Zusammenfassung
Die vorliegende Übersichtsarbeit fasst die wesentlichen klinischen Daten zur Wirksamkeit, Sicherheit und Verträglichkeit von Celecoxib bei der Therapie von Arthrose und rheumatoider Arthritis zusammen. Darüber hinaus werden für das Sicherheitsprofil des Arzneimittels relevante hämatologische, immunologische, hepatische, renale und kardiovaskuläre Daten präsentiert. Celecoxib erwies sich in kontrollierten klinischen Studien Plazebo als signifikant überlegen und als gleich wirksam wie Diclofenac oder Naproxen. Die Häufigkeit schwerer gastrointestinaler Nebenwirkungen (Blutung, Perforation, Magenobstruktion) unter Celecoxib war der von Plazebo vergleichbar und statistisch signifikant niedriger als unter Diclofenac, Ibuprofen und Naproxen. Celecoxib ist ein selektiver COX-2-Hemmer mit sehr günstigem Nutzen-Risiko-Verhältnis.
Clinical Data on the Selective Cyclooxygenase-2-Inhibitor Celecoxib
This review presents the essential clinical data on efficacy, safety and tolerability of celecoxib in the therapy of osteoarthritis and rheumatoid arthritis. Moreover hematologic, immunologic, hepatic, renal and cardiovascular data which are relevant for the safety profile are shown. In controlled clinical trials celecoxib was found to be significantly superior to placebo and equally efficacious as diclofenac or naproxen. On celecoxib therapy the frequency of severe gastrointestinal adverse events (bleeding, perforation, gastric outlet obstruction) was comparable to placebo and significantly lower than on diclofenac, ibuprofen and naproxen. The presented data prove celecoxib to be a selective COX-2 inhibitor with a very favourable benefit-risk-ratio.
Literatur
-
1
Bensen W G, Fiechtner J J, McMillen J I, Zhao W W, Yu S S, Woods E M, Hubbard R C, Isakson P C, Verburg K M, Geis G S.
Treatment of osteoarthritis with celecoxib, a cyclooxygenase-2 inhibitor: A randomized controlled trial.
Mayo Clin Proc.
1999;
74
1095-1105
-
2
Bensen W G, Agrawal N M, Zhao S Z, Burke T A, Zabinski R A, Maurath C J, Geis G S.
Upper gastrointestinal (UGI) tolerability of celecoxib, a COX-2 specific inhibitor, compared to naproxen and placebo.
Arthritis Rheum.
1999;
42
abstract 430
-
3
Bensen W G, Zhao S Z, Burke T A, Zabinski R A, Makuch R W, Maurath C J, Agrawal N M, Geis G S.
Upper gastrointestinal tolerability of celecoxib, a cox-2 specific inhibitor, compared to naproxen and placebo.
J Rheumatol,.
2000;
27
1876-1883
-
4
Boyce E G, Breen G A.
Celecoxib: A COX-2 inhibitor for the treatment of osteoarthritis and rheumatoid arthritis.
Formulary.
1999;
34
405-417
-
5
Burke T A, Goldstein J L, Pettitt A D, Maurath C J, Zhao S Z, Zabinski R A.
Increased upper gastrointestinal (UGI) distress among arthritis patients treated with NSAIDs compared to celecoxib and placebo.
Value Health.
1999;
2
154-155
-
6
Burr A M, Yu S S, Zhao W W, Hubbard R C, Geis G S.
Serial endoscopies confirm lower incidence of gastroduodenal ulceration with celecoxib as compared to naproxen.
Am J Gastroenterol.
1999;
94
2606, abstract 116
-
7
Caspi A.
Celecoxib: A new treatment for the pain of osteoarthritis and rheumatoid arthritis.
P & T.
1999;
24
211-212, 217
-
8
Clemett D, Goa K L.
Celecoxib. A review of its use in osteoarthritis, rheumatoid arthritis and acute pain.
Drugs.
2000;
59
957-980
-
9
Dougados M, Béhier J M, Jolchine I, Calin A, van der Heijde D, Dolivieri I, Zeidler H, Herman H.
