Efficacy, safety, and effects on blood pressure of naproxcinod 750 mg twice daily compared with placebo and naproxen 500 mg twice daily in patients with osteoarthritis of the hip: A randomized, double-blind, parallel-group, multicenter study

Arthritis Care and Research

Volumn 62, Issue 12, 2010, Pages 3635-3644

  Baerwald, Christoph ^a   Verdecchia, Paolo ^b   Duquesroix, Brigitte ^c   Frayssinet, Hayet ^c   Ferreira, Thierry ^c  

^a UNIVERSITY HOSPITAL LEIPZIG   (Germany)

^b SANTA MARIA DELLA MISERICORDIA HOSPITAL   (Italy)

^c NicOx SA   (France)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIRHEUMATIC AGENT; NAPROXCINOD; NAPROXEN; PLACEBO; UNCLASSIFIED DRUG; ANTIINFLAMMATORY AGENT; PARACETAMOL;

ADULT; ARTICLE; BLOOD PRESSURE MEASUREMENT; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DIASTOLIC BLOOD PRESSURE; DIZZINESS; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPEPSIA; FEMALE; HEADACHE; HIP OSTEOARTHRITIS; HIP PAIN; HUMAN; HYPERTENSION; HYPOTENSION; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; OUTCOME ASSESSMENT; PARALLEL DESIGN; PATIENT COMPLIANCE; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; RHINOPHARYNGITIS; RISK ASSESSMENT; SCORING SYSTEM; SYSTOLIC BLOOD PRESSURE; UNSPECIFIED SIDE EFFECT; UPPER ABDOMINAL PAIN; VERTIGO; BLOOD PRESSURE; DRUG EFFECT; HEALTH STATUS; PRIORITY JOURNAL;

AGED; ANTI-INFLAMMATORY AGENTS, NON-STEROIDAL; BLOOD PRESSURE; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; MALE; MIDDLE AGED; NAPROXEN; OSTEOARTHRITIS, HIP; PAIN MEASUREMENT; TREATMENT OUTCOME;

EID: 78650058340     PISSN: 21514658     EISSN: 15290131     Source Type: Journal    
DOI: 10.1002/art.27694     Document Type: Article

References (34)

