Seguridad de los inhibidores selectivos de la ciclooxigenasa 2
Palabras clave:
INHIBIDORES DE LA CICLOOXIGENASA
Resumen
Los antiinflamatorios no esteroideos (AINES) constituyen uno de los grupos farmacológicos más prescritos. La toxicidad gastrointestinal limita su uso a largo plazo. En los últimos años, los inhibidores selectivos de la ciclooxigenasa (COX) 2 han sido promocionados como alternativas más seguras.
Con el objetivo de evaluar la evidencia disponible acerca de la seguridad de los inhibidores selectivos de la COX 2, se analizaron todos los ensayos clínicos que valoran la toxicidad gastrointestinal, cardiovascular y renal de este grupo de fármacos publicados en los últimos cinco años.
Hasta el momento no existen datos que permitan afirmar que la seguridad de los inhibidores selectivos de la COX 2 es claramente superior a la de los AINES clásicos. El ensayo VIGOR es el único que ha mostrado un beneficio en la reducción de las complicaciones de la úlcera gastroduodenal, pero ha suscitado el problema, aún no resuelto, de sus efectos protrombóticos. Es probable que los efectos adversos renales sean similares a los de los AINES clásicos.
Sólo el análisis crítico de la información biomédica permite aplicar en forma racional los datos aportados por los ensayos clínicos al tratamiento de los pacientes.
Citas
1) Begaud B, Chaslerie A, Carne X, Bannwarth B, Laporte JR, Sorbette F, et al. Upper gastrointestinal bleeding associated with analgesics and NSAID use: a case-control study. J Rheumatol 1993; 20(8): 1443-4.
2) Roberts LJ, Morrow J. Analgésicos-antipiréticos y antiinflamatorios, y fármacos antigotosos. In: Hardman J, Limbird L, Gilman R, eds. Goodman y Gilman. Las bases farmacológicas de la terapéutica. 10 ed. México: Mc Graw- Hill, 2001: 697-742.
3) Eras J, Perazella MA. NSAIDs and the kidney revisited: are selective cyclooxigenase-2 inhibitors safe? Am J Med Sci 2001; 321(3): 181-90.
4) Lipsky PE, Brooks P, Crofford LJ, DuBois R, Graham D, Simon LS, et al. Unresolved issues in the role of cyclooxigenase-2 in normal physiologic processes and disease. Arch Intern Med 2000; 160(7): 913-20.
5) McMurray RW, Hardy KJ. Cox-2 inhibitors: today and tomorrow. Am J Med Sci 2002; 323(4): 181-9.
6) Anónimo. Selective COX-2 inhibitors: are they safer NSAIDs? Therapeutics Letter, 2001, January/February; 39. http://www.ti.ubc.ca/pages/letter39.htm (Consulta: noviembre 2002).
7) Huang SH. Rheumatology: 7. Basics of therapy. CMAJ 2000; 163(4): 417-23.
8) Gatro-intestinal Drugs. In: Parfitt K, Sweetman SC, Blake PS, Parsons AV, eds. Martindale: the complete drug reference. 33rd ed. NewTown: Taunton, 2002: 1208.
9) Wooltorton E. What’s all the fuss? Safety concerns about COX-2 inhibitors rofecoxib (Vioxx) and celecoxib (Celebrex). CMAJ 2002; 166(13): 1692-3.
10) Hawkey C, Kahan A, Steinbruck K, Alegre C, Baumelou E, Begaud B, et al. Gastrointestinal tolerability of meloxicam compared to diclofenac in osteoarthritis patients. International MELISSA Study Group. Meloxicam Large-scale International Study Safety Assessment. Br J Rheumatol 1998; 37(9): 937-45.
11) Dequeker J, Hawkey C, Kahan A, Steinbruck K, Alegre C, Baumelou E, et al. Improvement in gastrointestinal tolerability of the selective cyclooxigenase (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(9): 946-51.
12) Lichtenstein DR, Wolfe MM. Cox-2 selective NSAIDS: new and improved? JAMA 2000; 284(10): 1297-9.
13) Laporte JM. Las supuestas ventajas de celecoxib y rofecoxib: fraude científico. Butlletí Groc 2002; 15(4): 13-5.
