Prescription and tolerability of meloxicam in day-to-day practice: Postmarketing observational cohort study of 13,307 patients in germany

Journal of Clinical Rheumatology

Volumn 8, Issue 6, 2002, Pages 305-315

  Zeidler, Henning ^a,e   Kaltwasser, Joachim P ^b   Leonard, Joachim P ^c   Kohlmann, Thomas ^d   Sigmund, Ralf ^c   Degner, Frank ^c   Hettich, Marceline ^c  

^a LEIBNIZ UNIVERSITY HANNOVER   (Germany)

^b GOETHE UNIVERSITY   (Germany)

^c BOEHRINGER INGELHEIM PHARMA GMBH AND CO KG   (Germany)

^d UNIVERSITY OF LÜBECK   (Germany)

^e HANNOVER MEDICAL SCHOOL   (Germany)

Author keywords

GI adverse drug reactions; Meloxicam; NSAID; Postmarketing observational study; Selective COX 2 inhibition

Indexed keywords

MELOXICAM; METHOTREXATE; PREDNISOLONE;

ABDOMINAL PAIN; ACUTE DISEASE; ADULT; AGED; ANALGESIA; ANKYLOSING SPONDYLITIS; ARTICLE; BLEEDING; CARDIOVASCULAR DISEASE; CHRONIC DISEASE; CLINICAL OBSERVATION; CLINICAL PRACTICE; CLINICAL TRIAL; COHORT ANALYSIS; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DAILY LIFE ACTIVITY; DIARRHEA; DOSE RESPONSE; DRUG EFFICACY; DRUG HYPERSENSITIVITY; DRUG MARKETING; DRUG OVERDOSE; DRUG SAFETY; DRUG TOLERABILITY; DYSPEPSIA; ECZEMA; ERYTHEMA; FACE EDEMA; FEMALE; GASTRITIS; GASTROINTESTINAL SYMPTOM; GERMANY; HEADACHE; HIGH RISK PATIENT; HUMAN; ILEUS; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; OSTEOARTHRITIS; PERIPHERAL EDEMA; POSTMARKETING SURVEILLANCE; PRESCRIPTION; PRIORITY JOURNAL; PRURITUS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; RASH; RHEUMATIC DISEASE; RHEUMATOID ARTHRITIS; STOMACH PERFORATION; STOMACH ULCER; VERTIGO;

EID: 0036899628     PISSN: 10761608     EISSN: None     Source Type: Journal    
DOI: 10.1097/00124743-200212000-00005     Document Type: Article

References (38)

