A Doubleblind Comparison of the Gastroduodenal Safety and Efficacy of Diclofenac and a Fixed Dose Combination of Diclofenac and Misoprostol in the Treatment of Rheumatoid Arthritis

Verdickt, W; Moran, Christopher J.; Häntzschel, H; Fraga, Antonio; Stead, Helen; Geis, Gilbert

doi:10.3109/03009749209095074

Cited by 63 publications

(27 citation statements)

References 16 publications

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“…Misoprostol is a synthetic prostaglandin [15]that is effective in the treatment and prevention of gastrointestinal complications in long-term NSAID users when compared with placebo [16, 17, 18, 19]and sucralfate [20]. However, despite the efficacy of misoprostol, poor patient compliance is evident with this drug because of the need to ingest up to four tablets per day and because of the high incidence of dose- and drug-related adverse events such as diarrhea, abdominal pain, and flatulence [17, 21].…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Tolerability of Pantoprazole Compared with Misoprostol for the Prevention of NSAID-Related Gastrointestinal Lesions and Symptoms in Rheumatic Patients

Stupnicki¹,

Dietrich

González-Carro³

et al. 2003

Digestion

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Aim: To compare the efficacy and tolerability of pantoprazole 20 mg once daily (o.d.) with misoprostol 200 µg twice daily (b.i.d.), administered for 6 months to rheumatic patients who required long-term therapy with nonsteroidal anti-inflammatory drugs (NSAIDs) and who were at increased risk of developing gastrointestinal lesions. Methods: This randomized, double-blind, multicenter, parallel group comparison study was performed with rheumatic patients (n = 515) who were likely to take NSAIDs continuously for at least 6 months. Patients were 55 years or older, at risk to develop gastrointestinal lesions, had less than five erosions/petechiae in the stomach and duodenum, no ulcers, no reflux esophagitis (endoscopy-proven), and gastrointestinal symptoms of at most moderate intensity. A minimum daily dose was defined for NSAIDs (COX-2 inhibitors were not available at the time). Patients were randomized to take either pantoprazole 20 mg o.d. (n = 257) or misoprostol 200 µg b.i.d. (n = 258) for 6 months while continuing NSAID therapy. Endoscopy was performed at baseline, 3, and 6 months. Results: Pantoprazole was superior to misoprostol (p < 0.001) with regard to ‘therapeutic failure’ (occurrence of a peptic ulcer, ten or more erosions/petechiae in the stomach/duodenum, reflux esophagitis, severe gastrointestinal symptoms, and/or ‘likely’ or ‘definitely’ related adverse event leading to study termination). Estimated remission rates at 3 and 6 months (Kaplan-Meier life-table analysis) were, respectively, 93 and 89% (pantoprazole) and 79 and 70% (misoprostol). Pantoprazole was superior to misoprostol (p = 0.005) with regard to ‘endoscopic failure’ (occurrence of a peptic ulcer, ten or more erosions/petechiae in the stomach/duodenum, or reflux esophagitis) after 6 months. Estimated remission rates at 3 and 6 months were, respectively, 98 and 95% (pantoprazole) and 95 and 86% (misoprostol). Patients discontinuing the study early due to adverse events ‘likely’ or ‘definitely’ related to the study drug accounted for 13/257 (5%) in the pantoprazole and 33/258 (13%) in the misoprostol treatment groups. Conclusion: Pantoprazole 20 mg o.d. is superior to misoprostol 200 µg b.i.d. in the prevention of NSAID-induced gastrointestinal lesions and symptoms in patients on continuous long-term treatment with NSAIDs due to rheumatic diseases and at risk to develop such lesions or symptoms.

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Section: Introductionmentioning

confidence: 99%

Efficacy and Tolerability of Pantoprazole Compared with Misoprostol for the Prevention of NSAID-Related Gastrointestinal Lesions and Symptoms in Rheumatic Patients

Stupnicki¹,

Dietrich

González-Carro³

et al. 2003

Digestion

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“…[22) All economic evaluations use the probability of developing an endoscopically detected gastric ulcer with misoprostol prophylaxis observed in a 3-month double-blind randomised trial by Graham et al 17 ] Although the association between dyspepsi~ and mucosal lesions is weak, [21] the ulcer rate of 21.7% observed by these investigators is likely to be high. In clinical studies conducted by Verdickt et al [8] and Melo Gomes et al, [9] the absolute risk of endoscopically confirmed gastroduodenal ulcer without misoprostol prophylaxis was 2% for diclofenac, [8] 8.6% for naproxen and 10.3% for piroxicam; [9] these rates are considerably lower than those used in the economic evaluations. Using the smaller absolute risk reduction in the economic evaluations would have resulted in net costs for misoprostol in all studies.…”