14) Silverstein FE, Faich G, Goldstein JL, Simon LS, Pincus T, Whelton A, et al. Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized controlled trial. Celecoxib Long-term Arthritis Safety Study. JAMA 2000; 284(10): 1247-55.
15) Juni P, Rutjes AW, Dieppe PA. Are selective COX 2 inhibitors superior to traditional non steroidal anti-inflammatory drugs? BMJ 2002; 324(7349): 1287-8.
16) Wright JM, Perry TL, Bassett KL, Chambers GK. Reporting of 6-month vs 12-month data in a clinical trial of celecoxib. JAMA 2001; 286(19): 2398-400.
17) Hrachovec JB, Mora M. Reporting of 6-month vs 12-month data in a clinical trial of celecoxib. JAMA 2001; 286(19): 2398-400.
18) US Food and Drug Administration. Celebrex capsules (celecoxib) NDA 20-998/S-009- Medical Officer Review. 2000. www.fda.gov/ohrms/dockets/ac/01/briefing/3677b.htm [Consulta: 28 noviembre 2002].
19) Anónimo. COX-2 inhibitors update: do journal publications tell the full story? Therapeutics Letter. 2001-2002; November/December/January, 43. http://www.ti.ubc.ca/pages/letter43.htm [Consulta: noviembre 2002].
20) Lefkowith JB, Geis GS, Silverstein F. Safety of celecoxib vs other nonsteroidal anti-inflammatory drugs. JAMA 2000; 284(24): 3123-4.
21) Kohler L, Zeidler H, Merkesdal S, Kuipers JG. Safety of celecoxib vs other nonsteroidal anti-inflammatory drugs. JAMA 2000; 284(24): 3123-4.
22) Silverstein FE, Faich G, Goldstein JL, Simon LS, Pincus T, Whelton A, et al. Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized controlled trial. Celecoxib Long-term Arthritis Safety Study. JAMA 2000; 284(10): 1247-55.
23) Gottlieb S. Researchers deny any attempt to mislead the public over JAMA article on arthritis drug. BMJ 2001; 323(7308): 301.
24) Bombardier C, Laine L, Reicin A, Shapiro D, Burgos-Vargas R, Davis B, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. N Engl J Med 2000; 343(21): 1520-8.
25) Analgesics Antiinflamatory Drugs and Antipyretics. In: Parfitt K, Sweetman SC, Blake PS, Parsons AV, eds. Martindale: the complete drug reference. 33rd ed. NewTown: Taunton, 2002: 63-6.
26) Heerdink ER, Leufkens HG, Herings RM, Ottervanger JP, Stricker BH, Bakker A. NSAIDs associated with increased risk of congestive heart failure in elderly patients taking diuretics. Arch Intern Med 1998; 158(10): 1108-12.
27) Page J, Henry D. Consumption of NSAIDs and the development of congestive heart failure in elderly patients: and underrecognized public health problem. Arch Intern Med 2000; 160(6): 777-84.
28) Mukherjee D, Nissen SE, Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA 2001; 286(8): 954-9.
29) Pitt B, Pepine C, Willerson JT. Cyclooxygenase-2 inhibition and cardiovascular events. Circulation 2002; 106(2): 167-9.
30) Konstam MA, Weir MR, Reicin A, Shapiro D, Sperling RS, Barr E, et al. Cardiovascular thrombotic events in controlled, clinical trials of rofecoxib. Circulation 2001; 104(19): 2280-8.
31) Jaeschke R, Gajewski P, Brozek J. Cardiovascular thrombotic events in controlled, clinical trials of rofecoxib. Circulation 2002; 106(5): e18.
32) Frankish H. Why do COX-2 inhibitors increase risk of cardiovascular events? Lancet 2002; 359(9315): 1410.
33) Vu D, Murty M, McMorran M. Selective COX-2 inhibitors: suspected cardiovascular/cerebrovascular adverse reactions. Can Adverse React Newsl 2002; 12 (2): 1-2. http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/publicat.html [Consulta: noviembre 2002].
