rating
Hawkey
1998
International (14 countries including USA) Treatment or prevention
Mean age 58 (range 20 to 85)
38% male
23% smokers
39% H. pylori positive
8% history of bleeding ulcer
41% gastric ulcer
38% rheumatoid arthritis
20 mg or 40 mg of omeprazole once daily (duration not clearly stated, assumed to be 8 weeks)200 mcg of misoprostol four times daily935 enrolled Treatment Success at 8 weeks: 76% (o20), 75% (o40), 71% (m) (NS)
ITT analysis: 75% (o20), 75% (40), 71% (m)
GU only:
87% (o20), 80% (o40), 73% (m) (P=0.004 (o20) vs (m); 0.14 (o40) vs (m)
GU and DU:
85% (o20), 79% (o40), 74% (m)
DU only: 93% (o20), 89% (o40), 77% (m)
Erosions only:
77% (o20), 79% (o40), 87% (m)
H. pylori positive:
83% (o20), 83% (o40), 69% (m)
H. pylori negative:
73% (o20), 70% (o40), 74% (m)
Symptoms:
Reduction in mod-severe dyspepsia at 4 weeks
34% (o20), 39% (o40), 27% (m)
Proportion of days with abdominal pain
43% (o20), 43% (o40), 50% (m)
Proportion of days with heartburn
16% (o20), 14% (o40), 29% (m)
QOL (completed by 68% (o20), 66% (o40), 62% (m))
Gastrointestinal Symptom Rating Scale at 8 weeks
change in total score −0.47 (o20), −0.36 (o40), −0.20 (m)
change in reflux score: −0.82 (o20), −0.75 (o40), −0.33(m)
change in diarrhea score: −0.24 (o20), −0.06 (o40), +0.22 (m)
Nottingham Health Profile
change in sleep score: −3.1 (o20), −8.6 (m), (o40 not reported)
470 patients reported adverse events (48% (o20), 46% (o40), 59% (m)
Most common reported was diarrhea (4.5% (o20), 5.3% (o40), 11.4 % (m)
Fair Comment:
Patients without healing at eight weeks received open treatment with 40 mg of omeprazole daily for a further four to eight weeks.
Yeomans
1998
International (15 countries) Treatment or prevention
Mean age 57
33% male
10% history of bleeding ulcer
39% gastric ulcer
46% H. pylori positive
44% rheumatoid arthritis
20 mg or 40 mg of omeprazole once daily for four or eight weeks150 mg of ranitidine twice daily for four or eight weeks541 enrolled Treatment Success at 8 weeks:
80% (o20), 79% (o40), 63% (ran)
GU only:
84% (o20), 87% (o40), 64% (ran)
DU only:
92% (o20), 88% (o40), 81 (ran)
Erosions only:
89% (o20), 86% (o40), 77% (ran)
H. pylori positive:
83% (o20), 82% (o40), 72% (m)
H. pylori negative:
75% (o20), 71% (o40), 55% (m)
Symptoms: reduction of ‘moderate to severe’ category at 4 weeks:
46% (o20), 38% (ran) (o40 not reported)
190 moderate to severe adverse events were reported (30% (o20), 38% (o40), 40% (r) GI effects (diarrhea, nausea, constipation, and flatulence) were the most common reported Discontinuation of therapy due to either and adverse event or lack of efficacy (not reported separately):
2.8% (o20), 3.2% (o40), 8.5% (ran)
Fair
Agrawal
2000
USA and Canada, multicenter healing only
Mean age 60
35% male
90% white
21% smokers
31% alcohol users
29% H. pylori positive
Lansoprazole, 15 or 30 mg once daily for 8 weeksRanitidine 150 mg twice daily for 8 weeksEndoscopy was performed on 669 patients, 353 met inclusion criteria. Healing: Gastric Ulcer
4 weeks:
47% (l15), 57% (l30), 30% (ran)
8 weeks:
69% (l15), 73% (l30), 53% (ran)
GU and DU 8 weeks:
93% (l15), 81% (l30), 88% (ran)
GU or erosions 8 weeks:
85% (l15), 100% (l30), 86% (l30)
H. pylori positive: 8 weeks:
67% (l15), 82% (l30), 60% (ran)
H. pylori negative:
70% (l15), 69% (l30), 51% (ran)
Symptoms:
4 weeks:
no daytime pain 66% (l15), 64% (l30), 60% (ran)
no nighttime pain 67% (l15), 69% (l30), 64% (ran)
% days antacids used 67% (l15), 70% (l30), 62% (ran)
8 weeks: no daytime pain 70% (l15), 66% (l30), 63% (ran)
no nighttime pain 71% (l15), 71% (l30), 69% (ran)
% days antacids used 69% (l15), 71% (l30), 64% (ran)
33 patients reported an adverse event, 15 patients stopped taking study medication because of adverse events (5 (l15), 4 (l30), 6 (ran)). The most commonly reported treatment- related event was diarrhea.Good/Fair

From: Evidence Tables

Cover of Drug Class Review: Proton Pump Inhibitors
Drug Class Review: Proton Pump Inhibitors: Final Report Update 5 [Internet].
McDonagh MS, Carson S, Thakurta S.
Portland (OR): Oregon Health & Science University; 2009 May.
Copyright © 2009, Oregon Health & Science University, Portland, Oregon.

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