[en] OBJECTIVES: Nonsteroidal anti-inflammatory drugs vary in their impact on blood pressure and the effect of lumiracoxib 100 mg once daily has not been studied previously. To examine whether lumiracoxib 100 mg once daily would result in lower 24-h mean systolic ambulatory blood pressure than ibuprofen 600 mg three times daily in osteoarthritis patients with controlled hypertension, a 4-week, randomized, double-blind, parallel-group study was conducted in 79 centres in nine countries. METHODS: Hypertensive osteoarthritis patients of 50 years at least whose office blood pressure was less than 140/90 mmHg on stable antihypertensive treatment were randomized to lumiracoxib (n = 394) 100 mg once daily or ibuprofen 600 mg three times daily (n = 393) and 24-h ambulatory blood pressure monitoring was performed at baseline and end of study. The primary outcome measure was a comparison of the change in 24-h mean systolic ambulatory blood pressure from baseline to week 4. Secondary analyses included other blood pressure-related endpoints and efficacy (pain) measurements. RESULTS: Compared with baseline, the 24-h mean systolic ambulatory blood pressure (least square mean) decreased in lumiracoxib-treated patients (-2.7 mmHg) and increased in ibuprofen-treated patients (+2.2 mmHg) at 4 weeks, estimated difference -5.0 mmHg (95% confidence interval -6.1 to -3.8) in favour of lumiracoxib. The 24-h mean diastolic ambulatory blood pressure changes were -1.5 mmHg (lumiracoxib), +0.5 mmHg (ibuprofen), difference -2.0 mmHg (95% confidence interval -2.7 to -1.3). Efficacy results were comparable. CONCLUSIONS: Treatment with lumiracoxib 100 mg once daily resulted in clinically significant lower blood pressure compared with ibuprofen 600 mg three times daily in osteoarthritis patients with well controlled hypertension.
Disciplines :
General & internal medicine
Author, co-author :
MacDonald, Thomas M
Reginster, Jean-Yves ; Université de Liège - ULiège > Département des sciences de la santé publique > Santé publique, Epidémiologie et Economie de la santé
Littlejohn, Thomas W
Richard, Dominik
Lheritier, Karine
Krammer, Gerhard
Rebuli, Rosemary
Language :
English
Title :
Effect on blood pressure of lumiracoxib versus ibuprofen in patients with osteoarthritis and controlled hypertension: a randomized trial.
Publication date :
2008
Journal title :
Journal of Hypertension
ISSN :
0263-6352
eISSN :
1473-5598
Publisher :
Lippincott Williams & Wilkins, London, United Kingdom
Johnson AG, Nguyen TV, Day RO. Do nonsteroidal anti-inflammatory drugs affect blood pressure? A meta-analysis. Ann Intern Med 1994; 121:289-300.
Pope JE, Anderson JJ, Felson DT. A meta-analysis of the effects of nonsteroidal anti-inflammatory drugs on blood pressure. Arch Intern Med 1993; 153:477-484.
Aw TJ, Haas SJ, Liew D, Krum H. Meta-analysis of cyclooxygenase-2. inhibitors and their effects on blood pressure. Arch Intern Med 2005; 165: 490-496.
Morgan TO, Anderson A, Bertram D. Effect of indomethacin on blood pressure in elderly people with essential hypertension well controlled on amlodipine or enalapril. Am J Hypertens 2000; 13:1161-1167.
MacMahon S, Peto R, Cutler J, Collins R, Sorlie P, Neaton J, et al. Blood pressure, stroke, and coronary heart disease. Part 1: prolonged differences in blood pressure: prospective observational studies corrected for the regression dilution bias. Lancet 1990; 335:765-774.
Gurwitz JH, Avorn J, Bohn RL, Glynn RJ, Monane M, Mogun H. Initiation of antihypertensive treatment during nonsteroidal anti-inflammatory drug therapy. JAMA 1994; 272:781-786.
Grover SA, Coupal L, Zowall H. Treating osteoarthritis with cyclooxygenase-2-specific inhibitors. What are the benefits of avoiding blood pressure destabilization. Hypertension 2005; 45:92-97.
Sowers JR, White WB, Pitt B, Whelton A, Simon LS, Winer N, et al., Celecoxib Rofecoxib Efficacy and Safety in Comorbidities Evaluation Trial (CRESCENT) Investigators. The effects of cyclooxygenase-2. inhibitors and nonsteroidal anti-inflammatory therapy on 24-h blood pressure in patients with hypertension, osteoarthritis, and type 2. diabetes mellitus. Arch Intern Med 2005; 165:161-168.
Whelton A, White WB, Bello AE, Puma JA, Fort JG, SUCCESS-VII Investigators. Effects of celecoxib and rofecoxib on blood pressure and edema in patients >65. years of age with systemic hypertension and osteoarthritis. Am J Cardiol 2002; 90:959-963.
Farkouh ME, Kirshner H, Harrington RA, Ruland S, Verheugt FWA, Schnitzer TJ, et al., TARGET Study Group. Comparison of lumiracoxib with naproxen and ibuprofen in the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET), cardiovascular outcomes: randomised controlled trial. Lancet 2004; 364:675-684.