34) Perazella MA, Tray K. Selective cyclooxygenase-2 inhibitors: a pattern of nephrotoxicity similar to traditional nonsteroidal anti-inflammatory drugs. Am J Med 2001; 111(1): 64-7.
35) Zhao SZ, Reynolds MW, Lejkowith J, Whelton A, Arellano FM. A comparison of renal-related adverse drug reactions between rofecoxib and celecoxib, based on the World Health Organization/Uppsala Monitoring Centre safety database. Clin Ther 2001; 23(9):1478-91.
2) Roberts LJ, Morrow J. Analgésicos-antipiréticos y antiinflamatorios, y fármacos antigotosos. In: Hardman J, Limbird L, Gilman R, eds. Goodman y Gilman. Las bases farmacológicas de la terapéutica. 10 ed. México: Mc Graw- Hill, 2001: 697-742.
3) Eras J, Perazella MA. NSAIDs and the kidney revisited: are selective cyclooxigenase-2 inhibitors safe? Am J Med Sci 2001; 321(3): 181-90.
4) Lipsky PE, Brooks P, Crofford LJ, DuBois R, Graham D, Simon LS, et al. Unresolved issues in the role of cyclooxigenase-2 in normal physiologic processes and disease. Arch Intern Med 2000; 160(7): 913-20.
5) McMurray RW, Hardy KJ. Cox-2 inhibitors: today and tomorrow. Am J Med Sci 2002; 323(4): 181-9.
6) Anónimo. Selective COX-2 inhibitors: are they safer NSAIDs? Therapeutics Letter, 2001, January/February; 39. http://www.ti.ubc.ca/pages/letter39.htm (Consulta: noviembre 2002).
7) Huang SH. Rheumatology: 7. Basics of therapy. CMAJ 2000; 163(4): 417-23.
8) Gatro-intestinal Drugs. In: Parfitt K, Sweetman SC, Blake PS, Parsons AV, eds. Martindale: the complete drug reference. 33rd ed. NewTown: Taunton, 2002: 1208.
9) Wooltorton E. What’s all the fuss? Safety concerns about COX-2 inhibitors rofecoxib (Vioxx) and celecoxib (Celebrex). CMAJ 2002; 166(13): 1692-3.
10) Hawkey C, Kahan A, Steinbruck K, Alegre C, Baumelou E, Begaud B, et al. Gastrointestinal tolerability of meloxicam compared to diclofenac in osteoarthritis patients. International MELISSA Study Group. Meloxicam Large-scale International Study Safety Assessment. Br J Rheumatol 1998; 37(9): 937-45.
11) Dequeker J, Hawkey C, Kahan A, Steinbruck K, Alegre C, Baumelou E, et al. Improvement in gastrointestinal tolerability of the selective cyclooxigenase (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(9): 946-51.
12) Lichtenstein DR, Wolfe MM. Cox-2 selective NSAIDS: new and improved? JAMA 2000; 284(10): 1297-9.
13) Laporte JM. Las supuestas ventajas de celecoxib y rofecoxib: fraude científico. Butlletí Groc 2002; 15(4): 13-5.
14) Silverstein FE, Faich G, Goldstein JL, Simon LS, Pincus T, Whelton A, et al. Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized controlled trial. Celecoxib Long-term Arthritis Safety Study. JAMA 2000; 284(10): 1247-55.
15) Juni P, Rutjes AW, Dieppe PA. Are selective COX 2 inhibitors superior to traditional non steroidal anti-inflammatory drugs? BMJ 2002; 324(7349): 1287-8.
16) Wright JM, Perry TL, Bassett KL, Chambers GK. Reporting of 6-month vs 12-month data in a clinical trial of celecoxib. JAMA 2001; 286(19): 2398-400.
17) Hrachovec JB, Mora M. Reporting of 6-month vs 12-month data in a clinical trial of celecoxib. JAMA 2001; 286(19): 2398-400.
18) US Food and Drug Administration. Celebrex capsules (celecoxib) NDA 20-998/S-009- Medical Officer Review. 2000. www.fda.gov/ohrms/dockets/ac/01/briefing/3677b.htm [Consulta: 28 noviembre 2002].
