- Email: [email protected]
FAREWELL, DR. MESKIN
L E T T E R S
M.P.H. Parivash Nourjah, Ph.D. U.S. Food and Drug Administration Center for Drug Evaluation and Research Office of Postmarketing Drug Risk Assessment Rockville, Md. 1. Silverstein FE, Faich G, Goldstein JL, et al. Gastrointestinal toxicity with celecoxib vs. nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized controlled trial. JAMA 2000;284(10):1247-55. 2. Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 2000;343(21):1520-8. 3. Arthritis Advisory Committee briefing information (Feb. 7, 2001). Available at: “www.fda.gov/ohrms/dockets/ac/01/ briefing/3677b1.htm”; click on the “doc” option for OPDRA postmarketing safety review— gastrointestinal. Accessed July 6, 2001. 4. Arthritis Advisory Committee briefing information (Feb. 8, 2001). Available at: “www.fda.gov/ohrms/dockets/ac/01/ briefing/3677b2.htm”; click on the “doc” option for OPDRA postmarketing safety review— gastrointestinal. Accessed July 6, 2001. 5. Weaver J, Bonnel RA, Karwoski CB, Brinker AD, Beitz J. Gastrointestinal events leading to death in association with celecoxib and rofecoxib. Am J Gastroenterol (in press).
Authors’ response: We appreciate the comments of Drs. Brinker, Bonnel, Feight and Nourjah, and we compliment Drs. Brinker and Bonnel on their upcoming publication in the American Journal of Gastroenterology.1 While we certainly agree with them that the general tolerability of the COX-2 inhibitors appears to be no better than traditional NSAIDs, the results of the CLASS2 and VIGOR3 trials unambiguously and undebatably indicate that six to 12 months’ worth of dosing with either celecoxib or rofecoxib decreased the incidence of significant GI bleeding, obstructions, perforations and symptomatic ulcers by approximately 50 to 60 percent compared with the traditional NSAIDs ibuprofen, diclofenac and naproxen. 1502
While both celecoxib and rofecoxib have been associated with significant GI events including deaths,1,4,5 a reduction anywhere near 50 percent in the estimated 107,000 hospitalizations and 16,500 deaths annually thought to be caused by the gastropathy induced by chronic NSAID ingestion6 would represent a tremendous health care benefit. We agree that the findings of the CLASS and VIGOR trials,2,3 performed in a relatively healthy patient population with a mean age of 60 years, may not necessarily be applicable to patients at the highest risk of GI complications, including those with previous ulcers, those on concomitant anticoagulant therapy, those on other NSAIDs and those with advanced age. More research is needed to see if this safety advantage does in fact hold in an older, “more fragile” patient population. Paul Moore, D.M.D, Ph.D., M.P.H. Professor of Pharmacology Department of Public Health Dentistry University of Pittsburgh School of Dental Medicine Elliot V. Hersh, D.M.D., M.S., Ph.D. Associate Professor of Pharmacology and Director Pharmacology and Clinical Therapeutics University of Pennsylvania School of Dental Medicine Philadelphia 1. Weaver J, Bonnel RA, Karwoski CB, Brinker AD, Beitz J. Gastrointestinal events leading to death in association with celecoxib and rofecoxib. Am J Gastroenterol (in press). 2. Silverstein FE, Faich G, Goldstein JL, et al. Gastrointestinal toxicity with celecoxib vs. nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized controlled trial. JAMA 2000;284(10):1247-55.
3. Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 2000;343(21):1520-8. 4. Arthritis Advisory Committee briefing information (Feb. 7, 2001). Available at: “www.fda.gov/ohrms/dockets/ac/01/ briefing/3677b1.htm”; click on the “doc” option for OPDRA postmarketing safety review— gastrointestinal. Accessed Aug. 1, 2001. 5. Arthritis Advisory Committee briefing information (Feb. 8, 2001). Available at: “www.fda.gov/ohrms/dockets/ac/01/ briefing/3677b2.htm”; click on the “doc” option for OPDRA postmarketing safety review— gastrointestinal. Accessed Aug. 1, 2001. 6. Singh G. Recent considerations in nonsteroidal anti-inflammatory drug gastropathy. Am J Med 1998;105(1B):S31-8.
FAREWELL, DR. MESKIN
I have enjoyed all 130 of Dr. Meskin’s editorials (“Pluses” July JADA). Congratulations and thanks for his work—a tribute to our profession. Frank Spalding, D.D.S. Peoria, Ill. I would like to say that the potential audience for JADA is much higher than Dr. Meskin thought in his editorial, “Pluses” (July JADA). I am an undergraduate senior and I have been reading JADA online since my summer vacation started. I and my friends who also wish to be dentists read JADA as a resource to prepare for our dental school admission test. I just want to say thank you for Dr. Meskin’s professional opinions on subjects that are new and fascinating to me. I learn so much by reading JADA. His dedicated service as editor is never going to be “a void.” Christopher Tiu Laie, Hawaii AIR-ABRASION TREATMENT
Dr. James Hamilton and colleagues reported on a 12-month
JADA, Vol. 132, November 2001 Copyright ©1998-2001 American Dental Association. All rights reserved.