Efficacy of celecoxib, a cox-2 specific inhibitor in ankylosing spondylitis: a placebo and conventional NSAID (ketoprofen) six-week control study.
Ann Rheum Dis.
2000;
59
204, abstract POS-605
-
10
Emery P, Zeidler H, Kvien T K, Guslandi M, Naudin R, Stead H, Verburg K M, Isakson P C, Hubbard R C, Geis G S.
Celecoxib versus diclofenac in long-term management of rheumatoid arthritis: randomized double-blind comparison.
Lancet.
1999;
354
2106-2111
-
11
Fisch U W, Brauer H G, Mahr G, Vergin H.
Cyclooxygenase-2-spezifische Inhibitoren: Grundlegende Aspekte des Wirkmechanismus.
Akt Rheumatol.
1999;
24
63-68
-
12
Fort J.
Celecoxib, a COX-2-specific inhibitor: the clinical data.
Am J Orthop.
1999;
28
13-18
-
13
Geba G P, Weaver A L, Schnitzer T J, Fleischmann R M, Polis A B, Matzura-Wolfe D M, Dixon M E, Gormley G J.
A comparison of rofecoxib to celecoxib and acetaminophen in the treatment of osteoarthritis.
Arthritis Rheum.
2000;
43 (9, Suppl.)
S384
-
14
Geis G S, Hubbard R C, Woods E M, Lefkowith J B, Yu S, Zhao W W.
Efficacy of celecoxib, a COX-2 specific inhibitor, in osteoarthritis of the hip.
Arthritis Rheum.
1999;
42
abstract 441
-
15
Geis G S, Hubbard H C, Woods E M, Lefkowith J B, Yu S, Zhao W W.
Efficacy and safety of celecoxib, a specific cyclooxygenase-2 (COX-2)inhibitor, in rheumatoid arthritis.
Ann Rheum Dis.
1999;
99
abstract 854
-
16
Goldenberg M M.
Celecoxib, a selective cyclooxygenase-2 inhibitor for the treatment of rheumatoid arthritis and osteoarthritis.
Clin Ther.
1999;
21
1497-1513
-
17
Goldstein J L, Agrawal N, Silverstein F, Burr A, Maurath C J, Verburg K M, et al.
Effect of celecoxib (CEL) versus placebo (PBO) or NSAIDs in healing of gastric or duodenal erosions in arthritis patients: analysis of controlled endoscopic studies.
Am J Gastroenterol.
1999;
94
2608, abstract 126
-
18
Goldstein J L, Silverstein F E, Agrawal N M, Hubbard R C, Kaiser J, Maurath C J, Verburg K M, Geis G S.
Reduced risk of upper gastrointestinal ulcer complications with celecoxib, a novel COX-2 inhibitor.
Am J Gastroenterol.
2000;
95
1681-1690
-
19 Isakson P, Zweifel B, Masferrer J, Koboldt C, Seibert K, Hubbard R, Geis S, Needleman P. Specific COX-2 inhibitors: from bench to bedside. In: Vane J, Botting J, editors Selective COX-2 inhibitors. Pharmacology, clinical effects and therapeutic potential. Proceedings of a conference held on March 20 - 21, 1997 in Cannes, France. Dordrecht: Kluwer Academic Publishers and London; William Harvey Press 1998: 127-133
-
20
Leese P T, Hubbard R C, Karim A, Isakson P C, Yu S S, Geis G S.
Effects of celecoxib, a novel cyclooxygenase-2 inhibitor, on platelet function in healthy adults: A randomized, controlled trial.
J Clin Pharmacol.
2000;
40
124-132
-
21 McKenna F. Summary of Faculty Presentations - Satellite Symposium at the XV European League Against Rheumatism (EULAR) Congress, Nice, 22 June 2000.
-
22
Patterson R, Bello A E, Lefkowith J.
Immunologic tolerability profile of celecoxib.
Clin Ther.
1999;
21
2065-2079
-
23
Rossat J, Maillard M, Nussberger J, Brunner H R, Burnier M.