1. Andrianakos AA, Kontelis LK, Karamitsos DG, Aslanidis SI, Georgountzos AI, Kaziolas GO, et al. ESORDIG study: prevalence of symptomatic knee, hand, and hip osteoarthritis in Greece. J Rheumatol 2006; 33: 2507-13.
2. Grotle M, Hagen KB, Natvig B, Dahl FA, Kvien TK,. Prevalence and burden of osteoarthritis: results from a population survey in Norway. J Rheumatol 2008; 35: 677-84.
3. Leveille SG,. Musculoskeletal aging. Curr Opin Rheumatol 2004; 16: 114-8.
4. Jinks C, Jordan K, Croft P,. Disabling knee pain-another consequence of obesity: results from a prospective cohort study. BMC Public Health 2006; 6: 258.
5. Tepper S, Hochberg M,. Factors associated with hip osteoarthritis: data from the First National Health and Nutrition Examination Survey (NHANES-1). Am J Epidemiol 1993; 137: 1081-8.
6. Juhakoski R, Heliovaara M, Impivaara O, Kroger H, Knekt P, Lauren H, et al. Risk factors for the development of hip osteoarthritis: a population-based prospective study. Rheumatology (Oxford) 2009; 48: 83-7.
7. Quintana JM, Arostegui I, Escobar A, Azkarate J, Goenaga JI, Lafuente I,. Prevalence of knee and hip osteoarthritis and the appropriateness of joint replacement in an older population. Arch Intern Med 2008; 168: 1576-84.
8. Cimmino MA, Sarzi-Puttini P, Scarpa R, Caporali R, Parazzini F, Zaninelli A, et al. Clinical presentation of osteoarthritis in general practice: determinants of pain in Italian patients in the AMICA study. Semin Arthritis Rheum 2005; 35: 17-23.
9. Kadam UT, Jordan K, Croft PR,. Clinical comorbidity in patients with osteoarthritis: a case-control study of general practice consulters in England and Wales. Ann Rheum Dis 2004; 63: 408-14.
10. Farooq M, Haq I, Qureshi AS,. Cardiovascular risks of COX inhibition: current perspectives. Expert Opin Pharmacother 2008; 9: 1311-9.
11. Johnson AG,. NSAIDs and blood pressure: clinical importance for older patients. Drugs Aging 1998; 12: 17-27.
12. White WB, Schnitzer TJ, Fleming R, Duquesroix B, Beekman M,. Effects of the cyclooxygenase inhibiting nitric oxide donator naproxcinod versus naproxen on systemic blood pressure in patients with osteoarthritis. Am J Card 2009; 840-5.
13. Wallace JL, Miller MJ,. Nitric oxide in mucosal defense: a little goes a long way. Gastroenterology 2000; 119: 512-20.
14. Lanas A,. Role of nitric oxide in the gastrointestinal tract. Arthritis Res Ther 2008; 10: S4.
15. Lohmander LS, McKeith D, Svensson O, Malmenas M, Bolin L, Kalla A, et al. A randomised, placebo controlled, comparative trial of the gastrointestinal safety and efficacy of AZD3582 versus naproxen in osteoarthritis. Ann Rheum Dis 2005; 64: 449-56.
16. Hochberg MC, Chang RW, Dwosh I, Lindsey S, Pincus T, Wolfe F,. The American College of Rheumatology 1991 revised criteria for the classification of global functional status in rheumatoid arthritis. Arthritis Rheum 1992; 35: 498-502.
17. Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW,. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol 1988; 15: 1833-40.
18. Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves J, Hill MN, et al, Recommendations for blood pressure measurement in humans and experimental animals. Part 1: blood pressure measurements in humans: a statement for professionals from the Subcommittee of Professional and Public Education of the American Heart Association Council on High Blood Pressure Research. Hypertension 2005; 45: 142-61.
19. Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, et al, and the National High Blood Pressure Education Program Coordinating Committee. Seventh report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure. Hypertension 2003; 42: 1206-52.
20. Reginster JY, Malmstrom K, Mehta A, Bergman G, Ko AT, Curtis SP, et al. Evaluation of the efficacy and safety of etoricoxib compared with naproxen in two, 138-week randomised studies of patients with osteoarthritis. Ann Rheum Dis 2007; 66: 945-51.
21. Karlsson J, Pivodic A, Aguirre D, Schnitzer T,. Efficacy, safety, and tolerability of the cyclooxygenase-inhibiting nitric oxide donator naproxcinod in treating osteoarthritis of the hip or knee. J Rheumatol 2009; 36: 1290-7.
22. Svensson O, Malmenas M, Fajutrao L, Roos EM, Lohmander LS,. Greater reduction of knee than hip pain in osteoarthritis treated with naproxen, as evaluated by WOMAC and SF-36. Ann Rheum Dis 2006; 65: 781-4.
23. Zhang W, Robertson J, Jones AC, Dieppe PA, Doherty M,. The placebo effect and its determinants in osteoarthritis: meta-analysis of randomized controlled trials. Ann Rheum Dis 2008; 67: 1716-23.
24. Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, et al. Evaluation of clinically relevant states in patients reported outcomes in knee and hip osteoarthritis: the patient acceptable symptom state. Ann Rheum Dis 2005; 64: 34-7.
25. Staessen JA, Wang JG, Thijs L,. Cardiovascular protection and blood pressure reduction: a meta-analysis. Lancet 2001; 358: 1305-15.
26. Turnbull F,. Effects of different blood-pressure-lowering regimens on major cardiovascular events: results of prospectively-designed overviews of randomised trials. Lancet 2003; 362: 1527-35.
27. Whelton PK, He J, Appel LJ, Cutler JA, Havas S, Kotchen TA, et al. Primary prevention of hypertension, clinical and public health advisory from the National High Blood Pressure Education Program. JAMA 2002; 288: 1882-7.
28. Verdecchia P, Staessen JA, Angeli F, de Simone G, Achilli A, Ganau A, et al. Usual versus tight control of systolic blood pressure in non-diabetic patients with hypertension (Cardio-Sis): an open-label randomised trial. Lancet 2009; 374: 525-33.
29. Julius S, Kjeldsen SE, Weber M, Brunner HR, Ekman S, Hansson L, et al. Outcomes in hypertensive patients at high cardiovascular risk treated with regimens based on valsartan or amlodipine: the VALUE randomised trial. Lancet 2004; 363: 2022-31.
30. Pope JE, Anderson JJ, Felson DT,. A meta-analysis of the effects of nonsteroidal anti-inflammatory drugs on blood pressure. Arch Intern Med 1993; 153: 477-84.
31. Chrischilles EA, Wallace RB,. Nonsteroidal anti-inflammatory drugs and blood pressure in an elderly population. J Gerontol 1993; 48: M91-6.
32. Johnson AG, Nguyen TV, Day RO,. Do nonsteroidal anti-inflammatory drugs affect blood pressure? A meta-analysis. Ann Intern Med 1994; 121: 289-300.
33. Johnson AG,. NSAIDs and blood pressure: clinical importance for older subjects. Drugs Aging 1998; 12: 17-27.
34. Armstrong EP, Malone DC,. The impact of nonsteroidal anti-inflammatory drugs on blood pressure, with an emphasis on newer agents. Clin Ther 2003; 25: 1-18.