19) Anónimo. COX-2 inhibitors update: do journal publications tell the full story? Therapeutics Letter. 2001-2002; November/December/January, 43. http://www.ti.ubc.ca/pages/letter43.htm [Consulta: noviembre 2002].
20) Lefkowith JB, Geis GS, Silverstein F. Safety of celecoxib vs other nonsteroidal anti-inflammatory drugs. JAMA 2000; 284(24): 3123-4.
21) Kohler L, Zeidler H, Merkesdal S, Kuipers JG. Safety of celecoxib vs other nonsteroidal anti-inflammatory drugs. JAMA 2000; 284(24): 3123-4.
22) Silverstein FE, Faich G, Goldstein JL, Simon LS, Pincus T, Whelton A, et al. Gastrointestinal toxicity with celecoxib vs nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized controlled trial. Celecoxib Long-term Arthritis Safety Study. JAMA 2000; 284(10): 1247-55.
23) Gottlieb S. Researchers deny any attempt to mislead the public over JAMA article on arthritis drug. BMJ 2001; 323(7308): 301.
24) Bombardier C, Laine L, Reicin A, Shapiro D, Burgos-Vargas R, Davis B, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. VIGOR Study Group. N Engl J Med 2000; 343(21): 1520-8.
25) Analgesics Antiinflamatory Drugs and Antipyretics. In: Parfitt K, Sweetman SC, Blake PS, Parsons AV, eds. Martindale: the complete drug reference. 33rd ed. NewTown: Taunton, 2002: 63-6.
26) Heerdink ER, Leufkens HG, Herings RM, Ottervanger JP, Stricker BH, Bakker A. NSAIDs associated with increased risk of congestive heart failure in elderly patients taking diuretics. Arch Intern Med 1998; 158(10): 1108-12.
27) Page J, Henry D. Consumption of NSAIDs and the development of congestive heart failure in elderly patients: and underrecognized public health problem. Arch Intern Med 2000; 160(6): 777-84.
28) Mukherjee D, Nissen SE, Topol EJ. Risk of cardiovascular events associated with selective COX-2 inhibitors. JAMA 2001; 286(8): 954-9.
29) Pitt B, Pepine C, Willerson JT. Cyclooxygenase-2 inhibition and cardiovascular events. Circulation 2002; 106(2): 167-9.
30) Konstam MA, Weir MR, Reicin A, Shapiro D, Sperling RS, Barr E, et al. Cardiovascular thrombotic events in controlled, clinical trials of rofecoxib. Circulation 2001; 104(19): 2280-8.
31) Jaeschke R, Gajewski P, Brozek J. Cardiovascular thrombotic events in controlled, clinical trials of rofecoxib. Circulation 2002; 106(5): e18.
32) Frankish H. Why do COX-2 inhibitors increase risk of cardiovascular events? Lancet 2002; 359(9315): 1410.
33) Vu D, Murty M, McMorran M. Selective COX-2 inhibitors: suspected cardiovascular/cerebrovascular adverse reactions. Can Adverse React Newsl 2002; 12 (2): 1-2. http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/publicat.html [Consulta: noviembre 2002].
34) Perazella MA, Tray K. Selective cyclooxygenase-2 inhibitors: a pattern of nephrotoxicity similar to traditional nonsteroidal anti-inflammatory drugs. Am J Med 2001; 111(1): 64-7.
35) Zhao SZ, Reynolds MW, Lejkowith J, Whelton A, Arellano FM. A comparison of renal-related adverse drug reactions between rofecoxib and celecoxib, based on the World Health Organization/Uppsala Monitoring Centre safety database. Clin Ther 2001; 23(9):1478-91.
Publicado
2004-08-31
Cómo citar
1.
Banchero P, Giachetto G, Telechea H, Speranza N, Seade C. Seguridad de los inhibidores selectivos de la ciclooxigenasa 2. Rev. Méd. Urug. [Internet]. 31 de agosto de 2004 [citado 17 de noviembre de 2024];20(2):136-44. Disponible en: http://www2.rmu.org.uy/ojsrmu311/index.php/rmu/article/view/919
Sección
Trabajos de Revisión o Actualización y Puestas al día