Esser R, Berry C, Du Z, Dawson J, Fox A, Fujimoto RA, et al. Preclinical pharmacology of lumiracoxib: a novel selective inhibitor of cyclooxygenase-2. Br J Pharmacol 2005; 144:538-550.
Weaver ML, Flood DJ, Kimble EF, Fujimoto RA. Lumiracoxib demonstrates preferential distribution to inflamed tissue in the rat following a single oral dose: an effect not seen with other cyclooxygenase-2. inhibitors (abstract). Ann Rheum Dis 2003; 62. (Suppl 2):378; (abstract AB0044).
Scott G, Rordorf C, Reynolds C, Kalbag J, Looby M, Milosavljev S, et al. Pharmacokinetics of lumiracoxib in plasma and synovial fluid. Clin Pharmacokinet 2004; 43:467-478.
Brune K, Furst D. Combining enzyme specificity and tissue selectivity of cyclooxygenase-2. inhibitors: towards better tolerability? Rheumatology 2007; 46:911-919.
Fricke J, Davis N, Yu V, Krammer G. Lumiracoxib 400. mg compared with celecoxib 400. mg and placebo for treating pain following dental surgery: a randomized, controlled trial. J Pain 2008; 9:20-27.
Lehmann R, Brzosko M, Kopsa P, Nischik R, Kreiss A, Thurston H, et al. Efficacy and tolerability of lumiracoxib 100. mg once daily in knee osteoarthritis: a 13-week, randomized, double-blind study vs. placebo and celecoxib. Curr Med Res Opin 2005; 21:517-526.
Sheldon E, Beaulieu A, Paster Z, Dutta D, Yu S, Sloan VS. Efficacy and tolerability of lumiracoxib in the treatment of osteoarthritis of the knee: a 13-week, randomized, double-blind comparison with celecoxib and placebo. Clin Ther 2005; 27:64-77.
IMS Medical, 8. EU countries (BE, I, E, UK, D, F, PT, CH), OA = Diagn 3:M15-M19, YTD 6/2007. Data available upon request from www.imsresearch.com.
Bolognese JA, Schnitzer TJ, Ehrich EW. Response relationship of VAS and Likert scales in osteoarthritis efficacy measurement. Osteoarthritis Cartilage 2003; 11:499-507.
Friede T, Kieser M. Sample size recalculation in internal pilotstudy designs: a review. Biomed J 2006; 48:537-555.
Chalmers JP, West MJ, Wing LM, Bune AJ, Graham JR. Effects of indomethacin, sulindac, naproxen, aspirin and paracetamol in treated hypertensive patients. Clin Exp Hypertens A 1984; 6:1077-1093.
Dedier J, Stampfer MJ, Hankinson SE, Willett WC, Speizer FE, Curhan GC. Nonnarcotic analgesic use and the risk of hypertension in US women. Hypertension 2002; 40:604-608.
Whitehead A, Simmonds M, Mellein B, Friede T, Gitton X, Sallstig P. Blood pressure profile of lumiracoxib is similar to placebo in arthritis patients (abstract). Osteoarthritis Cartilage 2006; 14. (Suppl 2):S168-S169; (abstract P309).
Cheng HF, Harris RC. Renal effects of nonsteroidal anti-inflammatory drugs and selective cyclooxygenase-2. inhibitors. Curr Pharm Des 2005; 11:1795-1804.
Hinz B, Dormann H, Brune K. More pronounced inhibition of cyclooxygenase 2, increase in blood pressure, and reduction of heart rate by treatment with diclofenac compared with celecoxib and rofecoxib. Arthritis Rheum 2006; 54:282-291.
Brune K, Hinz B. Selective cyclooxygenase-2. inhibitors: similarities and differences. Scand J Rheumatol 2004; 33:1-6.
Singh G, Miller JD, Huse DM, Pettitt D, Russell MW. Prevalence of cardiovascular disease risk factors among US adults with self-reported osteoarthritis: data from the third national health and nutrition examination survey. Am J Manag Care 2002; 8:S383-S391.
Bruehl S, Chung OY, Jirjis JN, Biridepalli S. Prevalence of clinical hypertension in patients with chronic pain compared to nonpain general medical patients. Clin J Pain 2005; 21:147-153.
Ghione S. Hypertension-associated hypalgesia, evidence in experimental animals and humans, pathophysiological mechanisms, and potential clinical consequences. Hypertension 1996; 28:494-504.
Martin-Mola E, Munoz-Gomez J, S^nchez-Burson J, Bönninghoff E, Scholz D, Scott DL, et al. Celecoxib is as effective as ibuprofen in treating pain associated with osteoarthritis ofthe knee (abstract). Ann Rheum Dis 2005; 64. (Suppl III):495.
White WB, Kent J, Taylor A, Verburg KM, Lefkowith JB, Whelton A. Effects of celecoxib on ambulatory blood pressure in hypertensive patients on ACE inhibitors. Hypertension 2002; 39:929-934.
Farkouh ME, Verheugt FWA, Kirshner H, Ruland S, Sallstig P, Stricker K, et al. Lumiracoxib provides superior blood pressure profile compared to NSAIDs after 4. weeks of treatment (abstract). Arthritis Rheum 2006; 54. (Suppl 1):S678; (abstract 1692).