Section: Assumptions About the Reduction In Gi Eventsmentioning

confidence: 94%

Use of Misoprostol in the Elderly

1996

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Misoprostol is a prostaglandin E1 analogue which reduces both gastric ulcerations and clinically important bleeding in patients taking nonsteroidal anti-inflammatory drugs (NSAIDs). Economic evaluations of prophylactic use of misoprostol with NSAIDs differ in their conclusions mainly because of different assumptions regarding the absolute risk reduction of symptomatic ulcers. Assuming a conservative estimate of the absolute risk reduction based on new effectiveness data, all studies would have concluded that misoprostol prophylaxis results in net costs in the general population of NSAID users. However, in the elderly with a clearly increased risk of gastrointestinal (GI) lesions and ulcer complications, and an increased hospitalisation rate, misoprostol may be cost saving. Also, in the elderly the gain in quality of life seems to offset the uncertain reduction in quality of life due to the adverse effects of misoprostol. However, the suggestion that misoprostol prophylaxis in the elderly is cost effective or cost saving needs to be confirmed in further studies.

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“…18 The rate of 21.7% observed in the study of Graham et al 15 and used by four studies 9 " 12 is likely to be high. In recent studies by Verdickt et al 19 and Graham et al 20 on cotherapy of misoprostol with different NSAIDs, the absolute endoscopic gastric ulcer risk was 4% 19 and 9% 20 in the placebo group, which is considerably smaller than the one used in the economic evaluations. Using the correspondingly smaller absolute risk reduction would have led to net costs for misoprostol in all studies.…”

Section: Critique Of the Studiesmentioning

confidence: 95%

Is Misoprostol Cost-effective in the Prevention of Nonsteroidal Anti-inflammatory Drug—Induced Gastropathy in Patients With Chronic Arthritis?

Stucki¹

1994

Arch Intern Med

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MAXAIR™ AUTOHAIiR™(pirbuterol acetate inhalation aerosol) Bronchodilator Aerosol For Inhalation Only BRIEF SUMMARY INDICAT10NS AND USAGE: MAXAIR AUTOHALER is indicated ior the prevention and reversal of bronchospasm in patients wilh reversible bronchospasm including asthma. It may be used with or without concurrent theophylline and/or Steroid therapy. CONTRAINDICATIONS: MAXAIR is contraindicated in patients with a history of hypersensitivity to any of its ingredients. WARNINGS: As with other beta adrenergic aerosols, MAXAIR should not be used in excess. Controlled clinical studies and other clinical experience have shown that MAXAIR like other inhaled beta adrenergic agonists can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, Symptoms, and/or EC6 changes. As with other beta adrenergic aerosols, the potential for paradoxical bronchospasm (which can be life threatening) should be kept in mind. If it occurs, the preparation should be discontinued immediately and alternative therapy instituted.Fatalities have been reported in association with excessive use of inhaled sympattiomimetic drugs. The contents of MAXAIR AUTOHALER are under pressure. Do not puncture. Do not use or störe near heat or open flame. Exposure to temperature above 120'F may cause bursting. Never throw Container into fire or incinerator. Keep out of reachotchildren. PRECAUTIONS: General -Since pirbuterol is a sympathomimetic amine, it should be used with caution in patients with cardiovascular disorders, including ischemic heart disease, hypertension, or cardiac arrhythmias. in patients with hyperttiyroidism or diabetes mellitus, and in patients who are unusually responsive to sympathomimetic amines or who have convulsive disorders. Significant changes in systolic and diastolic blood pressure could be expected to occur in some patients alter use of any beta adrenergic aerosol bronchodilator. Information for Patients -MAXAIR effects may last up to five hours or longer. It should not be used more often than recommended and the patient should not increase the number of inhalations or frequency of use without lirst asking the physician. If spptorns of asthma get worse, adverse reactions occur, or the patient does not respond to the usual dose, the patient should be instructed to contact the physician immediately. The patient should be advised to see the lllustrated Patient's Instructions for Use.The Autohaler actuator should not be used with any other inhalation aerosol canister. In addition, canisters Ior use with MAXAIR AUTOHALER should not be utilized with any other actuator. Drug Interactions -Other beta adrenergic aerosol bronchodilators should not be used concomitantly with MAXAIR because they may have additive effects. Beta adrenergic agonists should be administered with caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, since the action of beta adrenergic agonists on the vascular System may be potentiated. Carcinogenesis, Mutagenes^ and Impai...

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A Doubleblind Comparison of the Gastroduodenal Safety and Efficacy of Diclofenac and a Fixed Dose Combination of Diclofenac and Misoprostol in the Treatment of Rheumatoid Arthritis

Cited by 63 publications

References 16 publications

Efficacy and Tolerability of Pantoprazole Compared with Misoprostol for the Prevention of NSAID-Related Gastrointestinal Lesions and Symptoms in Rheumatic Patients

Efficacy and Tolerability of Pantoprazole Compared with Misoprostol for the Prevention of NSAID-Related Gastrointestinal Lesions and Symptoms in Rheumatic Patients

Use of Misoprostol in the Elderly

Is Misoprostol Cost-effective in the Prevention of Nonsteroidal Anti-inflammatory Drug—Induced Gastropathy in Patients With Chronic Arthritis?

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