M.P.H. Parivash Nourjah, Ph.D. U.S. Food and Drug Administration Center for Drug Evaluation and Research Office of Postmarketing Drug Risk Assessment Rockville, Md. 1. Silverstein FE, Faich G, Goldstein JL, et al. Gastrointestinal toxicity with celecoxib vs. nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized controlled trial. JAMA 2000;284(10):1247-55. 2. Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 2000;343(21):1520-8. 3. Arthritis Advisory Committee briefing information (Feb. 7, 2001). Available at: “www.fda.gov/ohrms/dockets/ac/01/ briefing/3677b1.htm”; click on the “doc” option for OPDRA postmarketing safety review— gastrointestinal. Accessed July 6, 2001. 4. Arthritis Advisory Committee briefing information (Feb. 8, 2001). Available at: “www.fda.gov/ohrms/dockets/ac/01/ briefing/3677b2.htm”; click on the “doc” option for OPDRA postmarketing safety review— gastrointestinal. Accessed July 6, 2001. 5. Weaver J, Bonnel RA, Karwoski CB, Brinker AD, Beitz J. Gastrointestinal events leading to death in association with celecoxib and rofecoxib. Am J Gastroenterol (in press).
Authors’ response: We appreciate the comments of Drs. Brinker, Bonnel, Feight and Nourjah, and we compliment Drs. Brinker and Bonnel on their upcoming publication in the American Journal of Gastroenterology.1 While we certainly agree with them that the general tolerability of the COX-2 inhibitors appears to be no better than traditional NSAIDs, the results of the CLASS2 and VIGOR3 trials unambiguously and undebatably indicate that six to 12 months’ worth of dosing with either celecoxib or rofecoxib decreased the incidence of significant GI bleeding, obstructions, perforations and symptomatic ulcers by approximately 50 to 60 percent compared with the traditional NSAIDs ibuprofen, diclofenac and naproxen. 1502
While both celecoxib and rofecoxib have been associated with significant GI events including deaths,1,4,5 a reduction anywhere near 50 percent in the estimated 107,000 hospitalizations and 16,500 deaths annually thought to be caused by the gastropathy induced by chronic NSAID ingestion6 would represent a tremendous health care benefit. We agree that the findings of the CLASS and VIGOR trials,2,3 performed in a relatively healthy patient population with a mean age of 60 years, may not necessarily be applicable to patients at the highest risk of GI complications, including those with previous ulcers, those on concomitant anticoagulant therapy, those on other NSAIDs and those with advanced age. More research is needed to see if this safety advantage does in fact hold in an older, “more fragile” patient population. Paul Moore, D.M.D, Ph.D., M.P.H. Professor of Pharmacology Department of Public Health Dentistry University of Pittsburgh School of Dental Medicine Elliot V. Hersh, D.M.D., M.S., Ph.D. Associate Professor of Pharmacology and Director Pharmacology and Clinical Therapeutics University of Pennsylvania School of Dental Medicine Philadelphia 1. Weaver J, Bonnel RA, Karwoski CB, Brinker AD, Beitz J. Gastrointestinal events leading to death in association with celecoxib and rofecoxib. Am J Gastroenterol (in press). 2. Silverstein FE, Faich G, Goldstein JL, et al. Gastrointestinal toxicity with celecoxib vs. nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: the CLASS study: a randomized controlled trial. JAMA 2000;284(10):1247-55.
3. Bombardier C, Laine L, Reicin A, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med 2000;343(21):1520-8. 4. Arthritis Advisory Committee briefing information (Feb. 7, 2001). Available at: “www.fda.gov/ohrms/dockets/ac/01/ briefing/3677b1.htm”; click on the “doc” option for OPDRA postmarketing safety review— gastrointestinal. Accessed Aug. 1, 2001. 5. Arthritis Advisory Committee briefing information (Feb. 8, 2001). Available at: “www.fda.gov/ohrms/dockets/ac/01/ briefing/3677b2.htm”; click on the “doc” option for OPDRA postmarketing safety review— gastrointestinal. Accessed Aug. 1, 2001. 6. Singh G. Recent considerations in nonsteroidal anti-inflammatory drug gastropathy. Am J Med 1998;105(1B):S31-8.
FAREWELL, DR. MESKIN
I have enjoyed all 130 of Dr. Meskin’s editorials (“Pluses” July JADA). Congratulations and thanks for his work—a tribute to our profession. Frank Spalding, D.D.S. Peoria, Ill. I would like to say that the potential audience for JADA is much higher than Dr. Meskin thought in his editorial, “Pluses” (July JADA). I am an undergraduate senior and I have been reading JADA online since my summer vacation started. I and my friends who also wish to be dentists read JADA as a resource to prepare for our dental school admission test. I just want to say thank you for Dr. Meskin’s professional opinions on subjects that are new and fascinating to me. I learn so much by reading JADA. His dedicated service as editor is never going to be “a void.” Christopher Tiu Laie, Hawaii AIR-ABRASION TREATMENT
Dr. James Hamilton and colleagues reported on a 12-month
JADA, Vol. 132, November 2001 Copyright ©1998-2001 American Dental Association. All rights reserved.