Renal effects of selective cyclooxygenase-2 inhibitors in normotensive salt-depleted subjects.
Clin Pharmacol Ther.
1999;
66
76-84
-
24
Silverstein F E, Faich G, Goldstein J L, Simon L S, Pincus T, Whelton A, Mackich R, Eisen G, Agrawal N M, Stenson W F, Burr A M, Zhao W W, Kent J D, Lefkowith J B, Verburg K M, Geis G S.
Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis. The CLASS study: a randomized controlled trial.
JAMA.
2000;
284
1247-1255
-
25
Simon L S, Lanza F L, Lipsky P E, Hubbard R C, Talwalker S, Schwartz B D, Isakson P C, Geis S G.
Preliminary study of the safety and efficacy of SC-58 635, a novel cyclooxygenase 2 inhibitor: Efficacy and safety in two placebo controlled trials in osteoarthritis and rheumatoid arthritis, and studies of gastrointestinal and platelet effects.
Arthritis Rheum.
1998;
41
1591-1602
-
26
Simon L S, Weaver A L, Graham D Y, Kivitz A J, Lipsky P E, Hubbard R C, Isakson P C, Verburg K M, Yu S S, Zhao W W, Geis G S.
Anti-inflammatory and upper gastrointestinal effects of celecoxib in rheumatoid arthritis. A randomized controlled trial.
JAMA.
1999;
282
1921-1928
-
27
SHEP Cooperative Research Group .
Prevention of stroke by antihypertensive drug treatment in older persons with isolated systolic hypertension. Final results of the Systolic Hypertension in the Elderly Program (SHEP).
JAMA .
1991;
295
-
28 Singh G, Ramey D R, Triadafilopoulos G. Experience with selective COX-2 inhibitors: Safety profile in over 780,000 patient years of use. Poster American Congress of Rheumatology, 63rd Annual Scientific Meeting, November 13 - 17,. Boston, USA; 1999
-
29
Stucki G, Meier D, Stucki S, Michel B A, Tyndall A G, Dick W, Theiler R.
Evaluation einer deutschen Version des WOMAC (Western Ontario und McMaster Universities) Arthroseindex.
Z Rheumatol.
1996;
55
40-49
-
30
Whelton A, Maurath C J, Verburg K M, Geis G S.
Renal safety and tolerability of celecoxib, a novel cyclooxygenase-2 inhibitor.
Am J Ther.
2000;
7
159-175
-
31
Whelton A, Schulman G, Wallemark C, Drower E J, Isakson P C, Verburg K M, Geis G S.
Effects of celecoxib and naproxen on renal function in the elderly.
Arch Intern Med.
2000;
160
1465-1470
-
32
Whelton A, Fort J, Puma J, Normandin D, Ello A, Verburg K.
Cyclooxygenase-2 specific inhibitors and cardiorenal function. A randomized controlled trial of celecoxib and rofecoxib in elderly hypertensive osteoarthritis patients.
Am J Ther.
2001;
8
85-95
-
33
Williams G W, Ettlinger R E, Ruderman E M, Hubbard R C, Lonien M E, Yu S S, Zhao W, Geis G S.
Treatment of osteoarthritis with a once-daily dosing regimen of celecoxib.
J Clin Rheumatol.
2000;
6
65-74
-
34
Zhao S Z, Dedhiya S D, Verburg K, Fort J, Osterhaus J T.
Celecoxib improves health related quality of life (HRQOL) of elderly patients with osteoarthritis (OA).
Arthritis Rheum.
1999;
42
abstract 1356
-
35
Zhao S Z, McMillen J I, Markenson J A, Dedhiya S D, Zhao W W, Osterhaus J T, Yu S S.
Evaluation of the functional status aspects of health-related quality of life of patients with osteoarthritis treated with celecoxib.
Pharmacotherapy.
1999;
19
1269-1278
Dr. med. U. W. Fisch
Pharmacia GmbH
Am Wolfsmantel 46
91058 Erlangen
