Primary prevention of diclofenac associated ulcers and dyspepsia by omeprazole or triple therapy in Helicobacter pylori positive patients: a randomised, double blind, placebo controlled, clinical trial

Labenz, Joachim; Al, Blum; Bolten, W.; Dragosics, B; Rösch, Wolfgang; Stolte, Manfred; Koelz, H. R.

doi:10.1136/gut.51.3.329

Cited by 95 publications

(47 citation statements)

References 44 publications

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“…In low-risk patients undergoing short-term treatment, the ulcer incidence may also be appreciably lower. For example, in a recent largescale study excluding patients with an ulcer history in which diclofenac was administered over 5 weeks, we noted an ulcer incidence of only 6% [18] . On the other hand, there have also been controlled studies in which more than 45% of the patients developed ulcers [19] .…”

Section: Discussionmentioning

confidence: 99%

NSAID-Associated Dyspepsia and Ulcers: A Prospective Cohort Study in Primary Care

Hollenz

Stolte²,

Leodolter³

et al. 2006

Dig Dis

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Background and Aim: Nonsteroidal anti-inflammatory drugs (NSAIDs) cause dyspeptic complaints and lesions in the upper gastrointestinal tract. The true incidence of these side effects in the everyday situation remains uncertain. We therefore investigated as to how often patients on NSAIDs in the primary care setting must be expected to develop troublesome dyspepsia and/or ulcers in the upper gastrointestinal tract. Patients and Methods: Admitted to the study were consecutive patients requiring NSAID treatment for at least 2 weeks, who were free of treatment-requiring dyspeptic symptoms, and who were not receiving any prophylactic co-medication. After a minimum of 2 weeks of treatment with a NSAID, a standardized questionnaire and endoscopy of the upper gastrointestinal tract were obtained. Results: 104 patients (median age 53 years, 91 women) were recruited to the study. Four patients had to be excluded for protocol violations. NSAID treatment was applied mainly with diclofenac (n = 67), followed by ibuprofen (n = 22) and rofecoxib (n = 9). The main indication was degenerative complaints affecting the vertebral column and joints. Under treatment, 35% of the patients developed troublesome dyspepsia that required treatment. The frequency of dyspepsia was independent of the duration of NSAID use. Ulcer prevalence was 16% (duodenal ulcer: n = 5; gastric ulcer: n = 11; cardiac ulcer: n = 1). Relevant epigastric pain was experienced more frequently by ulcer patients than those with no ulcer (35 vs. 18%, p = n.s.), but their overall symptom frequency was no higher than in the latter. Predictors for the development of ulcer were smoking (odds ratio 5.11 [1.59–16.48]), regular use of alcohol (odds ratio 4.49 [1.34–15.07]) and duration of treatment less than 1 month (odds ratio 4.95 [1.06–23.09]). No ulcer complications occurred during the period under observation. Overall, 44% of the patients developed troublesome dyspepsia and/or ulcer. Conclusion: Primary care patients with an average risk profile frequently develop dyspeptic symptoms requiring treatment, and ulcers while on NSAIDs. Patients who developed an ulcer were not identifiable on the basis of symptoms or risk factors.

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Section: Discussionmentioning

confidence: 99%

NSAID-Associated Dyspepsia and Ulcers: A Prospective Cohort Study in Primary Care

Hollenz

Stolte²,

Leodolter³

et al. 2006

Dig Dis

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“…A major concern with the use of COX inhibitors is the increased frequency of gastric ulcers, which can result in gastrointestinal bleeding severe enough to require hospitalization (17)(18)(19)(20)(21)(22)(23)(24). We therefore chose a preparation of a pan COX inhibitor, ketorolac tromethamine that was formulated as a rinse to reduce the risk of gastrointestinal bleeding (25)(26)(27).…”

Section: Introductionmentioning

confidence: 99%

Randomized, Double-Blind, Placebo-Controlled Phase IIB Trial of the Cyclooxygenase Inhibitor Ketorolac as an Oral Rinse in Oropharyngeal Leukoplakia

Mulshine¹,

Atkinson

Greer

et al. 2004

Clinical Cancer Research

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Purpose: Nonselective cyclooxygenase (COX) inhibitors have been reported to decrease the frequency of upper aerodigestive cancers. Ketorolac tromethamine oral rinse has been shown to resolve another COX-dependent process, periodontal disease, without incurring gastrointestinal side effects. This trial evaluated if a topically delivered oral rinse containing ketorolac was as safe as and more effective than oral rinse alone in reducing the area of oral leukoplakia.Experimental Design: 57 patients were randomized (2:1 ratio) in a double-blind, placebo-controlled study of ketorolac (10 ml of a 0.1% ketorolac rinse solution; n ‫؍‬ 38) or placebo (10 ml of rinse solution; n ‫؍‬ 19) given twice daily for 30 s over 90 days. Primary end point was evaluated visually obtaining bidimensional measurement of the size of leukoplakia lesion(s) at entry and at 90 days. Secondary end point was histological assessment of the leukoplakia as sampled by serial punch biopsy and independently reviewed by three pathologists.Results: The patients included 67% males, 11% nonCaucasian, and 86% used tobacco with no significant differences between the two arms. Both rinses were well tolerated with good compliance, and there was no significant difference in adverse events (P ‫؍‬ 0.27). Major response rate (complete response and partial response) was 30% for ketorolac and 32% for the placebo arm. There was no significant difference in change in histology between the two arms.Conclusion: Local delivery of a COX-containing oral rinse was well tolerated but produced no significant reduction in the extent of leukoplakia compared with the placebo. However, the favorable response rate to placebo arm remains unexplained and additional investigation of the tissue penetration with ketorolac is warranted.

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“…129 Labenz et al found that eradication of H. pylori, proton-pump-inhibitor therapy or combination therapy were comparable in preventing ulcers among NSAID users. 72 By contrast, Hawkey et al found in a post hoc subgroup analysis that eradication of H. pylori retarded ulcer healing. 73 It appears that H. pylori infection leads to an excessive ulcer risk in NSAID-na€ ıve patients.…”

Section: Duodenal Ulcermentioning

confidence: 93%

Helicobacter pylori and benign upper digestive disease

Lai¹,

Sung²

2007

Best Practice & Research Clinical Gastroenterology

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Primary prevention of diclofenac associated ulcers and dyspepsia by omeprazole or triple therapy in Helicobacter pylori positive patients: a randomised, double blind, placebo controlled, clinical trial

Cited by 95 publications

References 44 publications

NSAID-Associated Dyspepsia and Ulcers: A Prospective Cohort Study in Primary Care

NSAID-Associated Dyspepsia and Ulcers: A Prospective Cohort Study in Primary Care

Randomized, Double-Blind, Placebo-Controlled Phase IIB Trial of the Cyclooxygenase Inhibitor Ketorolac as an Oral Rinse in Oropharyngeal Leukoplakia

Helicobacter pylori and benign upper digestive disease

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