1. Vane J. The future of NSAIDs therapy: Selective COX-2 inhibitors. Int J Clin Pract 2000;54:7-9.
2. Singh G, Triadafilopoulos G. Epidemiology of NSAIDs induced gastrointestinal complications. J Rheumatol 1999;26(Suppl 56):18-24.
3. Warner TD, Giuliano F, Vojnovic I, et al. Nonsteroidal drug selectivities for cyclo-oxygenase-1 rather than cyclo-oxygenase-2 are associated with human gastrointestinal toxicity: A full in vitro analysis. Proc Natl Acad Sci U S A 1999;96:7563-8.
4. Vane JR, Warner TD. Nomenclature for COX-2 inhibitors. Lancet 2000;356:1373-4.
5. Churchill L, Graham AG, Shih CK, et al. Selective inhibition of human cyclo-oxygenase-2 by meloxicam. Inflammopharmacology 1996;4:125-35.
6. Patrignani P, Panara MR, Sciulli MG, et al. Differential inhibition of human prostaglandin endoperoxide synthase-1 and -2 by nonsteroidal antiinflammatory drugs. J Physiol Pharmacol 1997;48:623-31.
7. De Meijer A, Vollard H, de Metz M, et al. Meloxicam, 15 mg/day, spares platelet function in healthy volunteers. Clin Pharmacol Ther 1999;66:425-30.
8. Van Hecken A, Schwartz JI, Depré M, et al. Comparative inhibitory activity of rofecoxib, meloxicam, diclofenac, ibuprofen, and naproxen on COX-2 versus COX-1 in healthy volunteers. J Clin Pharmacol 2000;40:1109-20.
9. Panara MR, Renda G, Sciulli MG, et al. Dose-dependent inhibition of platelet cyclooxygenase-1 and monocyte cyclooxygenase-2 by meloxicam in healthy subjects. J Pharmacol Exp Ther 1999;290:276-80.
10. Stichtenoth DO, Wagner B, Frölich JC. Effects of meloxicam and indomethacin on cyclooxygenase pathways in healthy volunteers. J Invest Med 1997;45:44-9.
11. Pairet M, van Ryn J. Experimental models to investigate the differential inhibition of cyclooxygenase-1 and cyclooxygenase-2 by nonsteroidal antiinflammatory drugs. Inflamm Res 1998;47(Suppl 2):S93-110.
12. Rinder HM, Gagnier RP, Souhrada M, et al. Bleeding time and platelet function in normal volunteers receiving meloxicam. Ann Rheum Dis 2001;60(Suppl 1):229.
13. Fitzgerald GA, Patrono C. The coxibs, selective inhibitors of cyclooxygenase-2. N Engl J Med 2001;345:433-42.
14. Dequeker J, Hawkey C, Kahan A, et al. Improvement in gastrointestinal tolerability of the selective cyclooxygenase (COX)-2 inhibitor, meloxicam, compared with piroxicam: Results of the safety and efficacy large-scale evaluation of cox-inhibiting therapies (SELECT) trial in osteoarthritis. Br J Rheumatol 1998;37:946-51.
15. Dougados M, Gueguen A, Nakache J-P, et al. Ankylosing spondylitis: What is the optimum duration of a clinical study? A one-year versus a 6-weeks nonsteroidal antiinflammatory drug trial. Rheumatology 1999;38:235-44.
16. Hawkey C, Kahan A, Steinbrück K, et al. Gastrointestinal tolerability of meloxicam compared to diclofenac in osteoarthritis patients. Br J Rheumatol 1998;37:937-45.
17. Schoenfeld P. Gastrointestinal safety profile of meloxicam: A meta-analysis and systematic review of randomized controlled trials. Am J Med 1999;107:48-54.
18. Yocum DE, Fleischmann R, Dalgin P, et al. Safety and efficacy of meloxicam in the treatment of osteoarthritis: A 12-week, double-blind, multiple-dose, placebo-controlled trial. Arch Intern Med 2000;160:2947-54.
19. De Mey C. Sinn und unsinn von anwendungsbeobachtungen. Med Klinik 2000;95:56-62.
20. Benson K, Hartz AJ. A comparison of observational studies and randomized, controlled trials. N Engl J Med 2000;342:1878-86.
21. Bullinger M, Kirchberger I, Steinbüchel N. Der fragebogen alltagsleben: Ein verfahren zur erfassung der gesundheitsbezogenen lebensqualität. Z Med Psychol 1993;3:121-31.
22. Kohlmann T, Raspe H. Der funktionsfragebogen hannover zur alltagsnahen diagnostik der funktionsbeeinträchtigung Dutch rückenschmerzen (FFbH-R). Rehabilitation 1996;35:1-8.
23. Fries JF, Spitz P, Kraines RG, et al. Measurement of patient outcome in arthritis. Arthritis Rheum 1980;23:137-45.
24. Lautenschlager J, Mau W, Kohlmann T, et al. Vergleichende Evaluation einer deutschen version des Health Assessment Questionnaires (HAQ) und des funktionsfragebogens Hannover (FFbH). Z Rheumatol 1997;56:144-55.
25. Degner F, Sigmund R, Zeidler H. Efficacy and tolerability of meloxicam in an observational, controlled cohort study in patients with rheumatic disease. Clin Ther 2000;22:400-10.
26. Martin RM, Biswas P, Mann RD. The incidence of adverse events and risk factors for upper gastrointestinal disorders associated with meloxicam use amongst 19,087 patients in general practice in England: Cohort study. Br J Clin Pharmacol 2000;50:35-42.
27. Lanes SF, Garcia Rodriguez LA, Hwang E. Baseline risk of gastrointestinal disorders among new users of meloxicam, ibuprofen, diclofenac, naproxen, and indomethacin. Pharmacoepidemiol Drug Saf 2000;9:113-7.
28. Degner F, Lanes S, van Ryn J, et al. Pharmacological and clinical profile of meloxicam. In: Vane JR, Botting RM, eds. Therapeutic Roles of Selective COX-2 Inhibitors. London: William Harvey Press; 2001; p. 498-523.
29. Mukherjee D, Nissen S, Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA 2001;286:954-9.
30. Singh G. Meloxicam does not increase the risk of acute myocardial infarction, congestive heart failure, edema, or hypertension compared to NSAIDs: Results from a pooled analysis of 27,039 patients. Am Rheum Dis 2001; 60(Suppl 1):151.
31. Jick SS. The risk of gastrointestinal bleed, myocardial infarction, and newly diagnosed hypertension in users of meloxicam, diclofenac, naproxen, and piroxicam. Pharmacotherapy 2000;20:741-4.
32. Guidance on the Use of and Evaluation of Cyclooxygenase II Selective Inhibitors, Celecoxib, Rofecoxib, Meloxicam and Etodolac for Osteoarthritis and Rheumatoid Arthritis. London: National Institute for Clinical Excellence; 2001. Available at: www.nice.org.uk. Accessed July 26, 2001.
33. Brewer T, Colditz GA. Postmarketing surveillance and adverse drug reactions. JAMA 1999;281:824-9.
34. Ioannidis JPA, Haidich A, Pappa M, et al. Comparison of evidence of treatment effects in randomized and nonrandomized studies. JAMA 2001;286:821-30.
35. Dantes R, Amante CM, Torralba TP. Clinical review and assessment of the tolerability and efficacy (C-R-E-A-T-E) of meloxicam: A nationwide surveillance study among Filipinos. Philipp J Intern Med 1998;36:323-6.
36. Gromnica-Ihle E, Rau R, Huskisson EC. Longterm efficacy and safety of meloxicam [abstract]. Rheumatol Eur 1998;27(Suppl 2):115.
37. Huskisson EC, Ghozlan R, Kurthen R, et al. A long-term study to evaluate the safety and efficacy of meloxicam therapy in patients with rheumatoid arthritis. Br J Rheumatol 1996; 35(Suppl 1):29-34.
38. Hosie G. Long-term safety and efficacy of meloxicam in the symptomatic treatment of osteoarthritis of the hip and knee: Results of a 2-year open-label study [abstract]. Rheumatol Eur 1998;27(Suppl 2):117.